chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Thrombosis
Clinical narrative: Blood clots; Congestive heart failure; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  An 83-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, in 2022 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: THROMBOSIS (medically significant), outcome "unknown", described as "Blood clots"; CARDIAC FAILURE CONGESTIVE (medically significant), outcome "unknown", described as "Congestive heart failure". Clinical Course: Nurse described to me that her 83-year-old father developed blood clots after receiving the COVID vaccine in early 2022. She wasn't sure which vaccine he received but she was certain it was a result of the vaccine. The nurse also described other conditions that developed after receiving the COVID vaccine. She mentioned congestive heart failure.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events Thrombosis,congestive heart failure and the suspect drug cannot be excluded.  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: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID was mild: sore throat, congestion; COVID was mild: sore throat, congestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 13-year-old male 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; BNT162b2 (BNT162B2), in Sep2022 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID was mild: sore throat, congestion". Clinical course: 13-year old son received Pfizer vaccine Sep2022 and got COVID 4.5 months later Covid was mild: sold throat, congestion.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pulmonary embolism, Thrombosis
Clinical narrative: got my PE out of my lung; blood clots; 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), 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: PULMONARY EMBOLISM (medically significant), described as "got my PE out of my lung"; THROMBOSIS (medically significant), described as "blood clots". It was reported that the emergency room that the patient presented to, transferred the patient from one hospital to another via helicopter and got the patient's PE out of the lung with a hose. Also reported that the patient was plagued with blood clots and had to take Eliquis for the rest of the patient's life. The event "got my pe out of my lung" required emergency room visit. Therapeutic measures were taken as a result of pulmonary embolism, thrombosis. Outcome of the events was unknown.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : 202300034567 Same reporter/patient,diff drug;
Sex: F
Vaccine: COVID19-2
Symptoms: Feeling abnormal, Interchange of vaccine products, Off label use
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP), Program ID:  The reporter is the patient. An elderly 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: Moderna, for COVID-19 immunization, reaction(s): "no adverse effect". The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "I felt like I was being programed"; OFF LABEL USE (non-serious), outcome "unknown"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown".  Additional information: She felt like she was being programed. She had both types of COVID shots she reacted to Pfizer not to Moderna.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19-2
Symptoms: Cardiac disorder
Clinical narrative: 3 members of the family who had Heart problems after taking the vaccines; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:  An elderly male 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: CARDIAC DISORDER (non-serious), outcome "unknown", described as "3 members of the family who had Heart problems after taking the vaccines".  Additional information: The reporter mentioned that these vaccines are dangerous according to the news and it can be seen that all the healthy people are dying from heart failure. The reporter had 3 members of the family who had heart problems after taking the vaccines.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s) : PFIZER INC-202300034770 same reporter/vaccine/event, different patient; PFIZER INC-202300034771 same reporter/vaccine/event, different patient;
Sex: U
Vaccine: COVID19
Symptoms: Dysphonia
Clinical narrative: my voice became hoarse after getting the COVID-19 booster shot months ago; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) 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 but unknown manufacturer), for Covid-19 immunization. The following information was reported: DYSPHONIA (non-serious), outcome "unknown", described as "my voice became hoarse after getting the COVID-19 booster shot months ago".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Drug ineffective, Pyrexia, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; terrific cough; higher fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (COMIRNATY), on 29Mar2021 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Oct2021, outcome "unknown" and all described as "COVID-19"; PYREXIA (non-serious) with onset Oct2021, outcome "recovered" (2021), described as "higher fever"; COUGH (non-serious) with onset Oct2021, outcome "unknown", described as "terrific cough". Clinical course: the patient had typical symptoms he described as higher fever that lasted for about three days and then it broke. Then he had a terrific cough. The worst cough I have ever had even though he was vaccinated.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Ankle fracture, Loss of personal independence in daily activities
Clinical narrative: broken ankle; not able to work; 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 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 but unknown manufacturer), for COVID-19 immunization. The following information was reported: ANKLE FRACTURE (medically significant), outcome "unknown", described as "broken ankle"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (medically significant), outcome "unknown", described as "not able to work".  Clinical course: The patient got vaccinated and a booster. The patient has been having medical issues, from a broken ankle and not able to work.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), . The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2), as dose 1, 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: That all of her shots including the 3 boosters she had had were all Pfizer. She had absolutely no complications and only a sore arm after each shot. That made her want to always use the same pharma company going forward.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300035212 same patient/event, different vaccine dose;US-PFIZER INC-202300035213 same patient/event, different vaccine dose;US-PFIZER INC-202300035214 same patient/event, different vaccine dose;US-PFIZER INC-202300035215 same patient/event, different vaccine dose;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (COMIRNATY), in Sep2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Unknown results, notes: only tested because he was exposed to COVID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 9.0
Sex: F
Vaccine: FLU3, FLUR3
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: flublok inadvertently ordered, staff administered to six patients, should have been fluzone with no adverse event; flublok inadvertently ordered, staff administered to six patients, should have been fluzone with no adverse event; Initial information received on 17-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 9 years old female patient to whom influenza quadrivalent recombinant vaccine [Flublok] inadvertently ordered, staff administered to six patients, should have been influenza USP trival A-B subvirion no preservative vaccine [Fluzone] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant disease or risk factor and family history were not provided.  On 04-Jan-2023, the patient received 0.5 ml dose of suspect influenza quadrivalent recombinant vaccine (lot UJ93AA; strength, formulation, frequency, expiry date: unknown) via intramuscular route in unknown administration site for prophylactic vaccination.  On 04-JAN-2023 the flublok inadvertently ordered, staff administered to six patients, should have been fluzone with no adverse event (wrong product administered) (product administered to patient of inappropriate age) (latency: same day).  It is unknown if there were lab data/results available  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.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: sick; Initial information received on 22-Jan-2023 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves a patient of unknown age and gender who got sick after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant disease or risk factor and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, route, formulation, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination (immunization).  On an unknown date, the patient fell sick (illness) (latency: unknown) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event.   At time of reporting, the outcome was Unknown for the event.
Age: 0.17
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product administration error
Clinical narrative: medication error due to the DTaP/IPV component of PENTACEL being administered without the Hib component (with no reported adverse event); Initial information received on 17-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 month old male patient who had administered DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)]  dtap/ipv component of pentacel without the hib component (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); ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ); and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Prophylactic vaccination.  On 05-Jan-2023, the patient received 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE for Suspension for injection (lot UJ613AAA, expiry date: 25-FEB-2023, strength not reported) via intramuscular route in the thigh nos for Immunization.  On 05-JAN-2023 the patient was administered the dtap/ipv component of pentacel being without the hib component (with no reported adverse event) (product administration error) ( latency: same day).  No lab data available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Not Recovered / Not Resolved for the 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: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error, Product use in unapproved indication, Single component of a two-component product administered, Tuberculin test
Clinical narrative: gave PENTACEL to a child without the powder, the diluent only, liquid component of PENTACEL was administered but not the lyophilized powder,with no reported adverse event; Pentacel once for TB skin test with no reported adverse event; gave PENTACEL to a child without the powder, the diluent only, liquid component of PENTACEL was administered but not the lyophilized powder,with no reported adverse event; Initial information received on 19-Jan-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves unknown gender Child Patient of age <1 year who received Pentacel without the powder, the diluent only, liquid component of pentacel was administered but not the lyophilized powder once for TB skin test 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 HIB VACCINE CONJ (TET TOX) (ACTHIB) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTOTECH for Immunisation   On an unknown date, the patient received a (0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test 0.25 mL) dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number: UJ737AA) (Expiry date: 18-Sep-2023) (Frequency: once) (Strength: standard) Via unknown route in site UTR for Immunization or TB skin test.  On an unknown date the patient received pentacel without the powder, the diluent only, liquid component of pentacel was administered but not the lyophilized powder once for tb skin test with no reported adverse event (product use in unapproved indication) (product preparation error) (Single component of a two-component product administered) (unknown latency).  It was reported that patient had Emergency Room /Dr. visit and date UTR (Abbreviation unspecified) (estimates around: 4-Jan-2023)  Relevant laboratory test results included: Tuberculin test - On an unknown date:  [Unknown]  Action taken: was not applicable.  At time of reporting, the outcome was Unknown for all 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 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: 101.0
Sex: F
Vaccine: COVID19-2
Symptoms: Angiogram cerebral abnormal, Arteriogram carotid, Blood test, Carotid artery stenosis, Cerebral artery occlusion
Clinical narrative: Patient had acute/subacute CVA involving the posterior right temporal and occipital lobes on CT angiogram of the head and, diagnosed on 11/20/2022 by CT scan. She had seen her eye doctor, Dr. on November 18, after experiencing loss of peripheral vision sometime in mid to late October. Dr. exam caused her to suspect a stroke had occurred previous to this visit. Patient had also been taken to the ER on October 12 complaining of "head pressure." Nothing at that time was found by exam except very high blood pressure. She was discharged. She had a repeat occurrence of the head pressure on November 19 and went to the ER again. This time she was very ill  with high BP and blurred vision. The neurologist determined she had a stroke as described above. She was admitted to Hospital for a week. She was prescribed atorvastatin 40 mg tablet, clopidogreL 75 mg tablet,  and told to continue her regular medications. She was then sent to The rehab facility where she received PT for a week. She was discharged AMA and returned to Residence.
Age: 101.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cerebrovascular accident, Condition aggravated, Echocardiogram normal, Head discomfort, Hypertension
Clinical narrative: Patient had acute/subacute CVA involving the posterior right temporal and occipital lobes on CT angiogram of the head and, diagnosed on 11/20/2022 by CT scan. She had seen her eye doctor, Dr. on November 18, after experiencing loss of peripheral vision sometime in mid to late October. Dr. exam caused her to suspect a stroke had occurred previous to this visit. Patient had also been taken to the ER on October 12 complaining of "head pressure." Nothing at that time was found by exam except very high blood pressure. She was discharged. She had a repeat occurrence of the head pressure on November 19 and went to the ER again. This time she was very ill  with high BP and blurred vision. The neurologist determined she had a stroke as described above. She was admitted to Hospital for a week. She was prescribed atorvastatin 40 mg tablet, clopidogreL 75 mg tablet,  and told to continue her regular medications. She was then sent to The rehab facility where she received PT for a week. She was discharged AMA and returned to Residence.
Age: 101.0
Sex: F
Vaccine: COVID19-2
Symptoms: Malaise, Vision blurred, Visual field defect
Clinical narrative: Patient had acute/subacute CVA involving the posterior right temporal and occipital lobes on CT angiogram of the head and, diagnosed on 11/20/2022 by CT scan. She had seen her eye doctor, Dr. on November 18, after experiencing loss of peripheral vision sometime in mid to late October. Dr. exam caused her to suspect a stroke had occurred previous to this visit. Patient had also been taken to the ER on October 12 complaining of "head pressure." Nothing at that time was found by exam except very high blood pressure. She was discharged. She had a repeat occurrence of the head pressure on November 19 and went to the ER again. This time she was very ill  with high BP and blurred vision. The neurologist determined she had a stroke as described above. She was admitted to Hospital for a week. She was prescribed atorvastatin 40 mg tablet, clopidogreL 75 mg tablet,  and told to continue her regular medications. She was then sent to The rehab facility where she received PT for a week. She was discharged AMA and returned to Residence.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Amyotrophic lateral sclerosis, COVID-19, Electromyogram abnormal, Magnetic resonance imaging head normal, Magnetic resonance imaging spinal normal
Clinical narrative: Patient reported getting booster on 10 June. Developed fever on 15 June, tested (+) for Covid-19. On/around 17 June developed muscle twitches in left arm and right leg, followed by right leg weakness. Symptoms have persisted and worsened to include abnormal speech. Sought care with PC November who referred to Neurology while on travel.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle twitching, Muscular weakness, Pyrexia, SARS-CoV-2 test positive, Speech disorder
Clinical narrative: Patient reported getting booster on 10 June. Developed fever on 15 June, tested (+) for Covid-19. On/around 17 June developed muscle twitches in left arm and right leg, followed by right leg weakness. Symptoms have persisted and worsened to include abnormal speech. Sought care with PC November who referred to Neurology while on travel.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 57 year old patient received the FLUZONE HIGH-DOSE QIV vaccine, with no reported adverse event; Initial information received on 20-Jan-2023 regarding an unsolicited valid non-serious case received from a Non-Healthcare Professional.  This case involves a 57-year-old female patient who received the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Diabetes mellitus and Hypertension, but not immunocompromised.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for Immunisation.  On 20-Jan-2023, the patient received 0.7ml total dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation: unknown) (lot number: UJ9330AA and expiry date: 30-Jun-2023) via intramuscular route in the right deltoid for Immunization and a 57-year-old patient received the fluzone high-dose qiv vaccine, with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  It was reported, the caller is requesting recommendations and further guidance and requesting validity and safety information.   Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable.  At time of reporting, the 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.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Sleep disorder
Clinical narrative: had deep muscle pain at the injection site that comes and goes and often wakes at night; Initial information received  on 23-Jan-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 73 years old female patient who had deep muscle pain at the injection site that comes and goes and often wakes at night while receiving vaccine influenza quadrival a-b high dose hv vaccine [fluzone high-dose quadrivalent].  The patient's past medical history, medical treatment(s), concomitant medication (s) and family history were not provided.   On 28-Nov-2022, the patient had received 0.7ml QD (daily) dose of suspect influenza quadrival a-b high dose hv vaccine lot number not reported via intramuscular route in the left deltoid (formulation, strength, expiration date: not provided) as Immunization.  On 28-Nov-2022 the patient had developed a non-serious deep muscle pain at the injection site that comes and goes and often wakes at night (vaccination site pain) (latency- same day) following the administration of influenza quadrival a-b high dose hv vaccine.  It was reported Patient said her left arm where the shot was administered started hurting 1 week after she got the shot. Patient said it happens on and off during the day and the pain wakes her up at night from her sleep. Patient said it is not on the outside that hurts (sore) but from the inside of her arm where the shot was administered.  Action taken- Not applicable.  It was not reported if the patient received a corrective treatment for the event (vaccination site pain).  At time of reporting, the outcome was Not Recovered / Not Resolved.
Age: 48.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient received an expired TENIVAC/ that expired yesterday (with no reported adverse event); Initial information received  on 23-Jan-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 48 years old male patient who received an expired diphtheria-2/ tetanus-5 adsorbed toxoids no preservative adult [Tenivac] that expired yesterday with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 23-Jan-2023, the patient received 0.5 mL expired dose of suspect diphtheria-2/ tetanus-5 adsorbed toxoids no preservative adult, suspension for injection (strength: standard) (lot: U6922AA; expiry date: 22-Jan-2023) via intramuscular route in the left arm for immunization with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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 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: 21.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: 2 expired doses of tenivac were administered today 9with no reported adverse event); Initial information received on 23-Jan-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 21 year old female patient who was administered expired doses of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.   On 23-Jan-2023, the patient received an 0.5 mL dose of expired suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult, Suspension for injection (strength - unknown, frequency - once (1x), lot U6922AA and expiry date - 21-Jan-2023) via unknown route in unknown administration site for prophylactic vaccination with no reported adverse event) (expired product administered) (unknown latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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 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: 0.83
Sex: M
Vaccine: FLU4
Symptoms: Arthritis bacterial, Joint fluid drainage, Joint swelling
Clinical narrative: swelling in their left septic joint (knee).; swelling in their left septic joint (knee).; Initial information received on 23-Jan-2023 regarding an unsolicited valid serious case received from a nurse.  This case involves a 10 months old male patient who had swelling in their left septic joint (knee) after receiving influenza quadrival A-B multidose vaccine preserved [Fluzone quadrivalent multidose].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 19-Jan-2023, the patient received 0.25 ml(milliliter) (dose 2 ) (once) suspect influenza quadrival A-B multidose vaccine preserved, suspension for injection, (lot number: UJ899AB, expiry date:30-Jan-2023) via intramuscular route in the left thigh for Prophylactic vaccination (immunization).  On 21-Jan-2023, the patient developed swelling in their left septic joint (knee) (arthritis bacterial) (joint swelling) (latency:2 days) following the administration of influenza quadrival A-B multidose vaccine preserved.  It was reported that "The area was drained by an orthopedic in the hospital and the infectious disease team is involved".  No lab data were reported.  Action taken: not applicable.  An infant received Antibiotics (intravenous) for both events as treatment.  At time of reporting, the outcome was Unknown .  Seriousness criteria: Medically significant for septic joint and its symptom.; Sender's Comments: Sanofi company comment dated 25-Jan-2023: This case involves a 10 months old male patient who had swelling in their left septic joint (knee) after receiving influenza quadrival A-B multidose vaccine preserved [Fluzone quadrivalent multidose].The time to onset was compatible with the role of vaccine. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based on information provided, the role of an individual vaccine cannot be assessed.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: nurse inadvertently administered an expired dose of MENACTRA with no reported adverse event; Initial information received on 23-Jan-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 11 years old female patient and it was reported that nurse inadvertently administered an expired dose of meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitants and family history were not provided.   On 20-Jan-2023, the patient was inadvertently administered an expired dose (0.5 mL) of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine solution for injection (batch/lot number: U7140BA and expiry date: 07-Nov-2022; strength: unknown; 1X) via intramuscular route in the left deltoid for immunization (expired product administered) (latency: same day).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the 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 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.; Sender's Comments:  01456176:
Sex: U
Vaccine: FLU3, FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: Sick with flu, received Fluarix and Influenza vaccine/Suspected vaccination failure; Sick with flu; This case was reported by a consumer via other manufacturer and described the occurrence of vaccination failure in a patient who received Flu Seasonal TIV Dresden (Fluarix) for prophylaxis.   Co-suspect products included Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Fluarix and Influenza vaccine. On an unknown date, unknown after receiving Fluarix and Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Fluarix and Influenza vaccine.     Additional Information: GSK receipt date: 19-Jan-2023  Reporter's comment: The patient of unknown age and unknown gender who experienced was sick with flu for 14 days after receiving vaccines fluarix and influenza vaccine by unknown manufacturer (strength, formulation, dose, expiration date and lot number not reported) vis unknown route in unknown administration site . The patient's past medical history, medical treatments, vaccinations and family history were not provided. Lab data was not reported Corrective treatment was not reported for the event (was sick with flu for 14 days). Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of influenza were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: Got flu shot Sick as hell; Initial information received  on 20-Jan-2023 regarding an unsolicited valid non-serious case received from a Non-Healthcare Professional.  This case involves an unknown age and unknown gender patient who got flu shot (INFLUENZA VACCINE) and sick as hell.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, route, dose: unknown) (lot number and expiry date: not reported) in unknown administration site for Prophylactic vaccination.  On an unknown date, the patient developed a non-serious event of got flu shot sick as hell (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/events. It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Got flu shot Sick as hell).  At time of reporting, the outcome was Unknown for the event got flu shot sick as hell.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; an expired dose was administered to a patient on 12/20/2022; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 20-DEC-2022, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) intramuscular injection (0.5 ml/ once, lot#: t021327, expiration date: 14-NOV-2022; strength, and route of administration were not reported) for prophylaxis (expired product administered). No adverse effects were reported. No additional adverse events (AE) were reported (no adverse event).
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Additional Details: Patient left a customer survey stating he was experiencing pain after a Pfizer Bivalent injection. Injection was given on 01/05/2023, the original complaint was received 01/08/2023.On 01/22/2023, customer replied again stating he was still experiencing "a level of discomfort that has caused concern" and he believed it would be prudent to consult with a physician.Pharmacy manager attempted to reach the patient via phone number on file, left a voicemail asking for a return call to get further info
Age: 70.0
Sex: M
Vaccine: FLUA4
Symptoms: Head discomfort, Headache, Lymphadenitis, Lymphadenopathy
Clinical narrative: Several days after injection, I felt severe pain on the left side of my head around the ear.  It felt like I had been in a fist fight and someone had pummeled me on the left side of my head.  I scheduled an appointment with Dr., my ear doctor, because I originally thought I must have a problem with my left ear.  He checked my ears and determined that they were normal.  Then he felt around my left ear and told me that I had lymphadenitis, inflammation or swelling of the lymph nodes around my ear.  There was no treatment prescribed either by Dr. or by facility.  After about one month the pain and discomfort on the left side of my head subsided.
Age: 26.0
Sex: F
Vaccine: FLUC4
Symptoms: Loss of consciousness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt received flu shot in left arm. Within 1 minute she received moderna vaccine in right arm. Within 30 seconds of Moderna she fainted. She has a history of fainting due to fear of shots. She regained consciousness within 30 seconds and was kept under observation for 30 min. No lingering symptoms after 20 min.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough case  dose 1 moderna 5/2/21  003C21A dose 2 moderna 5/30/21  011D21A
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: None stated.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Administration of Non-Viable Vaccine.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Head discomfort, Headache, Hot flush
Clinical narrative: She got the vaccine, by about 6:30 she had bad arm pain at the injection site.  Then by about 9:00 she started getting a headache, and through the night everything hurt.  She had body aches, joint pain, headache, pressure around her eyes and forehead.  She had chills and shivers through the night.  This morning she still has the body aches, and works from home and cannot sit up straight to work.  Said it's like a bad flu that wipes you out.  She was also having hot flashes about 1/2 an hour ago.  She did take some Advil when she got home from getting the shot.  Then sometime in the middle of the night she took 2 Tylenol.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Influenza, Injection site pain, Mobility decreased, Ocular discomfort
Clinical narrative: She got the vaccine, by about 6:30 she had bad arm pain at the injection site.  Then by about 9:00 she started getting a headache, and through the night everything hurt.  She had body aches, joint pain, headache, pressure around her eyes and forehead.  She had chills and shivers through the night.  This morning she still has the body aches, and works from home and cannot sit up straight to work.  Said it's like a bad flu that wipes you out.  She was also having hot flashes about 1/2 an hour ago.  She did take some Advil when she got home from getting the shot.  Then sometime in the middle of the night she took 2 Tylenol.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: She got the vaccine, by about 6:30 she had bad arm pain at the injection site.  Then by about 9:00 she started getting a headache, and through the night everything hurt.  She had body aches, joint pain, headache, pressure around her eyes and forehead.  She had chills and shivers through the night.  This morning she still has the body aches, and works from home and cannot sit up straight to work.  Said it's like a bad flu that wipes you out.  She was also having hot flashes about 1/2 an hour ago.  She did take some Advil when she got home from getting the shot.  Then sometime in the middle of the night she took 2 Tylenol.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Anaemia, Asthenia, Dysstasia, Pain in extremity
Clinical narrative: Extreme pain in bottom of feet, heels surrounding the facia muscle/tendon to a debilitating extent. Daily I can?t stand for longer than 20 minutes before having to take a break or just bearing with the pain. Initial treatment was to be sent to a  trainer who was qualified in physical therapy techniques regarding typical sports injuries. Next, I was sent to a physical therapist (Medical Center). Before I was able to complete the treatment or be moved up to a higher level of treatment I was discharged for a case anemia
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient received a vaccine that was expired due to being drawn up 24 hours earlier
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No reaction or symptoms were noted at the time of the visit, nor were they reported by the parent when they were notified.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Parosmia, Pyrexia
Clinical narrative: Phantosmia: scent of stale cigarette smoke all the time. Can smell other scents normally. Stale cigarette smoke/burnt dust smell is in background all the time. At first attributed scent to unwashed clothes due to 36 hour fever/sweats caused by vaccine, but upon bathing/changing, noticed scent was in nose. No treatment. It's been nearly two weeks.
Age: 10.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product preparation error
Clinical narrative: Spoke with the grandmother this morning the incident yesterday regarding the peds pfizer booster 5-11 yrs was not diluted and the signs and symptoms the family should watch out for grandmother said she did not notice any changes. He is fine he went to school and as his usual self no complaints. I explain I will check back tomorrow and Saturday for any changes.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Administration of Non-Viable Vaccine
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, Vaccination error
Clinical narrative: First dose of MMR was given 11/23/2022, due to an error, doctor was unaware dose was previously given and a 2nd administration was given on 01/25/2023.