chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia
Clinical narrative: No sense of smell; This is a spontaneous report from a contactable consumer (patient's husband). This consumer reported same event for two patients. This is the first of two reports. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL3302, expiry: unknown), via an unspecified route of administration in the left arm, on 04Feb2021 at a single dose for covid-19 immunisation. The patient has no medical history and concomitant medications. The patient got the Pfizer COVID vaccine on 04Feb2021. This morning (12Feb2021), she found out she has no sense of smell. Patient who no longer has a sense of smell noticed it a little while ago, about 9 AM. The reporter wanted to know since the patient had the vaccine if this would cause testing to come back positive. The outcome of the event was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021196187 same reporter/drug/AE, different patient
Sex: U
Vaccine: COVID19, UNK, UNK
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Hives; Rash all over my body; itching; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EM9809, expiry: unknown), via an unspecified route of administration on 03Feb2021 at a single dose for covid-19 vaccination; diphenhydramine hydrochloride (BENADRYL), via an unspecified route of administration from an unspecified date at 25 mg about every 4 hours for an unspecified indication;  and prednisone, route of administration, start and stop date, and dose were not reported for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient got the first Pfizer vaccine on 03Feb2021 and did not have any reaction until Tuesday night. Early Wednesday morning of this week (10Feb2021), the patient started with hives and a rash all over the body and the patient started with some oral Benadryl 25 mg about every 4 hours which did nothing and then on Wednesday night, the patient had to take some oral Prednisone and that was about 10:30 Wednesday night and the hives continue to get worse and about 1 o'clock in the morning Thursday the 11th, the patient took another 20 mg and then Thursday evening along with the Benadryl, the patient took 40 mg together for the hives and itching. Today, the patient was able to get in with a primary care doctor and she put the patient on a Prednisone dose pack for 6 day and to switch from Benadryl to Zyrtec (Intent: treatment) 1 tablet twice a day for the itching and the hives. The patient wanted to know if there are reports of hives starting this late after having the vaccine. The action taken in response to the events for diphenhydramine hydrochloride and prednisone was unknown. The outcome of the event hives was not recovered while the other events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Anosmia
Clinical narrative: No sense of smell; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two reports. This is the second of two reports.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration on 04Feb2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient went to get the COVID-19 vaccine and it was reported that she also experienced no sense of smell in Feb2021 with outcome of unknown.   Information on the lot/batch number has been requested.;
Sex: M
Vaccine: COVID19
Symptoms: Nerve injury, Pain in extremity
Clinical narrative: hit a nerve in his shoulder; arm pain; This is spontaneous report from a contactable consumer. A 65 year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route in shoulder on an unknown date for Covid-19 immunization. Medical history and concomitant drug were not provided. Her husband felt a lot. The reporter thought they hit a nerve in his shoulder. The patient experienced arm pain. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Gait disturbance, Musculoskeletal stiffness, Pain
Clinical narrative: pain became more intense & the now has gone up to my mid back & shoulders/pain is constant burning,soreness,aching; pain became more intense & the now has gone up to my mid back & shoulders; pain became more intense & the now has gone up to my mid back & shoulders; Its to the point where it hurts to walk & I trip a lot; stabbing & stiffening; This is a spontaneous report from a contactable nurse (patient). A 68-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6201; expiry date: unknown) via an unspecified route of administration in the right arm, on 19Feb2021, at a single dose, for COVID-19 immunisation. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a Public Health Clinic/Veterans Administration facility. Medical history included chronic obstructive pulmonary disease (COPD). She had about 3 surgeries in lumbar area for fusions due to scoliosis in the past years (history of failed lumbar fusions due to scoliosis). Last one was about 5 years ago. Concomitant medications included roflumilast (DALIRESP), duloxetine, loratadine, montelukast sodium (SINGULAIR) and "Spiri". The patient previously received pethidine hydrochloride (DEMEROL) and experienced allergies; and previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9264) in the right arm, on 28Jan2021 at 14:00, for COVID-19 immunisation and experienced a little lower back, bilateral hip and groin pain on 30Jan2021. The pain increased as time went on. On an unspecified date in Feb2021, after second injection, the pain (from first injection) became more intense and now has gone up to mid back and shoulders to the point where it hurts to walk, and she trips a lot. Nothing controls the pain including narcotics, heat, ice, Tylenol or ibuprofen. The pain was further described as constant burning, soreness, aching, stabbing and stiffening. The events were considered serious as the events resulted in disability or permanent damage. Outcome of the events was not recovered. The patient has not been tested for COVID-19 since vaccination.; Sender's Comments: Based on temporal association a contributory role of bnt162b2  to  the reported events  cannot  be totally  excluded.  The patient's history of scoliosis and failed lumbar fusions may also be contributory to the events.  Case will be reassessed if additional information is  received.    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: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Cough
Clinical narrative: pain became more intense & the now has gone up to my mid back & shoulders/pain is constant burning,soreness,aching; pain became more intense & the now has gone up to my mid back & shoulders; pain became more intense & the now has gone up to my mid back & shoulders; Its to the point where it hurts to walk & I trip a lot; stabbing & stiffening; This is a spontaneous report from a contactable nurse (patient). A 68-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6201; expiry date: unknown) via an unspecified route of administration in the right arm, on 19Feb2021, at a single dose, for COVID-19 immunisation. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a Public Health Clinic/Veterans Administration facility. Medical history included chronic obstructive pulmonary disease (COPD). She had about 3 surgeries in lumbar area for fusions due to scoliosis in the past years (history of failed lumbar fusions due to scoliosis). Last one was about 5 years ago. Concomitant medications included roflumilast (DALIRESP), duloxetine, loratadine, montelukast sodium (SINGULAIR) and "Spiri". The patient previously received pethidine hydrochloride (DEMEROL) and experienced allergies; and previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9264) in the right arm, on 28Jan2021 at 14:00, for COVID-19 immunisation and experienced a little lower back, bilateral hip and groin pain on 30Jan2021. The pain increased as time went on. On an unspecified date in Feb2021, after second injection, the pain (from first injection) became more intense and now has gone up to mid back and shoulders to the point where it hurts to walk, and she trips a lot. Nothing controls the pain including narcotics, heat, ice, Tylenol or ibuprofen. The pain was further described as constant burning, soreness, aching, stabbing and stiffening. The events were considered serious as the events resulted in disability or permanent damage. Outcome of the events was not recovered. The patient has not been tested for COVID-19 since vaccination.; Sender's Comments: Based on temporal association a contributory role of bnt162b2  to  the reported events  cannot  be totally  excluded.  The patient's history of scoliosis and failed lumbar fusions may also be contributory to the events.  Case will be reassessed if additional information is  received.    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: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Cerebrovascular accident
Clinical narrative: Bell's palsy; because it could be a stroke; This is a spontaneous report from a contactable consumer.   A 74-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot Number: EM9810), via an unspecified route of administration on the right arm on 19Feb2021 14:30 at single dose for COVID-19 immunisation.  The patient medical history was not reported. There were no concomitant medications. The patient previously took first dose of BNT162B2 on 29Jan2021 for COVID-19 immunisation and experienced a sore shoulder. A few years ago he got 2 at the same time, he got a flu shot and a pneumonia shot on the same day. He felt really bad for part of a day. He felt unwell that was years ago. he does not have any brand name, manufacturer name or lot number expiration information to provide for these vaccines from years ago.  The patient experienced bell's palsy on 25Feb2021. There is a drooping eye, his eye didn't fully close but his lip wasn't right and the doctor said no because it could be a stroke ( unspecified date in Feb2021), go to the ER and that is where he was diagnosed was in the hospital ER. He was discharged home from the emergency room. The outcome of the event was not recovered.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chills, Computerised tomogram, Electrocardiogram, Fall
Clinical narrative: Episode of Syncope which caused a fall; Episode of Syncope which caused a fall; Headache; Chills; Fever; Body Aches; This is a spontaneous report from a contactable consumer (patient).  A 38-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202), via an unspecified route of administration, administered in the left arm on 26Feb2021 at a single dose (at the age of 38-years-old) for Covid-19 immunisation in a workplace clinic. Medical history included allergies, migraines, low vitamin D and penicillin. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. The patient previously took Bactrum and doxycycline and experienced allergies. The patient was not pregnant at time of vaccination. The patient took the first dose of BNT162B2 on 05Feb2021 10:30 in the left arm at the age of 38-years-old for Covid-19 immunisation. No other vaccine was received in four weeks. The patient did not have COVID prior to vaccination. On 27Feb2021 at 02:30 AM, the patient experienced headache, chills, fever, body aches and an episode of syncope which caused a fall. The events resulted in emergency room/department or urgent care. The patient had a CatScan, EKG, IV medications, blood and urine test. The patient was not tested for COVID post vaccination. The patient recovered from the events on an unspecified date.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia, Syncope, Urine analysis
Clinical narrative: Episode of Syncope which caused a fall; Episode of Syncope which caused a fall; Headache; Chills; Fever; Body Aches; This is a spontaneous report from a contactable consumer (patient).  A 38-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202), via an unspecified route of administration, administered in the left arm on 26Feb2021 at a single dose (at the age of 38-years-old) for Covid-19 immunisation in a workplace clinic. Medical history included allergies, migraines, low vitamin D and penicillin. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. The patient previously took Bactrum and doxycycline and experienced allergies. The patient was not pregnant at time of vaccination. The patient took the first dose of BNT162B2 on 05Feb2021 10:30 in the left arm at the age of 38-years-old for Covid-19 immunisation. No other vaccine was received in four weeks. The patient did not have COVID prior to vaccination. On 27Feb2021 at 02:30 AM, the patient experienced headache, chills, fever, body aches and an episode of syncope which caused a fall. The events resulted in emergency room/department or urgent care. The patient had a CatScan, EKG, IV medications, blood and urine test. The patient was not tested for COVID post vaccination. The patient recovered from the events on an unspecified date.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Feeling abnormal
Clinical narrative: stroke; feeling funny from that point on & everything went down hill; This is a spontaneous report from a contactable consumer via the Pfizer-sponsored program. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 26Feb2021 at 11:00 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient felt good all week leading up to the vaccination, until the vaccination was given. From that point on (26Feb2021 at 11:00), the patient started to feel funny and everything went downhill. On 27Feb2021, the patient had a stroke. The clinical outcome of stroke and "feeling funny from that point on & everything went downhill" was unknown.   Information on batch/lot number was requested.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: Shingles flare up; Shingles flare up; This is a spontaneous report from a contactable nurse (patient). A 31-year-old male patient received his second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; lot number: EL9262; expiration date: unknown) at 31-year-old vaccination age via an unspecified route of administration in the right deltoid on 18Feb2021 9:00 AM as a single dose to protect self (covid-19 immunization). Medical history included chicken pox virus as a kid and shingles. The patient has no family medical history. There were no concomitant medications. Historical vaccination included varicella zoster vaccine (CHICKENPOX VACCINE) for vaccination for chicken pox and received his first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; lot number: EL3246) at unknown vaccination age via an unspecified route of administration in the left deltoid on an unspecified date as a single dose to protect self (covid-19 immunization). The patient received the vaccine in a hospital and did not receive other vaccines administered on same date of Pfizer suspect. The patient did not have prior vaccinations within 4 weeks. The patient reported that he just got a flare up of shingles on 28Feb2021 and doesn't know if it is related or not to the covid vaccination he took. The patient reported that he did nothing unusual in the last 14 days. Doesn't know if that is something to report to see if there was any trending. The patient inquired if a shingles flare-up has happened before after the COVID vaccine. He got the vaccine ten days before (18Feb2021) the shingles flare up started. He added that it is on right side of torso in the thorax area and goes from midline abdomen all the way to midline on his back on the right side. The adverse event required urgent care visit (emergency room visit). The nurse considered the event serious. The patient did not have relevant tests and was only clinically diagnosed with a shingles flare up. The outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported event "Shingles flare up" cannot be completely excluded based on temporal association.   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 identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, SARS-CoV-2 test
Clinical narrative: difficulty breathing had to be rushed to the ER.; COVID (nasal swab/rapid) tested post vaccination was positive; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204), via an unspecified route of administration, on right arm, on 08Mar2021 15:45 (at the age of 51-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history included allergies to latex, lactose, gluten; celiac disease, lactose intolerant, and had COVID prior vaccination. Concomitant medications included levothyroxine sodium (LEVOXYL), omeprazole (PROTONIX), tramadol, diclofenac and benzoate. No other vaccine in four weeks. Past drug included morphine and had allergies. On 09Mar2021 15:00 (also reported as "24 hours next day"), The patient experienced difficulty breathing had to be rushed to the ER (emergency room), and resulted in emergency room/department or urgent care and life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures, which included on 09Mar2021 COVID (nasal swab/rapid) tested post vaccination was positive. Therapeutic measures were taken as a result of event "difficulty breathing" and included treatment with "IV drip of vaccine" (as reported). The outcome of the event "difficulty breathing" was recovering, of event "COVID (nasal swab/rapid) tested post vaccination was positive" was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Renal disorder
Clinical narrative: kidney issue; This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer (patient's daughter) reported on behalf of patient. A male patient of unspecified age received 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration from an unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The reporter called on behalf of her father who was scheduled to get the second shot tomorrow (08Mar2021). Patient won't be able to make it because he was in the hospital due to a kidney issue. Outcome of the event was unknown. Reporter wanted to know how to reschedule vaccination.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Extra dose administered
Clinical narrative: A patient received 2 vaccinations within same pregnancy one month apart, no AE; Vaccine exposure during pregnancy; Initial information was received on 01-Mar-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case involves a female patient (age not reported) who received two doses of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Suspension for injection, batch number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination within same pregnancy one month apart on an unknown date (Extra dose administered) while she was pregnant.  The date of last menstrual period was not reported.  The estimated due date was not reported.  Past medical treatment, vaccination and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  It was case of vaccine exposure during pregnancy.   Pregnancy outcome was unknown at the time of report.  It was unknown if the patient experienced any additional symptoms/events.   The details of medication and reason for taking the medicine were not reported.  It was unknown if there were lab data/results available.  This was a case of actual medication error due to extra dose administered (latency unknown).  At the time of reporting, 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 holders 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.  There will be no information available on batch number for this case.
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; improperly stored doses of VARlVAX that was administered; This spontaneous report was received from a nurse and refers to two patients of unknown demographics. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided.  On 17-FEB-2021, the patients were vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml (route of administration and anatomical location were not reported), for prophylaxis. Nurse reported they had 10 lot numbers that were active in their freezer but was unsure of which lot numbers were administered: lot # T016000, expiration date 08-MAY-2022, lot # S008695, expiration date 21-MAR-2021, lot # S011952, expiration date 16-APR-2021, lot # S019461, expiration date was reported as 24-JUN-2021 but upon internal validation process, it was established as 16-APR-2021, lot # S025611, expiration date 18-AUG-2021, lot # S024366, expiration date 06-AUG-2021, lot # T022314, expiration date 30-JUN-2022, lot # T027302, expiration date 12-AUG-2022, lot # S006021, expiration date 27-FEB-2021, and lot # T000697, expiration date 07-JAN-2022.   Administered doses of vaccines were stored in the temperature of minus 6 degrees Celsius for 1 hour and 6 minutes.  There were no previous temperature excursions reported. The improper storage was not recorded by digital data logger. There was no additional adverse event reported.  Follow-up information was received from an other reporter on 08-MAR-2021.  The patient was a 36-year-old male. The patient had no illness at time of vaccination and had no pre-existing allergies, birth defects or concurrent medical conditions. There were no concomitant vaccines administered. On 17-FEB-2021, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml, subcutaneously (SQ) in the left art (LA), lot number T016000 was verified to be valid, expiration date reported and established as 08-MAY-2022. It was reported that the excursion occurred on 11-FEB-2021 at 17:03 and lasted for 1 hour and 6 minutes, and the temperature reached -6 Celsius degrees. The patient did not experience any additional adverse reactions after administration of the vaccine, and he did not require any prescription drug treatment. The vaccine was used according to the instruction and the operator was trained. The improper storage was recorded by digital data logger (previously reported as not recorded by digital data logger).   This is one of 2 reports received from the same reporter.  This report was previously non-valid due to lack of the patient's identifiers.; Sender's Comments:  US-009507513-2103USA002342:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No further AE; patient received expired dose of VAQTA; This spontaneous report was received from a healthcare professional and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.  On 26-FEB-2021, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) 1 injection, lot number: S036494, expiration date: 09-JAN-2021, for prophylaxis (exact dose and route of administration were not provided). No additional adverse events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S036494; expirationdate: 09-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The 1st dose was given 9/2/2020, 2nd dose 9/15/2020, 3rd 10/30/2020; This spontaneous report was received from a nurse practitioner, referring to a 11-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 02-SEP-2020, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection. On 15-SEP-2020, the patient received the second dose (inappropriate schedule of product administration), and on 30-OCT-2020, the patient was vaccinated with the third dose of the vaccine (doses, frequencies, lot numbers, and expiration dates were unknown by the reporter; routes of administration, and anatomical sites of injection were not reported). All of the vaccines were administered as prophylaxis.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Blood test, Catheterisation cardiac abnormal, Chest discomfort, Chest pain, Cold sweat
Clinical narrative: it was like someone was jumping up and down on his cheast/then pain went down left arm/heart attack; felt like his eyes were spinning in his head; cold sweats; myopericarditis; This spontaneous report was received from a 64 year old male consumer reporting on himself. The patient's concurrent conditions included allergy to nitrates and nitroglycerin. There was no pertinent medical history. On 27-SEP-2017, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose and route not reported) in the left arm. Concomitant therapies included vitamins and supplements.     The patient reported that he received the influenza virus vaccine (unspecified) in the right arm twenty minutes prior  pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). He stated that immediately after the vaccine was given, he said to his wife "something was wrong" it was like his eyes were spinning in his head. The patient stated that he had cold sweats and was told to sit for a few minutes, but he went home. The patient reported that the next day on 28-SEP-2017, he went to the emergency room for 4-5 hours where they tested everything and gave him "intravenous" and was sent home. The consumer reported that two weeks later, on 10-OCT-2017 at 2:00am he woke up and said it was like someone was jumping up and down on his chest. He went to the bathroom, got a glass of water and then pain went down left arm. The patient went to emergency room again and they did blood tests which included troponin levels (first one was zero, second one was 1.38 and third one was higher). The patient was told that he had a heart attack and was admitted for five days. The patient additionally stated that during hospital stay they did a catherization, no blockages, but had inflammation around heart (myopericarditis) and inflammation of lining of heart and muscle. The patient reported that the only reason they said it was a heart attack was because of enzyme on blood test levels were high. The patient was scared to get the Covid vaccine, so this was why he wanted to find out the ingredients of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) to compare. At the time of the report, the patient had recovered.  The causality between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was unknown.  Upon internal review heart attack and myopericarditis were considered to be medically significant.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Eye movement disorder, Immediate post-injection reaction, Myocardial infarction, Myocardial necrosis marker increased, Myocarditis
Clinical narrative: it was like someone was jumping up and down on his cheast/then pain went down left arm/heart attack; felt like his eyes were spinning in his head; cold sweats; myopericarditis; This spontaneous report was received from a 64 year old male consumer reporting on himself. The patient's concurrent conditions included allergy to nitrates and nitroglycerin. There was no pertinent medical history. On 27-SEP-2017, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose and route not reported) in the left arm. Concomitant therapies included vitamins and supplements.     The patient reported that he received the influenza virus vaccine (unspecified) in the right arm twenty minutes prior  pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). He stated that immediately after the vaccine was given, he said to his wife "something was wrong" it was like his eyes were spinning in his head. The patient stated that he had cold sweats and was told to sit for a few minutes, but he went home. The patient reported that the next day on 28-SEP-2017, he went to the emergency room for 4-5 hours where they tested everything and gave him "intravenous" and was sent home. The consumer reported that two weeks later, on 10-OCT-2017 at 2:00am he woke up and said it was like someone was jumping up and down on his chest. He went to the bathroom, got a glass of water and then pain went down left arm. The patient went to emergency room again and they did blood tests which included troponin levels (first one was zero, second one was 1.38 and third one was higher). The patient was told that he had a heart attack and was admitted for five days. The patient additionally stated that during hospital stay they did a catherization, no blockages, but had inflammation around heart (myopericarditis) and inflammation of lining of heart and muscle. The patient reported that the only reason they said it was a heart attack was because of enzyme on blood test levels were high. The patient was scared to get the Covid vaccine, so this was why he wanted to find out the ingredients of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) to compare. At the time of the report, the patient had recovered.  The causality between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was unknown.  Upon internal review heart attack and myopericarditis were considered to be medically significant.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Troponin increased
Clinical narrative: it was like someone was jumping up and down on his cheast/then pain went down left arm/heart attack; felt like his eyes were spinning in his head; cold sweats; myopericarditis; This spontaneous report was received from a 64 year old male consumer reporting on himself. The patient's concurrent conditions included allergy to nitrates and nitroglycerin. There was no pertinent medical history. On 27-SEP-2017, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose and route not reported) in the left arm. Concomitant therapies included vitamins and supplements.     The patient reported that he received the influenza virus vaccine (unspecified) in the right arm twenty minutes prior  pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). He stated that immediately after the vaccine was given, he said to his wife "something was wrong" it was like his eyes were spinning in his head. The patient stated that he had cold sweats and was told to sit for a few minutes, but he went home. The patient reported that the next day on 28-SEP-2017, he went to the emergency room for 4-5 hours where they tested everything and gave him "intravenous" and was sent home. The consumer reported that two weeks later, on 10-OCT-2017 at 2:00am he woke up and said it was like someone was jumping up and down on his chest. He went to the bathroom, got a glass of water and then pain went down left arm. The patient went to emergency room again and they did blood tests which included troponin levels (first one was zero, second one was 1.38 and third one was higher). The patient was told that he had a heart attack and was admitted for five days. The patient additionally stated that during hospital stay they did a catherization, no blockages, but had inflammation around heart (myopericarditis) and inflammation of lining of heart and muscle. The patient reported that the only reason they said it was a heart attack was because of enzyme on blood test levels were high. The patient was scared to get the Covid vaccine, so this was why he wanted to find out the ingredients of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) to compare. At the time of the report, the patient had recovered.  The causality between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was unknown.  Upon internal review heart attack and myopericarditis were considered to be medically significant.
Sex: U
Vaccine: HEPA, HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The vaccine was given 6 weeks and 6 days earlier than the recommended 6-18 month range; no adverse event; This spontaneous report was received from a nurse, concerning a currently 15-year-old patient of unknown age. No information was provided regarding the patient's pertinent medical history, concomitant medications and previous drug reactions or allergies.  On an unknown date, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) (dose, frequency, route of administration, anatomical location, vaccination scheme, lot number and expiration date were not reported) as prophylaxis. On an unspecified date, the patient received the second dose of hepatitis a vaccine, inactivated (VAQTA) (lot number T013205, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 03-DEC-2021) (dose, frequency, route of administration, anatomical location and vaccination scheme were not reported) as prophylaxis. According to the nurse, the second dose of the hepatitis a vaccine, inactivated (VAQTA) was given earlier than the recommendations in the prescribing information. The vaccine was given 6 weeks and 6 days earlier than the recommended 6-18 month range (inappropriate schedule of product administration). No additional adverse events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T013205; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse reactions; Varivax IM/LT; This spontaneous report was received from a nurse referring to a 12-month-old male patient. The patient had 2 brothers and 2 sisters. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided. Concomitant vaccine included pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13).  On 05-JAN-2021, the patient was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose and strength were not reported, lot# T017682 has been verifies as valid, expiration date reported as 01-MAY-2022, but upon internal validation established as 21-MAY-2022) intramuscularly (IM) in the left thigh (LT) (incorrect route of product administration). The medication error occurred in the process of preparation for administration. There was no product quality complaint. The patient had no adverse reactions.  This is one of 2 reports referring to the same patient.; Sender's Comments:  US-009507513-2101USA001770:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information; Caller is an office manager that reported a temperature excursion for VARlVAX and MMR II. / Caller stated during that time the vaccines were administered; This spontaneous report was received from an office manager, referring to a 4-year-old patient of unknown gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided.  On an unspecified date in 2021, the patient was vaccinate with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), administered at a dose of 0.5 milliliter, as prophylaxis(formulation, strength, vaccination scheme frequency, anatomical site of vaccination and route of administration were not reported, lot number T027111, which has been verified to be valid, expiration date reported and validated as 07-FEB-2022). The vaccine administered, experienced a temperature excursion of -10 degrees Celsius (C) for a time frame of 1 hour and 15 minutes. There was no previous temperature excursion reported and no data logger was involved. No additional adverse events were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE reported; the vaccine is no good; incorrect product storage; This spontaneous report was received from a medical assistance referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On 08-MAR-2021, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 2 ml, by oral route, lot # 1707447, expiration date on 20-FEB-2022, for prophylaxis (strength and anatomical location were not reported). The wholesaler stated the shipment was too long in transit as it should had been received within 2 days (no details provided) and the medical assistant did not see the dates on package before it was thrown away. Additionally, it was stated that vaccine was not good and it was given before finding out it was no good. Reporter did not have details of the excursion and did not know the temperature or time frame. There was no previous temperature excursion and the call was not because of a data logger. No additional adverse event (AE) was reported.
Age: 14.0
Sex: U
Vaccine: HPV9, UNK
Symptoms: Product storage error
Clinical narrative: No other adverse event reported; A patient received a dose of Gardasil 9 that underwent a temperature excursion; This spontaneous report was received from a medical assistant referring to a 14-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant therapies and drug reaction or allergies was provided.  On 26-JAN-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (product storage error) injection, lot number reported and validated as T026954, expiration date reported and validated as 13-APR-2022 (dose, route of administration, anatomical site of vaccination, and vaccination scheme frequency were not reported)  as prophylaxis.   The vaccine underwent a temperature excursion on an unspecified date. The vaccine was stored at 47.3 degrees Fahrenheit (F) and 35.2 F for 30 minutes and 48 minutes respectively. There was not a previous temperature excursion. The call was due to a digital data logger.  combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); devicelotnumber: T026954; expirationdate: 13-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Electrocardiogram, Pain in extremity
Clinical narrative: Arm was killing her; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a 73-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included hysterectomy.   In November 2020, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows:  The age at vaccination was not reported.  After receiving 1st dose of Shingrix, the patient experienced arm was killing. The reporter consent to follow up. For tolerance with 2nd dose of Shingrix, refer linked case US2021AMR011486.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever of 103.2; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th January 2021, the patient received the 2nd dose of Shingrix. On 19th January 2021, 1 days after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient patient experienced fever and body temperature was 103.2 degree F.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Crying, Pain in extremity, Tremor
Clinical narrative: arm was sore 6-7 days; shaking about half hour / whole body shaking; crying uncontrollably; weak / laid low; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received the 1st dose of Shingrix. In September 2020, less than 6 months after receiving Shingrix, the patient experienced pain in arm, tremor, crying uncontrollable and weakness. On an unknown date, the outcome of the pain in arm, tremor, crying uncontrollable and weakness were unknown.   It was unknown if the reporter considered the pain in arm, tremor, crying uncontrollable and weakness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of shingrix at 5:00 pm and experienced pain in arm,tremor,crying uncontrollable and weak. The patient was scheduled to get covid vaccine with an hour but not sure whether vaccinated or not. The information regarding consent to follow was not reported.
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Chest pain, Lymph node pain, Pain, Swelling
Clinical narrative: slight pain leading into left pectoral; armpit has swollen; lymph glands are tender; This case was reported by a consumer via call center representative and described the occurrence of pain in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 11th October 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced pain, local swelling and lymph node tenderness. On an unknown date, the outcome of the pain, local swelling and lymph node tenderness were unknown.   It was unknown if the reporter considered the pain, local swelling and lymph node tenderness to be related to Shingrix.  Additional details were reported as follows: The patient received the 1st dose on 6th August 2019. The patient received the second shot in the left arm.  The patient's armpit had swollen, the lymph glands were tender and there was a slight pain leading into the left Pectoral. Sonogram was done in 2020 to see if the swelling had become cancerous but the result was no.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Had a painful reaction; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received shingrix and had a painful reaction.