chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No other AEs/PQCs; VARIVAX was administered after temperature excursion.; This spontaneous report was received from a licensed vocational nurse (LVN) and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with improper stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dosage form, administered for prophylaxis lot# W022605, expiration date: 17-JUL-2024 (strength and route of administration were not provided) after temperature excursion of -13.5 degree Celsius for 5 minutes (product storage error ). There was no previous temperature excursion. No other adverse events reported.
After the second booster patient had a mild headache which lasted until the next day.; Fatigue/ Patient went to bed early; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HEADACHE (After the second booster patient had a mild headache which lasted until the next day.) and FATIGUE (Fatigue/ Patient went to bed early) in a 67-year-old male patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: Tetanus shot on 10-Aug-2022 and Influenza vaccine (Flu Vaccine). Past adverse reactions to the above products included No adverse event with Influenza vaccine and Tetanus shot. Concurrent medical conditions included Pollen allergy, COPD and Anxiety. Concomitant products included QUETIAPINE FUMARATE and BUPROPION for an unknown indication. On 09-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (After the second booster patient had a mild headache which lasted until the next day.) and FATIGUE (Fatigue/ Patient went to bed early). At the time of the report, HEADACHE (After the second booster patient had a mild headache which lasted until the next day.) had resolved and FATIGUE (Fatigue/ Patient went to bed early) outcome was unknown. On 14-Jan-2021, the patient received first dose of Moderna vaccine with lot number reported as 039K20A. On 11-Feb-2021, the patient received second dose of Moderna vaccine with lot number reported as 029L20A. On 26-Oct-2021, the patient received first booster dose of Moderna vaccine with lot number reported as 019F21A. Anatomical location for all the doses related to suspect product (Moderna vaccine) was reported as Left arm bicep and it was reported that patient was taking other medication.
Initial report received on 31 October 2013 from a consumer. A 76 year old female patient, medical history and concomitant medications were not reported, received a dose of Tetanus (tetanus toxoid) (lot number, route and site of vaccination was not reported) on an unspecified date. It was reported that a patient had allergy with the tetanus toxoid. Event was not resolved at the time of report. Corrective treatment included fexofenadine hydrochloride (Allegra allergy, 12 hr). List of documents held by sender: none.
Sore arm next day. Then on Jan 1 arm was red and inflamed and tight. Got vaccine on 12/30/20. Took ibuprofen and Tylenol. By Sunday 1/3/21 swelling was down, not red, only a little bump there. Then on 1/6/21 it was itchy, red circle, warm, inflamed and sore. On 1/7/21 arm is even worse.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2022 as dose 1, single (Lot number: Er8737), on 03May2022 as dose 2, single (Lot number: Ew0176) and on 22Nov2021 as dose number 3 (booster), single (Lot number: Fj1620) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). Concomitant medication(s) included: FINGOLIMOD, start date: 15Feb2018; GILENYA, start date: 15Feb2018. Past drug history included: Bnt162b2, start date: 03May2021, stop date: 03May2021, for COVID-19 Immunization, reaction(s): "Covid-19", notes: Dose Number: 2, Batch/Lot No: Ew0176; Bnt162b2, start date: 06Apr2022, stop date: 06Apr2022, for covid-19 immunization, reaction(s): "Covid-19", notes: Dose Number: 1, Batch/Lot No: Er8737. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, vaccination failure.  Additional information: Covid rebound. Consumer started Anti-viral treatment Paxlovid on 16May2022 for COVID 19 Treatment, stopped on 21May2022 (Lot number=FP6522).
around 2 a.m. patient woke up noticed weird smell in her nose, and tingling in her fingers and hands on left side and has headache
received the booster on 2nd Sep; having a widespread joint pain.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2021US118963_NS.  A 69 year-old male patient received bnt162b2 (BNT162B2), administration date 02Sep2021 (Batch/Lot number: unknown) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Patient received COVID shot on 23rd Feb 2021 and March of this year), administration date: 23Feb2021, when the patient was 68 years old, for COVID-19 immunisation; Bnt162b2 (Patient received COVID shot on 23rd Feb 2021 and March of this year), administration date: Mar2021, when the patient was 68 years old, for COVID-19 immunisation. The following information was reported: ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "having a widespread joint pain."; IMMUNISATION (non-serious) with onset 02Sep2021, outcome "unknown", described as "received the booster on 2nd Sep".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Healthy, active, and young female developed palpitations 43 hrs after receiving 1st dose of Pfizer-BioNTech vaccine and noted frequent PVCs on her watch and later confirmed with 12-lead EKG at the ER. These symptoms have improved but continue to persist. No history of palpitations or heart problems.
Neuromuscular weakness, tingling/numbness, and fall prior to admission.  Progressed to acute hypoxic respiratory failure requiring intubation.
we were unaware of the DOB of this patient before the clinic. he came to the clinic with his father, and we failed to identify that he was under the age of 18... no adverse symptoms reported from the patient.  subsequently, the second dose was also administered with his father present.
Episode of limpness, pallor, and perioral cyanosis, lasting about 6 minutes. Treated at home with mouth to mouth resuscitation. Taken to ED, where a second episode, lasting about 3 minutes, occurred.  Hospitalized x 2 days, with no further episodes or other symptoms.
nausea; diarrhea; fever; sore and swollen arm; sore and swollen arm; feeling terrible overall; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), DIARRHOEA (diarrhea), PYREXIA (fever), PERIPHERAL SWELLING (sore and swollen arm) and PAIN IN EXTREMITY (sore and swollen arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (nausea), DIARRHOEA (diarrhea), PYREXIA (fever), PERIPHERAL SWELLING (sore and swollen arm), PAIN IN EXTREMITY (sore and swollen arm) and MALAISE (feeling terrible overall). At the time of the report, NAUSEA (nausea), DIARRHOEA (diarrhea), PYREXIA (fever), PERIPHERAL SWELLING (sore and swollen arm), PAIN IN EXTREMITY (sore and swollen arm) and MALAISE (feeling terrible overall) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 15-APR-2013, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # 672558/1600AA, expired date 13-JAN-2013). No adverse effect reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
Currently pregnant, due date January 25th, 2022 Fatigue Sore throat Ear aches Dizziness Hot flashes
erythema, rash and pain on the administration site; erythema, rash and pain on the administration site; erythema, rash and pain on the administration site; This spontaneous report was received from a consumer, via a company representative, concerning a 25-years-old female patient. The patient's concurrent conditions, medical history, concomitant therapies, and drug allergies were not reported.   On 21-SEP-2021, the patient received one dose of varicella virus vaccine live (oka/merck)(VARIVAX), lot number T038830, with an expiration date not reported but, upon internal validation stablished as 17-NOV-2022, at the dose of 1 milliliter (ml) via subcutaneous (strength, vaccination scheme, and anatomical location were not reported) and one dose of hepatitis a vaccine, inactivated (manufacturer unknown) (route of administration, strength, exact dose, vaccination scheme, anatomical location, lot number, and expiration date were not reported), both for prophylaxis.   Subsequently, on 22-SEP-2021 (reported as "one day after vaccination"), the patient presented erythema, rash and pain on the administration site (vaccination site erythema, vaccination site rash and vaccination site pain). No other symptoms were developed, no treatment received.   At the reporting time, the outcome of the events, as well as the causal relationship between the events and the suspect vaccines were unknown.
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 18-year-old male patient who received BEXSERO for prophylaxis. Concomitant products included Hepatitis A vaccine and MENVEO. On 16th May 2018, the patient received the 1st dose of BEXSERO. On 16th May 2018, less than a day after receiving BEXSERO, the patient experienced injection site swelling, injection site warmth, injection site erythema and injection site nodule. On an unknown date, the outcome of the injection site swelling, injection site warmth, injection site erythema and injection site nodule were recovered/resolved. It was unknown if the reporter considered the injection site swelling, injection site warmth, injection site erythema and injection site nodule to be related to BEXSERO. Additional details reported as follows: The reporter was the mother. It was unknown on which arm BEXSERO was administered as the patient received 2 other vaccines (Hep A and MCv4) on the same day along with BEXSERO. There was redness and swelling in the form of a nodule at the injection site that lasted for 10 days. In May 2018, the events lasted for 10 days. The patient had denied permission to contact their physician. For tolerance after 2nd dose refer case US2018GSK146072.
Raised rash that was warm to the touch, wasn?t painful but made the arm feel tingly and tired, similar to a flu shot. Seeker care at a clinic where they told me I had cellulitis from the injection site. Prescribed an antibiotic for 7 days.
R leg rash, swollen, red and warm to touch. Prevnar caused problem no Rx.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 2:30 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 2:30 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was reported as 89.98. Concomitant products were not provided. For Lot no : 025L20A on 07-Jan-2021, excursion time was 9 AM and 10 Am and temperature was 34 and 34 respectively, total doses given for the day was 96, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 05-Jan-2021 and was moved to clinic on  07-Jan-2021. 06 vials was sent to clinic. Vaccine BUD date was 27-Jan-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
About ten hours after the vaccine I began to get the chills and severe body aches. I also had a low grade temperature. It is now 24 hours since I began feeling this way and I still feel the same. I?ve been taking Advil for the aches and fever.
Friend that is a doctor indicated it was "cellulites"; Red mark / From the band aid where the vaccine was injected up her arm; This case was reported by a pharmacist via call center representative and described the occurrence of injection site cellulitis in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced injection site cellulitis and injection site erythema. On an unknown date, the outcome of the injection site cellulitis and injection site erythema were unknown.   It was unknown if the reporter considered the injection site cellulitis and injection site erythema to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The healthcare professional reported that 2 days after a Shingrix vaccine was administered to a patient there was a red mark extending from the band aid where the vaccine was injected up her arm.   The patient indicated physician stated that it was cellulites. They thought the patient got cellulites from the injection. The  healthcare professional wondering if this was a side effect that was like that, or part of a reaction of an infection?  No additional information could be collected from HCP.
Large blotchy red rash on upper left arm.  Slightly itchy, raised and warm.  Symptoms began on 1/16/21 and are continuing through today.
Pt started to have his airway constrict. He had metallic taste in his mouth, face was slightly red and had a mild perspiration.
Temperature excursion due to Adacel left out side and exposed to 70 Fahrenheit for 6 hours/No AE; Temperature excursion due to Adacel left out side and exposed to 70 Fahrenheit for 6 hours. Stability data not reported in source document and there is no vaccine administered hence case considered as non case.
hospitalized 9/20/21, presented with generalized weakness and SOA,  admitted with hypoxia secondary to COVID-19 pneumonia.
This spontaneous report was received from a health care professional via Pfizer (2017057438) and refers to a patient of unknown demographics. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (dose, route and anatomical location not reported), for prophylaxis. On an unknown date, the patient had an allergic reaction to PNEUMOVAX23 (hence considered to be related to vaccine). Outcome of the event was not reported. Additional information has been requested.
Vaccine breakthrough, symptomatic.   Inpatient admit 9/8-9/11.
Information has been received from a registered nurse (RN) concerning, who breastfed her daughter, a 14 month old female with no pertinent medical history, drug reaction or allergies who on 16-JAN-2007 was vaccinated subcutaneously with 0.5 ml of varicella virus vaccine live (Oka/Merck) (Lot#652871/0430F). On approximately 01-FEB-2007, 29 days after being vaccinated, the patient developed a low temperature of 97.1F rectally, with lethargy and clear fluid discharge from the right ear canal. On 10-FEB-2007, nine days later, the patient became febrile with an axillary temperature of 102.2F and was subsequently diagnosed with otitis media. The patient was first treated with amoxicillin, followed by augementin. At the time of the report, the otitis media was considered to be resolving. There was no concomitant therapy. Unspecified medical attention was sought. There were no lab diagnostic studies performed. There was no product quality complaint. The nurse also noted that she is currently breastfeeding her daughter, and developed a widespread red, itchy rash on 25 FEB 2007. No further information is available.
administered, after gone out of range; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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: 27-APR-2022 Reporters comment: The patient received Boostrix after it had gone out of range. All information provided was reported.  It was reported that, for additional information, please reach out to the healthcare professional. Additional supportive information: The patient received Boostrix after it had gone out of range, which led to incorrect storage of drug. This was 1 of 7 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022070827:Same reporter. US-GLAXOSMITHKLINE-US2022070813:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071808:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071810:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071809:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071812:Same reporter. US-GLAXOSMITHKLINE-US2022070827:Same Reporter
Headache, ears are plugged, throat feels like I have a lump, severe joint pain, brain fog. Occasional vertigo is now every single Day and severe, diarrhea, nausea and chest pain which makes it hard to breathe.
Patient developed itchyness around eyes and tingling sensation around mouth ,arms and legs ( mild). Patient without sob, chest pain ,dizziness or other issue. No evidence of facial dissymetry . Ems called. See ems report for further assessment .
Three weeks after first shot my right knee started swelling badly, after the second shot it was so bad I was unable to walk. It then moved onto other joints specifically my wrists, fingers and elbows. I saw a specialist for my knee but there was nothing found. It continued to get worse and I was referred to a rheumatologist whom determined it was rheumatoid arthritis that was triggered by the vaccine.
This initial spontaneous case, was received from other non-health care professional on 21-Nov-2017, concerning a 62-year-old, adult, female patient. On 17-Nov-2017, the patient was administered with AFLURIA (TIV) (dose: less than 0.5ml (as reported), route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: was not reported). On the same day, while administration of the vaccine, it dripped down her arm (explicitly coded as under dose and underdose). It was reported that, the patient had cleansed her arm after contact. The reporter considered the event as non-serious.
Patient was vaccinated with vaccine that had expired 2 days prior.  Per Pfizer vaccine was stable no need to repeat the dose.
his hands were aching like arthritis; He had a little temperature, not as aggressive as 1st time; his arm was sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (his hands were aching like arthritis), PYREXIA (He had a little temperature, not as aggressive as 1st time) and VACCINATION SITE PAIN (his arm was sore arm at injection site) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in February 2021.   On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jun-2021, the patient experienced PAIN IN EXTREMITY (his hands were aching like arthritis), PYREXIA (He had a little temperature, not as aggressive as 1st time) and VACCINATION SITE PAIN (his arm was sore arm at injection site). At the time of the report, PAIN IN EXTREMITY (his hands were aching like arthritis), PYREXIA (He had a little temperature, not as aggressive as 1st time) and VACCINATION SITE PAIN (his arm was sore arm at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jun-2021, Body temperature: little (High) little.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-405978 (Patient Link).