chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After the Zostavax, pt was sitting in front of the pharmacy for about 15 minutes in case if there's any allergic reaction. About 20mins after the vaccination, pt came over the pharmacy and talked to me (the rph) that she's experiencing little tingling on her lips and she starts getting a bump above her lips. Her voice was deepened. We asked her to stay at the pharmacy for a little bit more and gave her a Benadryl capsule to take. After 10 minutes, pt said she felt better and wanted to go home to get the Proair because she also has asthma. We advised the pt to stay for additional check just in case if she has allergic reaction so we can give her Epipen but she wanted to go home. We advised her to call 911 if she has any swelling of the tongue, throat, rash, etc. Pt was verbalized understanding that she'll call 911 and take more Benadryl if the symptomps worsen or allergic reaction occur. Pt was gone from the pharmacy for about 2 hours, we called her at home and she said she did have the allergic reaction. Her lips were about to swell up but the Benadryl did helped calm it down and she felt fine now. She said if she it worsen, she'll take more Benadryl.
This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On 13-SEP-2016, the patients were vaccinated with improperly stored ZOSTAVAX lot # L036823/ expiration date-24--DEC-2016. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
4 hours following vaccine administration she experienced chest pain, tightness, inability to swallow and developeped hives.  She was home at that time.   Called 911.   Paramedics evaluated her, gave her benadryl, and ultimately she started to feel better.   Rash/hives lingered for 24 hours.   Breathing cleared up within 2 hours.  Swallowing returned to normal following dosing with benadryl.
Body aches, shortness of breath, very painful with in 5 hours after injection, Pt states arm very painful unable to lift on 4/22 + 4/23 area near injection site began itching on the evening of 4/23. Pt has current redness. Warm to touch, and 5/10 pain in entire arm L > 10 CM 12 CM redness and induration.
Approx 3 PM I noticed itching in axillary region of left arm.  I believed it to be a bug bite. Approx 7 PM the outer aspect of left elbow also began itching and a red rash similar to a bug bite was visible.  I treated them with cortisone and continued what I was doing at the time.  Since that did not help, I took Benadryl 25 mg at bedtime. During the night a third rash arose and now a fourth.  What I thought had been a bug bite is actually approx 7 little red bumps contained in one large red, swollen area. Sunday I applied cortisone approx 4 times to all reddened areas and again took benadryl at bedtime. There has been no relief and will continue the above treatment until rash and itching subsides.  Due to allergic
I still got them even with vaccinations/suspected vaccination failure; still got them; 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, unknown 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: 24-SEP-2022 Reporter's Comments:  This case was received from patient via interactive digital media. The patient reported he/she still got them even after vaccination. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available. Note:  Conservatively coded only one suspect due to insufficient info of dose number.  This case has been linked to the US2021AMR129948 case reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR129948:tag at post
We got a report from patient's husband that the patient passed away from heart attack approximately 20 hours after receiving the vaccine.
Administration of expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) in a 47-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products and treatment information were reported. It was reported that expired Moderna vaccine was given as booster shot. The vaccines were stored in freezer, one to two vials were taken out and placed in fridge each day as needed.
Right forearm pain, slight swelling, and neuropathy (burning pain) began 12/22 in the evening and lasted until Saturday 12/26 - responded and improved with acetaminophen and ibuprofen; slight fatigue x 2 day and some slight chills
Pain and stiffness in left shoulder began 2 to 3 hours after vaccination and did not alleviate with movement or time. Patient then proceeded to seek medical help. Her Primary Care Physician then referred her to the an Orthopedic specialists.
tip of her tongue numb; elevate heart rate; her left arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (tip of her tongue numb), HEART RATE INCREASED (elevate heart rate) and VACCINATION SITE PAIN (her left arm is sore) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Nov-2021, the patient experienced HYPOAESTHESIA ORAL (tip of her tongue numb), HEART RATE INCREASED (elevate heart rate) and VACCINATION SITE PAIN (her left arm is sore). At the time of the report, HYPOAESTHESIA ORAL (tip of her tongue numb), HEART RATE INCREASED (elevate heart rate) and VACCINATION SITE PAIN (her left arm is sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided No treatment medications were provided.  Patient reported that the paramedic had to come and medicate her,after these she felt sleep for a bit.   This case was linked to MOD-2021-069952 (Patient Link).
pt recvd vax & 1 wk later exp joint tenderness which has not subsided;
Sore arm for a few days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm for a few days) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced PAIN IN EXTREMITY (Sore arm for a few days). At the time of the report, PAIN IN EXTREMITY (Sore arm for a few days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment medications were not provided.   This case was linked to MOD-2021-065822 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Follow up received on 21-APR-2021 and it contains NO new information.
They were kind of itched; I was scratching and it was starts to bleed; They were kind of itched; I was scratching and it was starts to bleed; They were kind of itched; I was scratching and it was starts to bleed; They are scabbed like almost like scars; that scars on my arm; They were burning kind of and they scabbed over; I had a type of rash; little red dots on my arm, on my forearm and also my trapezius of on the same site of the injection; I had a type of rash; little red dots on my arm, on my forearm and also my trapezius of on the same site of the injection; I had a type of rash; little red dots on my arm, on my forearm and also my trapezius of on the same site of the injection; This is a spontaneous report from a contactable consumer reported for herself.  A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), lot number# EL0142 via unspecified route at the arm on 26Jan2021 (at 56 year old) at single dose for COVID-19 immunization. Medical history was not reported, and concomitant medications included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS). The patient reported as follows: "I was scratching and it was starts to bleed ,I had a type of rash; little red dots on my arm, on my forearm and also my trapezius of on the same site of the injection , they were kind of itched; they are scabbed like almost like scars; that scars on my arm , they were burning kind of and they scabbed over .Then the consumer added: I would say probably came on about I have to guess may be 3 to 5 days after I had the shot and they were kind of the itched and I was scratching and it was starts to bleed that want to I don't know about a week and a few days after I noticed on my arm, also noticed on my back of right trapezius muscle. So on top like on my in my back and behind my neck and it started all of my right side and I was awaken one night because they were burning kind of and they scabbed over so it was just look like scabbed kind of and when I scratch it scab kind of come off and it would bleeding kind of burn. "they are still there but they are having healed like on my arm have like you can see them, but they are scabbed like almost like scars. That scars on my arm, I can see they are still there, but they are not bleeding anymore." Regarding treatment she stated, "I only took Benadryl on one night because night before they woke me up because it was burning. They were hurting when I scratched them." The patient was recovered from wound bleeding while the outcome of the other events was unknown.
This spontaneous report received from a patient via other manufacturer concerned an adult male. The patient's height, and weight were not reported. The patient's concurrent conditions included: ankylosing spondylitis. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) dose, start therapy date were not reported, 1 total, administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. Non-company suspect drugs included: Humira (adalimumab) (solution for injection in pre-filled pen, citrate free, subcutaneous, batch number 1160837, expiry: unknown) dose, frequency and therapy dates were not reported for ankylosing spondylitis. On an unspecified date, the patient experienced swollen joints, hot flashes, and pain (Dose number in series 1). The patient additionally received booster dose of non-company suspect vaccine included: Moderna (elasomeran) (Dose number in series 2) (form of admin not reported, intramuscular, batch number: unknown, expiry: unknown) (1 in 1 Once) dose, start therapy date were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with booster dose of Moderna (elasomeran) covid-19 vaccine (Dose number in series 2). It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab, and elasomeran was not reported. The patient recovered from hot flashes, and the outcome of swollen joints and pain was not reported. This report was non-serious.
Nausea, headache, Violent chills and fever which spiked over a 2 hour period. The fever slowly came down through the night. Temperature normal at 8am. Flu like symptoms remain - body aches, nausea, headache - for 2 days after. Rash, redness and soreness at injection site.  Normal activity possible on 3/20/2020.   With the first shot, I had some muscle soreness, but nothing like this second injection.
body aches; diarrhea; felt so dizzy she fell and couldn't get up; felt so dizzy she fell and couldn't get up; it felt like she came down with the flu; felt so dizzy she fell and couldn't get up; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (it felt like she came down with the flu), MYALGIA (body aches), DIARRHOEA (diarrhea), DIZZINESS (felt so dizzy she fell and couldn't get up) and FALL (felt so dizzy she fell and couldn't get up) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 14-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (it felt like she came down with the flu) and FALL (felt so dizzy she fell and couldn't get up). On an unknown date, the patient experienced MYALGIA (body aches), DIARRHOEA (diarrhea), DIZZINESS (felt so dizzy she fell and couldn't get up) and MOBILITY DECREASED (felt so dizzy she fell and couldn't get up). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (it felt like she came down with the flu), MYALGIA (body aches), DIARRHOEA (diarrhea), DIZZINESS (felt so dizzy she fell and couldn't get up), FALL (felt so dizzy she fell and couldn't get up) and MOBILITY DECREASED (felt so dizzy she fell and couldn't get up) outcome was unknown. Not Provided
hot flashes; Nausea; vomiting; headaches; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (hot flashes), NAUSEA (Nausea), VOMITING (vomiting) and HEADACHE (headaches) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced HOT FLUSH (hot flashes), NAUSEA (Nausea), VOMITING (vomiting) and HEADACHE (headaches). At the time of the report, HOT FLUSH (hot flashes), NAUSEA (Nausea), VOMITING (vomiting) and HEADACHE (headaches) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-338526 (Patient Link).
TWO STROKES; This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN), 1 total, dose and start therapy date were not reported administered for prophylactic vaccination. Vaccination dose series was 1. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced two strokes. The reporter stated as, "my sister has lost her peripheral vision permanently, because of vaccine. She had two strokes, it has changed her life forever. She can no longer drive". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of two strokes was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20211220048 -covid-19 vaccine ad26.cov2.s- two stroke This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Tinnitus - ringing in my ears.  Developed slowly. Was unsure what it was initially. Seem to have progressively gotten worse.  Much louder and more frequent.
This spontaneous report as received from a certified medical assistant refers to multiple patients of an unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with an unspecified number of doses of improperly stored VARIVAX lot # L017145 with expiration date: 13-MAY-2017 (dose and route of administration were not reported). There were no adverse effects reported. Product quality complaint (PQC) was not involved. This is one several reports received from the same reporter. Additional information has been requested.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Additional Details: Patient reported itching all over her body, we gave patient 2 tablets of Benadryl and 2 bottles of water and monitored patient for an additional hour. Patient reported that her symptoms subsided after taking the Benadryl and she was comfortable leaving the pharmacy. She reported that she will be staying at her mom's house in case she required additional assistance.
severe swelling of the throat and face, only on the right side of my throat although the injection was in the left arm, extreme difficulty swallowing and extreme soreness on the right throat, soreness was comparable to bad strep throat Doctor advised one Allegra and no solid food until the throat is back to a normal size. I currently don't think I can eat sold food due to the swelling. The worst reaction was 11-12 hours after injection and has not gone away but I can swallow now.
Patient received both vaccinations October 24, 2017. She reports that she developed redness and swelling at the site of the injection on the right deltoid. The redness and swelling continued to spread and became painful. Patient was evaluated at urgent care October 26, 2017 and started KEFLEX for treatment of cellulitis to the right arm.
Severe fatigue  after first dose. 1 week after 2nd dose 3/18/21, developed worsening fatigue with 43% blasts on peripheral CBC indicating a transformation from CMML to AML.
lost her voice completely at night; This spontaneous case was reported by a consumer and describes the occurrence of APHONIA (lost her voice completely at night) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced APHONIA (lost her voice completely at night). The patient was treated with PARACETAMOL (TYLENOL) for Adverse reaction, at a dose of 1 dosage form and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Adverse reaction, at a dose of 1 dosage form. At the time of the report, APHONIA (lost her voice completely at night) outcome was unknown.            No concomitant medications reported.
Immediately following vaccine on Saturday, I experienced arm pain that increased over the day and evening. In the evening I was somewhat more fatigued. On Monday, two days after receiving vaccine, I experienced repeated episodes of tinnitus, shakiness, and light-headiness. On Tuesday, the third day following vaccine, I again experienced repeated incidence of tinnitus. On both Monday and Tuesday, the tinnitus was worse when I was upright and better when reclining. On Tuesday I also experienced a flu-like feeling along with loose bowels, nausea, headache, and increased emotional lability.
Immediate burning at site of injection- lump & redness x 2 days. Lethargy beginning evening of injection thru present time-pain bilat.  hips to knee & shoulders to elbow (hips worse area)-continues at present with occas. numbness of hips.
My period ended seven days prior to vaccination.  Approximately 6 hours after vaccination, I began bleeding like I?m having a light period,  and it?s now 11 days later and it?s still happening without stop