chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Tachypnoea, Throat tightness
Clinical narrative: tachycardia HR 135; shortness of breath; Mild Angioedema (local throat and tongue); Hoarse voice; Bilateral wheeze/ bronchospasm; Upper airway swelling; Tachypnoea: RR28; Sensation of throat closure; Irregular heart arrhythmia; Dry cough; This is a spontaneous report from a contactable other hcp (patient).  A 28-years-old female patient receive dose 2 of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL3249, intramuscular left deltoid on 08Jan2021 07:35 at the age of 28 years as a single dose for covid-19 immunisation.   Medical history included asthma from 04Apr2005 to an unknown date, obesity from an unknown date, seasonal allergy from 20Dec2007 to an unknown date , food allergy from 20Dec2007 (allergic to walnuts, peanuts, hazelnuts, palm oil)  to an unknown date.  Concomitant medication included fexofenadine hydrochloride (ALLEGRA), docusate sodium (COLACE), vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]), iron (IRON), calcium (CALCIUM) , diphenhydramine hydrochloride (BENADRYL), famotidine (PEPCID),  on 08Jan2021 07:05 and acetaminophen on 08Jan2021 07:05 for antipyretic prophylaxis.   The patient previously took sunflower seed oil base and experienced hypersensitivity. The patient carries EPI pen but never used, received allergy shot for 6 years only uses drug allergy season.  Historical vaccine dose 1 of BNT162B2 for covid-19 immunisation on 18Dec2020, Left deltoid, intramuscular, Batch/lot number: EJ1685 at 08:45 am at age 27 years.  The patient experienced mild angioedema (local throat and tongue) considered medically significant on 08Jan2021 08:00 with outcome of recovered 14:30 , hoarse voice on 08Jan2021 with outcome of unknown , shortness of breath on 08Jan2021 09:05 with outcome of recovered , tachycardia HR 135 on 08Jan2021 09:07 with outcome of recovered , bilateral wheeze/ bronchospasm on 08Jan2021 with outcome of unknown , upper airway swelling on 08Jan2021 with outcome of unknown , tachypnoea: RR28 on 08Jan2021 with outcome of unknown , dry cough on 08Jan2021 with outcome of unknown , sensation of throat closure on 08Jan2021 with outcome of unknown , irregular heart arrhythmia  on 08Jan2021 with outcome of unknown and "Vacematter 08:45".  Lab data all reported on 08Jan2021 included heart rate: 135 and 130, oxygen saturation: 98 %, respiratory rate increased 28.  Therapeutic measures were taken as a result of mild angioedema, hoarse voice, shortness of breath, tachycardia HR 135, bilateral wheeze/ bronchospasm, upper airway swelling, tachypnoea: RR28, dry cough, sensation of throat closure, and irregular heart arrhythmia.  The patient took Benadryl 50mg at 09:10 and experienced irregular heart arrhythmia.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Pneumonia
Clinical narrative: Covid-19 and pneumonia; Covid-19; pneumonia; This is a spontaneous report from a contactable consumer (patient's daughter). An 82-year-old male patient received two doses of bnt162b2, both via unspecified routes of administration on unspecified dates (Batch/Lot number was not reported) at single doses for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had two covid-19 vaccines and contracted COVID-19 and pneumonia on an unspecified date. The patient was hospitalized from 23Feb2021 and released on 01Mar2021. The patient was on antibiotics for pneumonia. Outcome of the events unknown.  Information on Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Echocardiogram, Electrocardiogram, Heart rate, Pain
Clinical narrative: Atrial fibrillation; Heart racing; Sore arm; mild body aches; Premature ventricular contractions; This is a spontaneous report from a contactable consumer reporting for her husband. A 36-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left, on 15Jan2021, as single dose, for COVID-19 immunisation. The patient's medical history included drug allergy to amoxicillin. Patient did not have COVID-19 prior to vaccination. Concomitant medications were not reported. The patient previously took the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation. The patient experienced atrial fibrillation (caused hospitalization on 17Jan2021) on 17Jan2021 at 09:00 with outcome of recovered on 17Jan2021 at 10:30, sore arm (non-serious) on 15Jan2021 with outcome of recovering, mild body aches (non-serious) on 15Jan2021 with outcome of recovering, heart racing (non-serious) on 17Jan2021 at 06:00 AM with outcome of recovering, premature ventricular contractions (non-serious) in Jan2021 a couple of times a day with outcome of recovering over the next couple of weeks. The patient underwent lab tests and procedures which included echocardiogram: normal on unspecified date, electrocardiogram: atrial fibrillation on 17Jan2021, heart rate: 170 on 17Jan2021. The events needed a physician office visit. Therapeutic measures were taken as a result of the events and included treatment with metoprolol, flecainide and heart monitor for 2 weeks. He took metoprolol for the next week as a precaution but did not go back into atrial fibrillation. Patient did not tested for COVID-19 post vaccination.   The information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Palpitations, Ventricular extrasystoles
Clinical narrative: Atrial fibrillation; Heart racing; Sore arm; mild body aches; Premature ventricular contractions; This is a spontaneous report from a contactable consumer reporting for her husband. A 36-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left, on 15Jan2021, as single dose, for COVID-19 immunisation. The patient's medical history included drug allergy to amoxicillin. Patient did not have COVID-19 prior to vaccination. Concomitant medications were not reported. The patient previously took the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation. The patient experienced atrial fibrillation (caused hospitalization on 17Jan2021) on 17Jan2021 at 09:00 with outcome of recovered on 17Jan2021 at 10:30, sore arm (non-serious) on 15Jan2021 with outcome of recovering, mild body aches (non-serious) on 15Jan2021 with outcome of recovering, heart racing (non-serious) on 17Jan2021 at 06:00 AM with outcome of recovering, premature ventricular contractions (non-serious) in Jan2021 a couple of times a day with outcome of recovering over the next couple of weeks. The patient underwent lab tests and procedures which included echocardiogram: normal on unspecified date, electrocardiogram: atrial fibrillation on 17Jan2021, heart rate: 170 on 17Jan2021. The events needed a physician office visit. Therapeutic measures were taken as a result of the events and included treatment with metoprolol, flecainide and heart monitor for 2 weeks. He took metoprolol for the next week as a precaution but did not go back into atrial fibrillation. Patient did not tested for COVID-19 post vaccination.   The information on the lot/batch number has been requested.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, SARS-CoV-2 test
Clinical narrative: I suffered a stroke 24 hours after receiving vaccine; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Left arm on 20Feb2021 (at the age of 69-year-old) at 11:15 AM at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient had no Covid prior vaccination and patient had COVID tested post vaccination. The patient suffered a stroke about 24 hours after receiving vaccine on 21Feb2021 at 10:30. The event result in hospitalization for 2 days in Feb2021 and considered as life threatening illness (immediate risk of death from the event).  The patient underwent lab tests and procedures which included Nasal swab was negative on 23Feb2021. Treatment included blood thinner. The outcome of the event was not recovered.  Information on lot number/batch number has been requested.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, SARS-CoV-2 test
Clinical narrative: intraparenchymal hemorrhage, right occiput; This is a spontaneous report from a contactable nurse (patient). This nurse reported that a 76-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262) at the age of 76-years, via an unspecified route of administration on 04Feb2021 17:30 at single dose for COVID-19 immunisation, in hospital. Medical history included MGUS; thyroid nodule; hyperlipidemia; single episode A fib. Patient had no known allergies, no COVID-19 prior vaccination, no other vaccine in four weeks. Concomitant medications included levothyroxine sodium (SYNTHROID); atorvastatin; colecalciferol (VIT D3); cyanocobalamin (VIT B12); rivaroxaban (XARELTO). The patient historically received first single dose of BNT162B2 (lot number: EL3247) at the age of 76-years on 14Jan2021 05:45 PM for COVID-19 immunisation. On 09Mar2021, the patient experienced intraparenchymal hemorrhage, right occiput. This adverse event resulted in emergency room/department or urgent care, 5 days of hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. Patient received XARELTO reversal and osmotic fluids to reduce brain s as treatments. The patient underwent lab tests and procedures, which included on 11Mar2021, COVID-19 test (Nasal Swab) was negative. Outcome of the event was unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Pulmonary thrombosis, SARS-CoV-2 test, Thrombosis
Clinical narrative: multiple blood clots in lungs; multiple blood clots in legs; feeling chest pain; short of breath; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient (pregnant: No) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269), via an unspecified route of administration in left arm on 06Feb2021 at 18:00 at single dose for covid-19 immunisation. The relevant medical history included DCIS Breast cancer from 2016, Known allergies: pencillin from an unspecified date. Concomitant medications included levothyroxine sodium (SYNTHROID). The patient previously received first dose of BNT162B2 on 16Jan2021 at the age of 68 years old (lot number: EL3249, at 06:15 PM, in Left arm) for covid-19 immunisation. The patient received 2nd Pfizer vaccine dose on Sat, 06Feb2021. On Wednesday 10Feb2021 she became short of breath. On 11Feb2021, she began feeling chest pain. On 12Feb2021, she was advised by primary care Dr to go to the emergency room. She was admitted on 12Feb2021 to ICU with multiple blood clots in her lungs and legs. She was told by the emergency Dr this was a sign of Covid, they did a Covid test, came back negative. She remained in the hospital till 18Feb2021. She was at the time of the report on Eliquis (10 mg/d). A hereditary blood clot test was done that came back negative. She had never had an issue before the vaccination with blood clots nor anyone in her family and she was in good health before the vaccination. Dr didn't think the vaccine caused the blood clots but her primary care Dr thought it did-which was why she was reporting it. The patient also stated that event multiple blood clots in her lungs and legs resulted in Emergency room/department or urgent care, Hospitalization and Life threatening illness. The patient had hospitalization for 7 days. Treatment Heparin 25,000unit in .45% NaCl Premix, Narcan received. No covid prior vaccination. The patient underwent lab test included Nasal Swab which showed negative on 12Feb2021; Hereditary blood clot test which showed negative on an unspecified date in 2021. Therapeutic measures were taken as a result of all the events. The outcome of the events was recovered with sequel.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pulmonary thrombosis, Respiratory arrest, SARS-CoV-2 test
Clinical narrative: I was transported by ambulance and admitted to the hospital with numerous blood clots in my lungs after I could not breathe.; I was transported by ambulance and admitted to the hospital with numerous blood clots in my lungs after I could not breathe.; This is a spontaneous report from a contactable consumer (patient).  A 51-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265) on 30Jan2021 09:00 (age at vaccination was 50-year-old) on left arm for COVID-19 immunisation. Medical history included hypothyroidism. No Known allergies. Concomitant medications in two weeks included thyroid (ARMOUR THYROID), ethinylestradiol, levonorgestrel (SEASONALE) and cetirizine hydrochloride (ZYRTEC). No other vaccine in four weeks. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) on 07Jan2021 14: 15 (age at vaccination was 50-year-old) on left arm for covid-19 immunization. Facility type vaccine was Hospital. She was transported by ambulance and admitted to the hospital with numerous blood clots in her lungs after she could not breathe on 22Feb2021 09:45 AM. AE resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Treatment received as Angioplasty to remove bigger clots. No covid prior vaccination. Nasal Swab test (PCR) on 22Feb2021 was negative. The outcome of the events was recovering.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram pulmonary abnormal, Anticoagulant therapy, Blood test, Mixed connective tissue disease, Pulmonary embolism
Clinical narrative: I was transported by ambulance and admitted to the hospital with numerous blood clots in my lungs after I could not breathe.; I was transported by ambulance and admitted to the hospital with numerous blood clots in my lungs after I could not breathe.; This is a spontaneous report from a contactable consumer (patient).  A 51-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265) on 30Jan2021 09:00 (age at vaccination was 50-year-old) on left arm for COVID-19 immunisation. Medical history included hypothyroidism. No Known allergies. Concomitant medications in two weeks included thyroid (ARMOUR THYROID), ethinylestradiol, levonorgestrel (SEASONALE) and cetirizine hydrochloride (ZYRTEC). No other vaccine in four weeks. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) on 07Jan2021 14: 15 (age at vaccination was 50-year-old) on left arm for covid-19 immunization. Facility type vaccine was Hospital. She was transported by ambulance and admitted to the hospital with numerous blood clots in her lungs after she could not breathe on 22Feb2021 09:45 AM. AE resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Treatment received as Angioplasty to remove bigger clots. No covid prior vaccination. Nasal Swab test (PCR) on 22Feb2021 was negative. The outcome of the events was recovering.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pulmonary resection
Clinical narrative: I was transported by ambulance and admitted to the hospital with numerous blood clots in my lungs after I could not breathe.; I was transported by ambulance and admitted to the hospital with numerous blood clots in my lungs after I could not breathe.; This is a spontaneous report from a contactable consumer (patient).  A 51-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265) on 30Jan2021 09:00 (age at vaccination was 50-year-old) on left arm for COVID-19 immunisation. Medical history included hypothyroidism. No Known allergies. Concomitant medications in two weeks included thyroid (ARMOUR THYROID), ethinylestradiol, levonorgestrel (SEASONALE) and cetirizine hydrochloride (ZYRTEC). No other vaccine in four weeks. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) on 07Jan2021 14: 15 (age at vaccination was 50-year-old) on left arm for covid-19 immunization. Facility type vaccine was Hospital. She was transported by ambulance and admitted to the hospital with numerous blood clots in her lungs after she could not breathe on 22Feb2021 09:45 AM. AE resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Treatment received as Angioplasty to remove bigger clots. No covid prior vaccination. Nasal Swab test (PCR) on 22Feb2021 was negative. The outcome of the events was recovering.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Subarachnoid haemorrhage
Clinical narrative: subarachnoid hemorrhages; This is a spontaneous report from a contactable consumer (patient self). A 68-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3248), via an unspecified route of administration (location: left arm) on 16Feb2021 at age of 68-year-old at single dose for COVID-19 immunisation. Medical history included polymyalgia rheumatica. No known allergies. Facility type vaccine was pharmacy or drug store. No other vaccine received within four weeks. No COVID prior vaccination. Concomitant medications included alendronate sodium (FOSAMAX), prednisone, methotrexate and hydroxychloroquine. The patient experienced subarachnoid hemorrhages on 23Feb2021 and sent to emergency neurosurgery on the same day for 2 subarachnoid hemorrhages. The event resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient was admitted into neurosurgery on unknown date and received treatment (unspecified). The patient was hospitalized for 9 days. COVID test (nasal swab) post vaccination on 23Feb2021 resulted negative. The outcome of event was recovering.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood pressure measurement, Pulmonary embolism
Clinical narrative: Pulmonary Embolism; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 84-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration (Lot Number: EL9261) at 9:00 am on 22Jan2021 (at 84-year-old) in arm right at single dose for COVID-19 immunization. Other medical history was reported as high blood pressure (HBP), high cholesterol, thyroid cancer removed in 2003 (thyroid cancer from an unspecified date to 2013), breast cancer from 2009, hemorrhoid surgery in 2011, polymyalgia rheumatica (2018 & 2020), hip injections in 2018 & 2020, and cataracts removed both eyes in 2018 (cataracts from an unspecified date to 2018). The patient had allergy to morphine. Concomitant medications (other medications in two weeks) included levothyroxine sodium (SYNTHROID), metoprolol, triamterene, montelukast, and atorvastatin calcium (ATOR), all taken for an unspecified indication, start and stop date were not reported. There's no other vaccine in four weeks. The patient experienced pulmonary embolism at 02:00 am on 01Feb2021. The event resulted in emergency room/department or urgent care, hospitalization for 3 days, life threatening illness (immediate risk of death from the event). The event treatment included apixaban (ELIQUIS). The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EM9809) via an unspecified route of administration at 9:00 am on 12Feb2021 in arm right at single dose for COVID-19 immunization. No COVID prior vaccination, and no COVID tested post vaccination. The outcome of the event was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Foetal death
Clinical narrative: Baby stop growing 3 days later (7 weeks 3 days per sono); Baby stop growing 3 days later (7 weeks 3 days per sono); This is a spontaneous report from a contactable Other HCP. This Other HCP reported events for herself and fetus. This is a fetus report.   A 40-year-old mother received bnt162b2 (BNT162B2), dose 2 administered in Arm Left on 20Feb2021 (Batch/Lot Number: El9266) as SINGLE DOSE, dose 1 administered in Arm Left on 27Jan2021 (Batch/Lot Number: El3248) as SINGLE DOSE for covid-19 immunisation. The mother medical history included allergies: Shellfish. No other vaccine in four weeks. No COVID prior vaccination. Concomitant medication included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). The mother was  pregnant. Last menstrual date: 04Jan2021. Due Date: 11Oct2021. The mother was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono) on 24Feb2021 08:00 AM. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient died on 24Feb2021 08:00 AM. It was not reported if an autopsy was performed.; Sender's Comments: Based on provided information and temporal association the reported events causal relationship with the suspect drug cannot be excluded. However there is very limited information provided in this report. Additional information is needed to better assess the case, including complete medical history and diagnostics workup. This case will be reassessed upon receipt of follow-up 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.,Linked Report(s) : US-PFIZER INC-2021277400 Same reporter/drug, different patient /event (mother case); Reported Cause(s) of Death: Baby stop growing 3 days later (7 weeks 3 days per sono); Baby stop growing 3 days later (7 weeks 3 days per sono)
Sex: F
Vaccine: COVID19
Symptoms: Liver disorder
Clinical narrative: The patient had liver problems and died; This is a spontaneous report from a contactable consumer. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient had liver problems and died on an unspecified date. It was unknown if an autopsy was performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: The patient had liver problems and died
Sex: U
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Reaction to Guillain-Barre Syndrome; This is a spontaneous report from a non-contactable consumer (the patient) from a Pfizer-sponsored program. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot/batch number and Expiration date were not provided), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient reported reaction to Guillain-Barre Syndrome (no other details provided). The clinical outcome of reaction to Guillain-Barre Syndrome was unknown.  No follow-up attempts are possible; information about batch/lot number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient information corrected.  Follow-up (16Mar2021): This is a follow-up report to notify that case 2021157553 and case 2021285669 are duplicates. All subsequent follow-up information will be reported under Manufacturer report number 2021285669.
Age: 11.0
Sex: M
Vaccine: MMRV, MNQ, TDAP
Symptoms: No adverse event, Product preparation error, Wrong product administered
Clinical narrative: Menactra liquid was accidentally mixed with Proquad powder before administration to a patien/ No AE; Proquad powder given instead of Adacel/No AE; Initial and additional information received on 26-Feb-2021 regarding an unsolicited valid non-serious case received from a nurse via physician via other health care professional via Regulatory Authority (Reference number- 00495489).  This case involves a 11 years old male patient who was administered MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] liquid dose: 0.5 ml, lot number: U6787AA, expiry date: 08-NOV-2021 via unknown route in the right arm on 26-Feb-2021 for prophylactic vaccination which was accidentally mixed with MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) [PROQUAD] powder before administration (product preparation issue) given instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included Human papillomavirus (HPV) VACCINE for prophylactic vaccination.  It was an actual medication error due to inappropriate reconstitution technique and wrong vaccine administered (latency same day).  Potential product technical complaint (PTC): No. Description: Nurse reports that MENACTRA was accidentally mixed with another vaccine before administration. Nurse reports that today, a medical assistant (MA) was supposed to administer Menactra and Proquad vaccines to an 11 year-old male. When preparing the vaccines, the MA did not reconstitute the Proquad correctly, instead mixing the Menactra liquid with the Proquad powder. Reporter relationship: health care professional (HCP). Product used.  Therapy ongoing: Unknown. Related to company product: Not reported. Nurse has called back to correct previously reported information. Nurse had reported that patient was supposed to receive HPV, Menactra and Proquad vaccines. After going back through the records, he realized that the doctor's order was actually for HPV, Menactra and Adacel. After administering the Proquad diluted with Menactra, the Adacel was not given.  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.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient was administered an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other healthcare professional (pharmacy intern) via Global Medical Information (GMI) (Reference number-00510958) and transmitted to Sanofi on 09-Mar-2021.  This case involves a 17 year old female patient who was administered a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number: U6543AA; expiry date: 23-Feb-2021; Strength: standard) via intramuscular route in the left arm for prophylactic vaccination on 08-Mar-2021 (expired product administered).  Medical history, medical treatment(s), past vaccination(s) and family history were not provided.  The patient had no other vaccines.   It was a case of an actual medication error due to expired vaccine used (latency same day).  On 08-Mar-2021, the patient came in needing a Menactra vaccine. It was administered without problem, but after administration, it was noted that the product expired on 23-Feb-2021. Therefore, the reporter wanted to know if it was needed to repeat the vaccination. It was decided that they would repeat the vaccination.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Expired product administered
Clinical narrative: A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Agency (Reference number- 00512996) and transmitted to Sanofi on 10-Mar-2021.  This case involves a 26-year-old female patient who received an expired 0.5 mL dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]( Oral solution, lot C5585BA and expiry date: 06-Mar-2021) via an intramuscular route in the left deltoid for prophylactic vaccination on 06-Mar-2021 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for prophylactic vaccination.  This was an actual medication error case due to expired vaccine used (latency same day).  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.
Sex: F
Vaccine: HEPAB, HEPAB, HEPAB, HEPAB
Symptoms: Hepatitis A virus test, Hepatitis B antibody, Therapy non-responder
Clinical narrative: It took 4 shots for her to body to respond/make antibodies; This case was reported by a consumer via call center representative and described the occurrence of therapy non-responder in a 68-year-old female patient who received HAB (Hepatitis A and Hepatitis B vaccine) for prophylaxis.   Co-suspect products included HAB (Hepatitis A and Hepatitis B vaccine) for prophylaxis, HAB (Hepatitis A and Hepatitis B vaccine) for prophylaxis and HAB (Hepatitis A and Hepatitis B vaccine) for prophylaxis.   The patient's past medical history included shingles and chickenpox. Concurrent medical conditions included hiv positive and immunodeficiency.   On an unknown date, the patient received the 1st dose of Hepatitis A and Hepatitis B vaccine, the 2nd dose of Hepatitis A and Hepatitis B vaccine, the 3rd dose of Hepatitis A and Hepatitis B vaccine and the 4th dose of Hepatitis A and Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis A and Hepatitis B vaccine, Hepatitis A and Hepatitis B vaccine, Hepatitis A and Hepatitis B vaccine and Hepatitis A and Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not reported. The reporter stated that she receved  hepatitis A and hepatitis B series a long time ago and she was immuno-compromised, which led therapy non-responder. The reporter did not remember the brand name of the shot(s). The patient stated that she had to receive a series of 4 shot in order for her to produce antibodies. The reporter indicated that normally it was a shorter series ( 3 shot series) but for her it took 4 shots for her to body to respond/make antibodies because she was and is immuno-compromised. The reporter consented to follow up. This case was 1 of 4 linked cases.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021013457:Same reporter. US-GLAXOSMITHKLINE-US2021AMR014254:Same reporter. US-GLAXOSMITHKLINE-US2021AMR014253:Same reporter. US-GLAXOSMITHKLINE-US2021013450:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This case was reported by a consumer described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. Eight family members of patient received Shingrix vaccine. After receiving Shingrix vaccine, the patient experienced shingles.  This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown. This case was 1 of the 4 linked cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR063288:Same reporter US-GLAXOSMITHKLINE-US2021AMR063310:Same reporter US-GLAXOSMITHKLINE-US2021AMR063311:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: COVID-19, Pyrexia
Clinical narrative: fever of 104; maybe Covid/suspected COVID; This case was reported by a consumer via call center representative and described the occurrence of fever in a elderly female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In February 2021, unknown after receiving Shingles vaccine, the patient experienced fever and suspected covid-19. On an unknown date, the outcome of the fever and suspected covid-19 were unknown.   It was unknown if the reporter considered the fever and suspected covid-19 to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's daughter-in-law. Age at vaccination was not reported but the patient was in her early 70's. The patient received a shingles shot. The reporter was not 100% sure that the shot was Shingrix or Zostavax.  The patient experienced a fever of 104 degrees F. The reporter stated that It was a few days ago. That seems very high to me. The reporter asked if a high fever that normal? The reporter had two kids and bad lungs and was afraid and up at night worried it could not be a normal symptom of the shingles vaccine and might be Covid. No further information was provided.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Lip swelling, Urticaria
Clinical narrative: hives on his chest, belly, waist line and the front of his neck in the middle area; his top lip is swollen; This case was reported by a consumer and described the occurrence of urticaria localized in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 11th March 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 11th March 2021, 1 days after receiving Shingrix, the patient experienced urticaria localized and lip swelling. On an unknown date, the outcome of the urticaria localized and lip swelling were not recovered/not resolved.   It was unknown if the reporter considered the urticaria localized and lip swelling to be related to Shingrix.  Additional information was provided as follows: The reporter was patient's spouse. The male patient received 2nd dose on 10th March 2021 and on the day of reporting his top lip was swollen and he had hives on his chest, belly, waist line and the front of his neck in the middle area. The reporter consented to follow up. Note- The vaccination date was provided in product section 11th March 2021 and in narrative it is 10th Mar 2021. However it is added as 10th Mar 2021 conservatively.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021061356:same reporter US-GLAXOSMITHKLINE-US2021AMR061693:same reporter
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness
Clinical narrative: Client c/o light headed feeling immediately after receiving vaccine.  Client denies any other symptoms.  Client seen and assessed by EMT and assessments are: BP 173/78, HR 94, O2 96%,  Client verbalized a decrease in symptom and cleared to go home by EMT.  Client advised to seek medical attention if symptoms worsened and she verbalized understanding.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Itchy, raised, red around injection site
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: Itchy rash/welts on scalp and forehead
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Mastication disorder, Oral pain, Palatal swelling, Sleep disorder
Clinical narrative: A few days after the shot I experienced persistent swelling and pain in the hard palate directly behind the incisors, extending back about an inch. It was as if I'd burned my mouth with hot coffee. Pain was intense enough to wake me at night and make eating solid food difficult. I had to use topical benzocaine to get through meals.   The episode lasted a full week before subsiding.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: Rash around injection site
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Vertigo, Vomiting
Clinical narrative: Systemic: Diarrhea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe, Additional Details: Admitted to ER on 3/15/21 released on 3/16/21. Experienced extreme vertigo, vomiting, and diarrhea.  Still a little weak today (3-18-21).
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Pyrexia
Clinical narrative: fever much worse than when i actually had COVID, tiredness. loss of appetite.  The day was as bad or worse of any of the days i had Covid
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye swelling, Mouth swelling, Swelling face, Swollen tongue
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood cholesterol, Carbohydrate antigen 125, Full blood count, Glycosylated haemoglobin, Lip swelling
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test, Swollen tongue
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Inflammation, Pruritus, Swelling
Clinical narrative: A week after injection, my arm started itching and then swelled up in a circle the size of a silver dollar and about 1/2" high. Still inflamed, red and itchy on 8th day.  Coated with Benadryl extra strength cream to combat itchiness.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Headache, Myalgia, Oropharyngeal pain
Clinical narrative: Sore throat with coughing and swelling, fever chills muscle aches, headache
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling
Clinical narrative: Sore throat with coughing and swelling, fever chills muscle aches, headache
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Pain
Clinical narrative: Severe body aches chills and temp of 100.3. Symptoms lasted about 12 hours.   Estimated due date 9/23/21
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Additional Details: patient fainted and fell from the chair he was sitting while being obeserved. after a few minutes, he woke up by him self and got up by himself.when i (rph at the store) got there,he was awake and able to talk to me .i took his blood pressure and it was normal and oxygen sat was also normal.we advised him to contact his pcp asap and fainted again and go to er.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Pain in extremity
Clinical narrative: Rash around injection site Pain in arm starting 03/10/2021
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pain and swollen lymph in left armpit where shot was administered.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: On 2/18, the day after my shot, I experienced: redness and swelling and pain at the injection site, Fever 101.2 degrees, Severe body aches, Severe headache and Extreme tiredness.  By 2/19, I was still extremely fatigued and my arm was still red, painful and very itchy. By 2/20, back to my usual state of health.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Pyrexia
Clinical narrative: On 2/18, the day after my shot, I experienced: redness and swelling and pain at the injection site, Fever 101.2 degrees, Severe body aches, Severe headache and Extreme tiredness.  By 2/19, I was still extremely fatigued and my arm was still red, painful and very itchy. By 2/20, back to my usual state of health.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Incorrect dose administered, No adverse event, Product dispensing issue
Clinical narrative: There was no adverse event, the syringe came from manuf already pulled back to 0.5m. so when filling multiple syringes for a vaccine clinic this one was mistakenly not filled with vaccine and the first dose given to her was only 0.5 ml of air. She was no injured, did not complain of pain and was observed for 15 to 20 minutes after. She was also given the correct dose of Janssen 0.5ml.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness
Clinical narrative: Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Vaccine positive rechallenge
Clinical narrative: Rash around injection site.  Took allergy medicine before going to bed.  Rash improved somewhat 3/19/21.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Headache, chills, low grade fever, and aching all over the body, along with excessive tiredness
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Unevaluable event
Clinical narrative: All but lose of taste/smell and no fever.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: Flulike symptoms from 4am - 8pm Nov 17. Symptoms included Headache, bodyaches and fever. Confined self to bed during time mentioned.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Palpitations
Clinical narrative: I started having heart palpitations the day after the vaccine and it was almost constant the first three days and then gradually slowed and stopped after the 6th day.  We were in the middle of a huge snow/ice storm so the doctors office was closed all week and didn't open up until the following Monday due to no electricity. Did go to the doctor after on that Monday to have EKG, but didn't show anything by that time. Was in contact with my doctor via email.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Body temperature increased, Chills, Nausea
Clinical narrative: Mild mental queasiness with several hours of sustained blood pressure elevation during a severe chilling of extremeties requiring flannel pajamas & robe, wool socks, down comfort and topped by electric blanket for 2 hours.  Transient, mild temperature elevation (2 degrees).  This event occurred  3/18/21   (26 days after dose#2.).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial flutter, Blood test, Electrocardiogram, Heart rate increased, Heart rate irregular
Clinical narrative: Rapid and irregular heart beat described in the ER as A-Flutter and possibly A-Fib
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site discomfort, Pain
Clinical narrative: Discomfort at injection site, fatigue, body aches , headache, chills(6 hrs) fever 12 hrs
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Discomfort at injection site, fatigue, body aches , headache, chills(6 hrs) fever 12 hrs
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, X-ray, X-ray limb
Clinical narrative: Joint and muscle attack on right leg including knee shin and foot
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rash, Skin warm
Clinical narrative: Rash hot to touch itchy and painful. Pain radiates into left shoulder. Rash size of grapefruit. Rash seems to move down arm
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Electrocardiogram, Heart rate, Vomiting
Clinical narrative: Patient started vomiting about 8 min. after vaccine administration.  Her vitals were normal and she decided she wanted to wait another 5 min. but she was fine afterwards.  No issues prior
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Rash macular
Clinical narrative: about 6 days after the injection I noticed a large swollen red spot around where the injection was administered. It is about the size of the palm of my hand, is red, swollen, sore to the touch, and extremely itchy.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Received vaccine on Thursday. Developed first ever episode of shingles on Sunday.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itchy bright pink rash from top of shoulder down the arm, about the size of a dollar bill.  Began about one week after the shot. Was worst on day 2 of the rash. Began fading on day 3 and was almost faded on day 4 of the rash.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness post vaccination