chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is spontaneous report from a non-contactable healthcare professional (other HCP).  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, at single dose, for COVID-19 immunisation. Co-suspect drugs included lidocaine (unknown manufacturer) and hyaluronic acid (JUVEDERM VOLUMA), both on an uspecified date(s), at unknown dose(s), for unknown indication(s), with no problems until four months ago. Medical history included rheumatoid arthritis. Concomitant medications were not reported. The patient had a flare up of rheumatoid arthritis and experienced swelling on an unspecified date. After one week the patient contacted the HCP who saw the patient and prescribed clarithromycin 500 mg twice a day and prednisone. After two weeks the swelling appeared to be going down but slowly. The patient contacted the HCP after Christmas with further swelling and now areas they had had treated by another practitioner around the mouth and tear trough started to swell. One week prior to this, on an unspecified date, the patient received the BNT162B2 vaccination. The patient started to swell again a few days after this. HCP saw the patient and began to use hyaluronidase. HCP did not know what the previous practitioner had used and the patient was reluctant to ask and didn't want to get in touch with the previous practitioner. HCP had seen the patient a few times and used hyaluronidase at three separate appointments. Symptoms resolved on an unknown date. Patient failed to inform the HCP that they had rheumatoid arthritis and since told them as it wasn't bothering them they didn't think it was important. Patient was now waiting to see the consultant regarding this.  Pfizer is a marketing authorization holder of lidocaine in the country of incidence. This may be a duplicate report if another marketing authorization holder of lidocaine has submitted the same report to the regulatory authorities.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: It is more likely that the event rheumatoid arthritis flare up was related to an acute flare up of the pre-existing condition and not related to BNT162b2 use.
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A31A, expiry: 21-SEP-2021) dose was not reported, administered on 01-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-OCT-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
6 months later got shingles/ suspected vaccination failure; shingles; This 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 6 months after receiving Shingles vaccine, 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 Shingles vaccine.     Additional Information: GSK Receipt Date: 28-FEB-2023 Reporter's comments: This case was reported by the patient via interactive digital media.  The reporter stated that he/she had got the shot and 6 months later also got shingles, so go figure it out. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Chills; fever 100.4; joint pain; mild headache; This is a spontaneous report from a contactable consumer for himself. A 65-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch number: Unknown) on 09Feb2021 11:45 via an unspecified route of administration in the left arm at SINGLE DOSE for COVID-19 Immunization. The patient's medical history included arthritis from an unknown date and unknown if ongoing. The patient had casein and dairy allergy. The patient's concomitant medications included Levothyroxine sodium (Levothyroxine), Amlodipine, Metoprolol and Omeprozole. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch number: Unknown) on 19Jan2021 11:45 via an unspecified route of administration in the left arm at SINGLE DOSE for COVID-19 Immunization. The patient didn't receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with Covid-19 prior to vaccination and was not tested after the vaccination for COVID-19. On 09Feb2021 20:00 the patient experienced chills, fever 100.4, joint pain and mild headache. The events were assessed as non-serious by the reporter. The patient received Advil and Tylenol as treatment medications. The outcome of the event was recovered.  Information on the lot/batch number has been requested.
No initial reaction.  It wasn't until eight days later that the area of the injection got red, swollen, hard and very itchy.  The affected area got bigger.
Patient received vaccination given 3 days too soon. Patient was on day 14 post first vaccination.
NOTE:  This is the patient?s 5th injectable IIV4 flu vaccine: 10/30/15,  12/4/15,  11/3/17,  12/14/18 and 1/8/20 1/9/20 office visit: History: The patient presents for rash.  Affected area includes left thigh.   The patient?s mother describes the affected area as itchy and red.  Associated symptoms include erythema (skin) and pruritus.  Additional information: Yesterday, afternoon he started having redness and itching on his left thigh from the influenza vaccine. 1/9/20 Physical Exam: Skin: left thigh with large urticaria area at the immunization injection site. 1/9/20  Assessment and Patient Plan: Allergic reaction, initial encounter.  Related to influenza vaccine.  Please use Benadryl cream and hydrocortisone cream.  If getting worse, or not improving, please return.  If he is having difficulty breathing or the area is getting larger, go to ER.  Follow up in 3 ? 5 days. 1/13/20  Scheduled office visit: History: Recheck rash.  The problem is improving.  Associated symptoms include pruritis.  Pertinent negatives include cough, fever, painful rash, vomiting and wheezing.  Additional information: possible allergic reaction to influenza vaccine ? came to walk-ins the day after vaccines for itching and redness.  Given Benadryl and hydrocortisone cream.  Mother thinks it is improved. 1/13/20  Assessment and Patient Plan:  Allergic reaction, initial encounter.  May discontinue Benadryl cream and hydrocortisone cream.  Will place alert in his chart for the influenza vaccine.  Return to office if no improvement or worsening. 1/24/20 at 9:25 Phone call:  Mom returned my call RE: flu vaccine given on 1/8: she says pt still has a dime size light bruise at the injection site (LVL) & tender to touch, otherwise he is fine.  She said sx's started the next day.
The patient was sitting in the chair per the mother when fainted.  No head trauma. Went to the patient's room was awake with a pale face, very scared, &  nauseous. Checked blood pressure 124/56mmHg,  pulse 62 bpm, oxygen saturation 100%.  She ate crackers and drank coca-cola (soda). Watched for 15 minutes. The patient left and was advised to call EMS if any loss of consciousness or repeated episode or new symptoms.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Tingling extremeties
received the full 1 milliliter dose; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 18-year-old male patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   In February 2022, the patient received Havrix 1 ml and Havrix Pre-Filled Syringe Device. In February 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose 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 reported as follows: The patient received a 1ml dose of Havrix instead of 0.4 ml dose which led to overdose and inappropriate age at vaccine administration. Consent to follow up was denied. This case was linked to US2022031545 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022031545:same reporter
Muscle spasms, fever, chills, rigors, rash, headache, joint swelling and pain
hospitalized due to diverticulitis; This case was reported by a consumer via other manufacturer and described the occurrence of diverticulitis in a 42-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included adalimumab (Humira) unknown for ulcerative colitis.   The subject's past medical history included diverticulitis. Previously administered products included Covid 19 Moderna (received third dose on 1st December 2021), Covid 19 Moderna (received second dose on 1st February 2021) and Covid 19 Moderna (received first dose on 1st January 2021). Concurrent medical conditions included ulcerative colitis (Moderate to severe).   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient started Humira (subcutaneous) 40 mg at an unknown frequency. On 21st March 2022, the dose was changed to 80 mg twice daily (160 mg daily). On 13th July 2022, unknown after receiving Shingrix, the patient experienced diverticulitis (serious criteria hospitalization and GSK medically significant). Humira was discontinued on 11th July 2022 (Dechallenge was positive). On an unknown date, the outcome of the diverticulitis was recovering/resolving.   The reporter considered the diverticulitis to be probably related to Shingrix.   Additional Information: GSK Receipt Date: 27-Jul-2022 Reporter's Comment: The case was reported by the patient. The patient had no known allergies. The patient received a dose of Shingrix and experienced diverticulitis and was hospitalized. The patient thought it was either because she had some nuts or received her first Shingrix vaccine. It was unknown if patient was enrolled in a Covid-19 vaccine trial. The reporter's causality for the event of diverticulitis with Humira (Adalimumab) was no reasonable possibility. Additional Supportive Information: The follow up would not possible as no contact details were available.
Chills; Little nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Little nausea) and CHILLS (Chills) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced NAUSEA (Little nausea). On 25-Mar-2021, the patient experienced CHILLS (Chills). At the time of the report, NAUSEA (Little nausea) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       multivitamins included in concomitant drugs no treatment drugs included
Ringing in ears noticed 2 days after 1st dose. It is always there, making it harder to concentrate and have trouble sleeping. Lack of sleep has affected my stress level and ability to perform my job and do chores at home. I have reported the progression of this on the V-SAFE site that has been sending me questionnaire since getting shot. I also reported it to my doctor during routine physical. I have not gotten a response for help with this condition. This was not mentioned as a possible side effect of vaccine, but was known to be a potential side effect. I had no other side effects. I have recently quit my job due to stress, so I no longer have healthcare.
Tingling in right index feeling, weakness in right leg and hand, fatigue, was diagnosed with TIA (Transient Ischemic Attack).
Inflammation, redness, heat, minor itching, and firmness at injection site. Gradually spreading in a circular pattern from the injection site.
some swelling and soreness at site of injection which increased the next day, and gradually I started feeling achy all over , in my joints and especially my lower pelvis,hip joints , lowered appetite. I feel like I have a bad flu. No temperature.
flu-like symptoms such as feeling tired, hot, and has a fever; flu-like symptoms such as feeling tired, hot, and has a fever; flu-like symptoms such as feeling tired, hot, and has a fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms such as feeling tired, hot, and has a fever), FATIGUE (flu-like symptoms such as feeling tired, hot, and has a fever) and PYREXIA (flu-like symptoms such as feeling tired, hot, and has a fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) UNK dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms such as feeling tired, hot, and has a fever), FATIGUE (flu-like symptoms such as feeling tired, hot, and has a fever) and PYREXIA (flu-like symptoms such as feeling tired, hot, and has a fever). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms such as feeling tired, hot, and has a fever), FATIGUE (flu-like symptoms such as feeling tired, hot, and has a fever) and PYREXIA (flu-like symptoms such as feeling tired, hot, and has a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not reported. Treatment information as not reported.
lost off my memory; anxiety; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (lost off my memory) and ANXIETY (anxiety) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concomitant products included METHOCARBAMOL (ROBAXIN), POTASSIUM CHLORIDE (KLOR-CON M20), PRAVASTATIN, AMLODIPINE BESILATE, VALSARTAN (AMLODIPINE/VALSARTAN), GABAPENTIN, APIXABAN (ELIQUIS), BUMETANIDE (BUMEX), TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) and TIZANIDINE HYDROCHLORIDE (ZANAFLEX) for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AMNESIA (lost off my memory) and ANXIETY (anxiety). At the time of the report, AMNESIA (lost off my memory) and ANXIETY (anxiety) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient woke up 2 days after the vaccine and forgot her whole life. She said she has changed and doesn't know how to function and doesn't know any of her people or her account numbers.  Treatment information was not provided.
nonoligaric acute renal failure secondary to interstitial nephritis which was demonstrated by percutaneous biopsy; 12JUN92 check up renal function was nl-interstitial hep was resolving;
sensation like "Needle injection on the face (mouth and nose); mild soreness arm; mild headache; This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA (sensation like "Needle injection on the face (mouth and nose)), PAIN IN EXTREMITY (mild soreness arm) and HEADACHE (mild headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PARAESTHESIA (sensation like "Needle injection on the face (mouth and nose)), PAIN IN EXTREMITY (mild soreness arm) and HEADACHE (mild headache). At the time of the report, PARAESTHESIA (sensation like "Needle injection on the face (mouth and nose)), PAIN IN EXTREMITY (mild soreness arm) and HEADACHE (mild headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
irritation; I experienced itching & redness on my right arm from the injection site; I experienced itching & redness on my right arm from the injection site; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EL8982) unknown route at right arm on 28Jan2021 10:00 at single dose for covid-19 immunization. Medical history includes Allergies to Aspirin, penicillin.  The patient previously received first dose of bnt162b2 on 07Jan2021 10:00 at Right arm single for Covid-19 immunization (Lot number: EK5730). patient not receive any other vaccines within 4 weeks prior to the COVID vaccine. other medications the patient received within 2 weeks of vaccination incldes Daily Multi Vitamins. It was reported six days after my second Pfizer injection (03Feb2021 19:00) patient experienced itching & redness on right arm from the injection site & below in an area about 3" x 4". On days seven & eight the redness & itching are gradually reducing in color (pink) & irritation. There was no treatment received for the adverse events. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient been not tested for COVID-19. The outcome of the events was recovering.
Chills and fever that night, cold sweat, nausea, dizziness throughout night.  Some muscle weakness.  Fever of 102, likely was higher last night.
rt arm @ inj is rock hard, chills, body aches, sore throat, weakness, hoarseness, dizziness;
Patient reporting dizziness, feeling lasted about 3 minutes, High blood pressure, body aches, headaches, and sore arm.
positive for Covid; positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Feb2021, for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), administration date: 2021, for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: 2021, for COVID-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), administration date: 2022, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Nov2023, outcome "recovered" and all described as "positive for Covid". The event "positive for covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) positive; (Nov2023) Negative; (Nov2023) negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: In Feb2021 the patient got their first shot and got 2 boosters in 2021, for a total of 3 doses in 2021. They got another dose in 2022. They just received a another booster on 24Oct2023. All Pfizer Covid-19 vaccines. The patient had no underlying conditions. After they got the 5th booster on 30Oct2023 they went to concert went out without a mask on 30Oct2023. By Thursday 02Nov2023 the patient had an earache. The patient came up positive for covid. Friday (03Nov2023) the patient called their physician and he put in for Paxlovid. The patient took the Paxlovid medication and she was testing negative. They did another test the next day and she was negative.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Pfizer Vaccine 45 min after dose, needed to clear my throat allot. Took Claritan and quieted down. By 8 pm left side neck ache. By 3 am the next day lots of trouble with throat and swallowing.  Moderate to sever neck pain, muscle tight and contracted like cervical dystonia. Took another claritan. 2 hours later 25 mg Bendadryl. 830am called healthcare clinic and was seen. "Immune response" Not "allergy" Recommends not getting shot number 2
21-22 hrs p/vax mom noted 4mm x 5mm area of blisters (3); area was red from upper deltoid down to elbow-tenderness; that evening pt vomited x 1 & had a low grade fever; mom called to report poss react to clinic; on exam healing scars noted;
Patient is a 76 y.o. PMHx of HTN, T2DM, OSA, MI 1999 s/p heart catheterization, SSS 2009 s/p pacemaker admitted due to acute hypoxic respiratory failure due to COVID 19 pneumonia. Chest x ray demonstrated moderate interstitail prominence and increased perihilar fullness. No PE or pneumothorax. He was found to be COVID 19 positive on 1/11/22. He was treated with IV solumedrol and remdesivir. He did require 2L oxygen on NC, but quickly was able to maintain saturations on room air. He improved both clinically and in lab findings. Patient completed two days of Remdesivir prior to discharge. He was discharged home in stable condition to complete prednisone course 40mg for 5 days.
11/18/21 presents to local ED for "DOE, fatigue, malaise". PMHx of "kidney transplant 2015, IDDM, HTN"
This case was reported by a pharmacist via a sales representative and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received a dose of FLUARIX. Less than one day after vaccination with FLUARIX, the subject experienced injection site pain. The next day, the area was hard (hardiness injection site) and a blister formed (injection site blisters). It was reported that it took a week for the events (issue) to resolve. The reporter indicated that this event occurred with seven patients that received FLUARIX. Linked cases include A0950536A, A0950541A, A0950542A, A0950544A, A0950545A and A0950546A.
Intermittent left-sided knee pain radiating down leg, spoke with physician who advised him to go to urgent care however he has not gone yet, took ibuprofen on Saturday which provided relief. Advised to follow up with PCP recs. -KLC Spoke with caller, has not yet seen PCP or gone to urgent care, however still c/o pain in leg radiating from knee to foot. Advised to contact PCP and follow recs -KLC
Pt says he started feeling sick the day after receiving the vaccine and it lasted about a week. The symptoms have not gone away. He felt body aches, sore throat, cough. Spoke to pt today (9/20/10) and he is still experiencing symptoms.