chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Presyncope
Clinical narrative: Almost fainted; This is a spontaneous report from a contactable consumer or other non hcp reported for his sister. A 25-year-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN) dose 1, via unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The reporter reported that his half-sister had a strange side effect after Pfizer he don't know when she got the Pfizer vaccine, when she got the first dose she almost fainted. The patient was hospitalized as a result of event. The reporter asked and concerned about getting the second dose of the vaccine. The outcome of the events was reported as unknown.  Information about lot/batch about number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Heart rate, Heart rate increased, Tremor
Clinical narrative: My heart rate was measured at 194 beat per minute/woke up from a very strong and fast heartbeat; My whole body was shaking; shortness of breath; general weakness; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 46 years old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 02May2021 at 16:00 (at age of 45 years old, no pregnant, Lot Number: ER8736) as a single dose for covid-19 immunization. Medical history included Penicillin Allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine and not receive any other medications within 2 weeks of vaccination. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 10Apr2021 at 13:00 (at age of 45 years old, no pregnant, Lot Number: EW0150) as a single dose for covid-19 immunization. The night of 15May2021 at 3:00, the patient woke up from a very strong and fast heartbeat. Her whole body was shaking, she had experienced shortness of breath and general weakness. After realizing that something was wrong she went to an Emergency room. The patient heart rate was measured at 194 beat per minute. Events resulted in Emergency room/department or urgent care. The patient received treatment (Valsalva Maneuver). Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovered.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Haemorrhage subcutaneous, Rash macular
Clinical narrative: Gets black spots and it gets better. He states it is kind of bloody under there; broke out with red spots on quite a bit of his body; Did not take the follow up vaccination; This is a spontaneous report received from a contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (Pfizer vaccine, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 20May2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On Unspecified date of Jun2021, the patient experienced that he gets black spots and it gets better. he states it is kind of bloody under there, broke out with red spots on quite a bit of his body, did not take the follow up vaccination. Patient did not received treatment for adverse events. Caller didn't provide his mail address and doesn't know whether his condition is serious or not. The outcome of the events was unknown.  Additional Context: Caller states he is calling about the vaccine, the COVID vaccine. Caller took the first dose of the vaccine on 20May, he states 2 weeks after he broke out with red spots on quite a bit of his body. His doctor said he should come in to let him look at it. He didn't know the regimen to do anything about it. He still has it though, it gets black spots and it gets better. He states it is kind of bloody under there. Caller states he did not take the follow up vaccination because his doctor recommended him not to. Caller is wondering if he should still have it. He is wondering if he should be able to take the other part of the vaccine. He does not know if he should do something about the spots. Caller states they have not really worsened. He states he does not have too much time, he could could call back at a different time to complete a safety report. The main question he is interested in is to know if doing nothing about these spots, is that alright. Are they going to go away, are they going to cause any damage. Rather than trying to figure out if he can receive the second shot or not. He guesses he has to do what the doctor says, he is seeing him again on the 7th. He didn't suggest putting anything on them and was not concerned what so ever. He does not know if it is ok for us to contact him should we have further questions about this report. He does go to a doctor and if its a controversy and this is something else. He doesn't want to be in a situation.  Information on the lot/batch, further information has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris
Clinical narrative: Pain around the heart; This is a spontaneous report from a non-contactable consumer (patient). A 24-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EP6955 and Expiration date: unknown), via an unknown route of administration on 09Apr2021 (at the age of 24-year-old) as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has no known allergy. Patient did not receive any other vaccine within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and not tested for COVID-19 since the vaccination. On an unknown date, the patient experienced pain around the heart. The event resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the event. Outcome of event was recovering.   Follow-Up (01Jul2021): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Inappropriate schedule of product administration, Pain in extremity, Palpitations
Clinical narrative: shortness of breath; palpitations; chest heaviness; achy arms; Her son got the 2nd dose of the vaccine 22Jun2021/The patient received his first dose of the series "back around February or end of March; This is a spontaneous report from a contactable consumer or other non hcp. A 33-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 22Jun2021 as single dose for covid-19 immunization. Medical history included covid-19 from an unknown date and unknown if ongoing, migraine from an unknown date and unknown if ongoing. Concomitant medication(s) included erenumab aooe (AIMOVIG) taken for migraine from an unspecified start date and ongoing. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration around February or end of March as single dose for covid-19 immunization. The reporter reported that the patient received his first dose of the series back around February or end of March. The family then got COVID19 without going anywhere. After having the virus, he had shortness of breath with palpitations before he had the chance to get the 2nd dose of the COVID19 vaccine. Her son got the 2nd dose of the vaccine on 22Jun2021 after the pharmacy advised him, he did not need to re start the vaccine series. Since having the 2nd dose, he had "achy arms, palpitations, shortness of breath, and chest heaviness. He had an appointment with HCP that day at 15:00. Reporter also stated that the patient was also on an injectable migraine medication as well; Aimovig. Reporter noted that her other son (she has 5 children) also had similar side effects following the vaccination however not to the extent that the one she was called about that day had. The other son received his vaccine on the same day as the 33-year-old son. He had shortness of breath since having COVID and got a fever of 100.0 the day he received the shot as well as chest heaviness and shortness of breath. Reporter stated that her HCP clinic in Illinois where they go to be a very large facility, but they had no clue on anything. Reporter would like to know what the follow up care would be for her son who had experienced side effects less than 1 week following his 2nd dose of the COVID19 vaccine. The outcome of events was not recovered.  Information about lot/batch number cannot be obtained. Additional information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Four of my colleagues (including myself) have contracting COVID within a week despite all having been vaccinated; Four of my colleagues (including myself) have contracting COVID within a week despite all having been vaccinated; This is a spontaneous report from a contactable consumer   A patient of unspecified age and gender received BNT162B2 (Formulation: Solution for injection; Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date of Jun2021 as single dose (dose number unknown) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Customer reported that four of my colleagues (including myself) have contracting COVID within a week despite all having been vaccinated. Exposure could not have occurred before Monday 21Jun2021 and symptom onset (all positive tested individuals were symptomatic) was by 25Jun2021. They were all researchers and recognize the impossibility of this not being a variant. Patient was totally willing to participate in any studies that might help understand variants and the efficacy of the vaccine on them. On 25Jun2021 the patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she received her first dose of the vaccine on 16Mar2021 but never received her second dose due to contracting COVID-19; she received her first dose of the vaccine on 16Mar2021 but never received her second dose due to contracting COVID-19; This is a spontaneous report from a contactable consumer. This 54-years-old female consumer (patient) reported for herself that she received first dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration on 16Mar2021 as DOSE 1, SINGLE for covid-19 immunization(at the age of 54-Years). Medical history included she was diagnosed with a rare form of Lupus which affects the skin in Dec2020. She stated that she had been good since the diagnosis, allergic reaction to the shingles vaccine. The patient's concomitant medications were not reported. She stated that she received her first dose of the vaccine on 16Mar2021 but never received her second dose due to contracting COVID-19. She stated that during March (Spring Break) she contracted COVID. She wore masks and was very angry that she got COVID because she was so safe. She had recently seen a Rheumatologist for her Lupus. When she was diagnosed with COVID, the doctor at the urgent care told her that she needed to wait 90 days to get her next vaccine and she needed to start the series over. She told this to her rheumatologist and her rheumatologist stated that she did not think that the vaccine series needed to be repeated and that she should call Pfizer to get clarification. She had to wait thirty minutes after getting the first dose because she had an allergic reaction to the shingles vaccine in the past but she had no symptoms from the first COVID-19 vaccine not even a sore arm. Her 90 days would be over on 15Jul2021 and she would be getting the vaccine then and wanted to know if she should repeat the series or just get the second vaccine. Caller stated that since she didn't have any issues from the first shot that getting the series over again probably wont hurt her. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Inflammation, Myocarditis
Clinical narrative: Myocarditis; Her son still has some inflammation; This is a spontaneous report from a contactable other hcp (Patients mother). A 14-years-old male patient received bnt162b2 (BNT162B2, Batch/Lot Number: EW0180 and Expiry Date: 19Jun2021), dose 2 via an unspecified route of administration, administered in Arm Left on 19Jun2021 as single dose for covid-19 immunisation. Patient previously received dose 1 of bnt162b2 (BNT162B2, Lot number: EW0178 and Expiration Date : Unknown to caller ) via an unspecified route of administration on 29May2021 as single dose for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. On 21Jun2021, The patient experienced myocarditis, About 2 days later, he was taken by ambulance to the ER, diagnosed with Myocarditis and admitted to the hospital, discharged on 23Jun2021. Caller states that she believes her son still has some inflammation, it is better but still ongoing, as he is still unable to exert himself at all. The claims are not in yet but it looks like they will be spending 5000  to 6000 dollar out of pocket. She is looking for some type of compensation for their expenses. Patient had no other vaccines on the same day as the suspect product. Myocarditis lead to Emergency Room. The outcome of the event myocarditis was recovering and inflammation was not recovered.; Sender's Comments: As per the information provided in the narrative, the causal association between the suspect drug and the event 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.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: He then developed Covid and tested on 01Jul2021; He then developed Covid and tested on 01Jul2021; This is a spontaneous report from a contactable other health care professional.  A 58-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN 6204) via intramuscular route on 03Mar2021 (at the age of 57-years-old) as dose 2, single and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EL 9267) via intramuscular route on 12Feb2021 (at the age of 57-years-old) as dose 1, single for covid-19 immunisation. The patient medical history was none and concomitant medications were not reported. The patient had no known allergies were not reported. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19. The patient received any vaccines within four weeks prior to the vaccination was unknown and no other medications in two weeks. On 01Jul2021, Nasal Swab (rapid PCR) test was positive. The patient received 2 doses of Pfizer vaccine, he then developed covid. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. The patient underwent lab tests and procedures which included positive rapid PCR, nasal swab on 01Jul2021. The events were reported as non-serious. The outcome of the events were unknown.; Sender's Comments: Based on the current available information and the consistency with the known safety profile of the suspect product BNT162B2, there is a reasonable possibility that events vaccination failure and covid-19 were related to suspect drug based on the temporal relation between the vaccination and onset of events. 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.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Renal function test, Renal impairment
Clinical narrative: Kidney Function dropped to 50% as of 4/19/21, diagnosed with Stage 3 Kidney disease; This is a spontaneous report from a contactable other hcp (patient). A 37-year-old female patient received bnt162b2 via an unspecified route of administration, administered in right arm on 19Apr2021 (Lot Number: Er8735) as dose 2, single at the age of 37-year-old for covid-19 immunization. Historic vaccine was bnt162b2, via an unspecified route of administration, administered in right arm on 29Mar2021 (Lot Number: Er8734) as dose 1, single at the age of 37-year-old for covid-19 immunization. The patient was not pregnant. Medical history included graves disease (in remission) from an unknown date. The patient had not gotten period since 19Mar2021, even after taking medroxy progesterone prescribed by OB/GYN to start period. The patient had known allergies to adhesives, zolpidem tartrate (AMBIEN), and codeine. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), lurasidone hydrochloride (LATUDA), aripiprazole (ABILIFY), lorazepam, eszopiclone (LUNESTA), and paracetamol (PA.), all taken for an unspecified indication, within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced Kidney function dropped to 50% as of 19Apr2021, diagnosed with Stage 3 Kidney disease on 19Apr2021 (pending clarification). The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included renal disorder kidney function dropped to 50% as of 19Apr2021. The outcome of events was not recovered.; Sender's Comments: Based on currently known drug safety profile, the reported event more likely represented intercurrent illness, but not related to bnt162b2.  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 RAs, Ethics Committees, and investigators, as appropriate.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired dose of PENTACEL was administered/ no AE; Initial information was received on 29-Jun-2021 regarding an unsolicited valid non-serious case received from a Nurse via Agency (Reference number- 00661687) and transmitted to Sanofi on 29-Jun-2021.  This case involves a patient (unknown demographics) who was vaccinated 0.5 ml of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number UJ350AAA and expiry date 22-Jun-2021) via unknown route in unknown administration site on 24-Jun-2021 for prophylactic vaccination and reported that an expired dose of PENTACEL was administered with no adverse event (expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of reporting, patient had no 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 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: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: patient was administered with an expired dose of the ActHib single-dose vial into the left deltoid , no reported adverse event; Initial information received on 30-Jun-2021 regarding an unsolicited valid  non-serious case from a other health professional via Information (reference number: 00663528).  This case involves an unknown age male patient who was vaccinated with an expired 0.5 ml dose of HIB (PRP/T) VACCINE [ACT-HIB] (1x single-dose vial in total, lot number UJ524AAA and expiration date 14-Jun-2021) via unknown route in the left deltoid for prophylactic vaccination on 28-Jun-2021 (expired product administered).  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  The patient had medical history of bone marrow transplant and reported that he had 5 other vaccines along with the Act-HIB (names of the vaccine available) on 28-Jun-2021.    It was a case of an actual medication error due to expired vaccine used (same day latency).  At time of reporting, it was unknown whether the patient had any adverse event.  It was reported that upon transfer, caller asked if there were any "cushion" after the expiration date of ActHib, where the product would still be good. Caller asked how to proceed if patient received an expired ActHib dose, and any safety concerns with having given an expired ActHib in a patient with his history. At the time of reporting, the outcome was unknown for the reported event 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 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: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired ACT-HIB was accidentally given to a 1-year-old female patient/ no AE; Initial information was received on 30-Jun-2021 regarding an unsolicited valid non-serious case received from a Other health care professional via Agency (Reference number- 00663874) and transmitted to Sanofi on 30-Jun-2021.  This case involves a one-year-old female who was mistakenly vaccinated with expired dose of 0.5 mL of (total) HIB (PRP/T) VACCINE [ACT-HIB] (lot number UJ329AB and expiry date 06-Jun-2021) via unknown route in unknown administration site for prophylactic vaccination on 30-Jun-2021 (expired vaccine used).]  Diluent batch number U6789AA and expiry date 21-Oct-2021.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for prophylactic vaccination, PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of reporting, patient had no 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 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: 1.25
Sex: M
Vaccine: HEPA, HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: 15 month old male patient received expired dose of ACT-HIB vaccine with no reported AE; Initial information received on 30-Jun-2021 regarding an unsolicited valid non-serious case received from a other health professional via physician.  This case involves a 15 month old male patient who was administered an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.   Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation.  On 30-Jun-2021, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE (lot UJ328ADA and expiry date: 29-Jun-2021) (Frequency: once) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  It was also reported that Nurse reports that today (6/30/2021), a 15 month-old male child received an ACTHIB vaccine that was then noted to have expired yesterday.  At the time of report, no adverse event was reported.  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: F
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was administed an expired dose of TENIVAC, no AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Agency (Reference number- 00663918) and transmitted to Sanofi on 30-Jun-2021.  This case involves a 58 year old female patient who was administered an expired dose (0.5ml) of the suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot number: U6265AA; expiry date: 19-Apr-2021; form: solution for injection) via unknown route in the right deltoid for prophylactic vaccination on 30-Jun-2021 (expired product administered).  Medical history, medical treatment(s), past vaccination(s), concomitant medications and family history were not provided.   It was a case of an actual medication error due to expired vaccine used (latency same day).  The reporter wanted information as to repeat the vaccination or not.  At the time of report, no adverse event was reported.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiomegaly, Insomnia
Clinical narrative: Enlarged heart from 05-24-21 to 05-25-21. Insomnia from 05-22-21 to the present and continuing. Treatment received - none.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus on both ears. None stop very high pitch.  Never had it beforehand.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No other adverse event; temperature excursion; This spontaneous report was received from a health business professional (HBP), referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.  On 07-JUN-2021, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (single dose, lot # T000883, expiration date: 28-MAY-2022, strength and route were not provided) for prophylaxis.  The administered dose of vaccine experienced the temperature excursion of 32.7 degrees Fahrenheit for 13 hours (product storage error) recorded by data logger. No previous temperature excursion was reported. No other adverse event or product quality complaints reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: A pharmacist reported VARlVAX was improperly stored and administered.; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On an unspecified date, the product varicella virus vaccine live (Oka/Merck) (VARIVAX) was improperly stored and were exposed to a temperature excursion of 41 degree Fahrenheit during a time frame of 24 hours. No previous temperature excursions were reported. Digital Data Logger was not involved.  On 26-JUN-2021, the patient was vaccinated with a dose of this improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter (mL), frequency reported as once, for prophylaxis (lot number T028306, that was verified to be valid with and expiration date reported and established to be 22-AUG-2022) (route and anatomical site of administration were not provided)(product storage error).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2107USA000111: US-009507513-2107USA000029: US-009507513-2107USA000236: US-009507513-2107USA000238:
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Pain, Pyrexia
Clinical narrative: Bell's palsy; Pain; Pyrexia; (Reference number: 1402825) on 29-Jun-2021 and was forwarded to Moderna on 29-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of BELL'S PALSY (Bell's palsy) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTIVITAMIN [VITAMINS NOS] and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 05-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2021, the patient experienced BELL'S PALSY (Bell's palsy) (seriousness criterion medically significant), PAIN (Pain) and PYREXIA (Pyrexia). At the time of the report, BELL'S PALSY (Bell's palsy), PAIN (Pain) and PYREXIA (Pyrexia) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   steroid, anti viral, and antibiotic were prescribed by doctor.  The patient's past medical history included Lyme disease. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was unknown.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: VARZOS
Symptoms: Product supply issue
Clinical narrative: It was the time when Shingrix was very hard to get / couldn't find the vaccine available; This case was reported by a pharmacist via call center representative and described the occurrence of product supply issue in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 7th Jnauary 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter did not have the lot number or expiration date of the vaccine at the time of the call. The reporter stated that, it was the time when Shingrix was very hard to get, the patient called several times to the pharmacy.could not find the vaccine available.The patient went back to the pharmacy today asking to get the 2nd dose. The patient had not received the second dose at the time of the call. Till the time of reporting, the patient did not receive 2nd dose of Shingrix. The reporter did not consented to follow up.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Product storage error
Clinical narrative: dose of Infanrix/ nonviable after a temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect product storage in a 4-year-old male patient who received DTPa (Infanrix) (batch number KGFM4, expiry date 6th February 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th June 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 25th June 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage 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 details were reported as follows: The patient received a dose of Infanrix on 25th June 2021, that was deemed nonviable after a temperature excursion, which led to incorrect product storage. No symptoms reported. The reporter consented to follow up. This was 5th of the 6 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021142812:Same reporter US-GLAXOSMITHKLINE-US2021142816:Same reporter US-GLAXOSMITHKLINE-US2021142813:Same reporter US-GLAXOSMITHKLINE-US2021142815:Same reporter US-GLAXOSMITHKLINE-US2021142818:Same reporter
Age: 13.0
Sex: U
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Shingrix/gven to 13 year old child; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 13-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional case details were reported as follows: The 13 year old patient was inadvertently given Shingrix vaccine, which led to inappropriate age at vaccine administration.   No other information was reported. The reporter could not provide any adverse event information on the patient. The reporter did not consented to follow up.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: SMALL AMOUNT OF PAIN AT THE INJECTION SITE THAT LASTED A FEW SECONDS/ARM PAIN; This spontaneous report received from a patient concerned a 72 year old male. The patient's weight was 174 pounds, and height was 71 inches. The patient's concurrent conditions included diabetic, copd (chronic obstructive pulmonary disease), smoker, and non alcoholic, and other pre-existing medical conditions included patient had no known allergies and no drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 02-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included dulaglutide for diabetic, and metformin for diabetic. On 02-JUL-2021, the subject experienced small amount of pain at the injection site that lasted a few seconds/arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from small amount of pain at the injection site that lasted a few seconds/arm pain on 02-JUL-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: "some people get Bell's palsy"; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY ("some people get Bell's palsy") in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY ("some people get Bell's palsy") (seriousness criterion medically significant). At the time of the report, BELL'S PALSY ("some people get Bell's palsy") outcome was unknown.            Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-034224 (Patient Link).
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: excursion was caused by employees going in and out the refrigerator with no adverse event; Human error involved, stability data of vaccine was not reported and vaccine was not administered hence it is a non case.; Sender's Comments:  SAD20210630001724:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Throat tightness
Clinical narrative: Tightness in throat and fast heart rate.  No difficulty breathing.  No swelling of tongue.  No difficulty swallowing.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Limb discomfort, Lymphadenopathy, Pain, Pain in extremity
Clinical narrative: About a week after the injection I started to feel a discomfort on my left side in the arm pit area.  Felt like it was swollen and it felt uncomfortable to lie down on my right side because my left arm was causing pressure on my arm pit area.  I felt minor pain/discomfort on left hand as well, the discomfort would radiate from my arm pit to my pinky finger and back.  By the second week the pain/discomfort was more noticeable during the day and night time. It was not constant, but it would appear during the day.  The third week I had one day (6/9/21) were the pain/discomfort caused me to not be able to sleep.  I looked at my arm pits, they did not look swollen, but they felt swollen.  By then both of my arm pits were now feeling discomfort but the left was more intense then the right side.  I feel like the left side has swollen lymph nodes.  I did not do anything but report.  Did not take tylenol or anything medications for the discomfort.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Swelling
Clinical narrative: About a week after the injection I started to feel a discomfort on my left side in the arm pit area.  Felt like it was swollen and it felt uncomfortable to lie down on my right side because my left arm was causing pressure on my arm pit area.  I felt minor pain/discomfort on left hand as well, the discomfort would radiate from my arm pit to my pinky finger and back.  By the second week the pain/discomfort was more noticeable during the day and night time. It was not constant, but it would appear during the day.  The third week I had one day (6/9/21) were the pain/discomfort caused me to not be able to sleep.  I looked at my arm pits, they did not look swollen, but they felt swollen.  By then both of my arm pits were now feeling discomfort but the left was more intense then the right side.  I feel like the left side has swollen lymph nodes.  I did not do anything but report.  Did not take tylenol or anything medications for the discomfort.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Visual impairment
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Visual Changes/Disturbances-Mild
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Flushing, Hyperhidrosis, Syncope
Clinical narrative: Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: patient fainted within 2 minutes after injection, EMT came and checked patient who came to within a few seconds
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: patient fainted within 2 minutes after injection, EMT came and checked patient who came to within a few seconds
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Medium
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Pallor, Vomiting
Clinical narrative: Patient received 1st dose of covid vaccine and instantly felt dizzy.  Client's skin pale, patient eventually vomited.  Patient stated they were very anxious over their 1st dose.  Patient fully recovered.  Symptoms no longer present.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Injection site pain, Syncope, Tinnitus, Unresponsive to stimuli
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Tinnitus-Mild, Additional Details: patient fint for 2 minutes but recovered consciousness
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Severe
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Flushing, Hyperhidrosis, Injection site bruising
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: left pharmacy in ambulance, gave iv in ambulane
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Throat tightness
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: left pharmacy in ambulance, gave iv in ambulane
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: left pharmacy in ambulance, gave iv in ambulane
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: Chest tightness.  No radiation to Arm.  VS 84, 116/80, 99%
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Rash, Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: Systemic: Allergic: Rash Generalized-Medium, Additional Details: metallic taste in mouth, hives/rash on chest, legs, and arms. red and a little itchy
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Headache, Hyperhidrosis, Paraesthesia
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Visual Changes/Disturbances-Medium, Additional Details: 10 minutes after 1st dose - tingling sensation, dizzy, sweating, blacked out vision for a minute. Was still able to move arms and body. Took BP 84/49 HR 79. Gave patient water and sat supported by the wall for over 30 minutes. Before leaving patient BP was taken again 121/71 78 HR.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Visual impairment
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Visual Changes/Disturbances-Medium, Additional Details: 10 minutes after 1st dose - tingling sensation, dizzy, sweating, blacked out vision for a minute. Was still able to move arms and body. Took BP 84/49 HR 79. Gave patient water and sat supported by the wall for over 30 minutes. Before leaving patient BP was taken again 121/71 78 HR.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: I received my first dose of the Pfizer vaccine on June 16th, the day after I started menstruating.  My period did not end until July 3rd resulting in 19 days of bleeding.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lethargy, Pyrexia
Clinical narrative: Headache, chills, low grade fever,  lethargic
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Error: Patient Too Young for Vaccine Administered-
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: patient had some redness, itching and swelling at site that started day of, it went down and then came back today 7/7/21.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early-
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Error: Patient Too Young for Vaccine Administered-