chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4/13: vaccine - Pfizer  4/14-4/15: arm sore 4/17: wake up in morning with calf twitching for prolonged period, went back to sleep  4/17-4/19: muscles in my body continue to twitch, mainly legs and arms 4/19: right eye begins to twitch 4/22: stopped drinking coffee and alcohol, began drinking much more water than normal to hydrate 4/27: drank alcohol for first time since I stopped  Twitching has not subsided or become better or worse in this previous timeframes  4/28: right eye didnt twitch that much during the day 4/28: playing video games and getting frustrated caused the my eye and hand to twitch 4/29: had coffee for first time, eye twitch was worse than normal In the late afternoon (last time drinking coffee until today 5/26) 4/29: abs twitched for first time 5/1: left eye begins twitching  4/30-5/1: tingling in right hand pinky finger like hand is falling asleep 5/1-5/2: went to bar 5/3: sneezed and both eyes began twitching (I had sneezed before and this has happened, this is the first note I had written)  5/4: I went to my primary care doctor and shared these notes. Stopped taking notes since. Doctor had me take a blood test (see below) as well as referred to a neurologist for an EMG.  5/4-5/26: I've since been on some extra vitamins (b12 and d, as my b12 was on the low side but not outside the recommended range and d was also low) and have not seen any decrease or increase in symptoms. Some days are better than others. My right eye has stopped twitching, but I continue to have it throughout my body in my arms, back, legs, feet, left eye. I've been on an average diet since the beginning of march.
Headache, Myalgia, NauseaVomiting, fatigue sore arm chills 5 days
Narrative: Patient admitted to hospital on 11/7/2021 and reported HA, numbness of right side of face and perioral paresthesia and mild dysphagia. Diagnosed with Bell's Palsy. Unknown exact date of vaccine administration or other vaccine details.
Breakthrough COVID infection Symptoms began 8/23 and patient tested positive on 8/25
Pregnant; headache; nausea; Fatigue; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 32-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy, Penicillin allergy and Drug allergy (Ceclor).    On 21-Dec-2020 at 12:21 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 20-Aug-2020 and the estimated date of delivery was 27-May-2021. On 21-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  seventeenth week of the pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Sep-2020, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's estimated date of conception was 04-Sep-2020. The patient had 2 previous pregnancies including a full term birth on 22-Aug-2017 and spontaneous abortion on 07-Mar-2020.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: TCR received. call received and provided email id; Sender's Comments: This is a case of product exposure during pregnancy with associated AEs for this 32-year-old female. Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
full body itching on and off, sometimes hives,  pain in upper abdomen on and off
very itchy throat; can't sleep; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 15Jan2021 as a single dose for COVID-19 immunization. Medical history included "underlying conditions." Concomitant medications were not reported. The patient reported after she received the vaccine her throat was very itchy and no pain on an unspecified date. It bothered her so much that she couldn't even sleep. She wanted to know if this was a normal side effect to be very itchy in the throat. She had called out of work since Monday (18Jan2021) and did not want to go to the emergency room where people had COVID. She did not want to be around people. The outcomes of the events were unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
10/28/02 pt came in for her second hep B shot, we had her lying down due to the fact she passed out last time. Gave her the shot then walked back to lab to get a sucker for her and had her sit up, she lost all color in face then stiffened up arms and clenched her fists and her eyes rolled back. MD was called into the room and I took pulse ox and got 100% on oxygen and 48 pulse B/P was 82/50. Having pt lying down for 20 min. then I will recheck bp and pulse. B/P was 100/50 and pulse ox was 100% oxygen and 90 on her pulse. She was well enough to leave after the 20 min.
Headache, began almost immediately. Lasted 3 -4 hours Pain in arm-began immediately, still painful at this time Swelling in arm at injection site- within 15 minutes of injection, still mildly swollen(small bump) Redness at injection site - with 10 minutes - still pink at this time
no symptoms reported; a 2 month of patient received one dsoe of gardasil 9; This spontaneous report as received from office manager refers to a 9-week-old (also reported as 2 month old) male patient.   The patient's pertinent medical history, concurrent condition and drug reactions/allergies were not reported. On 09-DEC-2019, the 2 month old patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot# expiry date, strength, dosage information, route of administration and anatomical locations were unknown) for prophylaxis (product administered to patient of inappropriate age).         The outcome of product administered to patient of inappropriate age and no adverse event is unknown. No symptoms reported. No additional AE information. No product quality complaint (PQC).
difficulty breathing; she was not ale to breathe; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (difficulty breathing; she was not ale to breathe) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced DYSPNOEA (difficulty breathing; she was not ale to breathe). The patient was treated with Physical therapy (Given oxygen) for Dyspnoea. At the time of the report, DYSPNOEA (difficulty breathing; she was not ale to breathe) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medication include Benadryl. (diphenhydramine HCL)
On 14-May-2021, received 1st dose by Moderna. On 19-Jun-2021, received 2nd dose by Moderna.; Vaccination site pain; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness), VACCINATION SITE PAIN (Vaccination site pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 14-May-2021, received 1st dose by Moderna. On 19-Jun-2021, received 2nd dose by Moderna.) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jun-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 started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 14-May-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). In May 2021, the patient experienced FATIGUE (Tiredness). On 19-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 14-May-2021, received 1st dose by Moderna. On 19-Jun-2021, received 2nd dose by Moderna.). At the time of the report, FATIGUE (Tiredness), VACCINATION SITE PAIN (Vaccination site pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 14-May-2021, received 1st dose by Moderna. On 19-Jun-2021, received 2nd dose by Moderna.) outcome was unknown.            No concomitant medications were reported.   In May 2021, the patient experienced first vaccinations had sore arm and felt tired. On 14-May-2021, the patient experienced first vaccinations had sore arm and felt tired. On 16-Nov-2021, the patient experienced felt like did not get full dosage of humira injection. Moderna was also considered suspect.   It was unknown if patient was enrolled in a COVID-19 vaccine trial.   No treatment medication was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Vaccine last wed 10/20/99, below site, itchy welt, l/arm, bright red.  After 11am became warm to touch.  Itching on 10/24 and redness continuing on 10/25.  Reaction to TD
pt recvd vax felt warm & mom gave tempra; 730PM dad reported pt started staring-didn't respond to naem, then started shaking all over and drew arms up; mom called it a grand mal sz which lasted x 10mins; taken to ER had another sz;
Fainting, patient says she was very hot about 10 minutes after shot. She told me that she had fainted before after the fact. She was given a cold compress and watched her for about 15 minutes. She called at 2:45 pm pt ok.
The next day after the second dose I experienced severe fatigue. About 48 hours after the vaccine I started with muscle aches mainly in across the back and shoulder area. Also noted there was a rash on both legs (no itching and no pain, no bleeding) within a week of vaccination. That is when I decided to see dermatologist who said it would disappear in about 2 weeks.  I am not getting any new rashes so far. As a precaution I took regular Tylenol 1-2 hours after second dose to minimize any side effects.  Injection site was red and sore (more than first dose) for about 2 days.
Information has received from a healthcare worker referring to patient of unknown age and gender. Information regarding concurrent conditions and medical history was not provided. On 23-MAR-2015 the patient was vaccinated with a dose of improperly stored VARIVAX (Merck), 0.5 ml, subcutaneously (lot # and application site were not reported). Concomitant therapy was not reported. No adverse effects reported. Additional information has been requested.
Get the shot,  got shingles, horrible/ Suspected vaccination Failure; Shingles in eye, almost lost it, every week in eye hospital, i almost lost my eye; 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 ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and ophthalmic herpes zoster were unknown.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine.     Additional Information: GSK receipt date: 19-FEB-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient got the shot and still got shingles inside on one of his/her eye. The patient almost lost eye and for three month every week patient was in the eye hospital and was horrible. 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 could not be possible as no contact details were available.
Rash on arm turned in to hives on body. Extremely itchy and hot. Shortness of breath developed over the next two days.  Received my shot at a hospital so they took me over to the ER for observation. Gave me Benedryl and was monitored for approximately 2 hours.
pt reported extreme sore arm, hege whelp, chills, feeling lethargic and aching all over his body starting the next day after vaccination. He also reported mild fever with a highest temp of 99.7F on 9/5/20. The fever and "flu-like" symtoms has now subside on the 2nd day and continues to have sore on arm and whelp on arm. The whelp on arm has also reduced in size on the second day.
Patient reported having a fungal infection and missed doses due to COVID vaccine, no add'l information noted. Patient does not consent to being contacted. Reporter doesn't consent for manufacturer follow-up.
The patient is younger that the EUA approved age of 18.  Patient is 17 years old and should not have received the vaccine.
On the 8th day post injection I developed a erythematous rash ,baseball sized , at the injection site.  There was increase in local temp with severe pruritis and induration. The rash gradually spread and later diminished in size.  There is still erythema and occasional pruritis and a small area of induration which is tender on palpation approximately 3 finger widths proximal to my elbow on the lateral left arm. No other systemic manifestations are noted.
She was given a Pfizer booster but she had the Moderna series (2 shots).
PATIENT HAD INFLAMMATION ABOUT THE SIZE OF AN ORANGE JUST BELOW THE INJECTION SITE.
Started feeling bad and had fever of 101.3 on Friday.  Also had rash the size of a hand across my stomach around belly button.  Felt sick to my stomach also.  Continued to run a fever all weekend, going up and down from 99.0 to 103.7.  Rash increased in size and extended around my left side.  It developed small blisters.  Saw Dr. on Monday.  Fever was down due to taking  fever reducer but it went up again that night. Had severe chills and a fever of 103 Monday night.  Fever has been going up and down today (Tues) and rash is red and warm.
Patient had prolonged crying and screaming for > 2 hours. Later had an episode of unresponsiveness associated with staring, rolling up of eyes, pallor and fever. Was admitted for observation.
Pt passed out 2 minutes after receiving flu shot. She was out for 20-30 seconds. She woke up and was fine without any problems.
I developed a fever of 102.6, chills, fatigue, vomiting five times, and headache. I started to not feel well around 4 pm the 11th of April. I threw up three times at 10 pm and twice at midnight. I took 4 extra strength tylenol at 7 am the next day. Which broke my fever and lessened my headache. I woke up feeling fine the 13th.
pt recv vax 7NOV96 & relates swelling, redness, gen fever & aching 10NOV96 appeared @ clinic 13NOV96 arm swollen, erythema 10cm by 8cm;pt related shot was given high in deltoid muscle;tx w/heat, elevation, heat;do not use arm for lifting;
Nausea  Vomiting  Headache  Fever 103.4 Muscle pain Loss of mobility due to loss of muscle strength in legs (this was very scary) Very tired
This spontaneous report as received from a nurse refers to a approximately 10 patients of unknown age and gender. Since 08-AUG-2014 the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (dose, route of administration and indication were not reported). The temperature excursion for (Oka/Merck) VARIVAX was found to be supported excursion with in-house stability data. No adverse effect reported. Additional information has been requested.
Fever, chills, full body aches, difficulty walking due to joint pain, lethargy, diarrhea, nausea
This spontaneous report was received from a nurse and refers to a 10 week old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 19-SEP-2017, the patient was vaccinated with improperly stored vaccines, RECOMBIVAX HB (dosing details not reported) (lot # N006321, expiry date: 08-NOV-2019) and ROTATEQ (dosing details not reported) (lot # M042170, expiry date: 22-JUN-2018, orally) for prophylaxis. No adverse effects were reported. The administered vaccines underwent a temperature excursion from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011.
A one to two min episode of stiffening of the extremities assoc w/shaking, no LOC or rolling eyes; appeared conscious & visually followed mom w/eyes; exam negative child admitted for observation, appeared well, was d/c;
fever onset late am 15JAN93 t100.4 given APAP; fever back up to 100.8 @ 6AM very pale, fussy, not able to console, not eating; fever up to 102-children's Advil given; very fussy, shot site extremely tender;
Patient is age 3 years 11 months.  Patient was given covid vaccine pfizer intended for age group 5-11 years of age. No adverse outcomes known.
No reaction at site but flu like symptoms no energy dizziness, fever, nausea, disorientation.
Started getting Nauseated at 3:45 and took Promethazine 25mg. Started throwing up at 4:30 PM and continued throughout the night.  Called my Primary Care Doctor the next morning and was given Zofran 4mg.  It did not help and I continued throwing up after drinking water.  I was bombarded with everything stinking.  I could not eat and cooking smells were nauseating me.  On Saturday, 04/24/2021 I could not even drink water and called EMS. I was hydrated via IV and test were done and I had a mild bladder infection and given IV antibiotic and a 5 day course of Tiadylt ER 300 mg taken twice a day.  I continued taking nausea meds which were helping and vomiting ceased but everything still tasted and smelled nasty. (Question
High fever after 24 hours (103.8). Blotchy skin on hands and feet. Shakes after fever.
Pins & Needles headache from the time of vaccine to current, almost feels like a concussion, teeth feel numb, body aches all over and muscular pain, feeling brain fog
Mom called and states (R) leg still red and knotted up. Had to get Imm. on 3-9-17. Informed to see PCP.
Tinnitus in both ears almost immediately after first shot, worsened almost immediately after the second one. I still have it today and it's not getting any better.
ActHIB powder from the Pentacel diluted with sterile water, no AE; Initial information received on 06-Mar-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a two month old patient who received 0.5 ml of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] via intramuscular route in the left thigh on 05-Mar-2020 for prophylactic vaccination, where ActHIB powder from the Pentacel was diluted with sterile water. The ActHIB was from lot UJ127AAA, Exp. Date 03-Nov-2020, and DTaP/IPV lot U6469AA, Exp. Date 03-Nov-2020 (product preparation issue).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE for prophylactic vaccination on 05-Mar-2020.  It was an actual medication error case due to inappropriate reconstitution technique.  At the time of reporting, no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or  contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from a woman at a physician's office concerning an 8 year old female patient who on 08/12/1996 was vaccinated subcutaneously with a first dose of varicella virus vaccine live.  Concomitant therapy administered on 08/12/1996 included a subcutaneous first dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  On 04/08/2004 the patient developed chickenpox.  It was reported that the patient recovered.  No additional information is expected.
Pt developed localized erythema with 2 small urticarial lesions within 5 mins of receiving vax. She developed 2 additional lesions on back 15 minutes post vax. She was given 20mg Benadryl.
This spontaneous report was received from a healthcare professional refers to an unspecified number of patients of unknown age and gender. The patients' medical history was not reported. On an unknown dates, the patients were vaccinated with the unspecified doses of GARDASIL (lot #, expiration date, dose, route and site of administration were not reported). Patient just didn't show when they should to be vaccinated. There were no concomitant medications provided. No adverse symptoms were reported. There was not product quality issue involved. On 01-SEP-2015, a phone call was placed to the physician who was unavailable. The phone call was transferred to the original reporter, the medical assistant who was unable to share any lot numbers, dates of vaccination or patient identities concerning to her original phone call. The medical assistant stated that the office did not like GARDASIL because most of the kids who had received it passed out (MARRS# 1507USA012048) or fainted (MARRS# 1509USA001926) following vaccination. The medical assistant did not have any specific patient or lot number concerning this statement. This is one of several reports from the same reporter. Additional information has been requested.
side effects; 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 VACCINATION COMPLICATION (side effects) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.            No treatment information was provided. No concomitant medication was provided.