chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain, Diarrhoea, Nausea, Palpitations, Pyrexia
Clinical narrative: Intractable nausea and vomiting with syncope needing ER visit as not remitting... from ER NOTE 10/1/2023                                              "Head Injury      Patient had shingles shot 4 days ago and was vomiting violently at home after the shot and she passed out and hit top of her head on a nightstand. Now she has a headache when she lays flat. 10/10 several nights ago. After sitting up she states pain becomes mild. She is concerned "for head bleed after I googled my symptoms".    54 year old female presents to the ER today with reports she got her shingles shot 4 days ago and shortly after she got home she developed nausea/vomiting. She reports that night she was in her bed and woke up to vomit in a bucket next to her bed. She reports when she leaned forward she fell out of the bed striking her head on her bedside table. She reports she passed out and woke up on the floor next to the bed. She reports LOC was brief. She reports since then she has had a persistent headache that is worse with change in position especially when she lays down flat. She reports the headache is a throbbing pressure like pain mostly to the left side of her head. She reports all of her vomiting resolved 3 days ago and she has been eating/drinking fine. Pt reports she has not tried anything for her headaches. She denies ETOH use, use of anticoagulant medications, neck pain, visual changes, confusion, numbness/weakness in extremities, focal deficits, rashes, chest pains, SOA, hx of headaches. " ARNP  Nurse Practitioner Emergency Medicine   ED Provider Notes    Attested   Date of Service: 10/1/2023 10:35 AM
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Tremor, Vomiting
Clinical narrative: Intractable nausea and vomiting with syncope needing ER visit as not remitting... from ER NOTE 10/1/2023                                              "Head Injury      Patient had shingles shot 4 days ago and was vomiting violently at home after the shot and she passed out and hit top of her head on a nightstand. Now she has a headache when she lays flat. 10/10 several nights ago. After sitting up she states pain becomes mild. She is concerned "for head bleed after I googled my symptoms".    54 year old female presents to the ER today with reports she got her shingles shot 4 days ago and shortly after she got home she developed nausea/vomiting. She reports that night she was in her bed and woke up to vomit in a bucket next to her bed. She reports when she leaned forward she fell out of the bed striking her head on her bedside table. She reports she passed out and woke up on the floor next to the bed. She reports LOC was brief. She reports since then she has had a persistent headache that is worse with change in position especially when she lays down flat. She reports the headache is a throbbing pressure like pain mostly to the left side of her head. She reports all of her vomiting resolved 3 days ago and she has been eating/drinking fine. Pt reports she has not tried anything for her headaches. She denies ETOH use, use of anticoagulant medications, neck pain, visual changes, confusion, numbness/weakness in extremities, focal deficits, rashes, chest pains, SOA, hx of headaches. " ARNP  Nurse Practitioner Emergency Medicine   ED Provider Notes    Attested   Date of Service: 10/1/2023 10:35 AM
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Computerised tomogram head normal, Fall, Head discomfort, Head injury, Headache
Clinical narrative: Intractable nausea and vomiting with syncope needing ER visit as not remitting... from ER NOTE 10/1/2023                                              "Head Injury      Patient had shingles shot 4 days ago and was vomiting violently at home after the shot and she passed out and hit top of her head on a nightstand. Now she has a headache when she lays flat. 10/10 several nights ago. After sitting up she states pain becomes mild. She is concerned "for head bleed after I googled my symptoms".    54 year old female presents to the ER today with reports she got her shingles shot 4 days ago and shortly after she got home she developed nausea/vomiting. She reports that night she was in her bed and woke up to vomit in a bucket next to her bed. She reports when she leaned forward she fell out of the bed striking her head on her bedside table. She reports she passed out and woke up on the floor next to the bed. She reports LOC was brief. She reports since then she has had a persistent headache that is worse with change in position especially when she lays down flat. She reports the headache is a throbbing pressure like pain mostly to the left side of her head. She reports all of her vomiting resolved 3 days ago and she has been eating/drinking fine. Pt reports she has not tried anything for her headaches. She denies ETOH use, use of anticoagulant medications, neck pain, visual changes, confusion, numbness/weakness in extremities, focal deficits, rashes, chest pains, SOA, hx of headaches. " ARNP  Nurse Practitioner Emergency Medicine   ED Provider Notes    Attested   Date of Service: 10/1/2023 10:35 AM
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Loss of consciousness, Nausea, Sleep disorder, Syncope, Vomiting
Clinical narrative: Intractable nausea and vomiting with syncope needing ER visit as not remitting... from ER NOTE 10/1/2023                                              "Head Injury      Patient had shingles shot 4 days ago and was vomiting violently at home after the shot and she passed out and hit top of her head on a nightstand. Now she has a headache when she lays flat. 10/10 several nights ago. After sitting up she states pain becomes mild. She is concerned "for head bleed after I googled my symptoms".    54 year old female presents to the ER today with reports she got her shingles shot 4 days ago and shortly after she got home she developed nausea/vomiting. She reports that night she was in her bed and woke up to vomit in a bucket next to her bed. She reports when she leaned forward she fell out of the bed striking her head on her bedside table. She reports she passed out and woke up on the floor next to the bed. She reports LOC was brief. She reports since then she has had a persistent headache that is worse with change in position especially when she lays down flat. She reports the headache is a throbbing pressure like pain mostly to the left side of her head. She reports all of her vomiting resolved 3 days ago and she has been eating/drinking fine. Pt reports she has not tried anything for her headaches. She denies ETOH use, use of anticoagulant medications, neck pain, visual changes, confusion, numbness/weakness in extremities, focal deficits, rashes, chest pains, SOA, hx of headaches. " ARNP  Nurse Practitioner Emergency Medicine   ED Provider Notes    Attested   Date of Service: 10/1/2023 10:35 AM
Age: 76.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Body temperature increased, Fatigue, Full blood count, Heart rate increased, Respiratory rate increased
Clinical narrative: Exhaustion; Vertigo; This non-serious case was reported by a consumer via call center representative and described the occurrence of exhaustion in a 76-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 21-NOV-2023, the patient received Arexvy (intramuscular, right arm). On 22-NOV-2023, 1 days after receiving Arexvy, the patient experienced exhaustion (Verbatim: Exhaustion) and vertigo (Verbatim: Vertigo). The outcome of the exhaustion and vertigo were not resolved.   It was unknown if the reporter considered the exhaustion and vertigo to be related to Arexvy.     It was unknown if the company considered the exhaustion and vertigo to be related to Arexvy.   Additional Information: GSK Receipt Date: 26-DEC-2023 The reporter was the patient who stated she received Arexvy vaccine and next morning started to experience vertigo and exhaustion. Now the symptoms have been going on for 4 weeks and that had not gone away. The patient reported that the symptoms were not that severe today (at the day of reporting) but she was still having the symptoms and she was concerned about it. The patient wants to know if this was a reaction to the vaccine or some other problem. The patient did not provide date of birth, lot number or expiration date of product.  The patient provided the name, address and contact number for follow-up.  The reporter consented to follow up. This case was found as duplicate of case US2023180136. All the information from the case US2023180136 was merged into this case. The case US2023180136 was deleted and this case stand as case of record for this patient.
Age: 76.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Vertigo
Clinical narrative: Exhaustion; Vertigo; This non-serious case was reported by a consumer via call center representative and described the occurrence of exhaustion in a 76-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 21-NOV-2023, the patient received Arexvy (intramuscular, right arm). On 22-NOV-2023, 1 days after receiving Arexvy, the patient experienced exhaustion (Verbatim: Exhaustion) and vertigo (Verbatim: Vertigo). The outcome of the exhaustion and vertigo were not resolved.   It was unknown if the reporter considered the exhaustion and vertigo to be related to Arexvy.     It was unknown if the company considered the exhaustion and vertigo to be related to Arexvy.   Additional Information: GSK Receipt Date: 26-DEC-2023 The reporter was the patient who stated she received Arexvy vaccine and next morning started to experience vertigo and exhaustion. Now the symptoms have been going on for 4 weeks and that had not gone away. The patient reported that the symptoms were not that severe today (at the day of reporting) but she was still having the symptoms and she was concerned about it. The patient wants to know if this was a reaction to the vaccine or some other problem. The patient did not provide date of birth, lot number or expiration date of product.  The patient provided the name, address and contact number for follow-up.  The reporter consented to follow up. This case was found as duplicate of case US2023180136. All the information from the case US2023180136 was merged into this case. The case US2023180136 was deleted and this case stand as case of record for this patient.
Age: 76.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Fatigue, Vertigo
Clinical narrative: Exhaustion; Vertigo; This non-serious case was reported by a consumer via call center representative and described the occurrence of exhaustion in a 76-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 21-NOV-2023, the patient received Arexvy (intramuscular, right arm). On 22-NOV-2023, 1 days after receiving Arexvy, the patient experienced exhaustion (Verbatim: Exhaustion) and vertigo (Verbatim: Vertigo). The outcome of the exhaustion and vertigo were not resolved.   It was unknown if the reporter considered the exhaustion and vertigo to be related to Arexvy.     It was unknown if the company considered the exhaustion and vertigo to be related to Arexvy.   Additional Information: GSK Receipt Date: 26-DEC-2023 The reporter was the patient who stated she received Arexvy vaccine and next morning started to experience vertigo and exhaustion. Now the symptoms have been going on for 4 weeks and that had not gone away. The patient reported that the symptoms were not that severe today (at the day of reporting) but she was still having the symptoms and she was concerned about it. The patient wants to know if this was a reaction to the vaccine or some other problem. The patient did not provide date of birth, lot number or expiration date of product.  The patient provided the name, address and contact number for follow-up.  The reporter consented to follow up. This case was found as duplicate of case US2023180136. All the information from the case US2023180136 was merged into this case. The case US2023180136 was deleted and this case stand as case of record for this patient.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Chest X-ray, Drug ineffective, Full blood count, Interchange of vaccine products
Clinical narrative: He had two Moderna (Suspect captured as unspecified Vaccine) and the next booster he got, was the Pfizer; He was black and blue from his neck to his elbow; This is a spontaneous report received from a Consumer or other non HCP, Program ID: 200250.  An 84-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (DOSE 1, SINGLE), for COVID-19 immunisation; Moderna (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "He had two Moderna (Suspect captured as unspecified Vaccine) and the next booster he got, was the Pfizer"; SKIN DISCOLOURATION (non-serious), outcome "unknown", described as "He was black and blue from his neck to his elbow". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of skin discolouration.  Additional information: Reporter said Pfizer shot that patient got for the COVID, he was black and blue from his neck to his elbow. It was quite impressive but that time they were asking about the side effects so anyway. it was the booster shot that he took. Reporter stated, He had two Moderna and the next booster he got, was the Pfizer. No treatment just took take care.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300454410 same patient, same product, different events;
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Metabolic function test, SARS-CoV-2 test
Clinical narrative: He had two Moderna (Suspect captured as unspecified Vaccine) and the next booster he got, was the Pfizer; He was black and blue from his neck to his elbow; This is a spontaneous report received from a Consumer or other non HCP, Program ID: 200250.  An 84-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (DOSE 1, SINGLE), for COVID-19 immunisation; Moderna (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "He had two Moderna (Suspect captured as unspecified Vaccine) and the next booster he got, was the Pfizer"; SKIN DISCOLOURATION (non-serious), outcome "unknown", described as "He was black and blue from his neck to his elbow". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of skin discolouration.  Additional information: Reporter said Pfizer shot that patient got for the COVID, he was black and blue from his neck to his elbow. It was quite impressive but that time they were asking about the side effects so anyway. it was the booster shot that he took. Reporter stated, He had two Moderna and the next booster he got, was the Pfizer. No treatment just took take care.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300454410 same patient, same product, different events;
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Full blood count, Interchange of vaccine products, Metabolic function test, Skin discolouration
Clinical narrative: He had two Moderna (Suspect captured as unspecified Vaccine) and the next booster he got, was the Pfizer; He was black and blue from his neck to his elbow; This is a spontaneous report received from a Consumer or other non HCP, Program ID: 200250.  An 84-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (DOSE 1, SINGLE), for COVID-19 immunisation; Moderna (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "He had two Moderna (Suspect captured as unspecified Vaccine) and the next booster he got, was the Pfizer"; SKIN DISCOLOURATION (non-serious), outcome "unknown", described as "He was black and blue from his neck to his elbow". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of skin discolouration.  Additional information: Reporter said Pfizer shot that patient got for the COVID, he was black and blue from his neck to his elbow. It was quite impressive but that time they were asking about the side effects so anyway. it was the booster shot that he took. Reporter stated, He had two Moderna and the next booster he got, was the Pfizer. No treatment just took take care.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300454410 same patient, same product, different events;
Age: 2.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: they have not received any reports of adverse reactions from the patient; a 2-year-old patient was inadvertently administered a dose of GARDASIL 9 today, 12-DEC-2023, during a routine vaccination appointment.; This spontaneous report was received from an office manager referring to a 2-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.  On 12-DEC-2023, the patient was inadvertently vaccinated with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (lot number and expiration date were unknown), 0.5 mL, administered by a health professional for prophylaxis, during a routine vaccination appointment (concentration and route of administration were not reported) (product administered to patient of inappropriate age). The reporter confirmed that they had not received any reports of adverse reactions from the patient (no adverse event). No additional information was provided.
Age: 44.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE/PQC; A 44-year-old patient received GARDASIL 9 on 07-SEP-2023 and 29-SEP-2023; This spontaneous report was received from a pharmacy technician referring to a 44-year-old female patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.  On 27-JUN-2023, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (lot number and expiration date were unknown), administered by a health professional for prophylaxis (concentration, dose and route of administration were not reported). On 07-SEP-2023, the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (lot number and expiration date were unknown), administered by a health professional (concentration, dose and route of administration were not reported).  On 29-SEP-2023, the patient was inadvertently vaccinated with the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (lot number and expiration date were unknown), administered by a health professional (concentration, dose and route of administration were not reported) (inappropriate schedule of product administration). No additional adverse event (AE) or product quality complaint (PQC) was reported.
Age: 76.0
Sex: M
Vaccine: TDAP
Symptoms: Incorrect dose administered
Clinical narrative: male patient received 2 doses of Tdap on the same day; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 76-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number NRSDX, expiry date 02-FEB-2026) for prophylaxis.   Concomitant products included Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Tdap).   On 04-DEC-2023, the patient received the 2nd dose of Boostrix. On 04-DEC-2023, an unknown time after receiving Boostrix, the patient experienced overdose (Verbatim: male patient received 2 doses of Tdap on the same day). The outcome of the overdose was unknown.   This report is made by RA without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: RA Receipt Date: 20-DEC-2023 The reporter mentioned that, it came to the reporter's attention today (on the day of reporting), that a male patient received 2 doses of Tdap on the same day, which led to overdose. The first dose was of Tdap (unspecified manufacturer) was given at the patient's doctor's office.  The second dose of Tdap was given at the pharmacy (Boostrix). The reporter states that the patient had not experienced untoward effects. The reporter consented to follow up.
Age: 23.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Injected limb mobility decreased, Laboratory test, Pain in extremity, Pyrexia
Clinical narrative: fever, vomiting, severe left arm pain to the point where arm is immobile and needed to go to ER, weakness
Age: 23.0
Sex: F
Vaccine: UNK
Symptoms: Vomiting
Clinical narrative: fever, vomiting, severe left arm pain to the point where arm is immobile and needed to go to ER, weakness
Age: 35.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cognitive disorder, Fatigue, Lethargy, Menstrual disorder, Vision blurred
Clinical narrative: Same day after vaccine I felt extremely tired, and the  lethargy has never gone away.  I am almost always tired now, and have a hard time staring at screens or books for a long period of time without my eyes going blurry and me falling asleep.  Additionally I find my imagination has been affected a little, in that I am not having as easy of a time being imaginative.  I have also felt as if my heart rate were affected in that it will sometimes beat much more strongly than normal, although that symptom is come and go, whereas the lethargy has been going on for about 3 months now.  Please help if you can or know of any resources.  Added side effects include a more watery menstral cycle.  This lethargy is disturbing and persistent and occured after the vaccination and hasn't gone away.   Thanks!  (Also, I don't know the dose number in the series, this was just a booster this October, but I had the j&j 4/21, moderna 11/21, and pfizer 10/22.  Thanks.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired dose given to patient. No adverse reaction.
Age: 28.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood test normal, Chest X-ray normal, Chest pain, Costochondritis, Electrocardiogram normal
Clinical narrative: Chest pain diagnosed as Chostocondritis. Has been consistent ever since the vaccine
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Alanine aminotransferase increased, Aspartate aminotransferase, Aspartate aminotransferase increased, Blood alkaline phosphatase
Clinical narrative: Alkaline Phosphate had gone up to 91 to 188 (upper normal range for our system is 100.; elevation of SGOT and SGPT; elevation of SGOT and SGPT; This spontaneous case was reported by a nurse and describes the occurrence of BLOOD ALKALINE PHOSPHATASE INCREASED (Alkaline Phosphate had gone up to 91 to 188 (upper normal range for our system is 100.), ALANINE AMINOTRANSFERASE INCREASED (elevation of SGOT and SGPT) and ASPARTATE AMINOTRANSFERASE INCREASED (elevation of SGOT and SGPT) in a 61-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concurrent medical conditions included Metastatic breast cancer (Immunotherapy). Concomitant products included ATEZOLIZUMAB (TECENTRIQ) for Metastatic breast cancer, ATORVASTATIN CALCIUM (LIPITOR) and PARACETAMOL (TYLENOL) for an unknown indication.    On 15-Nov-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In November 2023, the patient experienced BLOOD ALKALINE PHOSPHATASE INCREASED (Alkaline Phosphate had gone up to 91 to 188 (upper normal range for our system is 100.), ALANINE AMINOTRANSFERASE INCREASED (elevation of SGOT and SGPT) and ASPARTATE AMINOTRANSFERASE INCREASED (elevation of SGOT and SGPT). At the time of the report, BLOOD ALKALINE PHOSPHATASE INCREASED (Alkaline Phosphate had gone up to 91 to 188 (upper normal range for our system is 100.), ALANINE AMINOTRANSFERASE INCREASED (elevation of SGOT and SGPT) and ASPARTATE AMINOTRANSFERASE INCREASED (elevation of SGOT and SGPT) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2023, Alanine aminotransferase: elevation of SGPT. In November 2023, Aspartate aminotransferase: elevation of SGOT. On 19-Dec-2023, Alanine aminotransferase: ALT went from 32 to 84 (upper normal range for our system is 33 ). On 19-Dec-2023, Aspartate aminotransferase: The AST went from 31 to 68 it was 10 before that and was always normal ( upper normal range for our system is 32 ). On 19-Dec-2023, Blood alkaline phosphatase: Alkaline Phosphate had gone up to 91 to 188 (upper normal range for our system is 100.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The nurse was reporting for herself. The patient had received dose 4 on 16Nov2022, batch- 015H22A and dose 5 on 24Jun2023, batch-AS7184B. It was unknown whether the patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The dosage text was reported as unknown. The patient had a CT was on 11Nov2023, result not reported. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-754625 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood alkaline phosphatase increased
Clinical narrative: Alkaline Phosphate had gone up to 91 to 188 (upper normal range for our system is 100.; elevation of SGOT and SGPT; elevation of SGOT and SGPT; This spontaneous case was reported by a nurse and describes the occurrence of BLOOD ALKALINE PHOSPHATASE INCREASED (Alkaline Phosphate had gone up to 91 to 188 (upper normal range for our system is 100.), ALANINE AMINOTRANSFERASE INCREASED (elevation of SGOT and SGPT) and ASPARTATE AMINOTRANSFERASE INCREASED (elevation of SGOT and SGPT) in a 61-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concurrent medical conditions included Metastatic breast cancer (Immunotherapy). Concomitant products included ATEZOLIZUMAB (TECENTRIQ) for Metastatic breast cancer, ATORVASTATIN CALCIUM (LIPITOR) and PARACETAMOL (TYLENOL) for an unknown indication.    On 15-Nov-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In November 2023, the patient experienced BLOOD ALKALINE PHOSPHATASE INCREASED (Alkaline Phosphate had gone up to 91 to 188 (upper normal range for our system is 100.), ALANINE AMINOTRANSFERASE INCREASED (elevation of SGOT and SGPT) and ASPARTATE AMINOTRANSFERASE INCREASED (elevation of SGOT and SGPT). At the time of the report, BLOOD ALKALINE PHOSPHATASE INCREASED (Alkaline Phosphate had gone up to 91 to 188 (upper normal range for our system is 100.), ALANINE AMINOTRANSFERASE INCREASED (elevation of SGOT and SGPT) and ASPARTATE AMINOTRANSFERASE INCREASED (elevation of SGOT and SGPT) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2023, Alanine aminotransferase: elevation of SGPT. In November 2023, Aspartate aminotransferase: elevation of SGOT. On 19-Dec-2023, Alanine aminotransferase: ALT went from 32 to 84 (upper normal range for our system is 33 ). On 19-Dec-2023, Aspartate aminotransferase: The AST went from 31 to 68 it was 10 before that and was always normal ( upper normal range for our system is 32 ). On 19-Dec-2023, Blood alkaline phosphatase: Alkaline Phosphate had gone up to 91 to 188 (upper normal range for our system is 100.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The nurse was reporting for herself. The patient had received dose 4 on 16Nov2022, batch- 015H22A and dose 5 on 24Jun2023, batch-AS7184B. It was unknown whether the patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The dosage text was reported as unknown. The patient had a CT was on 11Nov2023, result not reported. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-754625 (Patient Link).
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Extra dose administered, Pain
Clinical narrative: localized pain; pregnant patient who was accidentally given ADACEL (extra dose) within 21 days; pregnant patient who was accidentally given ADACEL (extra dose) within 21 days; Initial information received from RA on 22-Dec-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 35 years old pregnant female patient who was accidentally given diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] (extra dose) within 21 days and experienced localized pain.   The gestation period at onset was not reported. The date of last menstrual period was not reported. The estimated due date was not reported. The actual date of delivery was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancies.   On 01-Dec-2023, the patient received a dose of 0.5 ml (dose 1) of suspect diphtheria-2/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot number; strength; expiry date not reported) via intramuscular route in unknown administration site for Immunization. On 21-Dec-2023 she also received a dose 2 of the same vaccine (with an unknown batch number; strength; expiry date) via intramuscular route in the left arm for Immunization. Information regarding batch number pertaining to both doses of adacel will be requested in this case.  On 21-Dec-2023 the pregnant patient who was accidentally given adacel (extra dose) within 21 days (exposure during pregnancy) (extra dose administered) (latency: same day). On an unknown date the patient developed localized pain (pain) (unknown latency).  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (localized pain).  At time of reporting, the outcome was Unknown for the event localized pain.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Herpes simplex, Pain
Clinical narrative: HSV2 outbreak after 10 years without, severe headache, body ache.  Two days so far.  Bed rest.
Age: 1.33
Sex: M
Vaccine: RV5
Symptoms: Product administered to patient of inappropriate age, Product administration error
Clinical narrative: Administration error, patient was not supposed to receive vaccine, too old
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RVX
Symptoms: Pyrexia
Clinical narrative: Pt came in to receive 4 month well child vaccines. Vaxelis (Dtap, IPV, Hib, Hep B)- RVL Pneumococcal 20-RVL RSV (Beyfortus 100mg/ml)- LVL rotavirus- orally Patient mother called today stating patient has fever of 103. Made appt to be seen in the afternoon. Patient mother called back few hours later with child having temp of 105. Now under instruction to take child to Hospital Emergency Department.
Sex: M
Vaccine: COVID19, RSV
Symptoms: Blood test normal, Cardiac monitoring normal, Computerised tomogram normal, Electrocardiogram normal, Loss of consciousness
Clinical narrative: Loss of consciousness (3x) over 5 minute period on the morning of 24 OCT 23.  EMS call. Ambulance to ER. EKG, Blood work and contrast CAT scan all normal. Released. No issues since.
Sex: M
Vaccine: COVID19, RSV
Symptoms: Magnetic resonance imaging normal, Scan with contrast normal
Clinical narrative: Loss of consciousness (3x) over 5 minute period on the morning of 24 OCT 23.  EMS call. Ambulance to ER. EKG, Blood work and contrast CAT scan all normal. Released. No issues since.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Error occurred in outpatient clinic. 2-year-old was behind on shots. Varicella was given instead of Vaxelis vaccine. Both start with Va and wrong order was placed. It was patient was not due for varicella with 2 person verification. No harm to patient; confirmed with CDC and manufacturer that Varicella dose given early counts; so patient in the future. Patient will return for other vaccine.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Blood pressure decreased, Hyperhidrosis, Syncope, Unresponsive to stimuli
Clinical narrative: After 10 minutes of receiving the shot, patient became unresponsive, faint, and sweating while still breathing; After medical help arrived, pt was conscious and blood pressure was check which was very low.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pain, redness, swelling and intense itching at the site of vaccine.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient was administered a second influenza vaccine
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of frigerated
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cognitive disorder, Decreased appetite, Depression, Dyspnoea, Fatigue
Clinical narrative: Patient reported: acute depression, impaired decision making, extremely sore arm, headache, body ache, fever, stiffness, fatigue, apatite loss, profuse sweating, and labored breathing.
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Hyperhidrosis, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: Patient reported: acute depression, impaired decision making, extremely sore arm, headache, body ache, fever, stiffness, fatigue, apatite loss, profuse sweating, and labored breathing.
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia
Clinical narrative: Patient reported: acute depression, impaired decision making, extremely sore arm, headache, body ache, fever, stiffness, fatigue, apatite loss, profuse sweating, and labored breathing.
Age: 30.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Injection site erythema, Injection site pruritus
Clinical narrative: Patient 35 weeks pregnant. EDD 1/11/2024.  Pruritis and erythema at site of injection
Age: 54.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cognitive disorder, Decreased appetite, Depression, Dyspnoea, Fatigue
Clinical narrative: Acute Depression, Sore Arm, Headache, Impaired decision making, stiffness, fatigue, apatite loss, extreme sweating, labored breathing.
Age: 54.0
Sex: M
Vaccine: COVID19-2
Symptoms: Headache, Hyperhidrosis, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Acute Depression, Sore Arm, Headache, Impaired decision making, stiffness, fatigue, apatite loss, extreme sweating, labored breathing.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, C-reactive protein, Cardiac monitoring, Chest pain, Costochondritis
Clinical narrative: A few hours after getting one Pfizer vaccine I was sitting on my deck and I felt my heart do a flip flop. The same thing happened the next day while taking a bath. On Day 7 I woke up to my heart NON stop pounding out of my chest, this continues for 6 weeks. I also had crippling anxiety (I do not have anxiety), panic attack, chest pain, constrochonditis, tachycardia, POTS upon standing my resting heart rate was 105, high blood pressure, head pressure, dizziness, PVC's, PAC's, SVT, VT (I wore a heart monitor twice for4 days and 7-8 days). This is my second time filling out VAERS and NOBODY ever contacted me the first time. It's 2 1/2 years later and I am still dealing with some heart issues. I regret taking one vaccine and my doctor told me not to take anymore. She updated my chart that I had an adverse reaction to mRNA Pfizer vaccine. My healthy brother died after three Pfizer vaccines and we share some of the same DNA. I am lucky to have stopped at one but one vaccine has ruined my health and life. I can no longer drink coffee, if I do I feel weird heart beats and I was always able to drink coffee. One cardiologist thought I could have had pericarditis. I work out daily my entire life and I was 100% healthy before taking one vaccine. I hope that you will not ignore this report. The vaccine injured should NOT be ignored. We did nothing wrong by taking a vaccine and sadly doctors do NOT want to help us. They continue to gas light us and it's sad. I am hoping to hear back from you. Thank you.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Echocardiogram, Electrocardiogram, Extrasystoles, Head discomfort
Clinical narrative: A few hours after getting one Pfizer vaccine I was sitting on my deck and I felt my heart do a flip flop. The same thing happened the next day while taking a bath. On Day 7 I woke up to my heart NON stop pounding out of my chest, this continues for 6 weeks. I also had crippling anxiety (I do not have anxiety), panic attack, chest pain, constrochonditis, tachycardia, POTS upon standing my resting heart rate was 105, high blood pressure, head pressure, dizziness, PVC's, PAC's, SVT, VT (I wore a heart monitor twice for4 days and 7-8 days). This is my second time filling out VAERS and NOBODY ever contacted me the first time. It's 2 1/2 years later and I am still dealing with some heart issues. I regret taking one vaccine and my doctor told me not to take anymore. She updated my chart that I had an adverse reaction to mRNA Pfizer vaccine. My healthy brother died after three Pfizer vaccines and we share some of the same DNA. I am lucky to have stopped at one but one vaccine has ruined my health and life. I can no longer drink coffee, if I do I feel weird heart beats and I was always able to drink coffee. One cardiologist thought I could have had pericarditis. I work out daily my entire life and I was 100% healthy before taking one vaccine. I hope that you will not ignore this report. The vaccine injured should NOT be ignored. We did nothing wrong by taking a vaccine and sadly doctors do NOT want to help us. They continue to gas light us and it's sad. I am hoping to hear back from you. Thank you.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Immunisation reaction, Lipids, Palpitations, Panic attack
Clinical narrative: A few hours after getting one Pfizer vaccine I was sitting on my deck and I felt my heart do a flip flop. The same thing happened the next day while taking a bath. On Day 7 I woke up to my heart NON stop pounding out of my chest, this continues for 6 weeks. I also had crippling anxiety (I do not have anxiety), panic attack, chest pain, constrochonditis, tachycardia, POTS upon standing my resting heart rate was 105, high blood pressure, head pressure, dizziness, PVC's, PAC's, SVT, VT (I wore a heart monitor twice for4 days and 7-8 days). This is my second time filling out VAERS and NOBODY ever contacted me the first time. It's 2 1/2 years later and I am still dealing with some heart issues. I regret taking one vaccine and my doctor told me not to take anymore. She updated my chart that I had an adverse reaction to mRNA Pfizer vaccine. My healthy brother died after three Pfizer vaccines and we share some of the same DNA. I am lucky to have stopped at one but one vaccine has ruined my health and life. I can no longer drink coffee, if I do I feel weird heart beats and I was always able to drink coffee. One cardiologist thought I could have had pericarditis. I work out daily my entire life and I was 100% healthy before taking one vaccine. I hope that you will not ignore this report. The vaccine injured should NOT be ignored. We did nothing wrong by taking a vaccine and sadly doctors do NOT want to help us. They continue to gas light us and it's sad. I am hoping to hear back from you. Thank you.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Postural orthostatic tachycardia syndrome, Supraventricular extrasystoles, Supraventricular tachycardia, Tachycardia, Ventricular extrasystoles
Clinical narrative: A few hours after getting one Pfizer vaccine I was sitting on my deck and I felt my heart do a flip flop. The same thing happened the next day while taking a bath. On Day 7 I woke up to my heart NON stop pounding out of my chest, this continues for 6 weeks. I also had crippling anxiety (I do not have anxiety), panic attack, chest pain, constrochonditis, tachycardia, POTS upon standing my resting heart rate was 105, high blood pressure, head pressure, dizziness, PVC's, PAC's, SVT, VT (I wore a heart monitor twice for4 days and 7-8 days). This is my second time filling out VAERS and NOBODY ever contacted me the first time. It's 2 1/2 years later and I am still dealing with some heart issues. I regret taking one vaccine and my doctor told me not to take anymore. She updated my chart that I had an adverse reaction to mRNA Pfizer vaccine. My healthy brother died after three Pfizer vaccines and we share some of the same DNA. I am lucky to have stopped at one but one vaccine has ruined my health and life. I can no longer drink coffee, if I do I feel weird heart beats and I was always able to drink coffee. One cardiologist thought I could have had pericarditis. I work out daily my entire life and I was 100% healthy before taking one vaccine. I hope that you will not ignore this report. The vaccine injured should NOT be ignored. We did nothing wrong by taking a vaccine and sadly doctors do NOT want to help us. They continue to gas light us and it's sad. I am hoping to hear back from you. Thank you.
Age: 29.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity, Tenderness
Clinical narrative: Patient had near immediate onset of right arm pain with radiation to hand.  Pain has persisted now for 7 weeks.  She is increasingly unable to use the arm -- cannot internally rotate shoulder or lift arm above her head.  Tender to palpation over supraspinatus tendon
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Cyanosis, Dyspnoea, Stridor
Clinical narrative: Mother described that she had sudden shortness of breath and upper airway stridor in the evening after the vaccine.  Did not lose consciousness but had cyanosis and appeared to be struggling to breathe.  EMS called.  Eventually after a few minutes (after EMS arrived) she was able to relax and began to breathe normally again.  Did not have croup symptoms before or after.  No subsequent fevers or other symptoms of illness.  Appears to be an isolated event.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Asthenia, Benign prostatic hyperplasia, Brain natriuretic peptide normal, COVID-19
Clinical narrative: Patient is a 63 y.o. male patient of MD with history of severe COPD, chronic respiratory failure on 6 L of oxygen at home, hypertension, anxiety, depression, BPH, cachexia, history of tobacco use presented on 11/9/2023 with shortness of breath. Patient found to be in acute exacerbation of COPD as well as have COVID.   Acute on chronic hypoxic respiratory failure Acute exacerbation of COPD History of severe COPD Patient with history of severe COPD presented with shortness of breath, tested positive with COVID-19 History of chronic respiratory failure on 6 L of oxygen, requiring BiPAP in the ER. Patient on breztri and albuterol inhalers at home  Patient initially admitted to ICU, however was weaned down to 6 L while in the ER and was deemed to be stepdown appropriate where he stayed until discharge  Initial CBC unremarkable, lactic acidosis 2.8, troponin and BNP within normal range Blood cultures 11/9: NGTD In the ER received azithromycin and ceftriaxone CXR with severe bullous emphysema, new hazy and patchy right basilar density suspicious for infiltrate/pneumonia Treated with azithromycin, steroids, and treatment of COVID as below.  Home inhalers, breathing treatments continued at discharge.    Covid-19 Virus Infection Date of onset of symptoms: 2 weeks prior to admission  Symptoms present on admission: Shortness of breath, cough, fatigue, generalized weakness Date of covid positive test: 11/9/23 Vaccination status: vaccinated, no booster Imaging: CXR?severe bullous emphysema.  New hazy and patchy right basilar density suspicious for infiltrate/pneumonia. Oxygen requirements on admission: BIPAP Oxygen requirements on discharge: 6L nasal cannula (baseline) Medical therapy: remdesivir, steroids, azithromycin, tocilizumab  Procal negative  Patient stable on home O2 requirements x48 hours prior to discharge    Hypertension Home carvedilol restarted at time of discharge   Anxiety/Depression Continued citalopram  BPH Continued Flomax    Cachexia In setting of severe COPD BMI 14.2 Dietitian consulted and followed during admission; received Boost BID in addition to meals
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray abnormal, Chronic obstructive pulmonary disease, Condition aggravated, Cough, Depression
Clinical narrative: Patient is a 63 y.o. male patient of MD with history of severe COPD, chronic respiratory failure on 6 L of oxygen at home, hypertension, anxiety, depression, BPH, cachexia, history of tobacco use presented on 11/9/2023 with shortness of breath. Patient found to be in acute exacerbation of COPD as well as have COVID.   Acute on chronic hypoxic respiratory failure Acute exacerbation of COPD History of severe COPD Patient with history of severe COPD presented with shortness of breath, tested positive with COVID-19 History of chronic respiratory failure on 6 L of oxygen, requiring BiPAP in the ER. Patient on breztri and albuterol inhalers at home  Patient initially admitted to ICU, however was weaned down to 6 L while in the ER and was deemed to be stepdown appropriate where he stayed until discharge  Initial CBC unremarkable, lactic acidosis 2.8, troponin and BNP within normal range Blood cultures 11/9: NGTD In the ER received azithromycin and ceftriaxone CXR with severe bullous emphysema, new hazy and patchy right basilar density suspicious for infiltrate/pneumonia Treated with azithromycin, steroids, and treatment of COVID as below.  Home inhalers, breathing treatments continued at discharge.    Covid-19 Virus Infection Date of onset of symptoms: 2 weeks prior to admission  Symptoms present on admission: Shortness of breath, cough, fatigue, generalized weakness Date of covid positive test: 11/9/23 Vaccination status: vaccinated, no booster Imaging: CXR?severe bullous emphysema.  New hazy and patchy right basilar density suspicious for infiltrate/pneumonia. Oxygen requirements on admission: BIPAP Oxygen requirements on discharge: 6L nasal cannula (baseline) Medical therapy: remdesivir, steroids, azithromycin, tocilizumab  Procal negative  Patient stable on home O2 requirements x48 hours prior to discharge    Hypertension Home carvedilol restarted at time of discharge   Anxiety/Depression Continued citalopram  BPH Continued Flomax    Cachexia In setting of severe COPD BMI 14.2 Dietitian consulted and followed during admission; received Boost BID in addition to meals