chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Arthralgia, Chills, Dyspnoea, Laboratory test
Clinical narrative: Chills, arthralgia, SOB
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Apathy, Brain fog
Clinical narrative: brain fog; lack of motivation; This is a spontaneous report received from a Consumer or other non HCP from License Party.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Lot number: EN6200) at the age of 55 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BRAIN FOG (non-serious), outcome "unknown"; APATHY (non-serious), outcome "unknown", described as "lack of motivation". Clinical course: There Were complications that aroused from receiving this vaccine, such as brain fog and the lack of motivation and the virus kept mutating.  BNT162B2 is under agreement with BIONTECH SE.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300450887 same patient, different dose/event;US-PFIZER INC-202400067915 same patient, different dose/event;US-PFIZER INC-202400068366 same patient, different dose/event;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Lethargy, Pain in extremity, Pyrexia
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 71-year-old patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "mild asthma" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical course: The patient recently tested positive for COVID. The patient called the doctor to get Paxlovid and the "triage" nurse said the patient could get blood clots in legs & lungs from Paxlovid The patient don't take any medications besides OTC Zyrtec & have mild asthma which the patient does not take meds for. The nurse claimed that the patient probably got COVID from the recent Pfizer covid vaccine.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400035110 Same reporter,patient, different event and vaccine dose;US-PFIZER INC-202300335763 Same reporter,patient, different event and vaccine dose;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 71-year-old patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "mild asthma" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical course: The patient recently tested positive for COVID. The patient called the doctor to get Paxlovid and the "triage" nurse said the patient could get blood clots in legs & lungs from Paxlovid The patient don't take any medications besides OTC Zyrtec & have mild asthma which the patient does not take meds for. The nurse claimed that the patient probably got COVID from the recent Pfizer covid vaccine.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400035110 Same reporter,patient, different event and vaccine dose;US-PFIZER INC-202300335763 Same reporter,patient, different event and vaccine dose;
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Feeling abnormal, Injection site urticaria, Pain, Pyrexia, Rash
Clinical narrative: The patient identified 3 nodules the day after the vaccine about 1 inch below the site of injection. 2-3 weeks after the vaccination, the patient contacted their doctor when the nodules remained and were increasing in pressure. She had a nodule biopsied and pathology diagnosed it as a renal cell carcinoma metastasis. The patient was diagnosed with renal cell carcinoma in 2016. She also has renal cell carcinoma metastases in the soft tissues of her buttocks.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: The patient identified 3 nodules the day after the vaccine about 1 inch below the site of injection. 2-3 weeks after the vaccination, the patient contacted their doctor when the nodules remained and were increasing in pressure. She had a nodule biopsied and pathology diagnosed it as a renal cell carcinoma metastasis. The patient was diagnosed with renal cell carcinoma in 2016. She also has renal cell carcinoma metastases in the soft tissues of her buttocks.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Condition aggravated, Injection site nodule, Metastatic renal cell carcinoma
Clinical narrative: The patient identified 3 nodules the day after the vaccine about 1 inch below the site of injection. 2-3 weeks after the vaccination, the patient contacted their doctor when the nodules remained and were increasing in pressure. She had a nodule biopsied and pathology diagnosed it as a renal cell carcinoma metastasis. The patient was diagnosed with renal cell carcinoma in 2016. She also has renal cell carcinoma metastases in the soft tissues of her buttocks.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Biopsy skin abnormal, Condition aggravated, Injection site erythema, Injection site haematoma, Injection site rash
Clinical narrative: The patient identified 3 nodules the day after the vaccine about 1 inch below the site of injection. 2-3 weeks after the vaccination, the patient contacted their doctor when the nodules remained and were increasing in pressure. She had a nodule biopsied and pathology diagnosed it as a renal cell carcinoma metastasis. The patient was diagnosed with renal cell carcinoma in 2016. She also has renal cell carcinoma metastases in the soft tissues of her buttocks.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site reaction, Metastasis, Renal cancer metastatic, Swelling, Ultrasound scan abnormal
Clinical narrative: The patient identified 3 nodules the day after the vaccine about 1 inch below the site of injection. 2-3 weeks after the vaccination, the patient contacted their doctor when the nodules remained and were increasing in pressure. She had a nodule biopsied and pathology diagnosed it as a renal cell carcinoma metastasis. The patient was diagnosed with renal cell carcinoma in 2016. She also has renal cell carcinoma metastases in the soft tissues of her buttocks.
Sex: U
Vaccine: MMR, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No side effects or symptoms reported; Pharmacist called to report MMR II, which expired on 03/01/2024, was inadvertently administered to a patient on 3/20/2024.  Provided information per Post Expiry Memo.  Pharmacist granted permission to follow up, No side effects or symptoms reported.; This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 20-MAR-2024, the patient was inadvertently vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant Human albumin) (M-M-R II), formulation: injection, lot # W007181, expiration date: 01-MAR-2024 (exact dose, route of administration and anatomical location were not provided) for prophylaxis (expired product administered). No side effects or symptoms reported (no adverse event).
Age: 76.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Eye pain, Eye swelling, Photosensitivity reaction
Clinical narrative: My eye started watering that night. I looked to see if there was something in there. It started getting painful in a dull way and then sharp pain. The next morning I could not open my eye due to extreme light sensitivity. Any light at all was excruciating! I called my opthamologist and it was a saturday so i got the on call doctor and he numbed my eye and dilated it to look at the optic nerve. He said my eye was swollen on the inside membranes which is what was causing all the pain. He also stated that it was an adverse reaction to the RSV vaccine i had the day before. Today, 5 days later, my vision is cloudy and my depth perception is off. Its hard to read. everything is foggy. I dont normally wear glasses so this is all very new. It seems to be gradually going away. My eye also feels very heavy. I dont know how to describe it completely but it doesnt look swollen at all.
Age: 76.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Altered visual depth perception, Asthenopia, Eye pain, Eye swelling, Lacrimation increased
Clinical narrative: My eye started watering that night. I looked to see if there was something in there. It started getting painful in a dull way and then sharp pain. The next morning I could not open my eye due to extreme light sensitivity. Any light at all was excruciating! I called my opthamologist and it was a saturday so i got the on call doctor and he numbed my eye and dilated it to look at the optic nerve. He said my eye was swollen on the inside membranes which is what was causing all the pain. He also stated that it was an adverse reaction to the RSV vaccine i had the day before. Today, 5 days later, my vision is cloudy and my depth perception is off. Its hard to read. everything is foggy. I dont normally wear glasses so this is all very new. It seems to be gradually going away. My eye also feels very heavy. I dont know how to describe it completely but it doesnt look swollen at all.
Age: 76.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Ophthalmological examination abnormal, Photophobia, Vision blurred
Clinical narrative: My eye started watering that night. I looked to see if there was something in there. It started getting painful in a dull way and then sharp pain. The next morning I could not open my eye due to extreme light sensitivity. Any light at all was excruciating! I called my opthamologist and it was a saturday so i got the on call doctor and he numbed my eye and dilated it to look at the optic nerve. He said my eye was swollen on the inside membranes which is what was causing all the pain. He also stated that it was an adverse reaction to the RSV vaccine i had the day before. Today, 5 days later, my vision is cloudy and my depth perception is off. Its hard to read. everything is foggy. I dont normally wear glasses so this is all very new. It seems to be gradually going away. My eye also feels very heavy. I dont know how to describe it completely but it doesnt look swollen at all.
Age: 4.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The patient was vaccinated with improper storage dose of LIQUID PEDVAXHIB; This spontaneous report was received from a nurse practitioner and refers to a 4-year-old patient of unknown gender with no illness at the time of vaccination. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported.  On 10-JAN-2024, haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) was exposed to the temperature excursion of at total time in the range from -14 to -10 degrees Celsius for 24 minutes. On 22-JAN-2024, haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) was exposed to the temperature excursion at total time in the range from -14 to -10 degrees Celsius for 5 minutes.  On 24-JAN-2024, the patient was vaccinated with an improperly storage dose of  haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB), intramuscularly, lot # X003664, expiration date 10-NOV-2025 (also reported as 12-NOV-2025),  for prophylaxis (product storage error). The temperature excursion occurred because of a reading from Digital Data Logger in the vaccine storage in clinical practice. There was no adverse event.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2403USA004981: US-009507513-2403USA004979: US-009507513-2403USA004978: US-009507513-2403USA004977: US-009507513-2403USA004976: US-009507513-2403USA004975: US-009507513-2403USA004974: US-009507513-2403USA004980: US-009507513-2403USA004999: US-009507513-2403USA004998: US-009507513-2403USA004997: US-009507513-2403USA004996: US-009507513-2403USA004995: US-009507513-2403USA004994: US-009507513-2403USA004993: US-009507513-2403USA004986: US-009507513-2403USA004992: US-009507513-2403USA004991: US-009507513-2401USA016206: US-009507513-2403USA004989: US-009507513-2403USA004988: US-009507513-2403USA005000: US-009507513-2403USA004987: US-009507513-2403USA004990: US-009507513-2403USA005306: US-009507513-2403USA005307: US-009507513-2403USA005308: US-009507513-2403USA005309: US-009507513-2403USA005310: US-009507513-2403USA005305:
Sex: U
Vaccine: COVID19, DTAPIPV, HEPA, PNC15, VARCEL
Symptoms: Accidental overdose, Vaccination site pain
Clinical narrative: Accidental overdose; After vaccine, no noticible side effects besides achy shot site; This spontaneous report was received from other healthcare professional, via other company, concerning a patient of unknown age and gender.   No Concomitant medications provided by the reporter. No Medical History information was reported. Patient had no allergies to medications, food, and other products. Patient had no acute illnesses at the time of vaccination and up to one month before and had no chronic or long-standing health conditions. No treatment medications provided by the reporter.  On 26-OCT-2023, the patient vaccinated with the first doses of with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 1 dosage form, (lot #X011424, has been verified to be valid, expiration date not reported but upon internal validation established as 19-APR-2025), administered for prophylaxis (strength, and route of administration were not provided); hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1 dosage form, (lot #X010374, expiration date not reported but upon internal validation established as 13-NOV-2024) administered for prophylaxis (strength, and route of administration were not provided); pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 1 dosage form, (lot #X020316, expiration date not reported but upon internal validation established as: 18-OCT-2025) administered for prophylaxis (strength, and route of administration were not provided); diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (QUADRACEL) intramuscular injection, 1 dosage form (lot number 07656AA) (strength, , expiry date, route of administration were not provided) as prophylaxis; and elasomeran (MODERNA COVID-19 VACCINE) intramuscular injection, 0.5 milliliter, administered for covid-19 prophylaxis (lot number AU5558B) (strength, expiry date, and route of administration were not provided). On that same day, the patient experienced accidental overdose (The vaccination provider felt that the entire contents should be given to a patient as it is a single dose vial/Was given 0.5 ml when it should have been 0.25 ml)  On an unspecified date in 2023, the patient experienced vaccination site pain (after vaccine no noticeable side effects besides achy shot site). At the reporting time, the outcome of the event was unknown.   The action taken with all the vaccines was not applicable.   The causal relationship was not provided. ; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747540:
Age: 1.42
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: There were no adverse issues or side effects experienced by the patient.; A HCP called to report an AE in which both PROQUAD and VARIVAX were inadvertently administered to a patient on 03/18/2024 of instead of MMR II and VARIVAX.  There were no adverse issues or side effects experienced by the patient.; This spontaneous report was received from a registered nurse concerning a 17-months-old patient of unknown gender. Patient's concurrent conditions, pertinent medical history and concomitant therapies were not provided.  On 18-MAR-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, once, lot #X012268, expiration date: 30-APR-2025, and  measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) injection, 0.5 milliliter, once, lot #X018732, expiration date: 06-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided), instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (wrong vaccine administered).  There was no adverse issues or side effects experienced by the patient.
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Oedema peripheral, Pyrexia
Clinical narrative: patient had injection site pain, fever, and swollen armpit approximately 2 weeks after receiving a dose of Gardasil 9.; patient had injection site pain, fever, and swollen armpit approximately 2 weeks after receiving a dose of Gardasil 9.; patient had injection site pain, fever, and swollen armpit approximately 2 weeks after receiving a dose of Gardasil 9.; This spontaneous report was received from a nurse practitioner and refers to a female younger than 15-year-old.  The patient's pertinent medical history, concomitant medications, and drugs reactions and allergies were not reported.  On an unknown date, the patient was vaccinated with HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection as prophylaxis (dose, strength, lot #, expiry date, route of administration, and anatomical location were not provided).  On an unknown date, approximately 2 weeks after receiving a dose of HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), the patient had injection site pain (vaccination site pain), fever (pyrexia), and swollen armpit (swelling). The patient was concerned about the swollen armpit and went to the hospital. Therefore, on unspecified date, she was hospitalized. Furthermore, on unknown date, the patient recovered from the events.  The causal relationship between the events vaccination site pain, pyrexia, and swelling and HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not provided by the reporter.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: pt was given MMRV instead of just Varicella, which the child was due for instead. No adverse reaction after vaccinated.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 3rd dose administered on 24-SEP-2002; 2nd dose administered on 29-MAY-2002; This spontaneous report has been received from an other health care professional, via a medical records from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL) (MARRS # 2402USA003398), concerning a female 12-week-old (at the time of the event) patient. Her concurrent conditions, medical history and concomitant therapies were not provided.  On 06-MAR-2002, at the age of 2 days, the patient was vaccinated with the first dose of hepatitis B vaccine (manufacturer unknown) (dose, frequency, route of administration, lot # and expiration date were not provided) for prophylaxis. On 29-MAY-2002, she received the second dose of hepatitis B vaccine (manufacturer unknown) (dose, frequency, route of administration, lot # and expiration date were not provided) for prophylaxis (inappropriate schedule of product administration). On 24-SEP-2002, the patient was vaccinated with the third dose of hepatitis B vaccine (manufacturer unknown) (dose, frequency, route of administration, lot # and expiration date were not provided) for prophylaxis (inappropriate schedule of product administration).    This is one of 5 reports created for the same patient (linked MARRS # 2402USA003398, 2403USA007990, 2403USA007991 and 2403USA007992).; Sender's Comments:  US-009507513-2402USA003398:
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose administered on 24-MAR-2004; This spontaneous report has been received from an other health care professional, via a medical records from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL) (2402USA003398), concerning a female 2-year-old (at the time of the event) patient. Her historical vaccines included diphteria vaccine toxoid (+)  pertussis vaccine acellular 3-component (+) tetanus vaccine toxoid, hepatitis B vaccine, Haemophilus influenzae type B vaccine, pneumococcal 7PCV vaccine and polio vaccine. Concomitant therapies included varicella vaccine (VARIVAX) and Haemophilus influenzae type B vaccine. Her concurrent conditions and medical history were not provided.  On 06-MAR-2003 at the age of 1 year old,the patient was vaccinated with the first dose of measles (+) mumps (+) rubella vaccine (manufacturer unknown) (dose, frequency, route of administration, lot # and expiration date were not provided) for prophylaxis. On 24-MAR-2004, she received the second dose of measles (+) mumps (+) rubella vaccine (manufacturer unknown) (manufacturer unknown) (dose, frequency, route of administration, lot # and expiration date were not provided) for prophylaxis (inappropriate age at vaccine administration).   This is one of 5 reports created for the same patient (linked # 2402USA003398, 2403USA007990, 2403USA007989 and 2403USA007992).; Sender's Comments:  US-009507513-2402USA003398:
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose administered on 14-APR-2009; This spontaneous report has been received from an other health care professional, via a medical records from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL) (MARRS # 2402USA003398), concerning a female 7-year-old (at the time of the event) patient. Her historical vaccines included diphteria vaccine toxoid (+)  pertussis vaccine acellular 3-component (+) tetanus vaccine toxoid (INFANRIX), hepatitis B vaccine, Haemophilus influenzae type B vaccine, pneumococcal 7PCV vaccine and polio vaccine. Concomitant therapies included measles (+) mumps (+) rubella vaccine and Haemophilus influenzae type B vaccine. Her concurrent conditions and medical history were not provided.  On 06-MAR-2003 at the age of 1 year old,the patient was vaccinated with the first dose of varicella vaccine (VARIVAX) (dose, frequency, route of administration, lot # and expiration date were not provided) for prophylaxis. On 14-APR-2009, she received the second dose of varicella vaccine (VARIVAX) (dose, frequency, route of administration, lot # and expiration date were not provided) for prophylaxis (inappropriate age at vaccine administration).   This is one of 5 reports created for the same patient (linked MARRS # 2402USA003398, 2403USA007990, 2403USA007989 and 2403USA007991).; Sender's Comments:  US-009507513-2402USA003398:
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: sick). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK received date: 11-Mar-2024 This case was reported by a patient via interactive digital media. Patient had got the first shot in October doctor said come back after the holidays. Patient never did he/she was in an accident and then patient got sick. Patient stated, he/she should I have to start over. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: arm was so sore; arm was so sore, he/she could not hardly use it; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a 59-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: arm was so sore) and mobility decreased (Verbatim: arm was so sore, he/she could not hardly use it). The outcome of the pain in arm and mobility decreased were not reported.   It was unknown if the reporter considered the pain in arm and mobility decreased to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm and mobility decreased to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-MAR-2024 This case was reported by a patient via interactive digital media. The patient stated that he/she got 2 vaccine shots and his/her arm was so sore, he/she could not hardly use it. The patient was going to be very upset if he/she got them (shingles).
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: got shingles shots, and even though arm gets so sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had it in 40s), pain (shingles was painful) and blister (blisters go away even after patient still have pain inside, that lasted about a year). Previously administered products included Varicella zoster vaccine with an associated reaction of pain in extremity (received dose on an unknown date, for tolerance refer linked case US2024AMR032141).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: got shingles shots, and even though arm gets so sore). Rechallenge with Shingles vaccine was positive. The outcome of the pain in arm was resolved (duration 3 days).   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Linked case(s) involving the same patient: US2024AMR032141   Additional Information: GSK Receipt Date: 09-MAR-2024 This case was reported by a patient via interactive digital media. The patient reported that they got their Shingles shots and even though their arm gets so sore and that lasted about 3 days for each shot, it was nowhere as bad as the pain from shingles and patient suggested to get the shots. This case had been linked to the cases US2024AMR038200 and US2024AMR038204 reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR032141:Same reporter, same patient for initial unspecified dose US-GSK-US2024AMR038200:Same reporter, unspecified patient US-GSK-US2024AMR038204:Same reporter, unspecified patient
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Herpes zoster (Shingrix) (batch number HE4P7, expiry date 25-JAN-2024) and (batch number K2YA4) for prophylaxis.   On 12-MAR-2024, the patient received the 2nd dose of Shingrix. On 12-MAR-2024, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: Expired dose administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 12-MAR-2024 The nurse practitioner mentioned that they administered 2nd dose to 2 patients, but for 1 of the patients they administered a vaccine that expired, which led to expired vaccine used. But they did not know which patient received the expired vaccine. The lot number provided pertains to Shingrix powder vial that was already expired, and the nurse also provided lot number for the diluent vial pertaining to that vaccine K2YA4.  The reporter consent to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Thrombosis
Clinical narrative: STROKES; BLOOD CLOTS; This spontaneous report received from a consumer via J&J managed social media site and concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced blood clots, and strokes (dose series 1). The reporter stated that "Covid one dose shot put their sister, once had a thriving job at a hospital, on permanent disability due to blood clots and strokes". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots and strokes was not reported. This report was serious (Disability Or Permanent Damage).; Sender's Comments: V0-Cerebrovascular accident, Thrombosis. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Apathy, Dizziness, Hypoaesthesia, Impaired work ability, Influenza
Clinical narrative: Arm swelled up and needed ice packs both times. Benadryl was taking 100 mg. Flu symptoms four days fever of 100.2.      After the first shot I got dizzy off and on as well.  After the second shot vertigo also hit. This has continued to today.  Within two weeks of second shot a weird thing happened I started getting less feeling in lower legs. Within two months. Apathy started,  the apathy is way worse. Now. I thought it was neuropathy after thousands of dollars of test the neurosurgeon said it is not apathy.  I just read five studies that show connected to vaccine.  I now have severe mobility issues and had to quit teaching.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Mobility decreased, Neuropathy peripheral, Peripheral swelling, Vertigo
Clinical narrative: Arm swelled up and needed ice packs both times. Benadryl was taking 100 mg. Flu symptoms four days fever of 100.2.      After the first shot I got dizzy off and on as well.  After the second shot vertigo also hit. This has continued to today.  Within two weeks of second shot a weird thing happened I started getting less feeling in lower legs. Within two months. Apathy started,  the apathy is way worse. Now. I thought it was neuropathy after thousands of dollars of test the neurosurgeon said it is not apathy.  I just read five studies that show connected to vaccine.  I now have severe mobility issues and had to quit teaching.
Age: 1.17
Sex: M
Vaccine: HEP, HIBV, MMR
Symptoms: Blister, Pruritus, Skin lesion, Varicella virus test positive
Clinical narrative: On 3-6-24: Pt developed lesions - became blisters no fever. Lesions were itchy. 4yo sister had chicken pox 2 wks earlier (non immunized sister Approx 2 yo.) Pt had 1 Varivax previously Mom wanted Vaers aware, as well as clinic.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cardiac disorder, Cough, Hypersensitivity, Hypertension
Clinical narrative: Not only am I a patient, I am a nurse. I will never get another Covid vaccine again. I had 2. I had the Moderna dose one and two. The seocnd one almost killed me. I was severely sick for over 48 hours. And the kicker is the crap didn't even work. I've had Covid twice since and yes the first time was not long after the second dose. While Covid didn't feel good and yes I know people have died from Covid I have a close family friend that passed away from Covid in 2020, but while I know Covid wasn't fun, for me, the vaccine made me 10x sicker than actual Covid! Well oh that's because the vaccine worked and made the Covid better. So you don't want me to get severely sick or hospitalized.. so to prevent that we're gonna give you a shot that makes you severely sick and almost killed me!?! makes no sense. Also.. the biggest thing. I never and I say NEVER had seasonal allergies. None. I didn't sneeze. I didn't cough. SINCE taking these vaccines I have been a sickly little person. I don't even know what to call it because it's not seasonal.. no it's YEAR ROUND 24/7 365 all day everyday for the past 4 years I have SUFFERED with severe daily all day long allergies. I sneeze CONSTANTLY, my  nose runs constantly, I have so much snot and mucus all the time. I have a cough that won't go away since. I sound like a smoker. Do I smoke? Absolutely not. Have I sever? Nope. I didn't have this beforehand. I just didn't. I will never get this Covid vaccine again. It done me wayyy more harm than good and guess what I've still had Covid! It doesn't work. We see patients who has not only had there Covid vaccines but allll the boosters and these patients are still getting Covid! Shocker! So tell me again what is the point? Why did our nation force everyone they could to get this? For what?!
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Rhinorrhoea, Sneezing
Clinical narrative: Not only am I a patient, I am a nurse. I will never get another Covid vaccine again. I had 2. I had the Moderna dose one and two. The seocnd one almost killed me. I was severely sick for over 48 hours. And the kicker is the crap didn't even work. I've had Covid twice since and yes the first time was not long after the second dose. While Covid didn't feel good and yes I know people have died from Covid I have a close family friend that passed away from Covid in 2020, but while I know Covid wasn't fun, for me, the vaccine made me 10x sicker than actual Covid! Well oh that's because the vaccine worked and made the Covid better. So you don't want me to get severely sick or hospitalized.. so to prevent that we're gonna give you a shot that makes you severely sick and almost killed me!?! makes no sense. Also.. the biggest thing. I never and I say NEVER had seasonal allergies. None. I didn't sneeze. I didn't cough. SINCE taking these vaccines I have been a sickly little person. I don't even know what to call it because it's not seasonal.. no it's YEAR ROUND 24/7 365 all day everyday for the past 4 years I have SUFFERED with severe daily all day long allergies. I sneeze CONSTANTLY, my  nose runs constantly, I have so much snot and mucus all the time. I have a cough that won't go away since. I sound like a smoker. Do I smoke? Absolutely not. Have I sever? Nope. I didn't have this beforehand. I just didn't. I will never get this Covid vaccine again. It done me wayyy more harm than good and guess what I've still had Covid! It doesn't work. We see patients who has not only had there Covid vaccines but allll the boosters and these patients are still getting Covid! Shocker! So tell me again what is the point? Why did our nation force everyone they could to get this? For what?!
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Heart rate irregular, Influenza like illness, Pain
Clinical narrative: Patient received her first shingles vaccine 3/21/2024 and reported the normal soreness, and then flu-like symptoms on 3/22/24, then starting 3/23/24 she called reporting really bad heart pauses that occurs very frequently ~every 5 min and makes her feel like she's about to faint.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Vaccine expired on 1/31/24, but was given 3/25/24 Vaccine redosed with in date medication
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray normal, Chest discomfort, Chest pain, Electrocardiogram abnormal
Clinical narrative: I suffered from intense sudden chest pains within 2 days after my vaccination. I went to the emergency room on Sept 10, 2022 where I received an EKG, Chest X ray and bloodtest. My EKG was abnormal but they did not see anything on the XRay so they told me it was most likely a musculoskeletal problem and sent me home after a shot of Toradol. My condition improved after a couple of weeks and I was healthy again until January 2023 when my chest pain returned after I fell ill with a cold/Covid (I didn't check). It was milder than the first time and this resolved after about a week and I did not consult a doctor because I believed it was the same musculoskeletal issue. I was completely healthy once again until July 20th of 2023 while I was traveling when my chest pain returned, as intense as the very first time. After being unable to treat the pain with ibuprofen, I eventually went to a hospital,where I was admitted for 10 days and diagnosed with idiopathic pericarditis. I was put on corticosteroids as a treatment and the pericarditis returned once again in September 2023 as I was tapering off of this medication. I continue to deal with chest discomfort and inability to exercise as of March 27, 2024.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Exercise tolerance decreased, Foreign travel, Magnetic resonance imaging heart, Malaise, Musculoskeletal disorder
Clinical narrative: I suffered from intense sudden chest pains within 2 days after my vaccination. I went to the emergency room on Sept 10, 2022 where I received an EKG, Chest X ray and bloodtest. My EKG was abnormal but they did not see anything on the XRay so they told me it was most likely a musculoskeletal problem and sent me home after a shot of Toradol. My condition improved after a couple of weeks and I was healthy again until January 2023 when my chest pain returned after I fell ill with a cold/Covid (I didn't check). It was milder than the first time and this resolved after about a week and I did not consult a doctor because I believed it was the same musculoskeletal issue. I was completely healthy once again until July 20th of 2023 while I was traveling when my chest pain returned, as intense as the very first time. After being unable to treat the pain with ibuprofen, I eventually went to a hospital,where I was admitted for 10 days and diagnosed with idiopathic pericarditis. I was put on corticosteroids as a treatment and the pericarditis returned once again in September 2023 as I was tapering off of this medication. I continue to deal with chest discomfort and inability to exercise as of March 27, 2024.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pericarditis, Positron emission tomogram, Suspected COVID-19
Clinical narrative: I suffered from intense sudden chest pains within 2 days after my vaccination. I went to the emergency room on Sept 10, 2022 where I received an EKG, Chest X ray and bloodtest. My EKG was abnormal but they did not see anything on the XRay so they told me it was most likely a musculoskeletal problem and sent me home after a shot of Toradol. My condition improved after a couple of weeks and I was healthy again until January 2023 when my chest pain returned after I fell ill with a cold/Covid (I didn't check). It was milder than the first time and this resolved after about a week and I did not consult a doctor because I believed it was the same musculoskeletal issue. I was completely healthy once again until July 20th of 2023 while I was traveling when my chest pain returned, as intense as the very first time. After being unable to treat the pain with ibuprofen, I eventually went to a hospital,where I was admitted for 10 days and diagnosed with idiopathic pericarditis. I was put on corticosteroids as a treatment and the pericarditis returned once again in September 2023 as I was tapering off of this medication. I continue to deal with chest discomfort and inability to exercise as of March 27, 2024.
Age: 1.58
Sex: F
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: Patient was due for a D-tap immunization but was given Kinirx instead
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site discolouration, Injection site discomfort, Injection site haemorrhage, Injection site pain
Clinical narrative: Pt developed bruising/discoloration to skin as well as a blister at vaccine administration site. There is also pain and discomfort in the arm around the site. The area was assessed on 3/27/24 by PCP and antibiotics and steroids were prescribed.
Age: 1.33
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: Patient developed chicken pox, treated with Triamcinolone cream and Prednisolone -15mg/5mL -7.5mL once a day x 3 days
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received MMRV-Proquad and Varicella at the visit. No adverse event reported.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Balance disorder, Electrocardiogram, Magnetic resonance imaging, Syncope, Visual impairment
Clinical narrative: Within one month patient started having vision issues and balance issues. At two months she had her first syncopic episode. She has been having these episodes ever since.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Joint range of motion decreased, Musculoskeletal stiffness, Swelling
Clinical narrative: shoulder pain, localized swelling, shoulder stiffness, decreased range of motion   Tylenol as needed, icing as needed and no heavy lifing
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Cough, Ocular hyperaemia, Pruritus, Purulent discharge, Pyrexia
Clinical narrative: Patient developed rash on torso on 3/25/24. Seen in office on 3/26/24 with erythematous papular lesions on torso. Patient scratching at self in office. He was diagnosed with active chicken pox infection due to varicella vaccine given on 3/11/24. Patient was previously seen on 3/19/24 at an urgent care facility for left eye redness and purulent d/c starting 3/19/24, fever up to 101.5 F on 3/17/24 lasting 24 hours, sneezing, slight cough, and vomiting.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash, Rash papular, Sneezing, Varicella post vaccine, Vomiting
Clinical narrative: Patient developed rash on torso on 3/25/24. Seen in office on 3/26/24 with erythematous papular lesions on torso. Patient scratching at self in office. He was diagnosed with active chicken pox infection due to varicella vaccine given on 3/11/24. Patient was previously seen on 3/19/24 at an urgent care facility for left eye redness and purulent d/c starting 3/19/24, fever up to 101.5 F on 3/17/24 lasting 24 hours, sneezing, slight cough, and vomiting.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Constant Shingles pain but no rash front and back right ribs lasting 5 weeks
Age: 38.0
Sex: M
Vaccine: FLU4, HEP, HEPA, IPV, MMR, TDAP, VARCEL
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse reaction note. Just an med error were and adukt was given pediatric Hep A
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Inappropriate schedule of product administration
Clinical narrative: Vaccination Outreach Event: Patient's COVID "card"/personal record that was presented to RN was inaccurate as this person did have a COVID vaccination on1/12/2024 per EHR.   The CDC recommended second COVID vaccine for persons age  65 +   was administered 10 weeks from her 2023 updated COVID dose #1 versus at or after 4 months.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Inappropriate schedule of product administration
Clinical narrative: Vaccination Outreach Event: Patient's COVID "card"/personal record that was presented to RN was inaccurate as this person did have a COVID vaccination on1/2/2024 per EHR.   The CDC recommended second COVID vaccine for persons age  65 +   was administered 12 weeks from her 2023 updated COVID dose #1 versus at or after 4 months.   Medical provider notified.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Per patient's age, HPV should have been given 5 months apart.  Patient now has to return for a 3rd dose.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: patient began showing signs of shingles next day, now has active herpes zoster opthalmicus.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy, Pruritus, Swelling face, Urticaria
Clinical narrative: Facial swelling, hives for 7 weeks, still on going, itchy skin continue
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Contusion, Haematoma, Headache, Hyperhidrosis
Clinical narrative: She got her vaccine, everything went fine initially.  She then woke up at 2:00 AM drenched in sweat, her left arm throbbing.  She came to work the next day, called employee health.  A coworker got the vaccine right after her, she sent her a text that she was not feeling well and going to stay home.  She went to employee health and told them that she was sick, and her arm was in a lot of pain.  Thursday, still had pain, nothing taking away the pain, bad headache.  She called her doctor, tried to get into see him and not able to see  him on thursday or Friday.  She went back to Employee health on Thursday and showed it to them, had a softball size knot.  Friday showed it to them again, still had the not.  Sunday, had tingling in the left arm, headache and brusing started to appear.  From Sunday to Monday her bruise went from a little yellow spot to an area down to her elbow.  She went to her doctor and was told that she had a hematoma, nerve damage, internal bleeding.  Her INR is normally a 2, is 6.4.  They made a comment about the preservative, and had a reaction to the COVID vaccine, and feels that the preservative from the COVID wa sin her system and had problems with this vaccine.  She has bruises all over her body, arm looks like it was torn off by a dog and has had  a headache for a week now.  Her doctor gave her Phytonadione 5 mg tablet to take one by moouth for 10 days, and he instructed her to stop taking her Coumadin and goes on Friday to see him, and going to double check the hematoma and her INR levels.