chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: drowsiness; sore arm; Bad Cholesterol went down / Good Cholesterol went up/ cholesterol levels have decreased significantly after each dose of the Moderna COVID-19 vaccine / Dropping of the cholesterol level; This spontaneous case was reported by an other health care professional and describes the occurrence of SOMNOLENCE (drowsiness), PAIN IN EXTREMITY (sore arm) and THERAPEUTIC RESPONSE UNEXPECTED (Bad Cholesterol went down / Good Cholesterol went up/ cholesterol levels have decreased significantly after each dose of the Moderna COVID-19 vaccine / Dropping of the cholesterol level) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (had Covid in 2020 and first initial drop in cholesterol was noticed) in 2020. Concurrent medical conditions included Drug allergy and High cholesterol.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced SOMNOLENCE (drowsiness), PAIN IN EXTREMITY (sore arm) and THERAPEUTIC RESPONSE UNEXPECTED (Bad Cholesterol went down / Good Cholesterol went up/ cholesterol levels have decreased significantly after each dose of the Moderna COVID-19 vaccine / Dropping of the cholesterol level). At the time of the report, SOMNOLENCE (drowsiness), PAIN IN EXTREMITY (sore arm) and THERAPEUTIC RESPONSE UNEXPECTED (Bad Cholesterol went down / Good Cholesterol went up/ cholesterol levels have decreased significantly after each dose of the Moderna COVID-19 vaccine / Dropping of the cholesterol level) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, Low density lipoprotein: 176 (High) 176. In 2021, Low density lipoprotein: decreased (Low) cholesterol levels have decreased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. Patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine.  The low-density lipoprotein Cholesterol was at 176 initially and the last test done 10 days after the vaccine showed significant decrease in cholesterol levels. The patient reported that there were blood tests and medical records to prove the correlation.  No treatment medication were provided.   This case was linked to MOD-2022-564739, MOD-2022-564749, MOD-2022-564750 (Patient Link).
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood cholesterol decreased, Low density lipoprotein, Pain in extremity, Somnolence, Therapeutic response unexpected
Clinical narrative: drowsiness; sore arm; Bad Cholesterol went down / Good Cholesterol went up/ cholesterol levels have decreased significantly after each dose of the Moderna COVID-19 vaccine / Dropping of the cholesterol level; This spontaneous case was reported by an other health care professional and describes the occurrence of SOMNOLENCE (drowsiness), PAIN IN EXTREMITY (sore arm) and THERAPEUTIC RESPONSE UNEXPECTED (Bad Cholesterol went down / Good Cholesterol went up/ cholesterol levels have decreased significantly after each dose of the Moderna COVID-19 vaccine / Dropping of the cholesterol level) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (had Covid in 2020 and first initial drop in cholesterol was noticed) in 2020. Concurrent medical conditions included Drug allergy and High cholesterol.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced SOMNOLENCE (drowsiness), PAIN IN EXTREMITY (sore arm) and THERAPEUTIC RESPONSE UNEXPECTED (Bad Cholesterol went down / Good Cholesterol went up/ cholesterol levels have decreased significantly after each dose of the Moderna COVID-19 vaccine / Dropping of the cholesterol level). At the time of the report, SOMNOLENCE (drowsiness), PAIN IN EXTREMITY (sore arm) and THERAPEUTIC RESPONSE UNEXPECTED (Bad Cholesterol went down / Good Cholesterol went up/ cholesterol levels have decreased significantly after each dose of the Moderna COVID-19 vaccine / Dropping of the cholesterol level) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, Low density lipoprotein: 176 (High) 176. In 2021, Low density lipoprotein: decreased (Low) cholesterol levels have decreased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. Patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine.  The low-density lipoprotein Cholesterol was at 176 initially and the last test done 10 days after the vaccine showed significant decrease in cholesterol levels. The patient reported that there were blood tests and medical records to prove the correlation.  No treatment medication were provided.   This case was linked to MOD-2022-564739, MOD-2022-564749, MOD-2022-564750 (Patient Link).
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Low density lipoprotein, Pain in extremity, Somnolence, Therapeutic response unexpected
Clinical narrative: drowsiness; sore arm; Bad Cholesterol went down / Good Cholesterol went up/ cholesterol levels have decreased significantly after each dose of the Moderna COVID-19 vaccine / Dropping of the cholesterol level; This spontaneous case was reported by an other health care professional and describes the occurrence of SOMNOLENCE (drowsiness), PAIN IN EXTREMITY (sore arm) and THERAPEUTIC RESPONSE UNEXPECTED (Bad Cholesterol went down / Good Cholesterol went up/ cholesterol levels have decreased significantly after each dose of the Moderna COVID-19 vaccine / Dropping of the cholesterol level) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (had Covid in 2020 and first initial drop in cholesterol was noticed) in 2020. Concurrent medical conditions included Drug allergy and High cholesterol.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced SOMNOLENCE (drowsiness), PAIN IN EXTREMITY (sore arm) and THERAPEUTIC RESPONSE UNEXPECTED (Bad Cholesterol went down / Good Cholesterol went up/ cholesterol levels have decreased significantly after each dose of the Moderna COVID-19 vaccine / Dropping of the cholesterol level). At the time of the report, SOMNOLENCE (drowsiness), PAIN IN EXTREMITY (sore arm) and THERAPEUTIC RESPONSE UNEXPECTED (Bad Cholesterol went down / Good Cholesterol went up/ cholesterol levels have decreased significantly after each dose of the Moderna COVID-19 vaccine / Dropping of the cholesterol level) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, Low density lipoprotein: 176 (High) 176. In 2021, Low density lipoprotein: decreased (Low) cholesterol levels have decreased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. Patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine.  The low-density lipoprotein Cholesterol was at 176 initially and the last test done 10 days after the vaccine showed significant decrease in cholesterol levels. The patient reported that there were blood tests and medical records to prove the correlation.  No treatment medication were provided.   This case was linked to MOD-2022-564739, MOD-2022-564749, MOD-2022-564750 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory failure, COVID-19, Condition aggravated, Dyspnoea
Clinical narrative: update to previous report (e report # 841885)- updating with pt death 5/15/22 PRINCIPAL DIAGNOSIS Respiratory Failure With Hypoxia
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Respiratory failure
Clinical narrative: update to previous report (e report # 841885)- updating with pt death 5/15/22 PRINCIPAL DIAGNOSIS Respiratory Failure With Hypoxia
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dizziness, Feeling hot, Tachycardia
Clinical narrative: Became hot; Tachycardic; Lightheaded; Rather weak-feeling starting approx. 10 minutes after the injection/lasting only about 10 mins the first time; This spontaneous case was reported by a physician and describes the occurrence of FEELING HOT (Became hot), TACHYCARDIA (Tachycardic), DIZZINESS (Lightheaded) and ASTHENIA (Rather weak-feeling starting approx. 10 minutes after the injection/lasting only about 10 mins the first time) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20a) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced FEELING HOT (Became hot), TACHYCARDIA (Tachycardic), DIZZINESS (Lightheaded) and ASTHENIA (Rather weak-feeling starting approx. 10 minutes after the injection/lasting only about 10 mins the first time). On 14-Feb-2021, FEELING HOT (Became hot), TACHYCARDIA (Tachycardic), DIZZINESS (Lightheaded) and ASTHENIA (Rather weak-feeling starting approx. 10 minutes after the injection/lasting only about 10 mins the first time) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient neither had allergies nor was tested COVID positive.  It was reported that there was no history related to adverse event and both Acute and Chronic illnesses at the time of vaccination. Patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine.  The patient became hot, tachycardic then lightheaded and rather felt weak starting approximately 10 minutes after the injection. The reaction lasted only for about 10 minutes. The patient suspected the vaccine ingredient tromethamine for the cause of adverse reaction.   The patient did not seek medical care and no treatment medications were reported.   This case was linked to MOD-2022-566669, MOD-2022-566670 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2022: Patient demographic details, suspect drug details updated.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: Sore arm / left arm got sore; Severe chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Severe chills) and PAIN IN EXTREMITY (Sore arm / left arm got sore) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A and 012M20A) for COVID-19 vaccination. No Medical History information was reported. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2022 at 1:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (Severe chills). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm / left arm got sore). At the time of the report, CHILLS (Severe chills) had not resolved and PAIN IN EXTREMITY (Sore arm / left arm got sore) outcome was unknown. No concomitant medication was provided. On 17-Nov-2021, the patient got first booster dose. The patient got second booster (Moderna) around 10:30 am  on 11-May-2022. No treatment medication was provided. Most recent FOLLOW-UP information incorporated above includes: On 12-May-2022: Follow-Up includes no new information.
Sex: U
Vaccine: HPV9
Symptoms: Product dose omission issue
Clinical narrative: a patient missed their second dose in the GARDASIL 9 series; No additional AE reported; This spontaneous report was received from a health care professional referring to a currently 25-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported. It was confirmed that the patient was not enrolled in any program.   On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, frequency, route, lot# and expiration date were not provided) for prophylaxis.   On an unknown date, the patient missed the second dose in the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) series (product dose omission issue). No additional information was reported to confirm the date of the missed dose or to clarify any additional information related to the adverse event (AE). No additional AE reported.
Age: 0.42
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; improperly stored vaccine was administered; This spontaneous report was received from an office manager referring to a 5-month-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.   On 28-APR-2022, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot #T042013, expiration date: 22-JUL-2023 (strength, dose and route of administration were not provided) for prophylaxis (product storage error). No additional adverse event (AE) reported.  The administered dose of the vaccine experienced a temperature excursion in 11.43 degrees Celsius (C) for 4 hours and 45 minutes. There was no previous temperature excursion.   This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2205USA002848: US-009507513-2205USA002913: US-009507513-2205USA002951: US-009507513-2205USA002965: US-009507513-2205USA002988: US-009507513-2205USA003043: US-009507513-2205USA003118: US-009507513-2205USA003121: US-009507513-2205USA003266:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 6 patients administered with expired vaccines; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 patients administered with expired vaccines) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 012H21B) for an unknown indication.     No Medical History information was reported.    On 13-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 patients administered with expired vaccines). On 13-Apr-2022, EXPIRED PRODUCT ADMINISTERED (6 patients administered with expired vaccines) had resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported.  The reporter stated that they administered expired vaccines to 6 patients on 13Apr2022. Lot number from expired vials is 012H21B, and expiry date from this vial is 18Mar2022.  No AEs were reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever that lasted 24 h; chills that lasted 24 h; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever that lasted 24 h) and CHILLS (chills that lasted 24 h) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever that lasted 24 h) and CHILLS (chills that lasted 24 h). At the time of the report, PYREXIA (fever that lasted 24 h) and CHILLS (chills that lasted 24 h) had resolved.            Patient's regular medication included blood thinner medication . No treatment  medications were reported. Patient enquired if she can receive the 2nd booster and if she can receive Pfizer instead of Moderna for the 2nd booster.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Vaccine beyond the manufacturer's expiration date-3rd patient 10MAY2022/Two patients each received expired Moderna Covid-19 vaccine; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Vaccine beyond the manufacturer's expiration date-3rd patient 10MAY2022/Two patients each received expired Moderna Covid-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Vaccine beyond the manufacturer's expiration date-3rd patient 10MAY2022/Two patients each received expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Vaccine beyond the manufacturer's expiration date-3rd patient 10MAY2022/Two patients each received expired Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Reporter stated that two patients received Moderna Covid-19 vaccine which was expired. Date the vial was initially stored in the refrigerator was 13-APR-2022. The vial did not undergo any temperature excursions. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2022: Live Followup included primary and secondary reporter details and the date of vial was initially stored in the refrigerator was updated.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired dose of the Moderna COVID19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna COVID19 vaccine) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042j21a) for COVID-19 vaccination.     No Medical History information was reported.    In May 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna COVID19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna COVID19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Patient received booster dose.   It was reported that each vial was thawed the day before the appointment 3-May-2022, 07-May-2022 and 10-May-2022 and date of administration of vaccine was reported as 04-May-2022, 08-May-2022 and 11-May-2022.  Treatment information was not reported.   This case was linked to MOD-2022-565551, MOD-2022-565558 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2022: Followup received contains significant information. Added patient demographics, start date, dose number, dosage text of vaccine, event start date and updated inarrative supplement.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired doses of the Moderna COVID19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID19 vaccine) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     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. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  The date of administration 11-May-2022, 04-May-2022 and 08-May-2022.  Each vial (3 vails) was thawed the day before the appointment i.e. 03-May-2022, 07-May-2022 and 10-May-2022.  The vial did not undergo temperature excursion.  No treatment medications were provided.   This case was linked to MOD-2022-565558, MOD-2022-565522 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2022: Live Follow-up document received on 12-May-2022 contains significant information include patient details and suspect dose details added.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product administration error, Product storage error
Clinical narrative: vaccines,had emperature excursion with no reported adverse event; vaccines being given post temperature excursion with no reported adverse event; Initial information was received on 06-May-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 months old male patient, vaccines being given post temperature excursion with no reported adverse event and vaccines had temperature excursion with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant Vaccines included: Rotavirus vaccine; Pneumococcal vaccine CONJ 7V (CRM197) (Prevnar) and Hepatitis B vaccine for prophylactic vaccination.  On 04-May-2022, the patient received a dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine 0.5 ml (Batch number: UJ625AAA, expiration date: 07-Dec-2022) via intramuscular route in the right thigh for prophylactic vaccination.  On 04-May-2022, vaccines being given post temperature excursion with no reported adverse event (product administration error) (latency: same day). On an unknown date, vaccines had temperature excursion with no reported adverse event (product storage error) (unknown latency).  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown for the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 10.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: received Quadracel instead of a flu vaccination, with no reported adverse event; Initial information received on 10-May-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 10 years old female patient who experienced received quadracel instead of a flu vaccination, with no reported adverse event while receiving vaccine diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine [quadracel].  The patient's past vaccination(s) included DTAP in MAY-2016 and IPV in MAY-2016. The patient's past medical history and family history were not provided.  Concomitant medications included Influenza vaccine inact split 4v (fluzone quadrivalent) for Prophylactic vaccination.  On 09-May-2022, the patient received a  dose of suspect Diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine suspension of injection 0.5ml of lot C5862BA and unknown expiration date via intramuscular route in the right deltoid for immunization.  On 09-MAY-2022 the patient developed a non-serious received quadracel instead of a flu vaccination, with no reported adverse event (wrong product administered) following the administration of Diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine.  Action taken with Diphtheria, tetanus, ac pertussis and ipv vaccine (quadracel) was not applicable.  It was not reported if the patient received a corrective treatment for the event (received Quadracel instead of a flu vaccination, with no reported adverse event).  At time of reporting, the outcome was Unknown for the event received quadracel instead of a flu vaccination, with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: MNQ, YF
Symptoms: Drug interaction, Medication error, No adverse event, Product preparation error
Clinical narrative: medication error occurred due to a drug interaction, that the YF vaccine was given along with Menactra, instead of saline with no reported adverse event; Initial information received on 11-May-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who experienced medication error occurred due to a drug interaction and reported that the Yellow Fever Vaccine -  [Yf-Vax] was given along with meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra]  instead of saline with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect Yellow Fever Vaccine - , solution for injection (lot number not reported) via unknown route in unknown administration site was with meningococcal A-C-Y-W135 (D CONJ) vaccine, solution for injection (lot number not reported) via unknown route in unknown administration site for prophylactic vaccination which was reported as medication error occurred due to a drug interaction, that the yf vaccine was given along with menactra, instead of saline with no reported adverse event (product preparation error).  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event medication error occurred due to a drug interaction, that the yf vaccine was given along with menactra, instead of saline with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Impaired work ability, Interchange of vaccine products, Pyrexia
Clinical narrative: Significant fatigue occurring occasionally since Covid-19 vaccination #4.  Severe fatigue the day after vaccination (also including some minor feverish symptoms), less severe fatigue the following day, again today, and probably 2 other times since 4th  vaccination.  No treatment or evaluation has been attempted yet.  Possibly getting run down at all (lack of sleep) triggers this?  I had experienced no significant symptoms with the 3 prior Covid-19 vaccinations.  The first 2 were Pfizer, the last 2 were Moderna.  I believe this is the most severe fatigue I have experienced, at least in the last 40 years, without being obviously sick.  The day after 4th vaccination I had tremendous difficulty working my desk job.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Myalgia, Nausea, Vomiting
Clinical narrative: Nausea, Vomiting, Diarrhea, Headaches, and Muscle aches. Vomiting lasted 3 to 4 hours, Nausea was 2 to 3 days, and headaches was 2 days.
Age: 39.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Blood test abnormal, Type 1 diabetes mellitus
Clinical narrative: I don?t remember what kind of flu shot I had. I developed type 1 diabetes after having my 3rd Covid shot. I showed symptoms of diabetes about a month after vaccination and I was diagnosed in December 2021.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Erythema, Fatigue, Headache
Clinical narrative: Several hours after the shot on Friday morning my arm started to get sore and red and hot. Then it swelled. I got a headache later in the evening. I woke up that night with chills for a few hours. I was worn out the next day and had a fever so I spent most of the day resting in bed aching and sore and tired. The next day my arm was still sore and red and hot, the headache was less severe than the prior 2 days and the aching was better but now I was a bit lightheaded and nauseous. Day 4 early on in the morning I still have a bit of a headache and my arm is still red and hot and  sore.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Nausea, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Several hours after the shot on Friday morning my arm started to get sore and red and hot. Then it swelled. I got a headache later in the evening. I woke up that night with chills for a few hours. I was worn out the next day and had a fever so I spent most of the day resting in bed aching and sore and tired. The next day my arm was still sore and red and hot, the headache was less severe than the prior 2 days and the aching was better but now I was a bit lightheaded and nauseous. Day 4 early on in the morning I still have a bit of a headache and my arm is still red and hot and  sore.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Skin warm
Clinical narrative: Several hours after the shot on Friday morning my arm started to get sore and red and hot. Then it swelled. I got a headache later in the evening. I woke up that night with chills for a few hours. I was worn out the next day and had a fever so I spent most of the day resting in bed aching and sore and tired. The next day my arm was still sore and red and hot, the headache was less severe than the prior 2 days and the aching was better but now I was a bit lightheaded and nauseous. Day 4 early on in the morning I still have a bit of a headache and my arm is still red and hot and  sore.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Condition aggravated, Feeling abnormal, Herpes zoster
Clinical narrative: 3rd outbreak,,I'm so miserable; Blisters r back, go at it with a metal back scratcher; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included blister.   In April 2022, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a month after receiving Shingles vaccine, the patient experienced shingles and blister. On an unknown date, the outcome of the shingles and blister were recovered/resolved.   It was unknown if the reporter considered the shingles and blister to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 08-MAY-2022 Reporter's comment: This case was reported by a patient via interactive digital media. It was a 3rd outbreak, the patient was so miserable and was almost 60s, patients got the 1st shot a month prior to the reporting and blisters were back again all-over front shins on legs.  The patient literally goes at it with a metal back scratcher. The patient had never seen anything like this before. Sometimes patient want to just poof and be gone. seems nothing helps it stay gone Additional supportive information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: felt ill fir 2 days; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In April 2022, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 07-MAY-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received first vaccine last month of the reporting and really felt ill for 2 days. They said the 2nd was worse so would prepare to take a couple days to veg out next time. It was worth it though, did not want shingles. Additional supportive information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Just sore arm; This 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.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-MAY-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and experienced just sore arm. Additional supportive information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: COVID19
Symptoms: Supraventricular tachycardia
Clinical narrative: SUPRAVENTRICULAR TACHYCARDIA  (SVT); This spontaneous report received from a patient via social media via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported and expiry: Unknown) dose,1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced supraventricular tachycardia (SVT).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of supraventricular tachycardia (svt) was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220524538  -Covid-19 vaccine ad26.cov2.s -SUPRAVENTRICULAR TACHYCARDIA . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: Covid Relapse; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid Relapse) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Hypertension, Asthma and ADHD.   On 13-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2022, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 24-Apr-2022, received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Covid Relapse). At the time of the report, COVID-19 (Covid Relapse) was resolving.            Additional Past drug reported as no and reaction as allergy. No concomitant medications were reported. The patient was taking other unspecified medications/products within 2 weeks of starting COVID-19 treatment.  Company comment: This spontaneous case concerns a 43-year-old, female patient with medical history of Hypertension and Asthma, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 167 days after administration of third dose of mRNA-1273. The patient was administered with two doses of Pfizer 5 days prior to the event, the interval between the two doses is 5 days. The events were conservatively considered as related since the temporal association cannot be assessed/excluded due to the limited information available. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 43-year-old, female patient with medical history of Hypertension and Asthma, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 167 days after administration of third dose of mRNA-1273. The patient was administered with two doses of Pfizer 5 days prior to the event, the interval between the two doses is 5 days. The events were conservatively considered as related since the temporal association cannot be assessed/excluded due to the limited information available. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Hypoaesthesia, Paraesthesia, Pharyngeal swelling
Clinical narrative: anaphylaxis ended up in the hospital; swelling of the throat; tingling; numbness; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (anaphylaxis ended up in the hospital), PHARYNGEAL SWELLING (swelling of the throat), PARAESTHESIA (tingling) and HYPOAESTHESIA (numbness) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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. In 2021, the patient experienced ANAPHYLACTIC REACTION (anaphylaxis ended up in the hospital) (seriousness criteria hospitalization and medically significant), PHARYNGEAL SWELLING (swelling of the throat) (seriousness criterion hospitalization), PARAESTHESIA (tingling) (seriousness criterion hospitalization) and HYPOAESTHESIA (numbness) (seriousness criterion hospitalization). At the time of the report, ANAPHYLACTIC REACTION (anaphylaxis ended up in the hospital), PHARYNGEAL SWELLING (swelling of the throat), PARAESTHESIA (tingling) and HYPOAESTHESIA (numbness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.  It was reported that patient was on late 20s.  Company Comment: This spontaneous case concerns a female patient in her late 20s, with no reported medical history, who experienced expected, serious (hospitalization and medically significant) event of anaphylactic reaction together with unexpected, serious (hospitalization) events of pharyngeal swelling, paraesthesia and hypoaesthesia, after receiving a dose of mRNA-1273 on an unknown date.  Hospitalization details including clinical course, concomitant medications, and treatment details were not reported.  The outcome of the events was unknown.  The benefit risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient in her late 20s, with no reported medical history, who experienced expected, serious (hospitalization and medically significant) event of anaphylactic reaction together with unexpected, serious (hospitalization) events of pharyngeal swelling, paraesthesia and hypoaesthesia, after receiving a dose of mRNA-1273 on an unknown date.  Hospitalization details including clinical course, concomitant medications, and treatment details were not reported.  The outcome of the events was unknown.  The benefit risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Vaccine beyond the manufacturer's expiration date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Vaccine beyond the manufacturer's expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Vaccine beyond the manufacturer's expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Vaccine beyond the manufacturer's expiration date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported.  Vial did not undergo any temperature excursions.  The vial was initially stored in the refrigerator on 13 APR 2022.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2022: Live follow-up added: Reporter added, initial reporter address, the date of vial was initially stored in the refrigerator was updated
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received expired doses of the Moderna COVID19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired doses of the Moderna COVID19 vaccine) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042j21a) for COVID-19 vaccination.     No Medical History information was reported.    In May 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired doses of the Moderna COVID19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received expired doses of the Moderna COVID19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. The type of dose was reported as a booster dose. Each vial was thawed the day before the appointment 3-May-2022, 07-May-2022 and 10-May-2022 Dates of administration of vaccine were 11-May2022, 4-May-2022, 8-May-2022 The vial did not undergo any temperature excursions. No treatment information were provided.   This case was linked to MOD-2022-565522, MOD-2022-565551 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2022: Significant follow-up received : Added patient demographics and type of dose as booster.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore left injection site arm.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm.) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001J21-2A, 017C21A and 030C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2022, the patient experienced VACCINATION SITE PAIN (sore left injection site arm.). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm.) outcome was unknown.            No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.   This case was linked to MOD-2022-565868, MOD-2022-566260 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2022: Follow-up received contain No new information