chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: hives on his legs; This case was reported by a consumer via interactive digital media and described the occurrence of hives in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 20th October 2022, the patient received Shingles vaccine. In October 2022, less than a week after receiving Shingles vaccine, the patient experienced hives. On an unknown date, the outcome of the hives was not recovered/not resolved.   It was unknown if the reporter considered the hives to be related to Shingles vaccine.     Additional Information: GSK receipt date :21-OCT-2022 Reporters comment: This case was reported by wife for her husband via interactive digital media. The patient received shingle vaccine yesterday (day before reporting) and had hives on his legs
Sex: U
Vaccine: VARZOS
Symptoms: Neck pain
Clinical narrative: Neck pain after Shingrix; This case was reported by a consumer via interactive digital media and described the occurrence of neck pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced neck pain. On an unknown date, the outcome of the neck pain was unknown.   It was unknown if the reporter considered the neck pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-OCT-2022 Reporter's Comments:  This case was received from patient via interactive digital media. The reported stated was it common to had a neck pain after Shingrix Shot. The follow up would not possible as no contact details were available.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.     Additional Information: GSK receipt date: 21-OCT-2022 Reporters comment: The patient self-reported this case. The reporter did not consent to follow-up.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 27Aug2018, 2nd on 12Apr2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number 5NK3R, expiry date 11th May 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 27th August 2018).   On 12th April 2022, the patient received the 2nd dose of Shingrix. On 12th April 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 21-Oct-2022 Reporter's comment: The pharmacist called to inquire the patient need the second dose again or how did it work. The pharmacist reported the patient did not received the second dose until 12th April 2022.  How to proceed since the patient was over 6 months for the second dose. The healthcare professional confirmed that the patient received both the first and the second doses at other facilities and not theirs.  The reporter did not consent to follow up. Additional supportive information: The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This 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 HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   In October 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. In October 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-Oct-2022 Reporter's comment: The healthcare professional reported the administration of Havirx to a patient that was expired.  The healthcare professional disconnected chat prior to obtaining permission for safety follow up.  No additional details available at this time of this report.  Additional supportive information: The patient was administered an expired dose of Havrix, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose Aug2021, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (patient received 1st dose in August 2021).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 21-OCT-2022 Reporter's Comment: The reporter stated that a patient had not yet received his second dose.   The patient would like to come in for the second dose today (on the date of reporting).   At the time of reporting, the second dose has not been administered.  The pharmacist just spoke to the patient over the phone and did not know his age, date of birth, exact date of first dose, or any lot number information from first dose. The reporter gave consent to follow up. Additional supportive information: VAERS details reported were corresponding to the 1st dose as the 2nd dose had not been received yet.
Age: 36.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: patient received an expired dose of Havrix; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 36-year-old male patient who received HAV (Havrix) (batch number K2L279, expiry date 12th August 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st October 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 21st October 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 21-OCT-2022 Reporter's comment: A pharmacist had reported that a patient had received an expired dose of Havrix. The dose was expired since 12th August 2022. The reporter did not consented to follow up. Additional supportive information: The patient had received an expired dose of Havrix, which led to expired vaccine used.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Got the shot and 4 days later he dies; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Got the shot and 4 days later he dies) in an adolescent male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medication information was provided. It was reported that patient age was 12 or 13 years. No treatment medications were provided  Company Comment: This is a Spontaneous case concerning an adolescent male patient, with no medical history reported, who experienced the unexpected event of Death. The event occurred 4 days after an unspecified dose of mRNA-1273 vaccine. It is unknown if an autopsy was performed. The cause of death was not reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a Spontaneous case concerning an adolescent male patient, with no medical history reported, who experienced the unexpected event of Death. The event occurred 4 days after an unspecified dose of mRNA-1273 vaccine. It is unknown if an autopsy was performed. The cause of death was not reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Got the shot and 4 days later he dies
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; vaccinated again with a second Moderna Bivalent booster with in a month; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (vaccinated again with a second Moderna Bivalent booster with in a month) and NO ADVERSE EVENT (No adverse event) in a 42-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Oct-2022, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (vaccinated again with a second Moderna Bivalent booster with in a month). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (vaccinated again with a second Moderna Bivalent booster with in a month) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (vaccinated again with a second Moderna Bivalent booster with in a month).    No concomitant medication information was provided. It was reported that patient again vaccinated with a second Moderna Bivalent booster.  No treatment medication were provided.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Received the Moderna COVID-19 vaccine recently had COVID; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Received the Moderna COVID-19 vaccine recently had COVID) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Received the Moderna COVID-19 vaccine recently had COVID). At the time of the report, COVID-19 (Received the Moderna COVID-19 vaccine recently had COVID) outcome was unknown.            Concomitant medications were not reported. Reporter stated that the patient might have received the Pfizer or Moderna COVID-19 vaccine recently had COVID. No treatment information was provided by the reporter.   Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; second dose <35 days after first dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose <35 days after first dose) and NO ADVERSE EVENT (No adverse event) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose <35 days after first dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose <35 days after first dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose <35 days after first dose).    Concomitant products were not reported.  It was reported that patient did not had any other boosters. On 27-Oct-2022 patient went for new booster dose.  Treatment medications were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Patient Received 0.25ml of Bivalent booster instead of 0.5 ml; No Adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient Received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient Received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient Received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient Received 0.25ml of Bivalent booster instead of 0.5 ml).    No concomitant medication was reported.    Vaccination date was reported as 01-SEP-2022 to 26-OCT-2022. No treatment information was reported. This case was reported for 6th patient out of 20 patients.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Patient received 0.25ml of Bivalent booster instead of 0.5 ml; No Adverse event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Patient received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patient received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event). At the time of the report, UNDERDOSE (Patient received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event) outcome was unknown. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient received 0.25ml of Bivalent booster instead of 0.5 ml). No concomitant medications were reported. No treatment medications were reported. This case contains information for the 5th of 20 adult patients described by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Received 0.25ml of Bivalent booster instead of 0.5 ml; No Adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml).    No concomitant information was reported. It was reported that none of the patients were pregnant. Vaccination date was reported as 01-SEP-2022 to 26-OCT-2022. No treatment information was provided. This case is reported for 16th patient out of 20 patients.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Road traffic accident, Seizure
Clinical narrative: Seizures
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Blindness unilateral, Blood glucose abnormal, Cardiac flutter, Catheter placement
Clinical narrative: Lost vision in my right eye, lost feeling in my leg, could hardly walk, couldn?t urinate without self cathing for 3 months, took away feeling from my bowels so it?s hard to have a bowel movement, blood sugar imbalances, severe anemia, heart jitters
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dyschezia, Gait disturbance, Hyperglycaemia, Hypoglycaemia, Laboratory test
Clinical narrative: Lost vision in my right eye, lost feeling in my leg, could hardly walk, couldn?t urinate without self cathing for 3 months, took away feeling from my bowels so it?s hard to have a bowel movement, blood sugar imbalances, severe anemia, heart jitters
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head, Magnetic resonance imaging spinal, Migraine, Multiple sclerosis, Palpitations
Clinical narrative: Lost vision in my right eye, lost feeling in my leg, could hardly walk, couldn?t urinate without self cathing for 3 months, took away feeling from my bowels so it?s hard to have a bowel movement, blood sugar imbalances, severe anemia, heart jitters
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Papilloedema, Plasmapheresis, Presyncope, Sensory loss, Urinary retention
Clinical narrative: Lost vision in my right eye, lost feeling in my leg, could hardly walk, couldn?t urinate without self cathing for 3 months, took away feeling from my bowels so it?s hard to have a bowel movement, blood sugar imbalances, severe anemia, heart jitters
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Balance disorder, Dizziness, Fall
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Loss Balance-Mild, Additional Details: Patient recieved a moderna bivalent booster at 10:30 am. After the patient was seated and waited for 15 min and about to walk out of the pharmacy, the patient felt dizzy and lost her balance. She fell backwards landing on her back.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: Burning sensation, Inflammation, Pain, Rash
Clinical narrative: Severe rash with inflammation, burning, pain
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: 0.25ML GIVEN. NO ADVERSE EVENTS NOTED
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: 0.25ML GIVEN. NO ADVERSE EVENTS NOTED
Age: 87.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: 0.25ML GIVEN. NO ADVERSE EVENTS NOTED
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: 0.25ML GIVEN. NO ADVERSE EVENTS NOTED
Age: 7.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect Reconstitution-
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: 0.25ML GIVEN. NO ADVERSE EVENTS NOTED
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Contusion, Immediate post-injection reaction, Injection site pain, Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: brusing in hand after noticed tingling in arm immediately after shot
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium
Age: 8.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 49.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Additional Details: Still has pain at injection site.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain, Asthenia, Back pain, Chills, Decreased appetite
Clinical narrative: Patient contacted the pharmacy Sunday morning 10/30/2022.  She reported receiving vaccine on wed evening.  Friday at 8pm she had sudden onset of symptoms/side effects...extreme headache, back pain , abdominal pain, fever 101, chills (freezing, shaking), weakness, nausea, general muscle aches, loss of appetite, frequent urination (no dysuria).  As of Sunday, still had back pain, headache, stomach pain, nausea.   Directed her to contact MD, since still having various pains concerning her.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Feeling cold, Headache, Myalgia, Nausea, Pain
Clinical narrative: Patient contacted the pharmacy Sunday morning 10/30/2022.  She reported receiving vaccine on wed evening.  Friday at 8pm she had sudden onset of symptoms/side effects...extreme headache, back pain , abdominal pain, fever 101, chills (freezing, shaking), weakness, nausea, general muscle aches, loss of appetite, frequent urination (no dysuria).  As of Sunday, still had back pain, headache, stomach pain, nausea.   Directed her to contact MD, since still having various pains concerning her.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pollakiuria, Pyrexia, Tremor
Clinical narrative: Patient contacted the pharmacy Sunday morning 10/30/2022.  She reported receiving vaccine on wed evening.  Friday at 8pm she had sudden onset of symptoms/side effects...extreme headache, back pain , abdominal pain, fever 101, chills (freezing, shaking), weakness, nausea, general muscle aches, loss of appetite, frequent urination (no dysuria).  As of Sunday, still had back pain, headache, stomach pain, nausea.   Directed her to contact MD, since still having various pains concerning her.
Age: 43.0
Sex: M
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pruritus, Rash, Urticaria
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: PT  SAYS HAS RASH OVER WHOLE BODY, SHE SHOWED HIVES , RASH ON HER ARM
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Monocyte count increased
Clinical narrative: elevated AST/ALT 45/55 on 10/26/2022 & 32/51 on 5/4/2022 elevated monocyte count 10/26/2022 0.9 & 1.0 on 5/4/2022
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy skin, Blood test, Central venous catheterisation, Chemotherapy, Computerised tomogram
Clinical narrative: Hodgkin Lymphoma, Lump on L side of neck Nodular Sclerosis. lymph nodes of head, face neck C81.11 Chemotherapy CT Scan, postiron Emission tomography (PET SCAN) biopsy L side of neck, MUGA Scan IV Port Placed
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hodgkin's disease, Hodgkin's disease nodular sclerosis stage III, Multiple gated acquisition scan, Neck mass, Positron emission tomogram
Clinical narrative: Hodgkin Lymphoma, Lump on L side of neck Nodular Sclerosis. lymph nodes of head, face neck C81.11 Chemotherapy CT Scan, postiron Emission tomography (PET SCAN) biopsy L side of neck, MUGA Scan IV Port Placed
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Systemic: Fever-Medium
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Body aches, chills, tiredness; took Tylenol
Age: 13.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Head injury, Nausea, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Additional Details: Patient received flu and covid vaccines. Patient went to go sit in the waiting area for observation post covid booster. Fainted after 2 minutes of waiting in the waiting area and hit his head. Immediately was conscious after fall and had to lie down on the floor for ten minutes due to nausea. After paramedics assessed the patient and when he felt strong enough to stand, he left the store without going to the emergency room.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Decreased appetite, Dehydration, Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: DEHYDRATION. LOSS OF APPETITE-Severe, Systemic: Vomiting-Severe
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Vomiting
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: DEHYDRATION. LOSS OF APPETITE-Severe, Systemic: Vomiting-Severe
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain in jaw, Tinnitus
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Right Jaw Pain-Medium, Systemic: Tinnitus-Medium, Additional Details: Adverse effects occured in the opposite side of the patients body from injection site.  Patient was moved to cooler location in the store, monitored but complained of jaw pain 10/10 and ringing in her ear (tinnitus).  Informed pt that tinnitus was possible side effect that could occur post injection, but was concerned about the jaw pain.  Checked on patient multiple times, applied ice pack wrapped in plastic bag to jaw, patient started to feel better after approximately 30 mins- 1 hour, 2/10 ps
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Movement disorder, Periarthritis
Clinical narrative: Patient since received the vaccine had a frozen shoulder type reaction where she could not move the arm.  She had pain and swelling at the site.  Since then she has had about 40 physical therapy sessions for about 6 months.  Her arm is still not at 100%.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Intermittent, itchy, pink skin rash patches, daily, starting 11 days after the vaccine, and still continuing to this day (28 days), although fewer than initially.
Age: 62.0
Sex: F
Vaccine: FLUA4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Case is Instructor at Community College.  Nursing student gave case Fluad High Dose instead of Fluarix.  No adverse reactions or complications occurred after vaccination.  Case is aware of error.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Injection site pain, Insomnia, Joint range of motion decreased, Shoulder injury related to vaccine administration
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Unable to Sleep-Medium, Additional Details: pt reported "sirva" - left shoulder pain and limited range of motion, painful to touch, difficulty sleeping. pt has not sought medical help. took ibuprofen.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Sleep disorder
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Unable to Sleep-Medium, Additional Details: pt reported "sirva" - left shoulder pain and limited range of motion, painful to touch, difficulty sleeping. pt has not sought medical help. took ibuprofen.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, Confusional state, Dyspnoea, Lethargy, Seizure
Clinical narrative: patient was sent to the emergency room last evening after acute seizure activity--- apparently he had complained earlier on 10/28 of weak/lethargic.symptoms, but had only consumed one cup of water so far when seen, thus was discharged back to the block and encourage to increase fluid intake   As the ER report is not yet back, this provider spoke with the doctor from the hospital at 10:40 this a.m.-- the patient stated to the ER staff (& to this provider) that he had gone out previously for seizure activity after a Covid vaccine, however, he is apparently confused because he was sent out August 2020 for seizure activity and did not receive a Covid vaccine until 4/7/2021---he was seen on 4/8/2021 for complaints of shortness of breath and weakness, but did not have any reported seizure activity at that time. While at the ER last evening, the patient had a Keppra level drawn, which is still pending, and was given a 1 g dose of Keppra IV and subsequently returned where he was admitted to the infirmary. He denies any complaints at this time
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain
Clinical narrative: NASALLY, SORE THROAT
Age: 9.0
Sex: M
Vaccine: UNK
Symptoms: Expired product administered, Recalled product administered
Clinical narrative: On Oct. 12, stores received an internal Urgent Removal Notice regarding Pfizer COVID-19 Vaccine- Pediatric 5-11 Years Tris-sucrose, Lot #FL2757 with manufacturer?s expiration date of Sept. 30.  Information has been received from the manufacturer indicating that stability data supports the use of this product through Oct. 19.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cough, Rhinorrhoea
Clinical narrative: COUGH, RUNNY NOSE
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Bursal fluid accumulation, Exposure during pregnancy, Joint range of motion decreased, Magnetic resonance imaging abnormal
Clinical narrative: Right shoulder joint pain and limitation in range of motion worsened over a week and has been persistent. Evaluated by PCP, Rheumatology, and Orthopedics.  Patient was 35 weeks pregnant at the time of the event.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Oedema
Clinical narrative: Right shoulder joint pain and limitation in range of motion worsened over a week and has been persistent. Evaluated by PCP, Rheumatology, and Orthopedics.  Patient was 35 weeks pregnant at the time of the event.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Atrial fibrillation, Blood pressure increased, COVID-19, Cardioversion
Clinical narrative: Patient with 2 COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  "Patient presented to the emergency department after a few days of feeling fatigued with a dry cough, sore throat, body aches, chills.  He notes no fever home subjectively.  Denied chest pain or shortness of breath, though did say that it was hard to take a deep breath.    Patient was noted to have AFib with RVR, thought likely triggered by COVID infection.  He follows with Dr., has been aspirin and atenolol.  Given his chads Vasc score of 3, he was initiated on heparin and eventually transitioned to Xarelto.  He also was treated with amiodarone to normal sinus rhythm, converted to normal sinus rhythm.  Rate control with atenolol.   COVID-19 was treated with remdesivir is he was a high-risk patient.  He was not given steroids as he did not become hypoxic.  Sepsis likely due to COVID-19 was treated with IV fluid boluses.  Due to viral nature of infection, no antibiotics were initiated.  Following IV fluids, his sepsis resolved.  Lactic acidosis also resolved following mass.   Given patient's initial soft blood pressures, his home antihypertensive medications were held.  His blood pressure remained in the normal to slightly elevated range during hospitalization, the highest blood pressure noted to be 136/71.   Discussed patient's alcohol use disorder.  He states that in the past he has quit for 40-50 days at a time, but always returns to drinking.  Discussed possible treatment options including medications and social support groups.  He agreed to start oral naltrexone on discharge.  A prescription for this was sent to his pharmacy."
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Condition aggravated, Cough, Dyspnoea, Fatigue
Clinical narrative: Patient with 2 COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  "Patient presented to the emergency department after a few days of feeling fatigued with a dry cough, sore throat, body aches, chills.  He notes no fever home subjectively.  Denied chest pain or shortness of breath, though did say that it was hard to take a deep breath.    Patient was noted to have AFib with RVR, thought likely triggered by COVID infection.  He follows with Dr., has been aspirin and atenolol.  Given his chads Vasc score of 3, he was initiated on heparin and eventually transitioned to Xarelto.  He also was treated with amiodarone to normal sinus rhythm, converted to normal sinus rhythm.  Rate control with atenolol.   COVID-19 was treated with remdesivir is he was a high-risk patient.  He was not given steroids as he did not become hypoxic.  Sepsis likely due to COVID-19 was treated with IV fluid boluses.  Due to viral nature of infection, no antibiotics were initiated.  Following IV fluids, his sepsis resolved.  Lactic acidosis also resolved following mass.   Given patient's initial soft blood pressures, his home antihypertensive medications were held.  His blood pressure remained in the normal to slightly elevated range during hospitalization, the highest blood pressure noted to be 136/71.   Discussed patient's alcohol use disorder.  He states that in the past he has quit for 40-50 days at a time, but always returns to drinking.  Discussed possible treatment options including medications and social support groups.  He agreed to start oral naltrexone on discharge.  A prescription for this was sent to his pharmacy."
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lactic acidosis, Oropharyngeal pain, Pain, SARS-CoV-2 test positive, Sepsis
Clinical narrative: Patient with 2 COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  "Patient presented to the emergency department after a few days of feeling fatigued with a dry cough, sore throat, body aches, chills.  He notes no fever home subjectively.  Denied chest pain or shortness of breath, though did say that it was hard to take a deep breath.    Patient was noted to have AFib with RVR, thought likely triggered by COVID infection.  He follows with Dr., has been aspirin and atenolol.  Given his chads Vasc score of 3, he was initiated on heparin and eventually transitioned to Xarelto.  He also was treated with amiodarone to normal sinus rhythm, converted to normal sinus rhythm.  Rate control with atenolol.   COVID-19 was treated with remdesivir is he was a high-risk patient.  He was not given steroids as he did not become hypoxic.  Sepsis likely due to COVID-19 was treated with IV fluid boluses.  Due to viral nature of infection, no antibiotics were initiated.  Following IV fluids, his sepsis resolved.  Lactic acidosis also resolved following mass.   Given patient's initial soft blood pressures, his home antihypertensive medications were held.  His blood pressure remained in the normal to slightly elevated range during hospitalization, the highest blood pressure noted to be 136/71.   Discussed patient's alcohol use disorder.  He states that in the past he has quit for 40-50 days at a time, but always returns to drinking.  Discussed possible treatment options including medications and social support groups.  He agreed to start oral naltrexone on discharge.  A prescription for this was sent to his pharmacy."
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 0.5
Sex: F
Vaccine: COVID19
Symptoms: Electroencephalogram abnormal, Infantile spasms, Magnetic resonance imaging head abnormal, Thalamic stroke
Clinical narrative: 1 week after vaccines, patient presented to office with infantile spasms. In ER and admission, Infantile spasms were confirmed on EEG and MRI demonstrated thalamic stroke
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case   dose 1 2/1/21 Pfizer  EL9265 dose 2 2/22/21 Pfizer EM9810
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Restless legs syndrome
Clinical narrative: restless legs
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 16.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: Abdominal discomfort, Confusional state, Dizziness, Dysstasia, Eye movement disorder
Clinical narrative: 16 year old female had both Covid booster (Pfizer Bivalent) and the flu shot administered in one sitting on Sun., Oct. 30th at approximately 12:30 pm. This was her fourth overall Pfizer Covid shot; she has never had any issues with the past three shots except for some soreness at the site of the injection. She also has had her flu shots and also did not have any adverse reactions. This time, she reported arm pain throughout the day, nothing more serious. In the evening at dinnertime, around 7 pm, she said her stomach didn't feel great and she ate very lightly. She continued with a series of tasks, including homework and doing laundry with no complaint. At around 11 pm, as she went to bed, she said she felt very tired and "was done for the day," She fell asleep and had no issues throughout the night. At 6:15 am, she awoke to get ready for school and said she felt groggy. That is not unusual- as a teenager, she wakes up sleepy a bit. About 20 minutes later, at around 6:35 am, as she's brushing her teeth and we are reviewing what is ahead , she said "I don't feel well." I went to touch her forehead, stepped one foot closer, and she went to embrace me.  I heard her mumble something into my shoulder, and when I lifted my head, I heard her say more clearly, "I feel like I'm going to pass out." She then went fully limp in my arms, her eyes rolled back into her head and she collapsed on the floor, her body weight leaning against me. She was unresponsive and fully unconscious for about 1 minute but she would not respond and her eyes alternated between closed and open without her responding. I yelled her name, shook her lightly applied pressure with my palms to either side of her face but she did not respond. As I held her up off the floor, I tried to reach the phone to call 911. After about 1 minute, she came to, still very dazed, completely unable to stand on her own and with no balance. She was confused, out of it, unaware of what was happening.  I helped her move to the couch where she has been resting. I have called her doctor and she said to keep an eye on her. This has only happened in the last two hours so not sure what the day will bring. She has NEVER had any adverse reactions to any vaccines or medicines before and has no chronic or ongoing health issues. She has never passe d out before.
Age: 16.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: Fatigue, Hypotonia, Loss of consciousness, Malaise, Pain in extremity
Clinical narrative: 16 year old female had both Covid booster (Pfizer Bivalent) and the flu shot administered in one sitting on Sun., Oct. 30th at approximately 12:30 pm. This was her fourth overall Pfizer Covid shot; she has never had any issues with the past three shots except for some soreness at the site of the injection. She also has had her flu shots and also did not have any adverse reactions. This time, she reported arm pain throughout the day, nothing more serious. In the evening at dinnertime, around 7 pm, she said her stomach didn't feel great and she ate very lightly. She continued with a series of tasks, including homework and doing laundry with no complaint. At around 11 pm, as she went to bed, she said she felt very tired and "was done for the day," She fell asleep and had no issues throughout the night. At 6:15 am, she awoke to get ready for school and said she felt groggy. That is not unusual- as a teenager, she wakes up sleepy a bit. About 20 minutes later, at around 6:35 am, as she's brushing her teeth and we are reviewing what is ahead , she said "I don't feel well." I went to touch her forehead, stepped one foot closer, and she went to embrace me.  I heard her mumble something into my shoulder, and when I lifted my head, I heard her say more clearly, "I feel like I'm going to pass out." She then went fully limp in my arms, her eyes rolled back into her head and she collapsed on the floor, her body weight leaning against me. She was unresponsive and fully unconscious for about 1 minute but she would not respond and her eyes alternated between closed and open without her responding. I yelled her name, shook her lightly applied pressure with my palms to either side of her face but she did not respond. As I held her up off the floor, I tried to reach the phone to call 911. After about 1 minute, she came to, still very dazed, completely unable to stand on her own and with no balance. She was confused, out of it, unaware of what was happening.  I helped her move to the couch where she has been resting. I have called her doctor and she said to keep an eye on her. This has only happened in the last two hours so not sure what the day will bring. She has NEVER had any adverse reactions to any vaccines or medicines before and has no chronic or ongoing health issues. She has never passe d out before.