chrisvoncsefalvay/vaers-outcomes huggingface dataset:
heavier than normal vaginal bleeding following vaccination 2 weeks before unspecified date; This is a spontaneous report from a contactable Pharmacist reported that a 5 decade (40's) female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number and Expiration Date unknown) via an unspecified route of administration on an unknown date at single dose for covid-19 immunisation.  The patient's medical history and concomitant medications was not reported. Patient have heavier than normal vaginal bleeding following vaccination 2 weeks before unspecified date, now having vaginal bleeding for 12 days wondering if this was related to the vaccine. The outcome of event was not recovered.  Information on the batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported vaginal bleeding cannot be excluded.  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.
Fourth shot made patient weak; Fourth shot felt light headed almost passed out; Fourth shot felt light headed almost passed out; Fourth shot gave patient a headache; Fourth shot made patient vomit; Today patient feels better but tired; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Fourth shot made patient weak), PRESYNCOPE (Fourth shot felt light headed almost passed out), DIZZINESS (Fourth shot felt light headed almost passed out), FATIGUE (Today patient feels better but tired) and HEADACHE (Fourth shot gave patient a headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 052E21A, 031M20A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient does not have any allergies, did not test positive for COVID-19 and did not receive any other vaccine within 1 month prior to Moderna. The patient had 3 heart stents and lung emphysema prior to vaccination and did not register any change to illness status post vaccination.  Concurrent medical conditions included Emphysema pulmonary (Lung Emphysema prior to vaccination.). Concomitant products included ATORVASTATIN for Cholesterol, THEOPHYLLINE for Lung disorder NOS, METOPROLOL, DILTIAZEM, TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Today patient feels better but tired). On an unknown date, the patient experienced ASTHENIA (Fourth shot made patient weak), PRESYNCOPE (Fourth shot felt light headed almost passed out), DIZZINESS (Fourth shot felt light headed almost passed out), HEADACHE (Fourth shot gave patient a headache) and VOMITING (Fourth shot made patient vomit). At the time of the report, ASTHENIA (Fourth shot made patient weak), DIZZINESS (Fourth shot felt light headed almost passed out), HEADACHE (Fourth shot gave patient a headache) and VOMITING (Fourth shot made patient vomit) was resolving, PRESYNCOPE (Fourth shot felt light headed almost passed out) outcome was unknown and FATIGUE (Today patient feels better but tired) had not resolved.            The patient confirmed that the patient did not seek medical care post vaccination. The patient did not experience a similar event in the past.  On 05-Apr-2022 it was reported that the patient felt better but tired after receiving the 2nd booster shot on the 03-Apr-2022. No treatment was taken by the patient.   This case was linked to MOD-2022-533315, MOD-2022-533310, MOD-2022-533304 (Patient Link).
On 10/12/2000 the patient presented to the physician's office with a "classic varicella rash". She had approximately 20-30 lesions, no crusting and no fever. It was noted that the patient had just finished a course of antibiotics for strep throat. Additional information has been requested.
Light chain analysis dramatically increased; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of LIGHT CHAIN ANALYSIS INCREASED (Light chain analysis dramatically increased) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Multiple myeloma (in remission).   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LIGHT CHAIN ANALYSIS INCREASED (Light chain analysis dramatically increased). At the time of the report, LIGHT CHAIN ANALYSIS INCREASED (Light chain analysis dramatically increased) outcome was unknown. Not Provided          Patient's concomitant medication included unspecified multiple immunosuppressants.   Treatment information was not provided.   This case was linked to MOD-2021-085958 (Patient Link).   Reporter did not allow further contact
more than 35 days for 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 35 days for 2nd dose) 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 04-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 35 days for 2nd dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 35 days for 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.    Reporter did not allow further contact
diarrhea; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 09Feb2021 12:00 (Batch/Lot Number: EL3246) as single dose for covid-19 immunisation. Medical history included High BP. Concomitant medication(s) included metoprolol 50mg; valsartan 325mg. No Known allergies reported. The patient had diarrhea several times each day beginning the evening after the shot. It's worse at night but it's been 10 straight days of continuous going. Patient had not experienced any other side effects. No fever, pain, swelling, fatigue or anything. The patient experienced diarrhea on 09Feb2021 20:00. No COVID prior vaccination and no COVID tested post vaccination were reported. No treatment was received. The outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
Immediately following Td vaccine had swelling and acute flu-like symptoms. Very itchy, homogeneous erythema and induration. Give Alox for reaction. Keflex 500mg one Qid x 10d.
24 hours after shot produced fever of 101.8 that lasted 10 hours with body aches, chills, nausea, gas and watery stomach.
Patient's arm via phone picture was very red and inflammed around injection site (area was large, covered most of arm above elbow) for more than 7 days. Patient stated it was very painful, and she could not sleep because of pain. She also said that her hand on that arm felt "very heavy". It has gone away now.
p/vax pt exp swelling arm;also had diffuse swelling extending into middle of forearm;arm felt hot to touch;devel low fever, w/severe tenderness;pt adm to hosp;given IV ATB d/t medical history;MD not sure if pt had cellulitis or local rxn;60 day follow-up dated 10/25/00 provided no additional data.
1st dose Oct2021, 2nd not yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who did not receive Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix (on October 2021 the patient received 1st dose).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: 1st dose Oct2021, 2nd not yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 25-APR-2023 The pharmacist reported that a patient received in October 2021 the first dose of Shingrix.  Till the reporting time the second dose was not administer to the patient.  The patient did not knew that it was 2-part vaccine and well no one at the pharmacy informed him/her. The reporter consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
now purplish in color and 6 inches across; soreness; injection site rash; Tenderness; A Spontaneous report was received from a consumer concerning 78 years old, female patient who was administered with Moderna's COVID-19 vaccine and experienced tenderness, soreness/arthralgia , injection site discolouration, and injection site rash.  On 21Jan2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.   On 21 Jan 2021, the patient started experiencing symptoms of tenderness, soreness, at the time of this report purplish in color and 6 inches across with rash around the injection site. The patient took two Tylenol on the first day for symptoms and still experiencing some soreness.  The outcome of the event tenderness, soreness, injection site discolouration, and injection site rash was not reported.; Reporter's Comments: This case concerns a 78 Y/O F with nonserious unexpected tenderness, injection site discoloration and expected injection site rash, arthralgia.  Event onset the same day as first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Pt received FluzoneHD and Prevnar13 on 10/23/2020.  She called on 10/24/2020 complaining of back ache, chills, sore throat, and body aches.  She stated these symptoms started happening 3-4 hours after receiving the vaccines.  She used tylenol and ibuprofen around the clock and this helped.  After following up with the patient, the patient stated she was completely better by 10/25 and that the total time course of this reaction was about 24 hours.
There is a tender red spot about 4 inches in diameter at the injection site. This appeared 1 week after the first dose.
Woke up with a fever and extreme tiredness. Had a little nausea and dizziness. Fever broke early morning but stayed in bed until 11:30 am. Was able to eat normal meals and just relaxed most of the day. Just to tired to do anything. Woke up fine Tuesday morning.
4-6-04 Pt. began being fussy and feverish about 10:30 pm mom gave Tylenol every 4 hours during night by 6 AM had constant crying since then. Refused to eat since 6 AM & won't take liquids. Extremely fussy even with Tylenol given. Atarax Liq 10 mg 15 cc given orally 4-7-04 at doctor's office (ice at 3 pm) Pt. took 1 oz of Pedialyte & fell asleep. Will call 4-8 AM with update. Improved with Atarax orally.
The patient passed out for a few seconds about 5 minutes after the vaccine administration. She was very clammy, sweaty, and alert but very groggy when the pharmacists went out to  her. She also stated that her throat felt swollen and sore and that she felt like she was going to throw up. We called the EMS, and she left in the ambulance about 25 minutes after being vaccinated. We don't have any further update at this time.
Immediate localized reaction at injection site including erythema, hives, itching.  Given benadryl 25 mg p.o.  and ice to area.  Reaction resolving 25 minutes after.  Phone follow up next day patient reported no symptoms.
When area at injection site is scratched it puffs up to about 3 inches in diameter; Itchy at injection site; Small pain in left arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of SCRATCH (When area at injection site is scratched it puffs up to about 3 inches in diameter), VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE PAIN (Small pain in left arm at injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SCRATCH (When area at injection site is scratched it puffs up to about 3 inches in diameter), VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE PAIN (Small pain in left arm at injection site). At the time of the report, SCRATCH (When area at injection site is scratched it puffs up to about 3 inches in diameter), VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE PAIN (Small pain in left arm at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information not provided  Company comment: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.; 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.
Patient seen today in our office with head-to-toe red rash; MD diagnosed with Rubeola.  Had been receiving Amoxicillin x 2 weeks for a previous viral infection.  Received MMR vaccine on 7/8/10.
Had allergic rash reported by mom. States she had hives all over her body & they took her to E.R. MD told her it was reaction to shots given steroid shot.
No Adverse event; received 0.25 ml of bivalent dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No Adverse event) in a 41-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose).    No concomitant medications were reported.  It was reported that reporter was giving 0.25 ml instead of 0.5 ml of Moderna bivalent vaccine. Reported that 19 patients received the half doses on 15 Sep 2022, 22 Sep 2022, 29 Sep 2022, and 06 Oct 2022.  No treatment medications were reported.   This case was linked to MODERNATX, INC.-MOD-2022-662961, MODERNATX, INC.-MOD-2022-662973 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-662961:Same reporter MODERNATX, INC.-MOD-2022-662973:Same reporter
no additional adverse events reported; he vaccine sat outside of the refrigerator for 20-25 minutes and was placed back in the fridge.; This spontaneous report was received from a nurse and refers to a child patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On an unknown date, one of the medical assistants drew up hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and she was going to give it to a child. The nurse reported that the medical assistant reported that the child then began to "freaked out" so the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not given and series was not started on this patient. The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) sat outside of the refrigerator for 20-25 minutes at room temperature and was placed back in the fridge. On 22-FEB-2021, the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was administered to a different child. The patient did not experience any symptoms and enquired if the patient needs to be re-vaccinated. No additional adverse events were reported. No product quality complaint was reported. There were no previous temperature excursions and data digital logger was not filled. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687291; expirationdate: 11-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
A non-serious spontaneous report of redness and irritation around nose, mouth and eyebrows has been received from a consumer concerning a 14-year-old male patient, subsequent to FLUMIST. Patient has a history of asthma as a kid but hasn't taken asthma medication in 9-10 years. No concomitant medication has been reported for this patient. On 27-Nov-2010, the patient received FLUMIST. On 28-Nov-2010, the patient experienced redness and irritation around his nose, mouth, and eyebrows. Since then he had been to doctor and dermatologist and "they could not find anything wrong". He visited physician about 4-5 days after the symptoms began. He has been given prednisone (worked but came right back) and miconazole and both seemed to help. The outcome of the events redness and irritation around nose, mouth and eyebrows was unknown.
PT WAS GIVEN DOSE OF MENQUADFI THAT IS NOT INDICATED AT THIS TIME
07/08/21 I woke up with a really bad headache.  I have never had a headache like it.  Lasted 3 daysSo far.   Today being the 3rd.  Cold chills, congestion and really tired.  Got the shot on the 7th, started feeling miserable on the 8th.  Actually left my keys walked away from my job.  That night I was up and down just wanting some relief.  It could have felt worse for me because I don?t normally experience headaches.  Feel some what more comfortable today.
Two weeks after second shot, I experienced all over body myalgia, chills, extremely fatigue and weakness.  It lasted for ten days.  Extra strength Tylenol, 2 every 8 hours helped.  Then the symptoms would return.  This lasted off and on for weeks.  Gradually feeling better but still taking some Tylenol now and then.  Had blood work and my sed rate which is usually 5 was 67 and showed positive antibodies for Covid.  I have not had Covid 19.
Approximately 2 weeks after receiving vaccination, patient developed confusion and lethargy. He presented to the hospital where he was found to be febrile. Alteration mental status continued to worsen, and then had a generalized seizure.  Patient was empirically treated for possible meningoencephalitis but diagnosis is not confirmed.
Within 18 hours patient had intense pain, induration and erythema on wide area surrounding injection site. On exam 7/7/17 left deltoid was warm, tender, 10cm dia area of blanching erythema with mild induration, full range of motion, normal distal sensation and perfusion, normal grip strength.
Received Expired Vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     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, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.
he has been fully vaccinated with the Pfizer COVID 19 vaccine (2nd dose was in May 2021) and has tested positive for COVID; he has been fully vaccinated with the Pfizer COVID 19 vaccine (2nd dose was in May 2021) and has tested positive for COVID; I'm at the beginning stages of diabetes; He's had flu-like symptoms; He's been sick for the 5 days.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group for a Pfizer sponsored program (159558). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "he has been fully vaccinated with the Pfizer COVID 19 vaccine (2nd dose was in May 2021) and has tested positive for COVID"; DIABETES MELLITUS (medically significant) with onset 2021, outcome "unknown", described as "I'm at the beginning stages of diabetes"; INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "He's had flu-like symptoms"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "He's been sick for the 5 days.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Therapeutic measures were taken as a result of influenza like illness, illness.  Additional information: He's taken Tylenol, Advil, and cold medicine.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments:  ~~~
Terrible headache, body aches, slight fever, exhaustion for 2-3 days. kicked in about 20mhours after the vaccine shot. I had no problem with the first shot I received 3 weeks earlier but this one was difficult.