chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Patient reported developing new onset atrial fibrillation after receiving comarnity; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "Patient reported developing new onset atrial fibrillation after receiving comarnity".  Additional information: Patient reported developing new onset atrial fibrillation after receiving comarnity. Patient's cardiologist commented that he has seen a lot of new onset afib in patients and believes it to be related to the Pfizer Covid vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A contributory role of BNT162B2 to event atrial fibrillation cannot be excluded based on temporal association and available information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: Has them now, was given 2nd shot twice/ Suspected vaccination failure; Has them now, was given 2nd shot twice; 2nd shot given twice; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 16-FEB-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The reporters husband had them now and reporter believe because patient received 2nd shot twice. The reporter reported that they did not read the records and gave it to patient. The reporter was furious not sure how she going to handle this. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The patient had received the 2nd dose of Shingrix twice, which led to extra dose administered. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Malignant hypertension
Clinical narrative: she developed symptoms of malignant hypertension; She feared she was having a stroke; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  An adult (also reported as in her 40s) female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: MALIGNANT HYPERTENSION (medically significant), outcome "unknown", described as "she developed symptoms of malignant hypertension"; CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "She feared she was having a stroke". The events "she developed symptoms of malignant hypertension" and "she feared she was having a stroke" required emergency room visit. Therapeutic measures were taken as a result of malignant hypertension, cerebrovascular accident; patient had to be on a blood pressure medication.  Clinical course: It was reported that patient feels that the malignant hypertension started after the booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cerebrovascular accident, Pulmonary thrombosis, Seizure, Vaccination failure
Clinical narrative: lungs filled up with blood clots; seizures; strokes; Covid; Covid; This is a spontaneous report received from a contactable reporter (Consumer).  An 83-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (death, medically significant), COVID-19 (death, medically significant) all with onset 03Jan2023, outcome "fatal" and all described as "Covid"; PULMONARY THROMBOSIS (death, hospitalization, medically significant), outcome "fatal", described as "lungs filled up with blood clots"; SEIZURE (death, hospitalization, medically significant), outcome "fatal", described as "seizures"; CEREBROVASCULAR ACCIDENT (death, hospitalization, medically significant), outcome "fatal", described as "strokes". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient date of death was unknown. Reported causes of death: "lungs filled up with blood clots", "seizures", "strokes", "Covid". It was not reported if an autopsy was performed.  Clinical course information: Reporter's mother (patient) who was 83yrs old was vaccinated and her lungs filled up with blood clots and she had multiple seizures/strokes. She was hospitalized for a month. They had to move her to (Place withheld) with him/her which crippled him/her financially and mentally as a full-time caregiver. Reporter's mother continued to have seizures/blood clots/strokes which she has never had before in her life. On 03Jan2023, she contracted Covid and was given Paxlovid started bleeding and died. The reporter took Paxlovid and he/she too was bleeding he/she needs help ASAP.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: lungs filled up with blood clots; seizures; strokes; Covid; Covid
Sex: U
Vaccine: COVID19
Symptoms: General physical health deterioration, Impaired quality of life, Injury, Suicidal ideation
Clinical narrative: have even contemplated suicide; vaccine injured; my health continuing declining; You ruined my life; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUICIDAL IDEATION (medically significant, life threatening), outcome "unknown", described as "have even contemplated suicide"; INJURY (non-serious), outcome "unknown", described as "vaccine injured"; GENERAL PHYSICAL HEALTH DETERIORATION (non-serious), outcome "unknown", described as "my health continuing declining"; IMPAIRED QUALITY OF LIFE (non-serious), outcome "unknown", described as "You ruined my life". Additional information: Reporter stated "You ruined my life I hope who ever reads this knows the suffering this company has brought me. We are the vaccine injured and we have zero support instead we are being gaslighted by the medical professionals. You knew and hid the data. I was a healthy 23m and have even contemplated suicide. Due to the lack of support and my health continuing declining. We are real not rare."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Raynaud's phenomenon
Clinical narrative: raynauds; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RAYNAUD'S PHENOMENON (non-serious), outcome "unknown", described as "raynauds".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Lung disorder
Clinical narrative: Ruined my lungs; Made me weak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LUNG DISORDER (non-serious), outcome "unknown", described as "Ruined my lungs"; ASTHENIA (non-serious), outcome "unknown", described as "Made me weak".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Nausea, Pain
Clinical narrative: did not eat for 2 days; feverish; she had a severe headache; chills; body aches; nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-RA-000000150 (RA).  A 61-year-old female patient received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 19Mar2021 at 01:00, outcome "unknown", described as "body aches"; CHILLS (non-serious) with onset 19Mar2021 at 01:00, outcome "unknown"; PYREXIA (non-serious) with onset 19Mar2021 at 01:00, outcome "unknown", described as "feverish"; NAUSEA (non-serious) with onset 19Mar2021 at 01:00, outcome "unknown"; HEADACHE (non-serious) with onset 19Mar2021 at 01:00, outcome "unknown", described as "she had a severe headache"; DECREASED APPETITE (non-serious), outcome "unknown", described as "did not eat for 2 days". Additional information: the patient started treatment on 19Mar2021, 08Apr2021 and 11Oct2021 with Pfizer BioNTech Covid-19 Vaccine dose 1, dose 2 and dose 3 (reported as booster) respectively for COVID-19 immunisation. It was reported that on 19Mar2021, after the first dose of Pfizer, the individual was feverish and at 1am that morning, she had a severe headache, chills, body aches and nausea. She also did not eat for 2 days.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: did not eat for 2 days; feverish; she had a severe headache; chills; body aches; nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-RA-000000150 (RA).  A 61-year-old female patient received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 19Mar2021 at 01:00, outcome "unknown", described as "body aches"; CHILLS (non-serious) with onset 19Mar2021 at 01:00, outcome "unknown"; PYREXIA (non-serious) with onset 19Mar2021 at 01:00, outcome "unknown", described as "feverish"; NAUSEA (non-serious) with onset 19Mar2021 at 01:00, outcome "unknown"; HEADACHE (non-serious) with onset 19Mar2021 at 01:00, outcome "unknown", described as "she had a severe headache"; DECREASED APPETITE (non-serious), outcome "unknown", described as "did not eat for 2 days". Additional information: the patient started treatment on 19Mar2021, 08Apr2021 and 11Oct2021 with Pfizer BioNTech Covid-19 Vaccine dose 1, dose 2 and dose 3 (reported as booster) respectively for COVID-19 immunisation. It was reported that on 19Mar2021, after the first dose of Pfizer, the individual was feverish and at 1am that morning, she had a severe headache, chills, body aches and nausea. She also did not eat for 2 days.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 18.0
Sex: U
Vaccine: FLUX
Symptoms: Myasthenia gravis crisis, Refusal of vaccination
Clinical narrative: myasthenia gravis crisis; Initial information received on 15-Feb-2023 regarding an unsolicited valid  serious case received from a pharmacist.  This case involves a 18 years old and unknown gender patient who had myasthenia gravis crisis after receiving vaccine Influenza Vaccine (Quadrivalent).  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date (Last September), the patient received an unknown dose of suspect influenza vaccine (quadrivalent) (strength, formulation, produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination. Information for batch and expiry date was requested.  On an unknown date the patient developed a serious event of myasthenia gravis crisis (latency: unknown) following the administration of influenza vaccine (quadrivalent). Patient refuses mRNA COVID booster.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.   Outcome: Unknown  Seriousness criteria: Medically significant.; Sender's Comments: Sanofi company comment dated 21-Feb-2023: This case involves a 18 years old and unknown gender patient who had myasthenia gravis crisis after receiving vaccine Influenza Vaccine (Quadrivalent). The time to onset is not reported with the role of the vaccine. Patient's past medical history was unknown. Additional information regarding condition at the time of vaccination, concurrent condition, medical history, past vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Age: 0.08
Sex: M
Vaccine: UNK
Symptoms: Medication error, No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: Lowest temperature it reached was 30.9F for a total duration out of range of 4 hours and 30 minutes with no reported adverse event; administered Pentacel after temperature excursion deemed vaccines non-viable for usage with no reported AE; Initial information received on 15-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an 1 month old male patient who was administered Diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine (Pentacel) after temperature excursion deemed vaccines non-viable for usage with no reported AE (adverse event) and lowest temperature it reached was 30.9f for a total duration out of range of 4 hours and 30 minutes with no reported adverse event  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis B vaccine (hepatitis B vaccine) for Prophylactic vaccination.  On 13-Feb-2023, the patient received a dose of suspect diphtheria, tetanus, AC pertussis, IPV and HIB vaccine (Suspension for injection) lot UJ671AA (expiry date: 15-Mar-2023) via intramuscular route in the right vastus lateralis for immunization (strength: unknown).  On an unknown date lowest temperature it reached was 30.9f for a total duration out of range of 4 hours and 30 minutes with no reported adverse event (Product storage error) (latency-same day).  On 13-Feb-2023, the patient was administered pentacel after temperature excursion deemed vaccines non-viable for usage with no reported ae (poor quality product administered) (unknown latency).  Action taken: not applicable  Outcome was Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Additional information was received on 15-Feb-2023- Patient age, new event (lowest temperature it reached was 30.9f for a total duration out of range of 4 hours and 30 minutes with no reported adverse event (Product temperature excursion issue) and event onset date were added. Text amended accordingly.; Sender's Comments:  01493844   : 01493845:
Age: 1.0
Sex: M
Vaccine: UNK
Symptoms: Medication error, No adverse event, Poor quality product administered
Clinical narrative: inadvertently administered a dose of Pentacel that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees F with no reported adverse event; Initial information received on 15-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old male patient  who was inadvertently administered with a dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees f with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis A vaccine (Hepatitis A) and pneumococcal vaccine conj 7V (CRM197) (Prevnar) both for Prophylactic vaccination.  On 09-Feb-2023, the patient inadvertently administered  0.5 ml (dose 4) (total) dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine  (lot UJ682AAA: strength, formulation and expiry date not reported) via intramuscular route in the left leg (left thigh) for prophylactic vaccination that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees f with no reported adverse event (poor quality product administered) (latency: same day). Vaccines that had undergone temperature excursion down to 30 degrees F for 3 hours and 15 minutes, due to a refrigerator malfunction.  Action taken : not applicable.  Outcome :  Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2023SA057388:01493585 US-SA-2023SA056927:01493871 US-SA-2023SA057103:01493882 US-SA-2023SA055684:01493896 US-SA-2023SA057080:01493906 US-SA-2023SA057083:01495050 US-SA-2023SA057086:1495112 US-SA-2023SA056079:01495161 US-SA-2023SA057474:01495184 US-SA-2023SA057197:01495203 US-SA-2023SA057226:01495215 US-SA-2023SA056292:01495279 US-SA-2023SA056689:01495295
Age: 1.0
Sex: F
Vaccine: UNK
Symptoms: Medication error, Poor quality product administered, Product storage error
Clinical narrative: inadvertently administered a dose of pentacel that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees with no adverse event reported; inadvertently administered a dose of Pentacel that had been exposed to temperatures lower than recommended for 3 hours and 15 min, reaching a minimum temp of 30 deg F with no reported AE; Initial information was received on 15-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 1 years old female patient who inadvertently administered a dose of pentacel that had been exposed to temperatures lower than recommended for 3 hours and 15 min, reaching a minimum temp of 30 deg f with no reported adverse event after receiving diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [pentacel (vero).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 7V (CRM197) (PREVNAR) for Prophylactic vaccination.  On 09-Feb-2023, the patient received a dose 4 of 0.5 ml of suspect  diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine (Suspension for injection) (lot UJ682AAA) (with unknown expiry date) via intramuscular route in left leg for immunization.  On 09-Feb-2023 the patient developed a non-serious event of inadvertently administered a dose of pentacel that had been exposed to temperatures lower than recommended for 3 hours and 15 min, reaching a minimum temp of 30 deg f with no reported ae (poor quality product administered) (latency: same day) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine.  On an unknown date the patient developed a non-serious event of inadvertently administered a dose of pentacel that had been exposed to temperatures lower than recommended for 3 hours and 15 min, reaching a minimum temp of 30 deg f with no reported ae (product storage error) (unknown latency).  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event inadvertently administered a dose of pentacel that had been exposed to temperatures lower than recommended for 3 hours and 15 min, reaching a minimum temp of 30 deg f 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.; Sender's Comments:  US-SA-2023SA056272:01495184
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: inadvertently administered a dose of quadracel that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees F with no reported adverse event; inadvertently administered a dose of quadracel that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees F with no reported adverse event; Initial information was received on 15-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 4 years old male patient who was inadvertently administered a dose of quadracel that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees f with no reported adverse event after receiving diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine live (enders-edmonston), mumps vaccine live (jeryl lynn), rubella vaccine live (wistar ra 27/3), varicella zoster vaccine live (oka/merck) (Proquad) for Prophylactic vaccination.  On 10-Feb-2023, the patient received a dose 5 of 0.5 ml of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine (Suspension for injection) (lot: C6002BA) (expiry date, strength, frequency was unknown) via intramuscular route in the left deltoid for Immunisation.  On 10-Feb-2023 the patient developed a non-serious event of quadracel that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees f with no reported adverse event (product storage error) and (poor quality product administered) same day following the administration of diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was 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: 8.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: QUADRACEL was given to an 8-year-old male patient with no reported adverse event; patient was running behind with his routine vaccinations due to having Leukemia with no adverse event.; Initial information received on 16-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 8 years old male patient who was adminstered Diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine [Quadracel] with no reported adverse event (product administered to patient of inappropriate age) and patient was running behind with his routine vaccinations due to having Leukemia with no adverse event(Inappropriate schedule of product administration)   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation.  On an unknown date, the patient received suspect Diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine Suspension for injection at dose of 0.5 ml dose 5 (strength not reported) (lot C6002BA and expiry date- 18-May-2024) via intramuscular route in unknown administration site for Immunization.  On an unknown date,8 years old male patient who was adminstered Diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine [Quadracel] with no reported adverse event (product administered to patient of inappropriate age) and patient was running behind with his routine vaccinations due to having Leukemia with no adverse event(Inappropriate schedule of product administration)   It was reported that Medical Assistant was calling to report that a QUADRACEL was given to an 8-year-old male patient due to the patient being behind with his routine vaccinations due to having Leukemia and currently in remission.    Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event quadracel was given to an 8-year-old male patient.  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.
Sex: U
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Patients delayed in getting the other twinrix doses; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient did not  receive Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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: 10-Feb-2023 Reporter's comment:  The case was reported by the nurse. The nurse reported that they had patients that came in off schedule. In a case where a patient was delayed in getting the other Twinrix vaccines, the nurse asked if they have to start over, or was there a max time where the patient could be delayed between all doses. Additional supportive information: As patient did not received their next dose of twinrix which led to incomplete course of vaccination. Reporter consented to follow up.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram pulmonary abnormal, Cardiac disorder, Pulmonary embolism, SARS-CoV-2 test negative
Clinical narrative: Patient developed a large pulmonary embolism with right-sided heart strain.  COVID is negative.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough case  dose 1 Pfizer 3/5/21  EN6206 dose 2 Pfizer 3/26/21  ER2613
Age: 11.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Injection site pain
Clinical narrative: Administed 0.5 cc Moderna Bivalent covid booster to patient, age 11 on 2/10/23. Spoke w/mom @ 9 AM Sat. 2/11/23. Advised of dosage. Mom reported patient had normal soreness @ injection site/arm. Gave instructions to mom to observe, increase H2O, ice to arm, Tylenol or motrin, offered Pharmacist consult if desired. Mom declined.
Age: 9.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Administered 0.5 cc Moderna Bivalent Covid booster to patient, age 9 on 2/10/23. Spoke w/mom @ 900 AM Sat. 2/11/23. Advised of dosage. Mom reported no side effects at that time. Gave instructions to observe, increase H2O, ice to arm, Tylenol, Motrin, and offered Pharmacist consult if desired. Mom declined.
Age: 49.0
Sex: M
Vaccine: PNC13
Symptoms: Fatigue, Injection site rash, Injection site warmth, Pain, Pyrexia
Clinical narrative: HIGH FEVER 103+/EXTREME BODY ACHES FEVER BEGAN LESS THAN 24 HOURS AFTER INJECTION AND LASTED FOR APPROXIMATELY THREE DAYS. BODY ACHES SUBSIDED AFTER TWO DAYS. OVERALL FEELING OF TIREDNESS/ACHES THROUGHOUT BODY RASH AT AND AROUND INJECTION SITE/FELT WARM TO TOUCH FOR APPROXIMATELY FOUR DAYS AFTER INJECTION. I AM NOT SURE WHICH TYPE OF PNEUMOCOCCAL CONJUGATE VACCINE I RECEIVED AT THE OFFICE.  I AM GUESSING IT WAS THE PREVNAR 13 DUE TO MY ASTHAMA. I CALLED MY DOCTOR THE NEXT DAY AND ADVISED OF MY CONDITION.
Age: 49.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Medication error, Product storage error
Clinical narrative: Medication error. Vaccine not viable due to improper storage temperature.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Immediate post-injection reaction, Induration, Injection site pain
Clinical narrative: 1/24/22 I had my shot that afternoon. I had severe arm pain in my upper left arm immediately. Later it became swollen, red, and it was a hard knot. My fever went up to 101 for one day. I felt nauseated and had a headache. The main symptoms lasted a few days and my arm hurt for around 5 days.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Nodule, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: 1/24/22 I had my shot that afternoon. I had severe arm pain in my upper left arm immediately. Later it became swollen, red, and it was a hard knot. My fever went up to 101 for one day. I felt nauseated and had a headache. The main symptoms lasted a few days and my arm hurt for around 5 days.
Age: 10.0
Sex: F
Vaccine: HEPA
Symptoms: Chills, Dizziness, Feeling cold, Feeling hot, Hyperhidrosis
Clinical narrative: Immediately leaving room and entering waiting area to check out she became hot and sweating, turned pale, shakey and felt like she was going to pass out with extreme thirst and a rash on arm.  Twenty minutes later she became cold and shivering.
Age: 10.0
Sex: F
Vaccine: HEPA
Symptoms: Pallor, Rash, Thirst, Tremor
Clinical narrative: Immediately leaving room and entering waiting area to check out she became hot and sweating, turned pale, shakey and felt like she was going to pass out with extreme thirst and a rash on arm.  Twenty minutes later she became cold and shivering.
Age: 32.0
Sex: M
Vaccine: COVID19-2
Symptoms: Headache, Hyperhidrosis, Loss of consciousness, Neck pain, Pallor
Clinical narrative: Patient was asked to wait for 15 minutes post vaccination . Patient needed to use the rest room . He passed out in the restroom . Came to conscious and informed staff that he passed out . This happened within 5 to 10 minutes of receiving  vaccination.He was pale . Offered ice pack and water . Patient started sweating profusely . Patient said his head/neck  was hurting. ( May have hit head ).BP when checked by RPh showed 150/85 HR 81. All vitals were stable when EMS arrives. Patient did not go to hospital.
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Nasal congestion, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: A couple of weeks after getting the shot, I had a brief fever and nasal congestion at night. The fever only lasted about an hour, but the congestion lasted for some nights. I treated the nasal congestion with a nasal spray. I decided to take an at-home COVID-19 test on 12/22/2022 which came back positive. The next morning, I contacted my doctor to inform her on my positive test and was prescribed molnupiravir 200mg for treatment. After a couple of days of treatment, I made a pretty fast recovery and doing well now.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pfizer 1/5/21, 2/19/21, 10/22/21, 5/17/22, 11/9/22. Positive on 2/21/23
Age: 42.0
Sex: M
Vaccine: COVID19-2
Symptoms: Medication error, Product storage error
Clinical narrative: Medication error. Vaccine not viable due to improper temperature storage.
Age: 26.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: pfizer bivalent was stored from ultracold to freezer on 11/08/22.
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Pt was given first dose of Moderna primary series on 1/25/23.  Instead of getting her second dose in the primary series she was given the Moderna Bivalent on 2/17/23.
Age: 62.0
Sex: M
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: pfizer bivalent vaccine was stored in freezer on 11/08/22.
Age: 46.0
Sex: M
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: pfizer bivalent vaccine was stored in freezer on 11/08/22.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID-19
Age: 16.0
Sex: F
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: Pfizer bivalent vaccine was stored in freezer on 11/08/22.
Age: 33.0
Sex: F
Vaccine: COVID19-2, PNC20
Symptoms: Medication error, Product storage error
Clinical narrative: Medication error. Vaccine not viable due to improper temperature storage,
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: Pfizer bivalent vaccine was stored in freezer on 11/08/22.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Bronchitis bacterial, Chest X-ray normal, Cough, Lymphadenopathy
Clinical narrative: May of 2022- After having COVID in April of 2022, (VAERS report made for COVID after 3rd vaccine).  At the beginning of May, I presented with a cough and nasal drainage.  It got progressively worse, and I contacted my doctor.  On 5/12/22 I had a telehealth and diagnosed with bacteria bronchitis.  I was put on Doxycycline for 7 days, Codeine Cough syrup and Ibuprofen. On 5/24/22 I had a telehealth and diagnosed with a sinus infection and still had the bacteria bronchitis. I was started on Amoxicillin for 7 days.  I went to the doctor on 11/28/22 for a sinus infection and bronchitis.  I had a swollen gland on my left jaw. I was given benzonatate for cough. I had a chest x-ray which was normal, no pneumonia.  Two weeks ago, I got Bronchitis again. I used the benzonatate I had left over and took Mucinex, Dayquil and Nyquil.   I did not call the doctor. I continue to have a lingering cough.  I have bouts of Bronchitis since May of 22 , about every two months, but do not go to the doctor every time. I am a former smoker.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sinusitis
Clinical narrative: May of 2022- After having COVID in April of 2022, (VAERS report made for COVID after 3rd vaccine).  At the beginning of May, I presented with a cough and nasal drainage.  It got progressively worse, and I contacted my doctor.  On 5/12/22 I had a telehealth and diagnosed with bacteria bronchitis.  I was put on Doxycycline for 7 days, Codeine Cough syrup and Ibuprofen. On 5/24/22 I had a telehealth and diagnosed with a sinus infection and still had the bacteria bronchitis. I was started on Amoxicillin for 7 days.  I went to the doctor on 11/28/22 for a sinus infection and bronchitis.  I had a swollen gland on my left jaw. I was given benzonatate for cough. I had a chest x-ray which was normal, no pneumonia.  Two weeks ago, I got Bronchitis again. I used the benzonatate I had left over and took Mucinex, Dayquil and Nyquil.   I did not call the doctor. I continue to have a lingering cough.  I have bouts of Bronchitis since May of 22 , about every two months, but do not go to the doctor every time. I am a former smoker.
Age: 15.0
Sex: F
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: pfizer bivalent vaccine was stored in freezer on 11/08/22.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Administered vaccine to patient, after administration realized patient had already received a Moderna bivalent. Patient was unaware of vaccines received prior and only one vaccine card was visible prior to vaccination. Patient has now had two Moderna bivalent vaccines. Patient was not having any symptoms and is aware of situation.
Age: 14.0
Sex: F
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: pfizer bivalent vaccine was stored in the freezer on 11/08/22.
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: pfizer bivalent vaccine was stored in freezer on 11/08/22.
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: pfizer bivalent vaccine was stored in freezer on 11/08/22.
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: pfizer bivalent vaccine was stored in freezer on 11/08/22.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Condition aggravated, Dystonia, Eczema, Eye irritation
Clinical narrative: palpitations, chest pain,  high BP, fatigue, increased allergic response, burning eyes/swelling, increased blurred vision  eczema  exacerbation, worsening Dystonia (especially oromandibular) numbness/tingling lower legs/feet
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye swelling, Fatigue, Hypersensitivity, Hypertension, Hypoaesthesia
Clinical narrative: palpitations, chest pain,  high BP, fatigue, increased allergic response, burning eyes/swelling, increased blurred vision  eczema  exacerbation, worsening Dystonia (especially oromandibular) numbness/tingling lower legs/feet
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oromandibular dystonia, Palpitations, Paraesthesia, Vision blurred
Clinical narrative: palpitations, chest pain,  high BP, fatigue, increased allergic response, burning eyes/swelling, increased blurred vision  eczema  exacerbation, worsening Dystonia (especially oromandibular) numbness/tingling lower legs/feet
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Back pain, COVID-19, Chest X-ray abnormal, Cough, Fatigue
Clinical narrative: After I took the vaccine, I experienced lower back pain, fatigue, just feeling off. The next day it was the same just amplified. Even my cough was stronger. I decided to go to the urgent care afterwards where I was taken a chest Xray and was given amoxicillin to treat a raspatory infection. I was also diagnosed with COVID.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Feeling abnormal, Respiratory tract infection, SARS-CoV-2 test positive
Clinical narrative: After I took the vaccine, I experienced lower back pain, fatigue, just feeling off. The next day it was the same just amplified. Even my cough was stronger. I decided to go to the urgent care afterwards where I was taken a chest Xray and was given amoxicillin to treat a raspatory infection. I was also diagnosed with COVID.
Age: 65.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Medication error, Product storage error
Clinical narrative: Medication error. Vaccine not viable due to improper temperature storage.
Age: 46.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Death
Clinical narrative: Participant death 11/09/22
Age: 43.0
Sex: M
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: pfizer bivalent vaccine stored in freezer on 11/08/2022.
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: Pfizer bivalent vaccine was stored in freezer 11/08/22.
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pelvic pain, Vaginal haemorrhage
Clinical narrative: I experienced vaginal bleeding. I had had a hysterectomy many years ago, so this was abnormal. I contacted my doctor who had me to come in and explained the things I should watch for. I never experienced any of the symptoms he mentioned. However, I do still have vaginal bleeding with pelvic pain which I treat with a heating pad and over the counter medications. I was referred to an obstetrician/gynecologist for treatment. No medical test was performed but I do have upcoming appointments. I thought that this was due to the Endometriosis, but I am not sure.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Aortic root compression, Arthralgia, COVID-19, Communication disorder
Clinical narrative: I didn't feel good I was at work; I am a nurse, and I was trying to manage this was day 1 of five rotation. It started with a headache, and I had no appetite and I tried to force it was very bland. I had a peppermint patty, and I couldn't taste it. Then I went to the ER and I felt horrible I was having a hard time to keep my head up and I was sent home and they told me they would send the results. I was unable to walk around I had to crawl. I was so tired, and my body hurt so bad just extreme pain everywhere like in the joints. I thought the pain was because I wasn't sleeping in my bed. I tried to sleep on the floor on the sofa and the chair trying to find a way to get comfortable. I was called at 05:30 PM same day and told me I was positive. I was sent to get antibodies injections and I was given fluid hydration. This didn't help I had an appointment on the 18 of November and was told to go to the ER right away. I was then diagnosed aortic root high blood pressure and COVID lungs and pneumonia. I then prescribed an inhaler and antibiotics which helped. I have hypersensitivity to the body, and I couldn't wear jeans, bras, socks and I still fight with it but it's not as bad. I am also still having a brain fog where I can't recall certain things and I also can't multitask, and I have a hard time having conversations and keeping up. I have joined the COVID recovery program, which is 3 times a week which includes physical, pain, speech therapy. The program was about 8 weeks, but the speech was extended, and my husband passed away and that set me back. I then was given 6 weeks more to help me. I am still currently not working I had an evaluation because of the grief of losing my husband. I was also just told I couldn't go back to nursing after doing this for 28 years. I was also told I need to wear glasses and the treatment is as if I had a brain injury.