chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient got COVID-19 after primary dose; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Patient got COVID-19 after primary dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient got COVID-19 after primary dose). At the time of the report, COVID-19 (Patient got COVID-19 after primary dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.  This is a spontaneous case concerning a patient of unknown age and gender with no medical history reported, who experienced the unexpected event of Covid-19. The event occurred on an unknown date while the second dose of mRNA  1273 vaccine was received on March 2021. At the time of report outcome was still unknown. The rechallenge is not applicable since no information about the first dose was disclosed. The reporter's assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender with no medical history reported, who experienced the unexpected event of Covid-19. The event occurred on an unknown date while the second dose of mRNA  1273 vaccine was received on March 2021. At the time of report outcome was still unknown. The rechallenge is not applicable since no information about the first dose was disclosed. The reporter's assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.
PATIENT DEVELOPED ITCHY HIVES SIMILAR TO VARICELLA LESIONS ON HER FACE AND BODY.
Per CRNP on 4/12/12 Patient with loss of consciousness x 5-10 second, after receiving vaccines. Patient did not eat or drink this morning before coming into office. After regaining consciousness patient denied any SOB, CP, difficulty with vision or hearing. Given gatorade and crackers, monitored for 20 minutes and allowed to leave when B/P was 117/71.
Patient stated he had a fever of over 103 and ended up in the Hospital. He said the Doctors diagnosed him with Pneumonia from the vaccine.
Reaction after second dose; A spontaneous report  was received from a consumer, concerning a group of patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced reaction after second dose/ adverse reaction.  The patients' medical history was not provided. Concomitant products use was not provided by the reporter.   On unspecific date, few hours prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: [unknown] not specified site for prophylaxis of COVID-19 infection.   On unknown date, after vaccine administration the patient experienced adverse reaction. Treatment for the event was not provided.   Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the events, reaction after second dose was unknown.
received Fluarix expired dose; This case was reported by a pharmacist and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number Z7275, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 22nd September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received expired dose of Fluarix season 2020-2021, which led to expired vaccine used. The patient was revaccinated with correct Fluarix Tetra 2021-2022 season. The VARES report was filled by facility for the patient. The reporter confirmed that, there were 52 patients who received expired dose of vaccine and this is one of 52 cases, reported by the same reporter. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR201274:Same reporter
~4-6 hours after the vaccine, injection site (R anterior thigh) became erythematous with a dime-sized area of swelling. Over the next week developed significant ecchymosis. Was seen in office 8/14/13. At that time still had a 'knot' per Mom that was tender with pressure. On exam he had ~1.5x3/4" bluish ecchymosis on his R thigh with a palpable firm well-circumscribed pea-sized subcutaneous nodule, tender with pressure. He was seen again on 9/18/13. At that time he had a residual nickel-sized area of faint hyperpigmentation. Subcutaneous nodule was relatively unchanged. Was most recently seen 2/11/14. Still has ~1 cm faint hyperpigmentation with a 2-3mm firm subcutaneous round nodule. Never got a fever or rash.
Initial report was received from another manufacturer (doc number 45232482, service request number 1-3455878489) on 05 March 2010, who received the report from a health care professional who is also the patient's wife. A male patient (age not reported) had received an injection of ADACEL (manufacturer not specified; lot number, route, site and date of administration not reported), and an unspecified amount of time later, he experienced nerve pain in his arm. The reporter requested that they not be contacted for follow-up and no further information was provided at the time of the report. Documents held by sender: None.
Marble-sized knot at injection site. Redness around injection site and swelling/pain around injection site.
had double vax still got the shingles/suspected vaccination failure; still got the shingles; they were painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (had the initial double vax on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: had double vax still got the shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: still got the shingles ) and pain (Verbatim: they were painful ). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 26-Mar-2023 The case was received from the patient via interactive digital media. The patient had the updated vax and still got the shingles. The patient stated that they were painful, but probably not as painful as they would had been without the vax. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Complete body rash within three weeks of receiving vaccine.   Fever and fatigue.  Swelling and pain in both lower legs below the knee.  Infection of the swollen areas.  Treated on two separate occasions with antibiotics and steroids.  Remaining rash on lower legs to this day.
VOMITING; BODY ACHES; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid 19 infection, and concurrent conditions included diabetes, shortness of breath, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808978,expiry: UNKNOWN) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-JUN-2021, the subject experienced vomiting. On 05-JUN-2021, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body aches, and the outcome of vomiting was not reported. This report was non-serious.
Developed rash 15 mins after Hep B was administered above lip (2 pea sized lesions). Pt did not have resp. distress clear lungs and was happy and smiling. Mom stated pt. had 2 eggs reaction, one in the morning and the first.
22 y/o male with suspected generalized vaccinia vs postvaccinia nonviral pustulosis. Multiple pustules on trunk, upper arms, thighs 10 days after immunization.
patient reports began to feel unwell today 12/30/2020 1 day after vaccination, reports felt dizzy and like throwing up and had headache patient reports had shortness of breath with mask on and contacted emergency department, was screened by phone and did not need to go in but plans to rest
Beginning, 10 mins after the injection: Sinus pressure  9 hours after injection: pain/soreness at injection site and surrounding area (couldn't lift arm); sinus pressure continue 1 day after injection: mild sore throat; bruise at injection site; sinus pressure subsided 2 days after injection: significant swelling at injection site and surrounding area (upper arm at shoulder- 4"length x 3" width area); bruise and pain/soreness continue 5 days after injection: Round red rash appeared below injection site (1" length x 2" width area); bruise improving but still present; swelling continues  8 days after injection: Red rash has turned into a large round red ring below injection site (3" length x 4" width area); bruise still present; swelling continues although has improved
Abscess on her chest; A spontaneous report was received from a consumer, who was also a 80-years old, female patient, who developed chest wall abscess (abscess on her chest).   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection on unknown date.  On 16 Feb 2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (Batch number: 006M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On an unknown date, prior to receiving the second dose of mRNA-1273, the patient developed abscess on her chest. On 17 Feb 2021, the dermatologist drained the abscess. Further treatment included sulfa antibiotic. Reportedly, the patient did not have any side effects from the vaccine (second dose) and was feeling fine.   The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the event, chest wall abscess, was unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time. The event was consistent with infectious process confounded by elderly age of patient. Further information has been requested. Company assessed the events to be unlikely related to company product.
103 -104 fever and chills, took Tylenol, and covered up with a lot of blankets.
Two weeks after the 1st shot, I had a headache leading all way up towards the 2nd shot. I have never had headache. I had sore arm after the shot.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: AGITATION (hospitalization), DISCOMFORT (hospitalization), outcome "unknown" and all described as "his son was agitated, uncomfortable, he was taken to the hospital". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Clinical information: The patient was agitated, uncomfortable, he was taken to the hospital. The patient got a shot of the Pfizer Covid vaccine but in the clinic they have a big mistake and the reporter was worried about his son.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow-up (29Sep2022): This is a spontaneous follow-up report from a contactable consumer. This consumer reported in response to Non-HCP letter sent via telephonic follow-up activity which included that:    Updated information included: New events added. Hospitalization check box checked.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
he contracted Covid-19; he contracted Covid-19; strong muscle pain; This is a spontaneous report from a contactable consumer (Patient). A 82-years-old male patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on 17Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Previously patient received BNT162B2 (COMIRNATY, Formulation: solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on 25Jan2021 (age at vaccination: 82-year-old) as dose 1, single for COVID-19 immunization and experienced strong muscle pain. Patient was complaining of strong muscle pain after the 1st dose on 25Jan2021, of the Pfizer COVID vaccine, which then subsided for about a week, and then returned after receiving the 2nd dose on 17Feb2021. On unspecified date in 2021 which continued until he contracted COVID-19, at which point it stopped, and then resumed after COVID-19 infection passed, nobody can find out what is wrong with him. Patient was looking for treatment information. Verified above information, and added he have been seen, by his PCP, then an internist, then he went to a COVID-19 clinic, and then he went to a rheumatoid arthritis specialist, now they want him to go to a neurologist. Side effect that have been reported with COMIRNATY (COVID-19 Vaccine, mRNA) or the Pfizer BioNTech COVID-19 Vaccine include Muscle pain. The patient visited physician office visit. The outcome for the event he contracted COVID-19 (Drug ineffective) was unknown and he contracted COVID-19 (COVID-19) was recovered on unspecified date in 2021 and event strong muscle pain was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Headache, Myalgia, Fever,  Chills,  Narrative:  Pt had fever/chills, myalgias and headache start the evening of injection 1/20/21. Headache lasted until 1/24/21, other symptoms improved by 1/23/21. Missed work x 1 day 1/22/21 due to symptoms. No known prior COVID infection.
No additional AE details available.; HBP in charge of vaccine storage calling for TE evaluation on refrigerated products that occurred 9/5/2022. Products were administered; This spontaneous report was received from a healthcare business professional (HBP) and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 07-SEP-2022, the patient was administered a dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) syringe, intramuscular injection, lot # W002889 with expiration date 06-MAR-2023, for prophylaxis (exact dose, route of administration and anatomical site were not provided) (product storage error). The vaccine was improperly stored for 8 hours in the temperature above 46 degrees Fahrenheit (F) (62.8 F) on 05-SEP-2022. There was no previous temperature excursion. No additional adverse event details were available (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA003021: US-009507513-2209USA003055: US-009507513-2209USA002557: US-009507513-2209USA002540: US-009507513-2209USA002566: US-009507513-2209USA002779: US-009507513-2209USA002746: US-009507513-2209USA002481: US-009507513-2209USA002745: US-009507513-2209USA002570: US-009507513-2209USA002722: US-009507513-2209USA002574: US-009507513-2209USA002469: US-009507513-2209USA002559: US-009507513-2209USA002573: US-009507513-2209USA002606: US-009507513-2209USA002532:
This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 23rd June 2018, the patient received SHINGRIX. On 23rd June 2018, less than a day after receiving SHINGRIX, the patient experienced allergic reaction, tremor, malaise, fever and chills. On 24th June 2018, the outcome of the allergic reaction, tremor, malaise, fever and chills were recovered/resolved. It was unknown if the reporter considered the allergic reaction, malaise and chills to be related to SHINGRIX. The reporter considered the tremor and fever to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to the physician. The age at vaccination was not reported. The patient experienced overall illness and category 3 allergic reaction. At 22:05, the patient experienced violent shakiness. At 22:00, the patient experienced fever. The patient had an acute reaction and was resolved within 24 hours. This case has been linked to the US2018115060, reported by the same reporter.
Rash developed 12 hours post immunization. 48 hours post immunization rash spread to 6 x 6 area around injection site.
This case was reported by a physician via sales rep and described the occurrence of generalized maculopapular rash in a adult female patient who received SHINGRIX for an unknown indication. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 6 days after receiving SHINGRIX, the patient experienced generalized maculopapular rash. On an unknown date, the outcome of the generalized maculopapular rash was recovered/resolved. The reporter considered the generalized maculopapular rash to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported, but the patient was in her early 50's. The physician reported this case for a colleague. The patient experienced a generalized maculopapular rash. The rash appeared about 6 to 7 days after the dose of SHINGRIX and resolved in the next week. The patient did not require hospitalization and did not miss work due to the rash. The GlaxoSmithKline representative called to update the adverse event submitted in the initial report. The physician would like to be contacted about the adverse event that was submitted in the initial report.
disorientation, confusion, opening closets and drawers without reason, could not answer simple questions  back to normal in 24 hrs
Child developed a facial rash noticed by her mother 4 days after she received a seasonal flu injection at a school flu clinic. The rash was described as barely perceptible, seen best in the sun and 1-2mm in diameter. Her 8 yr old brother received the seasonal flu shot at the same school clinic and developed pain and swelling at injection site and also total body rash and swollen lips.
This child has a red area to her right thigh that is warm to touch and slightly swollen.  Area is approximately 3x3.  Patient received immunization 01/21/2005.  Patient visited doctor on 01/23/2005 and 01/24/2005.  Still being followed up by care provider.
Patient initial began with a severe headache and neckache.  He then proceeded to have several days of severe fever and vomiting.
Warmth at injection site; Headache; sluggish; Tired; Fever; Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (sluggish), VACCINATION SITE WARMTH (Warmth at injection site), FATIGUE (Tired), PYREXIA (Fever) and CHILLS (Chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   No relevant Medical history Reported.  Concomitant products included LEVOTHYROXINE for an unknown indication.  On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced SLUGGISHNESS (sluggish), FATIGUE (Tired), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches). On 26-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warmth at injection site) and HEADACHE (Headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 26-Feb-2021, SLUGGISHNESS (sluggish), FATIGUE (Tired), PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, VACCINATION SITE WARMTH (Warmth at injection site), MYALGIA (Body aches) and HEADACHE (Headache) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  Concomitant medication included unspecified prescription eye drops used for an unknown indication.
New onset of papular rash covering body from neck down onto chest, back, abdomen, arms and legs. Not on face. Itchy rash.
administered with the vaccine from vial which has been punctured for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the vaccine from vial which has been punctured for more than 12 hours) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the vaccine from vial which has been punctured for more than 12 hours). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (administered with the vaccine from vial which has been punctured for more than 12 hours) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided. Patient reported no adverse reactions