chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I got a headache on the right side of my head from front to back.  On 04/07/2012 I was too weak to get out of the chair or bed and still had the headache.  On 04/08/2012 I was still weak and still had the headache but the weakness was not as bad as the previous day.  I had no appetite on 04/07/2012.
Patient received FLUVIRIN according to standard protocol for intramuscular injection and within 3 hours developed localized swelling, redness, pain at injection site. Pain had abated as well as swelling and redness when evaluated on 11/15/2010 at 1130AM but size of reaction was 8cm x 5.5cm.
Pfizer-BioNTech COVID-19 Vaccine EUA Hives/Rash on the right side of the body, Itching, Arm Pain (1 day after vaccine) Benadryl was taken and reduced the hives and itching
Client reports that about a week after he had the Janssen vaccine he had muscle weakness that resulted in a fall. He reports that he was unable to get himself up out off the floor, laying there until the next day delivery came. He reports that the driver called for help and they were able to help him to the couch. He was weak but able to use the walker to get around. reports that he had not slept during that time and reports having some delusions due to lack of sleep.  He does report that he has a history of muscle weakness, but never this bad and is now having to use a walker all of the time. He denies going to the ER, hospital or doctor for treatment and that he is slowly recovering but still having to use a walker.
Place of vaccine hurts, Body ache,  used ice pack on place of vaccination, took Advil for pain relief.
Patient reports extreme fatigue, malaise, nausea, and body pains that persisted for 7 days and kept her bed-bound for most of that time. She reports that the administration site became very red, and that her upper arm became swollen "to the size of a saucer." She now remembers that she had a similar, less severe, reaction after the first dose of the vaccine, but did not tell anyone at the time and did not remember to tell the pharmacist before getting her second dose. She did not call her doctor, and is feeling much better today.
Immunizations given 6 mos too early for MMR and Varicella. KINRIX not indicated for under 4 yrs of age.
Initial dose in left arm. Soreness at injection site for 3 days. Experienced ringing (tinnitus) in left ear 5-6 hours after vaccine. It has been 2 weeks and the constant ringing has not stopped. I did not have any hearing issues until I received the Shingrix  vaccine on Dec 22 2021.
22 hours after receiving the flu vaccine she experienced a headache, weakness, achiness, and paleness with nausea. I saw her the next day, approx. 48 hours after adm. of the flu vaccine. At that time the headache was improved. She still felt shaky and was pale. No local reaction was experienced. Called the health dept said that symptoms were unrelated to flu vaccine. Will reevaluate next fall before getting the flu vaccine. No allergy to eggs.
Received injection 5/8/06-Wed. On Thursday morning, mom noted a fine rash, infant had  101.4 temp., rash continued to spread across thigh denies redness  or excessive warmth of legs. 5/8/06 presented with papular lesion across bilateral thighs Rt and mild /// /// prescribed. F/u 1 wk. Mom will call of worsens.
Temp averaging 101.2, extreme sore throat, body aches, lethargy all lasting 24 hours (My normal temp is 95.7) Felt impending head ache which never materialized but I rarely get headaches. Felt Nausea never resulted in vomiting.  Most sick I have been in decades. Had lesser reaction to first dose of Moderna with sore throat being the most pronounced. That dose was administered on 01/26/2021 at 3PM
This spontaneous report was received from the patients father regarding his two daughters of unknown age. This case report refers to the youngest daughter. The patient's pertinent medical history and concurrent conditions were unspecified. On an unknown date the patient was vaccinated with two out of the three GARDASIL. No concomitant medications were reported. It was discovered that she had missed the third dose. The patient experienced soreness at the injection site each time she was vaccinated. No product quality complaint (PQC) was involved. The outcome of the events is unknown. The causality assessment for the events soreness at the injection site was not provided. This is one of the two reports received from the same reporter. Additional information is not expected, no contact details were provided.
extreme salt taste on tongue 2 days later; Metallic taste immediately after both vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11May2021 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic migraines" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DYSGEUSIA (medically significant) with onset 11May2021 at 10:00, outcome "not recovered", described as "Metallic taste immediately after both vaccines"; DYSGEUSIA (medically significant) with onset 13May2022, outcome "not recovered", described as "extreme salt taste on tongue 2 days later". The events "metallic taste immediately after both vaccines" and "extreme salt taste on tongue 2 days later" required physician office visit. Therapeutic measures were taken as a result of dysgeusia, dysgeusia. She told to take zinc on a daily basis as treatment for AE.  Additional information: No known allergies. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination and not tested covid post vaccination. Patient received dose 2 on 01Jun2021 at 10:00 AM in left arm (Batch/Lot number: unknown) for covid-19 immunisation. Metallic taste immediately after both vaccines, then changed to extreme salt taste on tongue 2 days later. It was not improved at all (it had been over a year at the time of report).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Initial information received on 21-Nov-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old female patient who received vaccine before being reconstituted only diluent was administered, while she received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient also received Rotavirus & PREVENAR 13 concomitantly. On 19-Nov-2018, the patient received a only liquid DTaP/IPV dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE not reconstituted with the lyophilized ACTHIB component lot number - C5592AA, expiry date- 15-Nov-2019 intramuscularly in right thigh. It was a case of actual medication error due to inappropriate reconstitution technique. The patient outcome is reported as Not Applicable for vaccine that was administered to a patient before being reconstituted only diluent was administered. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Red hard large lump, very hot and itchy. The redness is spreading out over the last few hours.
Fever, body aches and lethargy lasting 2-3 days. Resolved on it's own.
Information has been received from a physician via a company representative referring to a 36 years old female patient. The patient's medical history, concurrent condition and concomitant medication were unknown. On an unknown date in 2006 the patient was vaccinated with GARDASIL (dose, route, lot # and expiration date were unknown) for prophylaxis. On an unknown date the patient experienced stage 3 cervical cancer even after receiving GARDASIL. The patient sought unknown type of medical attention. It was unknown if any lab diagnostics were performed or any treatment was given for the events. Outcome of the events was unknown. Causality was not reported. Upon internal review, stage 3 cervical cancer was considered to be medically significant.
The patient received her Moderna Covid-19 vaccine and was sitting in the waiting area with her companion. Approximately 12 minutes after receiving the vaccine, the patient fainted.  The pharmacist was alerted and immediately went to assist.  The patient was unconscious 1 minute or less, never fell out of her chair and recovered quickly.
Information has been received from a nurse practitioner concerning a female who was vaccinated with 3 doses of GARDASIL on unspecified dates. Subsequently she had an abnormal pap. The patient did not have an abnormal PAP prior to receiving GARDASIL. The outcome was unknown at time of reporting. No further information is available.
pt recv vax 21OCT96 that same day pt exp severe abd pain for 12hr & flu-like synd, including nausea, vomiting & diarrhea;pt recovered;
spoke with grandmother (guardian) on 06/28/2021 she says Pt is Fine. Pt had A sore  arm for a few days
C/O nausea. Seeing spots, feeling like going to faint. Abd pain, shaking. States tongue feeling thick. TX: SOLUMEDROL 125 mg IM, BRETHAIRE epi 0.3 SC. BENADRYL 25 mg IVP, O2 2L NC. IVF NS 1000 ml then 250ml/m. Transported to hospital.
Pain; Fever of 102 F; Achiness; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 102 F), PAIN (Achiness) and PAIN (Pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced PYREXIA (Fever of 102 F) and PAIN (Achiness). On 14-Feb-2021, the patient experienced PAIN (Pain). On 14-Feb-2021, PYREXIA (Fever of 102 F) had resolved. On 15-Feb-2021, PAIN (Achiness) and PAIN (Pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
Cataracts; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4244415-00 (RA).  A 75 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for product used for unknown indication. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CATARACT (hospitalization, medically significant), outcome "unknown", described as "Cataracts". The action taken for adalimumab was unknown. Clinical course: On unknown dates, the patient experienced cataracts and hospitalized after receiving pfizer covid-19 vaccination. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. The patient was hospitalized after receiving pfizer covid vaccine. He was scheduled for cataracts surgery. He did not agreed to have physician contacted. It was unknown if patient was enrolled in a covid-19 vaccine trial. He received dose of covid-19 vaccine manufactured by pfizer/biontech.  Causality for humira (adalimumab)The reporter's causality for the event(s) of cataracts and hospitalized after receiving pfizer covid-19 vaccination was not provided. (withheld) opinion is that there is no reasonable possibility that the events of cataracts and hospitalized after receiving pfizer covid-19 vaccination are related to humira (adalimumab).  The reporter's assessment of the causal relationship of the cataracts  with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between event cataract and suspect drug BNT162B2.  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
R arm pain/ ? vaccine reaction.  C/O itching & headache x2 days.  Rx MOTRIN/observe.
Low grade fever 100.4 for 12-19 hours Slight headache for 12-19 hours Swollen lymph nodes (3) above left side collarbone noticed on day 5 Sore arm at injection site Rash below injection site from day 3-5
Patient came in with a localized reaction to the FLUZONE vaccine in his Right Deltoid. Patients Deltoid is warm to the touch and red. Red area is 7.5 cm x 5.5 cm on Right Deltoid.
On day #11 post-vaccine (3/14/21), woke with red welts on left arm (approx 3 inches by 4 inches wide), swelling, and itching at site of vaccination. Allergic to Benadryl..so took Claritin and Advil; put cortisone cream on site.  On day #12  post-vaccine (3/15/21), welts expanded to one big  red welt on left arm. Less swollen than day before. Still mildly itchy.
Axillary pain, 2 day later pain in pectoral ms and biceps unilateral. Worsened through first weeks in Nov. Palpable tender nodes pectoral areas. No fever, some fatigue.
Considerable redness and pain at and surrounding the injection site... approximately 5 inches in diameter.
pt recv vax 29JUL97 & became pregnant;pt LMP was 22JUN97;AUG97 pt devel a mild but gen rash;pt was seeing a dermatologist for further eval of rash;pt was seronegative prior to vax;
Patient developed red marks and papules around injection site, then spread all over the body. Patient went to physician and was diagnosed with chicken pox.
menstruation even though i am currently on birth control and do not get a monthly period that has continued for over a week and a half
HIGH TESTOSTERONE LEVELS; IRREGULAR PERIODS; This spontaneous report received from a parent concerned an 18 year old The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. Patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on left arm on 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 01-JUN-2021, the patient experienced irregular periods within two months after receiving the vaccine (Dose number in series 1). The patient received booster dose of non-company suspect Moderna vaccine (elasomeran) (Dose number in series 2) (form of admin, route of admin, and batch number were not reported) dose was not reported, administered in OCT-2021 (after 6 months of J and J vaccine) for prophylactic vaccination.  On 01-DEC-2021, the patient experienced high testosterone levels. Lab test reported unusually high testosterone levels (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient had not recovered from irregular periods, and high testosterone levels. This report was non-serious.
Cold symptoms -feverish. Runny nose,. Headache. Sore throat. Cough for three plus days
Bursitis; Swollen lymphoid; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of BURSITIS (Bursitis) and LYMPHADENOPATHY (Swollen lymphoid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BURSITIS (Bursitis) and LYMPHADENOPATHY (Swollen lymphoid). At the time of the report, BURSITIS (Bursitis) and LYMPHADENOPATHY (Swollen lymphoid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Vaccine breakthrough infection; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Feb-2022 and was forwarded to Moderna on 23-Feb-2022.    This literature-non-study case was reported in a literature article and describes the occurrence of VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Privacy    No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) (seriousness criterion medically significant). At the time of the report, VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) 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 considered VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) to be related.    No concomitant and treatment medications were reported by the reporter.  Company comment: This literature case concerns a  patient of unknown age and gender with no relevant medical history, who experienced the serious unexpected events of vaccine breakthrough infection. The events occurred on an unknown date following an unspecified dose of mRNA-1273 vaccine. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing infection. The rechallenge was unknown as the dosages and time of event onset were not reported. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-491471, MOD-2022-491472, MOD-2022-491473, MOD-2022-491474, MOD-2022-491475, MOD-2022-491476, MOD-2022-491477, MOD-2022-491478, MOD-2022-491479, MOD-2022-491379, MOD-2022-491481 (Patient Link).; Sender's Comments: This literature case concerns a  patient of unknown age and gender with no relevant medical history, who experienced the serious unexpected events of vaccine breakthrough infection. The events occurred on an unknown date following an unspecified dose of mRNA-1273 vaccine. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing infection. The rechallenge was unknown as the dosages and time of event onset were not reported. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Soreness at sites of injection right away. After about 2 weeks arm swollen, red and sore. Left breast is swollen and sore. Having problems raising arm.
Pt reported continued pain at injection site "bone" pain months later with no resolution/improvement (med OTC patches, creams).
Fever noticed beginning 11/15/21 in AM. Highest recorded temperature was 104.9 at 6:45PM on 11/15/21. Temperature was taken with ear thermometer. Also taken under arm with digital thermometer. He also noted headache and stomach ache in addition to arm pain.
Initial information received on 26-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves Adult patient who experienced extended soreness in my shoulder after receiving a typhoid vaccination, while he/she received vaccine TYPHIM VI. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE lot number not reported via unknown route in unknown administration site. The patient developed a non-serious extended soreness in my shoulder after receiving a typhoid vaccination following the administration of TYPHOID VI POLYSACCHARIDE VACCINE. (Other relevant tests included no lab data). Final diagnosis was extended soreness in my shoulder after receiving a typhoid vaccination. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for extended soreness in my shoulder after receiving a typhoid vaccination.
Pt experienced a possible allergic reaction to MMR. Treated with Benadryl. Pt developed a rash on trunk and neck. Vomited after going to ER. Rash disappearing as of this report.
BEGAN 6/10/20 EVENING WITH HIVES. NEXT MORNING STARTED ON BENADRYL AND ZYRTEC. RASH PROGRESSED, DIAGNOSED WITH ERYTHEMA MULTIFORME ON 6/12/20. HOSPITALIZED 6/12/20 FOR HYPOXIA, FEVER AND RASH.
experienced cellulitis after Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of cellulitis in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced cellulitis (serious criteria GSK medically significant). On an unknown date, the outcome of the cellulitis was unknown.   It was unknown if the reporter considered the cellulitis to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The pharmacist reported  that patient experienced cellulitis after Shingrix. The reporter did not consent to follow-up
Patient called in on 2/3/19 describing symptoms that began 1 or 2 days after receiving vaccine as experiencing severe tiredness, severe arm soreness, diarrhea, stomach pain, and throwing up. She believed it to be from the SHINGRIX vaccine. By 2/3 these symptoms had stopped or gotten much better and were resolving. She was referred to her doctor if symptoms persist and with the possibility of it being a stomach bug, that was already resolving (diarrhea and vomiting had stopped), tiredness and arm soreness still lingering, to continue fluids and rest.