chrisvoncsefalvay/vaers-outcomes huggingface dataset:
#1 series 12/24/02: On 12/26/02 piercing crying as if in severe pain; started focal seizures of hands. #2 series 4/17/03: More focal seizure, screaming, GERD, eyes rolling back. #3 Series 5/21/03: All the above only worse. Realized these were seizures. Went to ER; Grand mal 8/03 and stopped breathing 30 seconds. The hospital records received on 2/4/04 state infantile spasms, GERD, developmental delay and respiratory arrest.
cellulitis of upper arm progressing over 2 days from shoulder to elbow and went to physician on friday october 1st where she was prescribed an antibiotic.  the prescriber contacted us to make us aware of the event.  no other side effects and normal behavior reported by physician and parent.
12/29/21 pt had a positive COVID test ordered by Agency; per death certificate pt died at his home with the manner of death being natural and the causes being:  cardiopulmonary arrest, respiratory failure, COVID
Headache, Severe Injection Site Pain and Swelling, 99.5 degree fever, muscle aches, fatigue.   Treatment- Over the counter allergy medication, and pain meds, ice pack and heating pack. Not much relief at all.
PATIENT WAS ADMINISTERED FLU VACCINE IN LEFT ARM.  COMPLAINTS OF PAIN THAT IS RADIATING ABOVE ARM AND INTO NECK.  SHE HAS GOOD RANGE OF MOTION, BUT THE PAIN IS CONSTANT. DENIES ANY NUMBNESS OR TINGLING.
Fever over 102 degrees for 48 hours, body aches, feeling of bones being crushed, headache, extreme fatigue. After 48 hours, fatigue, headache, sore throat, congestion, dizziness, low grade fever above 100.
A healthcare professional reported that a male received an injection of Pnu-Imune 23 in 09/00. One day post-vaccination, the patient developed a fever and an "itchy rash on the back of his hands like a blister that pops and moves to different parts of the hand". A physician described this as a "pemphigoid rash". He was also found to have an increased LDL (lactic dehydrogenase level).
Partial loss of hearing in left ear.  Initially assumed to be allergies.  Following second vaccine shot on 4/7/2021 (Lot #ER8737) conditioned worsened.  Additionally following second vaccine dose, tinnitus in left ear became much worse.
Received 2nd dose of COVID-19 vaccine and developed symptoms within 12 hours causing me unable to go to work the next day. Received vaccine 1/21/21 7:45 a.m., missed work 1/22/21. Felt very sick-fever, chills, body aches, headache, vomiting after receiving  vaccine.
No adverse events at the moment- however the inmate was inadvertently laid in as needing his first dose, however he received his first dose on 7/20/21- his card looked like he got it on 7/2/21 as the 0 was not legible.  He received the dose today too soon.  No complaints at present time
Skin flushing, followed about one hour later by mild sweating,  Shortly after this had new onset vertigo, nystagmus, From 7pm until 2am severe nausea, vomiting.  Ataxia with mobility when trying to stand, ambulate, or crawl.  Was evaluated, treated, and observed for several hours in Hospital ED. Was in bigeminy at one time.  Treatment with IV meds and po meds.  Resolved after 3 days.
MODERNA COVID-19 Vaccine EUA  DELAYED SKIN REACTION - 6 days after receiving first shot . Redness on the arm directly below injection site, mild swelling, itching and warm to the touch.  The size of red spot is 4x3 inches.  This only appeared 6 days after vaccination.
Information has been received from a licensed practical nurse concerning a 60 day old male patient who on 23-JUN-2010 was vaccinated orally with a dose of ROTATEQ (lot# not reported). On 23-JUN-2010, immediately after administration, the patient vomited and he may have received an incomplete dose of ROTATEQ. At the time of this report, the patient had fully recovered. Additional information has been requested.
Patient has been experiencing productive cough, cloudy white mucus present. Tried DAYQUIL, which suppressed cough, but patient was unable to cough mucus up after taking. Stopped DAYQUIL and patient was able to cough mucus up again. Also tried VICK'S vapor rub and an OTC nasal spray, but is still experiencing the cough almost 3 weeks later.
Constipation constant and ongoing; Booster dose was administered on 18Sep2021; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received bnt162b2 (BNT162B2), administered in right arm, administration date 18Sep2021 (Lot number: 301308A) at the age of 58 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Food allergy" (unspecified if ongoing), notes: Known allergies: Mint. Concomitant medications were not reported. Other vaccines received within four weeks of vaccination included: FLU taken for Immunisation, start date: 11Sep2021, stop date: 11Sep2021. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot number: EN5318, Anatomical location: Right arm), administration date: 05Feb2021, when the patient was 57 years old, and Bnt162b2 (DOSE 1, SINGLE, Lot number: EL3302, Anatomical location: Right arm), administration date: 15Jan2021, when the patient was 57 years old, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (non-serious) with onset 18Sep2021, outcome "unknown", described as "Booster dose was administered on 18Sep2021"; IMMUNISATION (non-serious) with onset 18Sep2021, outcome "unknown", described as "Dose received: 3"; CONSTIPATION (non-serious) with onset 23Sep2021, outcome "not recovered", described as "Constipation constant and ongoing". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of constipation. Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Treatment included laxative for constipation. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
patients received the vaccines after the beyond use date/10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13DEC2022-17DEC2022; No Adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received the vaccines after the beyond use date/10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13DEC2022-17DEC2022) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 024H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received the vaccines after the beyond use date/10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13DEC2022-17DEC2022) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients received the vaccines after the beyond use date/10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13DEC2022-17DEC2022) and NO ADVERSE EVENT (No Adverse event) outcome was unknown. Not Provided      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 EXPIRED PRODUCT ADMINISTERED (patients received the vaccines after the beyond use date/10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13DEC2022-17DEC2022).    Concomitant medications were not reported.  They reported their beyond use date was on 12Dec2022 but they discovered it on 17Dec2022. This case contains information for the patient 7 out of 10 adult patients. Treatment medications were not reported.
Lethargic -3 weeks Heart palpitations- 2 days Chills - 4 days  Left arm limited mobility- 7 days Headache- 7 days  Metallic taste in mouth - 3 weeks
high pitched crying; shaking hard when cries; t102; vomiting; swelling in legs; swelling in face around mouth & cheeks; APAP given;
Dizzy; nauseous; This is a spontaneous report from a contactable consumer (patient).    A 72-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: CL8982, Expiration date: unknown) via an unspecified route of administration, administered in Deltoid Left on 29Jan2021 (at the age of 72-year-old) as first dose single dose for covid-19 immunisation. The patient Medical history and concomitant medications were not reported. On 01Feb2021 the patient experienced dizzy, nauseous. patient went for his vaccine shot on Friday, and yesterday morning, he woke up, got out of bed and was dizzy and a little nauseous, he had the same experience, not as bad as yesterday. the outcome of the event dizzy recovering, while nauseous outcome was unknown.    Follow-up attempts are completed. No further information is expected.
pt recv vax & w/in 24hr of vax pt devel welt @ the inj site, diarrhea & flu like sx;this is 1 of 2 pt from this site to have an adverse exp p/vax;
Irritable since Shots given 10-12-2006.  Crying more than usual; decreased appetite, drooling alot, abd gets tight, face gets red then starts to cry.
A report from Wyeth Labs (8-99214-011A, "A parent reported that his 4 month old daughtrer received Rota shield,Hib-Titer,DTaP (manufacturer unknown) (Acel-Imune,Wyeth), Hepatitis B (manufacturer unknown) and IPV (Adventis Pasteur SA) vaccines and subsequently developed constipation." From follow-up correspondence received on 05/15/01, it was reported that the patient recovered from this experience. "I vaguely remember this patient, since I left the group this patient belongs. As far as I can recall, He/she was fine not too long after. No further information available regarding this patient or this case. "ER 05/10/01' This case is closed
Patient came into the pharmacy after the vaccine was administered with a large erythema on her left arm. Pt purchased hydrocortisone cream.
Susspected Vaccination failure; shingles; pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got both the Shingles shots last year but at the time of reporting, the patient had the worst shingles out break and the patient was in so much pain. The patient did not wish them on anybody. This case was considered as suspected vaccination failure, since the details regarding the laboratory confirmation for shingles were not provided.
Mild fever first day.  Second Day I had two inflamed lymphnodes under my armpit and near my neck with medium to decent pain.
COULDN'T STOP MOVING BECAUSE OF SHAKING; DISCOMFORT; DIZZINESS; LOSS OF APPETITE; FREEZING; BAD CHILLS; ARM PAIN; HEADACHE; FEVER; MUSCLES WERE HURTING AND MUSCLE ACHES; This spontaneous report received from a patient via a company representative concerned an 18 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up request batch / lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced couldn't stop moving because of shaking, discomfort, dizziness, loss of appetite, bad chills, arm pain, freezing, headache, fever, and muscles were hurting and muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm pain, fever, and muscles were hurting and muscle aches, and the outcome of freezing, couldn't stop moving because of shaking, discomfort, dizziness, headache, loss of appetite and bad chills was not reported. This report was non-serious.   Additional information was received on 25-Mar-2021.The following information was updated and incorporated into the case narrative : Reporter details(company representative), events (Arm Pain, Dizziness, Bad Chills, Headache, Loss of Appetite, Muscle Aches, and Fever) added.
7/27/12 Patient came to pharmacy stating she had a reaction to ZOSTAVAX injection which consisted of redness and swelling at injection site. Approximate diameter was 4 inches. Pt had seen MD who advised ice packs & CLARITIN, Vaccine administered 7/24/12.
This case was reported by pharmacist via call center representative and described the occurrence of shingles in a 75-year-old female patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020). On 7th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, 61 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the shingles and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information was received as follows: The patient's doctor reached out to the pharmacy to report patient's adverse event. This case was associated with product complaint, as the patient felt that the lot was defective. The patient received SHINGRIX on left deltoid. The patient got a full blown case of shingles.
Information has been received from a pharmacist referring to a patient of unknown age and gender. There was no pertinent medical history, drug allergies or concomitant medications reported. On 03-OCT-2015 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # J013138; expired date 17-JAN-2015) (dose and route were not reported). No adverse effects reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
tasted very bad and appeared oily; not able to swallow full dose due to spitting out; not able to swallow full dose due to spitting out; This non-serious case was reported by a nurse via sales rep and described the occurrence of regurgitation of medication in a 3-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number SKBYL9YN) for prophylaxis. This case was associated with a product complaint.   On 13-APR-2023, the patient received Rotarix lyophilized formulation. On 13-APR-2023, less than a day after receiving Rotarix lyophilized formulation, the patient experienced regurgitation of medication (Verbatim: not able to swallow full dose due to spitting out) and accidental underdose (Verbatim: not able to swallow full dose due to spitting out). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: tasted very bad and appeared oily). The outcome of the regurgitation of medication was not reported and the outcome of the accidental underdose and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.  It was unknown if the company considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-APR-2023 The patient was not able to swallow full dose of Rotarix liquid due to spitting out. It was observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth. The patient did not receive a second dose.  The patient made face as if it tasted too bad to swallow. The patient previously had used Rotarix vial presentation and had no problems. The reporter agreed to follow up from GlaxoSmithKline.  The patient was not able to swallow full dose of Rotarix liquid due to spitting out and observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth , which led to accidental underdose and pharmaceutical product complaint. This was 1 of 12 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR059644:Same reporter US-GSK-US2023AMR059645:Same reporter US-GSK-US2023AMR059808:Same reporter US-GSK-US2023AMR059807:Same reporter US-GSK-US2023AMR060400:Same reporter US-GSK-US2023AMR060497:Same reporter US-GSK-US2023AMR060491:Same reporter US-GSK-US2023AMR060476:Same reporter US-GSK-US2023AMR060463:Same reporter US-GSK-US2023AMR060460:Same reporter US-GSK-US2023AMR060400:Same reporter US-GSK-US2023AMR060497:Same reporter US-GSK-US2023AMR060516:Same reporter
Fever, chills, headache, body aches, nausea, itching and re splotches on chest, face, arms, upper back. Took Benedryl and Aleve after onset of symptoms. Lasted 3 days, fine now.
Swelling, aching arm. Lethargic (slept all day).  Slight fever, but that passed.
Patient's eyes rolled back 3-4 minutes after injection and lost consciousness. Patient was seen by  Nurse practitioner after the event and was monitored via 02 saturations and heart rate. Patient observed for 20-30 minutes after event and was released when the patient seemed to totally recovered.
DAPTACEL and VARIVAX vaccines given into (L) leg. 8 x 11 cm area of erythema and warmth on anterior (L) thigh. Septra.
Fever, eyes hurt, legs feels "weird when walking", rash started on face, rash on stomach, neck back.
Non tender, moveable, firm 7 cm area at site of Pediarix vaccine in left thigh  Symptomatic treatment
Severe pain in arm/shoulder where shot was administered. Began around 3:30 pm on same date and pain was minimal at start but continued to become more severe up until around midnight where pain was VERY servere.
swelling of lips and face, fever 103 F, shakes.  No SOB, itching, rash or hives. Treatment: 4 Benadryl 25mg tabs.  Symptoms improved in the next few hours, completely resolved after 48 hours
pt recvd shot in AM went home napped for awhile; got up to do some dishes found self on the floor; had breast lump removed last Thursday 20OCT94;
Dose administered after 12 hours of vial puncture.; Dose administered after being more than 24 hours at room temperature; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours of vial puncture.) and PRODUCT STORAGE ERROR (Dose administered after being more than 24 hours at room temperature) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-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 EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours of vial puncture.) and PRODUCT STORAGE ERROR (Dose administered after being more than 24 hours at room temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours of vial puncture.) and PRODUCT STORAGE ERROR (Dose administered after being more than 24 hours at room temperature) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications reported. No concomitant medications reported.
Left eye started twitching a day or two after the first dose. Seems to correspond with headache, issues thinking, reading, etc. My left eye has been twitching every day since the first dose. I have a headache bad headache every day, and the headache seems to be worse on the left side of my head since the vaccine (although it's all over) Also, I have post covid syndrome, so I have a lot of other symptoms (that I am seeing specialists to diagnose and fix), and the vaccine seemed to make them all much worse after the first dose.
Extremely lethargic the first day second day muscle pain. Still really tired until the Sunday after.
Patient came in with younger brother. Patient received brothers shots-Pediatric dose of FLUZONE & Hepatitis A. We (staff) checked with Dr. to make sure everything was okay. Dr. came in to talk with mother to let her know the extra dose of Hepatitis A will not harm her. She may continue to get the other pediatric dose of FLUZONE, in order for her to get the full dose. Mom was okay with this. Patient then received her kindergarten shots and another dose of FLUZONE (PROQUAD, QUADRACEL, pediatric FLUZONE).
Woke up with a fever of 99.4. When I checked on her in the evening she was dead.
First 12 hours were fine just slight soreness in right arm. Got really tired 10 PM and got chills, went to bed as I tried to get out of bed next morning could hardly walk from very bad knee and hip pain, took acetaminophen and reviewed side effects on paper.. noticed extreme heat in injection site and noticed a swollen red mark about 3.5 inches diameter. Also had headache. Spent most of day laying down and taking acetaminophen, next day about 48 hours from injection time I am much better, except injection site is still red and swollen and a dizzy headache.
Got the vaccine.  2 weeks later went traveling (June 18-30, 2022) Returned home 06/30/2022 Started with a headache  & scratchy throat  07/05/2022.   Tested positive 07/06/2022 about 10 AM.  Got prescription for Paxlovid and started first dose on 07/06/2022 Finished Paxlovid 07/11/2022 Tested negative 07/10/2022
pt exp hives/rash over face around nostrils & eye & neck which later spread to inner thigh & over stomach;consulted PMD who told to take DPh & d/c rabies vax;pt reports rash on face has cleared on face/neck but still apparent by 9OCT98;