chrisvoncsefalvay/vaers-outcomes huggingface dataset:
back of her tongue and roof of her mouth felt like they were burning; back of her tongue and roof of her mouth felt like they were burning; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 52-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3246) intramuscular in the left arm on 11Jan2021 10:30 AM at a single dose as COVID vaccine in a hospital. The patient had no medical history. She had no known allergies. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730) intramuscular in the right arm on 21Dec2020 at 11:00 AM as COVID vaccine. It was reported that on 12Jan2021-13Jan2021, the patient noticed the back of her tongue and roof of her mouth felt like they were burning, similar to eating too much pineapple. It was persistent and had not lessened. Treatment was not received for the events. She had no COVID prior to vaccination. She did not have COVID tested post vaccination. The outcome of the events was not recovered.
12 YO patient received infanrix vaccine inadvertently; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-year-old male patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10th June 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th July 2022, the patient received Infanrix (intramuscular) and Infanrix Pre-Filled Syringe Device. On 25th July 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-Aug-2022 Reporter's comment: The nurse reported that the 12 year old patient received the Infanrix vaccine in left deltoid inadvertently. The consent to follow-up was granted. Additional Supportive Information: The patient received the dose of Infanrix at the age of 12 years, which led to inappropriate age at vaccine administration. Note: Dose number was not captured in the product field. As per the structural field mentioned in the source document, it was not confirmed, clarification had been raised.
Inappropriate dose administer,  an adult dose were administered instead of pediatric dose. Manufacture and CDC contacted , also parents and not side effect reported by parents.
Patient developed raised, erythematous well circumscribed lesion on right lateral thigh at site of varicella injection. Mom reported that patient has been scratching area. Area was also hot and had palpable macules within confluent erythema. Patient also had 3 macular papular lesions on right cheek and chin. Lesion on chin had vesicle-like center.
PATiENT WAS GIVEN VACCiNE 8-31-20 at 11:45 during office visit. By 5:30 patient Had developed arm swelling and pain. Patient was advised to take aleve for the pain and continue to monitor local site at home. If symptoms worsen contact the office.
Patient was admitted approximately 24-36 hours after vaccination with chest pain, fever.  Had elevated troponin, decreased ejection fraction.  He was treated with corticosteroids and high dose aspirin in addition to colchicine.  He did require oxygen.
Became extremely flushed; tingling in hands and feet; disorientation; This is a spontaneous report from a non-contactable nurse (patient). A 34-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EL0140/expiration date unknown), via intramuscular route of administration, on 28Dec2020 (at the age of 34 years old) as a single dose in the left arm for COVID-19 immunization at hospital facility. Relevant medical history included Gastrooesophageal reflux disease (GERD), Attention deficit hyperactivity disorder (ADD), Generalised anxiety disorder (GAD). The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included esomeprazole sodium (NEXIUM), venlafaxine hydrochloride (EFFEXOR), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Dec2020, at 09:00 PM, the patient became extremely flushed, tingling in hands and feet, disorientation. Treatment was received for the events became extremely flushed, tingling in hands and feet, disorientation included Diphenhydramine 50mg @2200 and again at 0200. The outcome of the events became extremely flushed, tingling in hands and feet, disorientation was recovered on unknown date. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of  extremely flushed, tingling in hands and feet and disorientation due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including  chemistry panel and Head CT/MRI, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is 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 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.
Information has been received from a medical assistant concerning a 12 month old female patient who on 26-MAR-2009 was vaccinated subcutaneously with a dose of VARIVAX (Merck) (lot #: 657755/1863U) in the right leg.  On the same day the patient was vaccinated with a dose of MMR II (MSD) (lot # 662559/1370X) in the left leg.  Subsequently, the patient had hives at the injection sites for both vaccines.  On an unspecified date the patient recovered.  Additional information has been requested.
heart attack; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (heart attack) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (heart attack) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (heart attack) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was provided by reporter.  It was reported that the boss got a heart attack.  No treatment medication was provided by reporter.  Company Comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the unexpected, serious, adverse event of special interest, Myocardial Infarction which was medically significant as reported by the regulatory authority and occurred on an unknown date after receiving an unspecified dose of mRNA-1273 Vaccine. No further information on risk factors, co morbidities, clinical course and management of the event was available in the report. The reported outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the unexpected, serious, adverse event of special interest, Myocardial Infarction which was medically significant as reported by the regulatory authority and occurred on an unknown date after receiving an unspecified dose of mRNA-1273 Vaccine. No further information on risk factors, co morbidities, clinical course and management of the event was available in the report. The reported outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
She developed a hot rash in it below injection site; She developed a hot rash fever in it below injection site; Headache; Legs were very stiff; States that she had to crawl up the stairs; Chest congestion; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Legs were very stiff), GAIT INABILITY (States that she had to crawl up the stairs), CHEST DISCOMFORT (Chest congestion), VACCINATION SITE RASH (She developed a hot rash in it below injection site) and VACCINATION SITE WARMTH (She developed a hot rash fever in it below injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Legs were very stiff), GAIT INABILITY (States that she had to crawl up the stairs), CHEST DISCOMFORT (Chest congestion) and HEADACHE (Headache). On 10-Mar-2021, the patient experienced VACCINATION SITE RASH (She developed a hot rash in it below injection site) and VACCINATION SITE WARMTH (She developed a hot rash fever in it below injection site). At the time of the report, MUSCULOSKELETAL STIFFNESS (Legs were very stiff), GAIT INABILITY (States that she had to crawl up the stairs), CHEST DISCOMFORT (Chest congestion), VACCINATION SITE RASH (She developed a hot rash in it below injection site), VACCINATION SITE WARMTH (She developed a hot rash fever in it below injection site) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: up to 102.5 up to 102.5.         No concomitant medications were reported.  No treatment medications were provided by the reporter.
05/21/2021, couldn't sleep, severe abdominal pain, self-diagnosed as shingles, I had noticed a rash earlier in the day. On Monday, 05/24/2021, I had a video visit with the doctor. The doctor said given the condition of the pustules he thought it probably started on 05/19/2021, he diagnosed it to be shingles. I was already taking CBD oil for it. And the doctor prescribed gabapentin. The shingles were pretty bad for 2 weeks on the 3rd week it subsided. On 06 /13/2021, at night my big toe was so painful I couldn't stand to have a sheet on it. On the 06/24/2021 I went to see a physician he put in the chart and said it was gout. He asked me a bunch of question about diet. He gave a uric acid blood test. The results were 4.7 value which he said was in a completely normal range. I received the results in a letter. The results it was inconsistent with gout and he said it was probably an immune reaction with gout- like features. He prescribed colchicine 0.6 mg, which is specific for gout and it worked pretty well.
Red Blisters / blisters all over the body; Red Blisters / blisters all over the body; Itching; Scabbing; Flu Like Symptoms; This case was reported by a pharmacist via call center representative and described the occurrence of blistery rash in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number 49Y35, expiry date 31st January 2020) for prophylaxis.   On 3rd August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In August 2019, less than a week after receiving Shingrix, the patient experienced blistery rash, red rash, pruritus, scab and influenza-like symptoms. In August 2019, the outcome of the influenza-like symptoms was recovered/resolved. On an unknown date, the outcome of the blistery rash, red rash, pruritus and scab were unknown.   It was unknown if the reporter considered the blistery rash, red rash, pruritus, scab and influenza-like symptoms to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left deltoid. Less than 2 weeks after receiving the vaccine, the patient experienced flu like symptoms that lasted for 2 days. The patient also experienced itching along with red blisters all over the body which started scabbing about a week later. No further details were provided. This case had been linked to the case US2019146724, reported by same reporter. In the document in narrative dose number was reported as 1st, but in structural field and database it was mentioned as 2nd, therefore kept as reported in database.
Both Pediarix (containing Hep B vaccine) and Engerix were inadvertently administered on the same day when provider only intended to give routine 4-month vaccines. No noted adverse events to date, though patient did receive 1 extra injection that was not needed.
adverse effects; developed a bad rash gets warmer at night and seems to be spreading to her arms, ankles, a little on feet and on chest; fever; tired; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (adverse effects), RASH (developed a bad rash gets warmer at night and seems to be spreading to her arms, ankles, a little on feet and on chest), PYREXIA (fever) and FATIGUE (tired) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Johnson & Johnson on 16-Apr-2021. Past adverse reactions to the above products included No adverse event with Johnson & Johnson. Concomitant products included OXCARBAZEPINE, MONTELUKAST, QUETIAPINE, PANTOPRAZOLE, CILNIDIPINE, AMLODIPINE, PAROXETINE ACETATE, CLOPIDOGREL BISULFATE (PLAVIX), LEVOTHYROXINE, HYDROCODONE BITARTRATE, PARACETAMOL (NORCO), SALBUTAMOL (ALBUTEROL HFA) and FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) for an unknown indication.    On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 10-Nov-2021, the patient experienced PYREXIA (fever) and FATIGUE (tired). On 11-Nov-2021, the patient experienced RASH (developed a bad rash gets warmer at night and seems to be spreading to her arms, ankles, a little on feet and on chest). On an unknown date, the patient experienced VACCINATION COMPLICATION (adverse effects). The patient was treated with PREDNISONE ongoing from 15-Nov-2021 for Rash, at a dose of 6-Pack (methylprednisolone). At the time of the report, VACCINATION COMPLICATION (adverse effects), PYREXIA (fever) and FATIGUE (tired) outcome was unknown and RASH (developed a bad rash gets warmer at night and seems to be spreading to her arms, ankles, a little on feet and on chest) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 11Nov2021, the patient developed a bad rash. She reported the rash got warmer at night and seemed to be spreading to ankles, a little on feet and on chest. Caller reported that she had it for a week and went to doctor and got prednisone on 15Nov2021. She states she didn't get a rash from the Johnson & Johnson COVID-19 vaccine first.   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Followup received with significant information where new events are added (Rash, pyrexia, fatigue). Reporter was added, Primary reporter type was changed. patient gender, treatment and concomitant drugs were added.
Headache, low grade fever, body aches on the evening that I received the second dose of the vaccine. These resolved the next day.
Cellulitis of left arm where patient recieved vaccination.  Stated immediatly after vaccination given.  ABX started (17jul04)-Azithromycin.
Information has been received from a physician concerning a 15 month old patient who was vaccinated IM with a first dose of VARIVAX (Merck). At the same visit, the patient was vaccinated with a dose of MMR II. Two days post-vaccination, the patient developed an arthus reaction which lasted approximately 72 hours. Unspecified medical attention was sought. The patient recovered after being treated with antihistamines. Additional information has been requested.
Myalgia & Diarrhea Narrative: The day of the injection I felt very lethargic and unwell about 8 hours after. I just felt unwell the rest of that day. The next morning around 4 am I awoke with body aches and joint pain head to toe. I also started with Bouts of diarrhea, this lasted about 36 hours. I started feeling better toward that evening By the 3rd morning I felt Back to normal with just a few more bouts of diarrhea. All was normal, my gold ball sized area of inflammation at the injection site had resolved as well. Day 10 I noticed a baseball size red area at the injection site, was not painful and was not hot. Resolved by that evening. Day 14 I awoke with a soft ball sized, raised, red, itchy, and hot area at this injection site again.
guillain barre syndrome; Initial information regarding an unsolicited valid serious courtesy case received from a pharmacist via Pfizer Pharmaceuticals (Reference number: 2021003640) on 06-Jan-2021.  This case involved an adult patient of an unknown gender who experienced Guillain Barre syndrome, after receiving influenza vaccine.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza vaccine (other details unknown) produced by unknown manufacturer (lot number and expiry date were not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (unknown latency), the pharmacist asked information on Pfizer coronavirus infectious disease (COVID-19) vaccine. Pharmacist asked if Pfizer coronavirus infectious disease (COVID-19) vaccine could be administered to any person who had a positive history of developing Guillain Barre Syndrome after receiving an influenza vaccine (Guillain Barre syndrome).  Final diagnosis was Guillain Barre syndrome.  No relevant laboratory details were provided.  The event of Guillain Barre syndrome was assessed as medically significant as per the important medical event list.  It was not reported if the patient received a corrective treatment.  Outcome of the event of Guillain Barre syndrome was reported as unknown.  There will be no information available on the batch number for this case.; Sender's Comments: This case involved an adult patient of an unknown gender who presented with Guillain Barre syndrome after receiving influenza vaccine (produced by unknown manufacturer). Time to onset is unknown. Although, medical history, comorbidities, concomitant medications, additional information on investigations ruling out other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Dose 1 - GI effects only (abdominal pain, diarrhea) the day after the vaccine Dose 2 - Fever (101 degrees), chills, body aches, headache; starting the day after the vaccine and improved/resolved on the 21st.  New reaction starting 1/21/21 at the injection site (presumed cellulitis, as site was hot, hard, and red).  Was seen by acute/urgent care and they recommended icing it every 4 hours, watch it for 2 days and marked the margins.
Patient presented a COVID-19 Vaccine Record card with only the primary series listed. Patient stated she had not received her first booster. When entering the patient's vaccine information from 6/17/2022, we discovered the patient was not truthful and had already received her 1st booster. She is under 50 and did not list any immunocompromising condition on her paperwork, therefore, she is not eligible to receive her 2nd booster.
administration of improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On 27-AUG-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot #  T002845 was verified to be valid, expiration date reported and establised as 23-JAN-2022 (strength, dose, frequency and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with a properly stored sterile diluent.  The administered dose of vaccine experienced a temperature excursion of 6 to 14 Fahrenheit degrees (10.56 Fahrenheit degrees) for 50 minutes. There was also a previous temperature excursion of 6 to 14 Fahrenheit degrees (8.47 Fahrenheit degrees) for 30 minutes. Digital Data Logger was involved.
This case was reported by a pharmacist and described the occurrence of nausea in three subject of unspecified ages and genders who were vaccinated with ENGERIX B, (GlaxoSmithKline).  On the morning of 10 July 2008, the subjects received unspecified doses of ENGERIX B (unknown).  After an unspecified amount of time following vaccination nausea.  All three subjects received doses of ENGERIX B from lot #AHBVB584AA, expiration date 06 November 2010.  At the time of reporting, the events were unresolved.  No further information was available at the time of this report.
This spontaneous report received from a patient concerned a 66 year old white non-Hispanic or Latino female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: Unknown) dose was not reported, dose number in series 1, 01 in total, administered on an unspecified date in MAR-2021 for prophylactic vaccination. On an unspecified date, following administration of Covid-19 vaccine ad26.cov2.s, the patient experienced blotchiness on the skin, sore arm and tender when treated with Covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, expiry: 11-APR-2022) dose was not reported, dose number in series 2, 01 in total, administered on 04-JAN-2022 at left deltoid for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in JAN-2022, following administration of Covid-19 vaccine ad26.cov2.s, the patient experienced tender arm (dose number in series 2). On 04-JAN-2022, the patient experienced aches and pains in joints, and sore arm (dose number in series 2). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from aches and pains in joints, sore arm/ arm still hurt, and tender arm (dose number in series 2). This report was non-serious. This case, involving the same patient is linked to 20210424792. This case, from the same reporter is linked to 20220112619.
Pt received Varivax vaccine on 3/30/1999. During 2/21/2000 visit, parents noticed rash on back. Was dx'd with Herpes Zoster.