chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 19-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 "0.5mL-10 Pk SD PFS-Luer-Lok" which had a lot number of L001312 and expiration date on 24-FEB-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified dates, the GARDASIL 9 vaccine had five temperature excursions as follows: one of 328 hours with the lowest recorded temperature of 29 F (-1.666666667 Celsius), two of 64 hours with a lowest recorded temperature of 31 F (-0.555555556 Celsius) and a highest recorded temperature was 48 F (8.888888889 Celsius), one of 264 hours with a lowest recorded temperature of 33 F (0.555555556 Celsius) and the other one of 64 hours with a lowest recorded temperature of 34 F (1.111111111 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several cases from the same reporter. Additional information has been requested.
pt recv vax & 13NOV97 pt exp a fever;15NOV97 pt devel several spots, breakthrough chickenpox;
About 12:02pm, C/O dizziness, "feel sick", shaky. Layed down 8-10 min. Felt better, sat up, took sip of pop, and within a minute felt dizzy & sick again. B/P, Pulse Ox, Pulse, Temp all taken and WNL. Around 12:20-25, became increasing non verbal, eyes closed, although responding with head nods and moved hands and feet when asked. Called Paramedics to transport to ER, arriving @ 12:30, Transported Pt. At 12:40pm.
Had the Moderna vaccine 4/16/2021 the following day developed swelling of her left eye, then progressed to left face. Has a fullness feeling in both eyes. No eye redness or drainage. No itching. Denies any difficulty with swallowing. No tongue swelling. No wheezing. No shortness of breath. The last 2 days has been taking Benadryl 25 mg every 6 hours without much relief.   Apart from the facial swelling she feels fine   No other facial care products used.   Has not had any Botox injections or facial fillers injected in the skin.  Patient was seen today for allergic reaction.   Diagnoses and all orders for this visit:   Allergic reaction to vaccine -     predniSONE 20 MG tablet; Take 2 tablets by mouth daily for 3 days. -     cetirizine (ZYRTEC) 10 MG tablet; Take 1 tablet by mouth daily for 7 days.   Swelling of face -     predniSONE 20 MG tablet; Take 2 tablets by mouth daily for 3 days. -     cetirizine (ZYRTEC) 10 MG tablet; Take 1 tablet by mouth daily for 7 days.   See orders, medications and pt instructions   Allergic reaction to the Moderna vaccine localized facial swelling no other systemic symptoms like shortness of breath or wheezing not responded to over-the-counter Benadryl we will give a course of prednisone 40 mg daily for 3 days switch to cetirizine 10 mg daily for 1 week apply cool compresses to face for 15 minutes 3-4 times a day if has any shortness of breath or tongue swelling or difficulty with swallowing or wheezing advised to go to the emergency room
HIBTITER given 25JUN92 mom states t100.0 for 1 days only 25JUN92 & swelling & redness @ inject site, & high pitched screaming for 8 hrs;
Vaccine adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccine adverse reaction) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccine adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccine adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
I began experiencing heart palpitations, extreme intolerance to heat, racing heartrate within days of getting the first vaccine.  I attributed these symptoms to stress at first, as I was moving between states at the time.  The symptoms continued to worsen over time, and I ended up in the hospital with A-fib due to Hyperthyroidism.
Patient had funny feeling in mouth/throat and voice got hoarse. She took a benadryl and waited 30 min. Since she has had many instances in the past she felt fine to wait it out. It did not progress and she left pharmacy feeling fine.
I was exposed and tested positive for Covid-19 from 1/17/22 to 1/19/22.  This was threer months after the third booster shot from Pfizer. On 1/27/22 and 1/28/22 I had two separate incidents of AFIB. On the last date I went to the emergency room.  Subsequent to that I was put on Elquis (5mg), Tambocor (50mg) and Toprol XI (50mg). I have had no AFIB incidents since going on these medications.
Pain in left shoulder where administered, Diagnosed with Encephalopathy. Started having seizures a week later.
Initially the spot of the injection started to swell and itch like a bug bite a week after my vaccine. Then another spot started to form followed by a third spot. They?re warm to the touch, itchy, and slightly raised. I?m on day 3 of having these splotches.
Pt presented to pharmacy on 11-16-13. Said day after vaccination - arm hot to touch/swelling present and bruised. Said vaccination was very painful when she was injected. On 11-16-13 - bruising still present 2 areas about 1x1 inch in diameter about 3 inches apart.
Anesthesia feeling throughout body first day. Second day feet extremely red and burning, extending into calves of both legs. Symptoms got increasingly worse, i.e, feet numbness/tingling that extended up to upper thighs and severe burning in lower back. Temperature normal. Symptoms continued and eventually went into arms.
Information has been received from a registered nurse concerning a male about 6 years old who "years ago" was vaccinated with a complete series of Recombivax HB. The patient did not seroconvert and subsequently developed hepatitis B. The patient required a liver transplant and the patient was hospitalized. At the time of this report, the outcome was unknown. No product quality complaint was involved. The patient's experiences were determined to be other important medical events by the reporter. Additional information has been requested.
hard time breathing, tightness in chest. ears started hurting, nausea , severe abdominal pain, could not swallow water body aches, chill, body aches, voice was hoarse.
Had MMR/Comvax 07/20/2005 ran fever 102-103 for next 5 days. Was symptom free from 07/26 to 08/01 when rash appeared. Macula Papular rash all over body, Erythematous, itchy and induration rash. Rash lasted 4-5 days. Has completely resolved.
MEDI-000610 is a non-serious spontaneous case from a nurse of itching and facial rash concerning a six-year-old male.  The patient has a medical history of behavioral issues and Asperger's Disease.  Concomitant medications include Abilify and Depakote.  The patient received intranasal Flumist on 25 Oct 2007.  Less than 24 hours after administration of Flumist, the patient developed a red facial rash with itching.  The reporter indicated that the patient telephoned the reaction to the clinic, however the patient was not brought to the clinic and was not medically evaluated by the pediatrician.  The reporter indicated that no further information will be available.  Outcome for the events was not reported.  There was no indication of action taken with Flumist.  The reporter did not provide a causality assessment for the adverse events.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
The vial was initially stored in the refrigerator on 13-Mar-2023 and was administered on 14-Apr-2023; No adverse event; Administered expired Moderna Vaccines to patient after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccines to patient after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Mar-2023 and was administered on 14-Apr-2023) and NO ADVERSE EVENT (No adverse event) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 14-Apr-2023, 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 14-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccines to patient after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Mar-2023 and was administered on 14-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccines to patient after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Mar-2023 and was administered on 14-Apr-2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccines to patient after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Mar-2023 and was administered on 14-Apr-2023).    No concomitant medications were provided.  Pharmacist was calling to find out about the stability of expired Moderna vaccines as it was administered to several patients after 30-day use by date.  Dose administered after 30-day use by date or after manufacturer date of expiry.  The individual vial size was 2.5 ml.   The vial was initially stored in the refrigerator on 13-Mar-2023.  The vial did not undergo any temperature excursions.  No treatment medication was provided.  This case contains information for the 2 nd of 11 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721115 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2023: Follow-up received included patient age, gender, initial, date of administration added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721115:Master case US-MODERNATX, INC.-MOD-2023-721147:Patient 2
erythema, induration, warmth to her right deltoid in the area of her injection. No other systemic symptoms.
Client received IMOVAX IM on 3/26/09 on L deltoid. Reports severe pain and knot at injection site and limited range of motion L arm at 9am on 3/27/09. Recommended anti-inflammatory (Ibuprofen) every 4 hours, heat to site encouraged Rom.
Severe fever, severe chills, severe body ache, dizziness, headache. All symptoms started about 12hrs after infection and lasted until 36hrs later. Still experiencing fatigue
Vomiting; Not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: she is in the hospital"; VOMITING (non-serious), outcome "unknown", described as "Vomiting"; MALAISE (non-serious), outcome "unknown", described as "Not feeling well". Clinical course was reported as, the reporter stated, "my fiance (patient) could not beat it and now she is stuck there, and we took the risk of taking your damn vaccine even though she did not need it and now she cannot even speak for herself, and she is in the hospital (further clarification unknown; captured as per verbatim) vomiting, not feeling well, etc. Reporter seriousness for all the events were, unspecified.  QR Comment: This case might be a split however further clarifications were unknown hence, split not made.  The lot number for bnt162b2 was not provided and will be requested during follow up.
A few weeks after 4 month vaccines (pediatric, hib, prevnar, rotateq) had left abducens nerve palsy thought to be viral lasting 1 month.  Then after 6 month vaccines (pediarix, prevnar, rotateq) the left abducens nerve palsy returned a couple later, but resolved more quickly.
fever; tired; feeling achey; This case was reported by a consumer via call center representative and described the occurrence of fever in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 14th June 2019, the patient received the 2nd dose of Shingrix (intramuscular). In June 2019, less than a week after receiving Shingrix, the patient experienced fever, tiredness and pain. On an unknown date, the outcome of the fever, tiredness and pain were recovered/resolved.   It was unknown if the reporter considered the fever, tiredness and pain to be related to Shingrix.  Additional details were provided as follows: The patient had second dose of Shingrix and he experienced fever, feeling tired and achey for about 10 hours after that dose and it resolved.   The reporter did not consent to follow-up. This case has been linked with the case US2019AMR116518, reported by same reporter for same patient.
I?m a breastfeeding mom. My supply dropped from 1500-1600ml a day to 1000ml a day with the first vaccine. After my 2nd dose it dropped again from 1000 ml a day to 800ml a day.
No additional AEs reported; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager referring to a 12-year-old male patient.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 09-SEP-2022, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023; lot #1775827, expiration date: 27-JUN-2024; lot #W009829, expiration date: 19-OCT-2024; lot #U032681, expiration date: 26-OCT-2023; and lot #1780876, expiration date: 09-NOV-2023; however, it was not specified which one was received by the patient) (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (product storage error). There were no additional adverse events (AEs) reported in the patient (no adverse event).  This is one of several reports received from the same reporter.
Information has been received from a registered pharmacist concerning a 67 year old female patient who on 23-JUN-2012 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) subcutaneously in the right arm (lot number not reported). The pharmacist reported that a "couple days ago" the patient showed her a small area at the right arm injection site, that was red, puffy and itchy. The pharmacist confirmed that the patient did not have a rash. BENADRYL oral was given as a treatment for the experience. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Large swollen lump at injection site. Tender to touch and hot. Lasted 7 days after injection the swelling Reduced and pain left.
My left arm and hand were swollen drastically and later in the day, I was sick to my stomach and couldn't keep anything down til later in the day. I had muscle aches so bad that it brought me to tears. My right knee was also swollen to about twice the size of the knee.  My joints in my hands, knees, where leg enters the body, hips and arms going into body plus my shoulders and neck ached.
Felt arm numb, pain shooting through tissue probably following nerve pathway. Redness gone only lasted for a couple of days but numbness continues and it is spreading. Today numbness down to elbow and gradually spreading to pectoral muscles. Today a bit of shortness of breath.
This spontaneous report was received from a medical assistant referring to a male patient of unknown age. No concurrent or historical conditions were reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL and on an unspecified date in June 2013, the patient was vaccinated with the second dose of GARDASIL (lot number and expiration date were not provided) dose, route and anatomical location were unknown. On 30-DEC-2015, the patient was in the physician's office intending to receive his third dose of GARDASIL, but at the time of the report it had not yet been administered (inappropriate schedule of drug administration). No concomitant therapies were provided. No adverse effect reported. No product quality complaint was involved. Additional information has been requested.
Swollen lymph nodes fever 100.6, 500 mg. Pt given treatment of Keflex for 10 days.
After finishing her 15 minute monitoring period she was in car when her throat began to feel tight and eyes began to swell. Returned into clinic- administered epinephrine  0.3mg and diphenhydramine 50mg IM with symptom improvement, called 911, taken via ambulance to ER.
Stabbing ear pain in one ear. I'm not sure if it's related to the vaccine or if I'm just developing an ear infection, but it started a few hours after I received the vaccine.
Post vax, at school clinic, pt developed erythema and induration at MMR II site. She was given po Benadryl and observed for 45 minutes. Back to class about 10:30. Mom states she was called by school nurse about 12:00 and told that pt was complaining of swollen throat and trouble breathing. Went to ER and was Rx'd with oral Benadryl, prednisone and Pepcid X 5 days. No further problems.
This case was reported by a healthcare professional and described the occurrence of extensive swelling of vaccinated limb in a 27-year-old female subject who was vaccinated with Tdap (manufacturer unspecified). The subject's medical history included delivery of baby on 20 July 2012. Concurrent medications included Pain medications. On an unspecified day in July 2012, on or after 20 July 2012, the subject received unspecified dose of Tdap (details unknown, left arm). On an unspecified day in July 2012, less than one week after vaccination with Tdap, the subject experienced extensive swelling of vaccinated limb. The subject reported that she experienced "large area of swelling at injection site" to her doctor's office on 24 July 2012. The subject received the vaccination in the hospital sometime after the birth of her baby. She delivered on 20 July 2012. The exact vaccination date was unknown. At the time of reporting the outcome of the event was unspecified.
Patient presented to clinic 2 days later with red swollen arm, with tenderness, heat, and itching.
pt recv vax & devel an inj site rxn characterized by pain, swelling, redness & a knot which extended to the elbow;these sx resolved p/1wk;
MY SON HAD A BOWEL MOVEMENT 2 IN 30 MINS AND THEN STARTED SCRATCHING PROFUSELY. HE'S NON VERBAL SO I DID A PHYSICAL CHECK & NOTICED HUGE BUMPS ON HIS BACK, ARMS & LEGS THAT WERE VERY HOT TO THE TOUCH. RESEMBLING HIVES. CONTACTED THE DR. OFFICE AND ANSWERING SERVICE NURSE TOLD ME TO ADMINISTER BENADRYL EVERY 2 HRS AND SEE THE DR. THE NEXT DAY.
HEART RATE OF 111-121; BLOOD PRESSURE OF 155/81; O2 SATURATION OF 99 %; CHILLS; HEADACHE; FEVER SPIKED 103.8; This spontaneous report received from a consumer concerned a 29 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced heart rate of 111-121. On 09-APR-2021, the subject experienced blood pressure of 155/81. On 09-APR-2021, the subject experienced o2 saturation of 99 %. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced fever spiked 103.8. Laboratory data included: Blood pressure (NR: not provided) 155/81 (unit not provided), 129/78 (unit not provided), Body temperature (NR: not provided) 101.8 to 102.8 (unit not provided), 103.8 (unit not provided), Heart rate (NR: not provided) 111-121 (unit not provided), and O2 saturation (NR: not provided) 99 %. On 09-APR-2021 21:00, treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever spiked 103.8, and the outcome of chills, headache, heart rate of 111-121, blood pressure of 155/81 and o2 saturation of 99 % was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
immediately after vaccine i received a headache and face from eye socket to chin felt as if my face was swelling with a numb feeling. Strong sensation continued with headache. Left calf started swelling early in daytime and was happening for several days. Went to the hospital where I work in Feb/March. Went to new doc and no diagnosis. Receive Ajovy because of headache
I started to see the neurologist so they took me of the prednisone that I was on due to the reaction from the first dose. and started to They did a large fiber nerve test and said it wasn't that and they did a general test and said my nerve responses were off. And the test came back that I have small fiber neuropathy and the pain seems to be getting better. They checked for different mineral levels and autoimmune diseases and they came back normal. She said that she's seen this with other patients where it's strong at the beginning after getting the vaccine and starts to dissipate over time. They put me on different kinds of medicine --Pregabalin. Gabapentin only on this for 2 days. .
11/4/22 Deep pressure, mid chest discomfort, radiating to jaw lasting several hours and worse with reclining, improved when leaning forward, not exertional, did not abate. Took 4 Tums with improvement of symptoms. 11/5/22 Presented to ER. EKG showed no acute injury. First troponin elevated. Differential: non-STEMI vs myocarditis. 11/6/22 Left Heart Catheterization showed normal coronary arteries 11/7/22 Cardiac MRI showed myocarditis. Colchicine added to medications.
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On multiple unspecified dates in 2016 the patients were administered improperly stored GARDASIL 9 (lot # L020015, expiration date 16-AUG-2017) (dosage, strength and route unknown) following a temperature excursion on 07-JAN-2016 (temperature 32.2 degree F, time frame 40 minutes). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.