chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling of eyelid
Clinical narrative: rashes on his hand; swelling of his eyelid; Itching; redness of his eyelid; "covid toe" blisters; chill; This is a spontaneous report from a Pfizer sponsored program by two contactable consumers (one of them was patient's wife and the other was patient self).   A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) Solution for injection, via an unspecified route of administration, administered in Arm on 31Mar2021 (Batch/Lot number was not reported) as dose 2, single (at the age of 57-year-old) for COVID-19 immunisation.  The patient medical history was not reported.  Concomitant medications included ibuprofen; acetylsalicylic acid, ascorbic acid (ASPIRIN).  The patient previously received BNT162B2 (at an unknown age) for COVID-19 immunisation as dose 1 and no reaction reported.  The patient did not take any vaccination 4 weeks prior to COVID 19 Vaccine.  Vaccination Facility Type was a set up clinic.  The patient received his second dose of BNT162B2 on 31Mar2021 and had been experiencing AEs. The patient's wife was wondering what they should do about the AEs. The patient had been having rashes on his hand and swelling of his eyelid. The patient has been diagnosed with the "covid toe" blisters on his toe that keep coming back and getting reinfected, and rashes on his hand that keep coming back and redness of his eyelid for which they had used hydrocortisone. Right after his second dose of BNT162B2, he experienced chill, struggled for a day and that the blisters on his foot and rashes on his hands and then his eyelids appeared 3 or 4 days later.  The consumer wanted to know how long will these AEs last.  Treatment included the patient went up to Podiatrist, they had the patient on some antibiotics for some days or so and then he used hydrocortisone for the itching and he had also taken the Benadryl time to time. Anatomical location of administration was in the arm.  Outcome of the events was unknown.  Information on Lot/Batch information has been requested.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris
Clinical narrative: After the 1st shot I noticed sporadic heart pains throughout the 2week period between shots; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 14May2021 11:30 (Lot Number: EW0167) at age of 53-year-old as single dose for covid-19 immunisation.  Medical history included allergies (Pollen, Mt Ceder) not 100% sure on what causes them.  Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. After the 1st shot, the patient noticed sporadic heart pains throughout the 2 week period between shots on 14May2021. The adverse event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. No treatment received. The outcome of event was unknown. Since the vaccination, it was unknown if the patient tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Impaired healing, Postoperative wound infection
Clinical narrative: Hole in her back was cauterized and it became infected; procedure on her back and it left a hole and it was not completely healed/still had a hole in her back; This is a spontaneous report from a contactable consumer (patient reported for herself) via a Pfizer Sponsored Program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 17May2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller stated she had a procedure on her back and it left a hole and it was not completely healed (2021). Caller asking if she got the vaccine, would it cause any adverse reactions or stop the process of healing. Caller stated it had been 42 days since she had the first injection and was wondering if she may have to restart the series or if she would just get her second dose. The reporter asked if the Pfizer-BioNTech COVID-19 vaccine can shed the virus. It was answered that: No, the Pfizer-BioNTech COVID-19 vaccine cannot shed the SARS-Cov-2 virus. Caller asking if there were any antibodies with the first or second shot of the Pfizer COVID vaccine. Caller stated she had a procedure on her back and it left a hole and it was not completely healed. The procedure was done after she had received the first dose of the Pfizer COVID vaccine, in which she had missed her second dose. Caller stated it had been 42 days since she's had her first dose of Pfizer's COVID vaccine. Caller asking with the new variants that are coming around, if there would be booster doses. The patient wanted to know if there were any antibodies in the first vaccine or were they all in the second dose. Caller had a procedure done after receiving the first dose, where a hole in her back was cauterized and it became infected (2021), so she was placed on an antibiotic, but she still had a hole in her back. Caller wanted to know if it was safe to get the second vaccine now, or should she wait until the back was completely healed, which would be about 2 months from now. Faxing AE of needing to have a hole in her back cauterized after receiving the first Covax vaccine and developing an infection after receiving the Pfizer vaccine. The outcome of the events was not recovered.  Information on lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: sudden sensory hearing loss; This is a spontaneous report from a contactable nurse (patient) from a Pfizer sponsored program. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)), first dose via an unspecified route of administration, administered in deltoid left on 16Apr2021 (Lot Number: EW0161; Expiration Date: Jul2021) at the age of 61 years old, as single dose for covid-19 immunisation. Medical history included thyroid, covid-19 from Dec2020. She has no medical history to add. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included ongoing levothyroxine sodium taken for thyroid. The patient experienced sudden sensory hearing loss on an unspecified date. She reported she lost her hearing suddenly. The doctor considered it an emergency. It was sudden sensory hearing loss. During that time she had a series of three injections in her ear. She did receive Lidocaine for those injections. She also received Prednisone injections in her ear. She reported it was a virus in her ear and she received three injections and wait and hope that her hearing resolves. She doesn't recall going on 04May2021 for an injection. She provided the dates of her injections as 22Apr2021, 26Apr2021, and 03May2021. The patient and her husband received letters stating that they may have received lidocaine that has been recalled. The date of the letter is 04May2021 which correlates to the time both her and her husband received their second Pfizer Covid-19 vaccine. The patient stated she received their Covid-19 vaccine on 04May2021, and her husband received his on 05May2021 and they both received the lidocaine recall letter. The patient stated the letter stated the recall drug was lidocaine injection and the company is hospira, with a NDC number and recall lot number, along with an expiration date and it stated some vials may contain another drug. The letter from the insurance company also says the Lidocaine vials may contain another drug. The patient stated her husband also had a dentist appointment on 05May2021 and received a lidocaine injection at this appointment. The outcome of the event was not recovered.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported hearing loss  and the use of BNT162B2 cannot  be fully excluded.  There is limited information in this case precluding a more meaningful assessment. The case will be assessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Condition aggravated, Dizziness
Clinical narrative: I received the 2nd shot and heart pains progressively got worse; I received the 2nd shot and heart pains progressively got worse; but this time it was accompanied by dizziness; This is a spontaneous report from a contactable consumer.     A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 05Jun2021 13:30 (Lot Number: EW0168) at age of 53 years old as a single dose for covid-19 immunisation. Medical history included allergies(Pollen, Mt Ceder) not 100% sure on what causes them.  The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 14May2021 11:30 (Lot Number: EW0167) at age of 53 years old as a single dose for covid-19 immunisation and experienced After the 1st shot I noticed sporadic heart pains throughout the 2week period between shots. The patient received the 2nd shot and heart pains progressively got worse, but this time it was accompanied by dizziness, both in Jun2021. No treatment received. The outcome of the events was unknown. The events were reported as non-serious.   Clinical course: After the 1st shot he noticed sporadic heart pains throughout the 2 week period between shots. At the 2nd shot he asked the nurse at the hospital if anyone else had experienced similar issues. They asked if he wanted the 2nd shot and he stated he was already committed at that point. He received the 2nd shot and heart pains progressively got worse,  but this time it was accompanied by dizziness. He went to the ER on Wednesday 09Jun2021 where they ran a battery of tests and immediately referred me to a cardiologist. The events were resulting in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was not COVID prior vaccination. It was unknown that covid tested post vaccination.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Cough, Feeling abnormal, Illness, Malaise
Clinical narrative: whooping cough; She just didn't get out of bed; sick; Her temp was 100.4; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for immunisation. Medical history included ongoing lung cancer. There were no concomitant medications. Clinical course: The first of Jan2021, she was extremely sick, with what felt to her like whooping cough. Her temp was 100.4. Her normal resting temperature is 96.5. 100.4 is a really high temperature for her. It lasted for a week. It felt like she was going to cough up her lungs. She just didn't get out of bed, it was horrible. Finally, at the end of 5 or 6 days, she was able to get up and got herself to the drug store. She got a bottle of Robitussin, which helped somewhat with the coughing. She hadn't been that sick in 40 years. It was that awful. She had wondered about that. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pertussis
Clinical narrative: whooping cough; She just didn't get out of bed; sick; Her temp was 100.4; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for immunisation. Medical history included ongoing lung cancer. There were no concomitant medications. Clinical course: The first of Jan2021, she was extremely sick, with what felt to her like whooping cough. Her temp was 100.4. Her normal resting temperature is 96.5. 100.4 is a really high temperature for her. It lasted for a week. It felt like she was going to cough up her lungs. She just didn't get out of bed, it was horrible. Finally, at the end of 5 or 6 days, she was able to get up and got herself to the drug store. She got a bottle of Robitussin, which helped somewhat with the coughing. She hadn't been that sick in 40 years. It was that awful. She had wondered about that. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Headache, Pain, Sinusitis, Upper respiratory tract infection
Clinical narrative: she developed a sinus infection; Within hours the typical symptoms of headache, body aches happened; Within hours the typical symptoms of headache, body aches happened; It has now turned into a Upper respiratory infection; This is a spontaneous report from a contactable consumer. A 14-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 09Jun2021 16:00 at age of 14-year-old (Lot Number: EW0178) as DOSE 2, SINGLE for covid-19 immunization. Medical history was none. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No concomitant medications were received. The patient previously received dose 1 via an unspecified route of administration, administered in Arm Left on 19May2021 16:00 at age of 14-year-old (Lot Number: ER8736) as DOSE 1, SINGLE for covid-19 immunization. The patient experienced she developed a sinus infection on 13Jun2021 with outcome of not recovered, within hours the typical symptoms of headache, body aches happened in Jun2021 with outcome of not recovered, it has now turned into a upper respiratory infection in 2021 with outcome of not recovered, the vaccine made her sick in 2021 with outcome of not recovered. Additional information included: Within hours the typical symptoms of headache, body aches happened. What is most important is exactly 4-5 days later, she developed a sinus infection and 3 weeks later and 2 antibiotics later, she is still sick. It has now turned into a Upper respiratory infection and had to spend a high amount of money on a CT scan of her lungs because she continues to get worse not better. Our Dr. is confident this is related to the vaccine. She was a perfectly healthy 14 yr. old girl and been sick ever since she got the vaccine. It is not a coincidence. The vaccine made her sick and we deserve answers. The reporter believe in vaccines and wanted to do the right thing to get the numbers down. Had the reporter known this would have been her body's response, reporter never would have had her get vaccinated. The patient underwent lab tests and procedures which included CT scan for her lungs: unknown results on unknown date. Therapeutic measures were taken as a result of all the events and the treatment included antibiotics. The events result in Doctor or other healthcare professional office/clinic visit.
Sex: U
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Premature baby
Clinical narrative: Maternal Exposure During Pregnancy; After vaccination sequence of body changes happened, which led to preterm delivery; This is a spontaneous report form a contactable consumer (mother). This consumer reported information for both imother and Neonate. This is the Neonate case.   A neonate patient of an unspecified gender received bnt162b2 (BNT162B2), transplacental on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. No known known allergies. The patient's concomitant medications were not reported. Last menstrual date Nov2020. The 32-year-old mother received bnt162b2 at the age of 32-year-old. The patient experienced maternal exposure during pregnancy and after vaccination sequence of body changes happened, which led to preterm delivery with outcome of unknown. Gestational period 30 weeks. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and Hospitalization for 24 days in 2021. The patient had no covid prior vaccination, no covid tested post vaccination.   Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021805597 mother case
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure timing unspecified
Clinical narrative: exposure via pregnancy; This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and neonate. This is the mother case.  A 32-year-old female patient (pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date in 2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Medical history was not reported. No known allergies. Last menstrual date Nov2020. Delivery date Aug2021. Concomitant medications were not provided. The patient experienced exposure via pregnancy in 2021 and after vaccination sequence of body changes happened, which led to preterm delivery in Jun2021. Gestational period was 30 weeks. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse event was preterm delivery. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the event was recovering. This report was assessed by the reporting consumer as serious with hospitalized.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021805560 baby case
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; FACILITATED COLLECT  This is a non study report received from a contactable consumer (patient) and physician based on information received by Pfizer  (manufacturer control number: 21K-163-3959431-00).  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization; pancreatin (CREON), orally from an unspecified date (Batch/Lot number was not reported), at unknown dose for exocrine pancreatic insufficiency. Medical history included exocrine pancreatic insufficiency. The patient's concomitant medications were not reported. It was unknown if patient was enrolled in a covid-19 vaccine trail. The patient experienced covid-19 on an unspecified date. The patient underwent lab tests and procedures which included COVID-19 test: positive on an unspecified date. The outcome of event was unknown. Causality for BNT162B2 as per reporter was not reported. Causality for pancreatin as per reporter  was not provided.  The reporter's assessment of the causal relationship of event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the current available information, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clots; This is a spontaneous report from a contactable physician via a sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient died one week after receiving Pfizer COVID vaccine, autopsy confirmed blood clots. Event took place after use of product.  Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory role of the suspect drug to the reported event  "blood clots" cannot be completely excluded based on temporal association. This case will be re-assessed when additional information becomes available.   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.; Reported Cause(s) of Death: blood clots
Sex: M
Vaccine: COVID19
Symptoms: Cough, Immunodeficiency, Lung disorder, SARS-CoV-2 test
Clinical narrative: severe lung disease; immunocompromised; Caller had several coughing spats during call; This is a spontaneous report from a Pfizer sponsored program COVAX US support via a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included covid-19. Family History included Has 19 y/o son and Wife also got Covid. The patient's concomitant medications were not reported. Caller is a Medical Social Worker that runs mental health clinics. Had covid and then got Pfizer covax, but is still immunocompromised. Concerned about Delta variant. Wants to know the effectiveness against. Last dose nearly killed him, 6 months after it, he is on oxygen 24/7 plus has severe lung disease. Receives transfusions every two weeks and is completely vulnerable. Caller had several coughing spats during call, some severe. The outcome of the events was unknown.   Information about batch/ lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Retinal vein thrombosis
Clinical narrative: I had two of my patients lose their eyes due to central retinal vein thrombosis after the second dose of the Pfizer BioNTech COVID-19 vaccine; This is a spontaneous report received  from a contactable physician. A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date: unknown), via an unknown route of administration on an unknown date as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 on an unknown date. The physician reported that, two of my patients lose their eyes due to central retinal vein thrombosis after the second dose of the Pfizer-biontech covid-19 vaccine. Outcome of event was unknown.   Information on Lot/Batch number has been requested.; Sender's Comments: Based on the available information in the case, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event retinal vein thrombosis. 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: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Colitis ulcerative, Weight
Clinical narrative: I feel that my Ulcerative colitis, which had been in remission for years has become active and I have been kicked back to 50 years; severe abdominal pain; This is a spontaneous report from a contactable consumer (patient) reported in response to consumer letter sent via follow-up letter. A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: EL9262) via unspecified route of administration on 10Feb2021, as SECOND DOSE, SINGLE for COVID-19 immunisation. The patient's medical history included ulcerative colitis and diabetes controlled by diet. Concomitant medications were not reported. Historical vaccination included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: OL1284) via unspecified route of administration on 20Jan2021, as FIRST DOSE, SINGLE for COVID-19 immunisation and experienced muscle ache and pain, vomiting, difficulty breathing, diarrhea, soreness of arm and severe fatigue, gastrointestinal upset and went on for a day, nausea and extreme tiredness. On an unknown date (reported as: one week following the second injection) the patient had constant severe abdominal pain for 7 days. The patient felt that her ulcerative colitis, which had been in remission for years has become active and she have been kicked back to 50 years. The patient experienced several narcolepsy events following the first injection where I lost up to 30 minutes of time. The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Overdose, SARS-CoV-2 antibody test
Clinical narrative: received a third Pfizer vaccine; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration on 24Jun2021 (Batch/Lot number was not reported) as DOSE 3, SINGLE for covid-19 immunisation. Medical history included chronic lymphocytic leukaemia (CLL) with a compromised immune system. Concomitant medication included PI3K inhibitor. The patient previously received dose 1 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE and dose 2 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. It was reported that the patient received second of two doses of the Pfizer vaccine in February. Patient since twice tested negative for the spike protein anti-body. On 24Jun2021, the patient received a third Pfizer vaccine. Outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart Attack-Mild/Heart Attack; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EL9267) via an unspecified route of administration in left arm on 23Feb2021 at 12:00 (at the age of 70-year-old) as single dose for COVID-19 immunization. Patient had no medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EL8982) via an unspecified route of administration in left arm on 03Feb2021 (at the age of 70-year-old) as single dose for COVID-19 immunization and experienced severe heart burn and was overall not feeling well. On 24Feb2021, at 17:00, the patient experienced mild heart attack. Adverse event resulted in visit to emergency room and physician office. Patient was admitted to the hospital in response to the event. Patient received the treatment in response to the event which included stent implant (Surgery: stent). Surgery was not planned before taking the vaccination. Outcome of the event was resolved on an unspecified date on 2021.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: child was given the PENTACEL but it had reached -2 degree Celsius for 2 hours with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from Pharmacist via Global Medical Information (Reference number- 00665902) and transmitted on 01-Jul-2021.  This case involves a child patient who was administered with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] but it had reached minus 2 degree Celsius for 2 hours (product storage error).  The patient's medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number and expiry date were not reported) via unknown route at an unknown administration site for prophylactic vaccination (product storage error).   Cause of the excursion is unknown to reporter. HCP (Healthcare professional) states that the patient should get his shots again but the mother thinks it's too quickly, is there anything she should look out for? Should she bring her baby in so soon?  It was an actual medication error case due to product storage error temperature too low(latency: same day).  At the time of reporting, the patient experienced 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 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.  There will be no information on the batch number for this case.
Age: 1.5
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: 18 month old male patient received expired dose of ACT-HIB vaccine, no AE; Initial information received on 02-Jul-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 month old male patient who was vaccinated with an expired dose of suspect HIB (PRP/T) VACCINE [ACT-HIB].  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for Immunisation.  On 29-Jun-2021, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE (lot UJ327AAB and expiry date: 28-Jun-2021) (Frequency: once) via an intramuscular route at an unknown administration site (expired product administered) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  It was also reported that the caller reported giving an ACT-HIB vaccine to a patient. That was within 24 hours after expiration date. No email was provided by caller. Patient Information Patient age greater 1 year enter as 2 month, 4 month etc. Many pediatric vaccines need month for age. Dosage Information: Frequency -once o Therapy Date: From Date of immunization To - leave blank-given 29Jun2021 by caller Route - route  and site- intramuscularly 0.5ml Dose - 0.25 mL to 2 mL for vaccines or 0.1 mL for TB (Tuberculosis) skin test-0.5ml Strength = standard except for Fluzone HD- standard o Indications -Immunization or TB skin test-immunization. Pregnancy- not applicable Last menstrual period, Due date, AE (adverse event) symptoms or no AE. If baby was delivered: delivery date and if baby experienced an adverse event, Inform that they will be receiving a follow up questionnaire, If calling specifically about being added to the pregnancy registry: all pregnancy cases are added to the registry.  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 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: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Scab, Squamous cell carcinoma of skin
Clinical narrative: Squamous Cell Skin Carcinoma (Keratoacanthoma); white scab; Initial information regarding an unsolicited non-valid non-serious case was received on 02-Jul-2021 from a Consumer via Medical Information (Reference number- 00667476) and transmitted to Sanofi on 02-Jul-2021.  This case involves a 60-year-old female patient who experienced white scab (scab) and diagnosed with non-serious squamous cell skin carcinoma (keratoacanthoma) (keratoacanthoma) while receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX) for prophylactic vaccination.  On 20-Sep-2020, the patient received 0.7 ml dose (total) (once) of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot UJ484AA via and expiry date 30-Jun-2021] via intramuscular route in the right arm for prophylactic vaccination.  On 20-Sep-2020 the patient developed non-serious white scab (scab) on the same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE and on 11-Mar-2021 the patient diagnosed with non-serious squamous cell skin carcinoma (keratoacanthoma) 5 months 22 days following the following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported that, "Caller from Pharmacy Claims Services reports that a patient received a Fluzone Quadrivalent High Dose vaccine on 20Sep2020 and then developed a white scab. On 21Feb2021, the patient went to the Dermatologist and was tested and returned on 11Mar2021 and was diagnosed with Squamous Cell Skin Carcinoma (Keratoacanthoma). The patient believes that it is due to the Fluzone Quadrivalent High Dose vaccine potentially leaking down her arm and causing the skin cancer. The skin cancer and the vaccine anre in the same location. This was treated by excising and removing the lesion. There is no further information regarding this. Product used: Used. Still using product: No. Was Device Used: Yes".  It was unknown if the patient experienced any additional symptoms/events.  Details of laboratory data were not reported.  The patient was treated by excising and removing the lesion.  At the time of report, the outcome of events was unknown.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Gait disturbance, Peripheral swelling, Vision blurred
Clinical narrative: Diarrhea and soft/loose stools EVERY DAY since to this day! Leg swelling...mostly in right leg & foot.  Trouble walking. Some unusual & day long blurred vision.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Sleep disorder
Clinical narrative: All of a sudden I?ve been having lower leg cramps. Both legs. It?s like Charlie horse but severe where I have to get up and walk to fix it. Woke me up at night. Happened twice now.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness unilateral, Tinnitus
Clinical narrative: Tinnitus (pulsatile) in my right ear started started in about two days. Loss of hearing in my right ear occurred gradually.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Muscle spasms, Musculoskeletal stiffness, Neuralgia, Pain in extremity
Clinical narrative: Increase nerve pain and flare ups - uncontrollable  Shaking Tingling and pains in arms  Cramping  in joints unable to move fingers
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Tremor
Clinical narrative: Increase nerve pain and flare ups - uncontrollable  Shaking Tingling and pains in arms  Cramping  in joints unable to move fingers
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Mild headache Fever Rest only
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol normal, Blood triglycerides normal, C-reactive protein decreased, Cardiac stress test, Chest pain
Clinical narrative: Patient states that didn't feel normal after her second Pfizer vaccine. She was tired in the afternoons and felt like she doesn't breathe properly. In mid June she started to feel occasional chest pain. Around June 30th she had chest pain that she thought she is having a heart attack. She was seen by a cardiologist on July 1st who diagnosed her with Pericarditis acuta and prescribed Azithromycin, Dexamethasone, Omeprazole, Xarelto and Bisocor (BP medicine).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram abnormal, Electrocardiogram, High density lipoprotein normal, Low density lipoprotein, Pericarditis
Clinical narrative: Patient states that didn't feel normal after her second Pfizer vaccine. She was tired in the afternoons and felt like she doesn't breathe properly. In mid June she started to feel occasional chest pain. Around June 30th she had chest pain that she thought she is having a heart attack. She was seen by a cardiologist on July 1st who diagnosed her with Pericarditis acuta and prescribed Azithromycin, Dexamethasone, Omeprazole, Xarelto and Bisocor (BP medicine).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Severe body aches and high fever . Swollen arm and enlarged lymph node on left arm .
Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Antinuclear antibody, Asthenia, Blood test, Headache, Hypoaesthesia
Clinical narrative: I am weak with headaches and my legs go numb and fall asleep just sitting around the house.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Heart rate increased, Myalgia
Clinical narrative: this was my second dose and I have experienced very bad side effects  for 20 days now; starting with headaches, severe muscle and joint aches, down both legs lower back and right arm and on the 18th day after I started experiencing a racing pulse of 112.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: arm pain for 48 hours after injection
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: ringing / static noise in ears
Age: 27.0
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: No additional adverse event; Expired product administered; This spontaneous report was received from a nurse concerning a 27 years old patient. No information about the current condition, medical history or concomitant therapy was reported.   On 07-JUL-2021, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # 1581027, expiration date: 03-JUN-2021 (also reported as 30-JUN-2021); at the dose of 0.5 milliliter) as prophylaxis (expired product administered).  No temperature excursion was reported. No additional adverse event was reported. 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); manufacturername: Merck Sharp & Dohme Corp.devicelotnumber: 1581027; expirationdate: 03-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Nerve compression, Pain
Clinical narrative: it is a pinched nerve; weird burning /sensations in my upper back that slowly came around to the upper part of my body; stinging sensations in my upper back that slowly came around to the upper part of my body/ it was very painful/ nothing to see just the pain; This case was reported by a consumer via interactive digital media and described the occurrence of pinched nerve in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pinched nerve, burning sensation and stinging. On an unknown date, the outcome of the pinched nerve, burning sensation and stinging were unknown.   The reporter considered the pinched nerve, burning sensation and stinging to be unrelated to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not reported. Patient reported that her husband and she received Shingrix shots a couple of years ago and after her second shot, she started getting weird burning and stinging sensations in her upper back that slowly came around to the upper part of my body and it was very painful to where she was in tears sometimes and there was nothing to see just the pain.  Patient reported to her doctor that she thought it was from the shots and doctor right away said no it was not that, it was a pinched nerve but it was quite a coincidence.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: First dose / Rash appeared after 2 days; This case was reported by a physician via sales rep and described the occurrence of rash in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided are as follows: The age at vaccination was not reported. The patient got her 1st dose of Shingrix from pharmacy and doctor administered it and 2 day after vaccination, the  patient experienced rash. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pyrexia
Clinical narrative: got the vaccine. Had a fever; got the vaccine / felt horrible; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever and feels awful. On an unknown date, the outcome of the fever and feels awful were unknown.   It was unknown if the reporter considered the fever and feels awful to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not provided. A year later after shingles the patient received Shingles vaccine and developed fever and felt horrible. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: had my 1st dose / Dec 30 2020 but have not done the 2nd dose; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 30th December 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follow: The patient had reported the case for himself/herself. The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter enquired was it too late to get the 2nd dose.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received 2 doses 31 days apart; This case was reported by a pharmacist and described the occurrence of drug dose administration interval too short in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received second dose of Shingrix 31 days apart from first dose, which led to shortening of vaccination schedule. No other information was reported.
Sex: F
Vaccine: MENB
Symptoms: Incomplete course of vaccination, Product prescribing error
Clinical narrative: They told me to come back in one month for the second dose. When; This case was reported by a consumer via interactive digital media and described the occurrence of drug prescribing error in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included Men B NVS (Bexsero) and meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device).   On an unknown date, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device and an unknown time after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced drug prescribing error. On an unknown date, the outcome of the drug prescribing error was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: This case was reported by patient's parent. The patient had received Bexsero vaccine 2 months before her 18th birthday at her neighborhood and told to come back in one month for the second dose and when reporter returned a month later, the pharmacist said it was one dose of vaccine which led to drug prescribing error