chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red, swollen arm larger than size of hand. Patient went to ER and was told by doctor to come back if swelling migrated outside lines drawn on arms. Patient had to go back to ER and then received antibiotics. Patient's arm is feeling less painful today.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information on patients' concurrent conditions and medical history was provided. On an unknown dates, multiple unspecified patients were vaccinated with improperly stored GARDASIL (dose, route, lot # and expiration date were not provided). No adverse effects were reported. This is one of the several reports from the same reporter source. Additional information has been requested.
This case was reported in a literature article and described the occurrence of clinically isolated syndrome in a unk subject who received DTPa-HBV-IPV vaccine. On an unknown date, 1 year after receiving DTPa-HBV-IPV vaccine and Hepatitis B vaccine, the subject developed clinically isolated syndrome. Serious criteria included GSK medically significant. The outcome of clinically isolated syndrome was unknown. It was unknown if the investigator considered the clinically isolated syndrome to be related to DTPa-HPV-IPV vaccine and Hepatitis B vaccine. Additional information received: This case was reported in a literature article and it described the occurrence of a clinically isolated syndrome in a subject of unknown age and gender who had been vaccinated with an unspecified hepatitis B-containing vaccine (manufacturer unknown). No information on the subject's medical history, concurrent medical conditions or concomitant medication was provided. On an unspecified date, from 1999 onwards, the subject received a dose of either PEDIARIX (GlaxoSmithKline; dosage, administration route and site unknown; batch number not provided) or other unspecified hepatitis B-containing vaccine (manufacturer unknown; dosage, administration route and site unknown; batch number not provided). On an unknown date after 1 January 2000, 1 year after receiving the vaccine, the subject developed a clinically isolated syndrome. Treatment was unknown. The outcome of the events was unspecified at the time of reporting. The authors did not comment on any causal relationship between the vaccine and the events. The authors concluded that "Findings from the present study show no long-term association of vaccines with an increased risk of multiple sclerosis and other central nervous system demyelinising diseases. In younger subjects, they observed a short-term increase in risk after vaccination of any type, which suggested that vaccines (like infections) could accelerate the transition from subclinical to overt autoimmunity in subjects with existing disease. The authors found no association between hepatitis B vaccination and an increased risk of multiple sclerosis or other central nervous system demyelinising diseases up to 3 years after vaccination. The results for human papillomavirus vaccine were inconclusive given the small number of cases and the paucity of previous studies on the topic. The findings reconciled the anecdotal clinical reports of a central nervous system demyelinising diseases onset shortly after vaccination with the larger body of epidemiologic literature showing no long-term increased risk of multiple sclerosis or other forms of central nervous system demyelinising diseases following vaccination. The findings do not warrant any change in vaccine policy". This case is 1 of the 9 valid cases reported in the same literature article (see case US2014GSK053625).
pt states the area around injection site is red and swollen about 3 1/2 inches in size and very painful.  Left leg is swollen on the front of the leg about 8" in size.  Pt called PCP and was told to take Benadryl.
Patient reports right-sided rash developed 5-6 hours after immunization. Rash is red & sl. itchy. Patient called 10/23/12 to report rash. Patient reports previously completing Hep B series in '1990's - never had titre done. Advised to get titre drawn & see PCP for evaluation of rash & discussed comfort measures. Advised not to get further Hep B vaccines if titre "positive". 10/29/12 - rash persists. No fever, no malaise, no N & V. Not recovered from rash on torso as of 10/30/12.
had just flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA (non-serious), outcome "recovered", described as "had just flu". Additional information: The patient got the Covid shot (clarified as Pfizer COVID-19 Vaccine) the other day (Sep2023) at the pharmacy. The patient had just flu.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
I was having some minor tingling and ticklishness in hands for a few days post vaccine but today suddenly it was more intense tingling in hands and inner upper and lower arms that turned to also pins and needles, burning, muscle seizing feelings in those areas and also moving to other parts of arms and fingers. It's kind of hard to type. My reflexes are fine, but I'm worried because I did have GBS after the meningitis vaccine when I was 18, and swore I'd never get another vaccine--but I really thought/still think I'll be fine! My feet and legs feel fine. Everything else feels fine. Right now as I type the tops of my arms have dry burning sensations. No one I've talked so seems to think this response is common..... I'm not sure if I should go to urgent care or an ER to get any testing done? Wouldn't they just say to watch it?
Mostly afternoons, feeling of electric charge through body, exhausted, insomnia, chills but no fever, agitated, shaky.  Same symptoms for next 8 days - pulsing, tingling sensation in hands and feet, slight tremor in hand when trying to use computer (can't control mouse) Over next couple months started feeling tingling in soles of feet and hands. Strange sensation in fingers. Hurts to do normal things. Any little bump hurts. Nervous system on overdrive, teeth ached, poor balance, finger nail beds sore
The patient was vaccinated at an outside clinic.  She reports severe HA, tingling sensations in her tongue and face, mild exertional SOB, and fatigue.
The pt's son call to say that his mom experienced itching on both arms and legs and also little red spots that seems to change locations. He said that it started the day after she received the vaccine and is ongoing. she has not taking any medication to treat the AE
headache; being tired; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (headache) and FATIGUE (being tired) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 007C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache) and FATIGUE (being tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, HEADACHE (headache) and FATIGUE (being tired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.   This case was linked to MOD-2021-281445 (Patient Link).
PATIENT REPORTED FEELING SWEATTY,NAUSEATED AND NON RUNNY DIARRHEA AND SHAKEY.
First symptom was controllable shaking over my entire body, then fever, chills, mild headache, fatigue - I could not stay awake the whole next day.
I got shingles 2 different times/ suspected vaccination failure; Shingles; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I got shingles 2 different times/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 23-MAR-2023 This case was reported by patient via interactive digital media. The patient reported that he or she received Shingles vaccine and experienced shingles for two different times.  This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow up was not possible, as no contact details were available.
The gradual onset macular erythematous rash which appears to be a type 4 hypersensitivity reaction which continues to worsen.
Diffuse urticarial and wheezing after vaccine administration. Given BENADRYL, SQ epinephrine, sent to ED, observed and discharged home.
Pt afebrile w/slight elev temp. VSS.  Pt w/moderate to severe reaction to Tdap vaccination.  Requests reaction to be documented.  Pt reports receiving imms on 24 May 2012.  Awoke following morning w/fever and HA 7/10.  Pt took aspirin, reported to work w/mild HA.  Home temp was 101.1F, txt at home w/OTC meds (Motrin, Tylenol), which resolved after 3 days.  Pt left work early on Fri and began to feel weak and dizzy.  Right arm at site of injection was swollen and painful to touch, w/ difficulty lifting arm x 3 days.  Pt asymptomatic for moderate to severe Tdap vaccination rxn at this time.
sore arms; This is Spontaneous report from a contactable Pharmacist via Medical Information Team. This Pharmacist reported similar events for himself and 1 patient. This is a 1st of 2 reports. This male pharmacist reported for himself.  A male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration on 27Jan2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, patient experienced a sore arm. The patient got vaccinated along with wife. The outcome of the event sore arm was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021122438 Same reporter/drug/AE and different patients.
regurgitate food 3 hours later; vomiting; stomach would "churn" about 1 hour after eating; swelling on arm; upset stomach; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (swelling on arm), ABDOMINAL DISCOMFORT (upset stomach), REGURGITATION (regurgitate food 3 hours later), VOMITING (vomiting) and NAUSEA (stomach would "churn" about 1 hour after eating) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M2 (orQ)0A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced PERIPHERAL SWELLING (swelling on arm) and ABDOMINAL DISCOMFORT (upset stomach). On 23-Feb-2021, the patient experienced REGURGITATION (regurgitate food 3 hours later), VOMITING (vomiting) and NAUSEA (stomach would "churn" about 1 hour after eating). The patient was treated with ALUMINIUM HYDROXIDE, MAGNESIUM TRISILICATE, SODIUM ALGINATE (PEPCID [ALUMINIUM HYDROXIDE;MAGNESIUM TRISILICATE;SODIUM ALGINATE]) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (swelling on arm), ABDOMINAL DISCOMFORT (upset stomach), REGURGITATION (regurgitate food 3 hours later), VOMITING (vomiting) and NAUSEA (stomach would "churn" about 1 hour after eating) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by reporter
Rash, fever 102F, cough, no appetite.  Lasted about 3 days.  Cough and rashes continued to come and go for four months.
Generalized hives day of and day after Hep A and VARICELLA vaccine 7/2/2009.
nauseous; threw up; Just feeling sluggish now; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration, administered in right arm on 05Feb2021 13:30 as first dose single for covid-19 immunisation. The patient medical history and concomitant medication were not reported. Patient did not receive any other vaccine in four weeks and any other medications in two weeks. Prior to the vaccination the patient did not have COVID. Patient did not test COVID post vaccination. It was reported that three days after getting the Pfizer vaccine, patient got very nauseous and threw up and just feeling sluggish now on 08Feb2021 04:00 PM. Patient did not receive treatment for the events. The outcome of the events was recovering.   Information on the lot/batch number has been requested.
Five minutes after administering the patient's second COVID-19 vaccine (Moderna), the patient claimed her throat was getting itchy and tight. She described the feeling as what happens to her when she has an allergic reaction to thiomersal - no history of anaphylaxis; anaphylaxis did not occur this time. Patient was asked if she'd like a dose of Benadryl to help with the reaction, she replied yes, and the patient was given 25mg of Benadryl liquid. Patient waited 20 minutes after the Benadryl dose until symptoms went away. She was called later in the day and reported she was feeling much better and had no issues when she left the pharmacy.
Red spot; A little itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red spot) and VACCINATION SITE PRURITUS (A little itchy) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus and Blood pressure high.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red spot) and VACCINATION SITE PRURITUS (A little itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (Red spot) and VACCINATION SITE PRURITUS (A little itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medications reported were oral medication for diabetes and high blood pressure medication .; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient appeared to lose consciousness moments after administration of 2nd vaccine (TWINRIX). RPh and pt's companion supported him and RPh confirmed pulse/breathing. PRh dialed 911, and patient regained consciousness as 911 operator picked up. Pt and companion refused RPh offer to call EMS to the pharmacy location. Pt was provided orange juice and he rested before leaving in friend's car. One day later, pt's friend confirmed he was feeling better and had appt.
red wheal like rash all over body; prob rxn to DTAP;given Prelone PO
Approx 17 hrs after vaccination, headache, body aching, slight dizziness, fatigue, chills, lasting 50 hrs or so. Large, tender red skin at site of reaction; soreness at injection site persisting 3 days after.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 81-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 at 14:30 as dose 5 (booster), single (Lot number: GH9694) at the age of 81 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 11Jan2021 at 12:00 as dose 1, single (Lot number: EL1283), on 01Feb2021 at 13:00 as dose 2, single (Lot number: EL9264), in left arm, on 29Aug2021 at 16:00 as dose 3 (booster), single (Lot number: EW01n) and on 08Mar2022 at 14:30 as dose 4 (booster), single (Lot number: FK9895), in right arm for covid-19 immunisation. The patient's relevant medical history included: "thyroid removed 2009", start date: 2009 (unspecified if ongoing), notes: otherwise good health for age. Concomitant medication(s) included: LEVOXYL; ATENOLOL; SIMVASTATIN, stop date: 08Sep2022; OCUVITE [ASCORBIC ACID;BETACAROTENE;COPPER;TOCOFERSOLAN;ZINC], start date: 24Aug2022; BAUSCH&LOMB, start date: 24Aug2022; MATURE MULTIVITAMINS and Kirkand. Past drug history included: Naproxyn, reaction(s): "Allergies: naproxyn". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.
2 days after shot, 2 days of extreme diarrhea,  awoke with all hands and feet in extreme pain . Left arm felt like a log then the trigger finger returned on left hand. All arthritis swelled with pain.  Right ear started popping as if traveling but still home. Ringing in ear got louder.
Pt recvd 3 doses of Engerix-B JUL91, AUG91, & 2JAN92 & following 3rd devel severe itching & dry skin; Pt was seen by MD & tx Pred; still some itching;
Severe hives-prednisone taper, hydrocortisone cream, persistent eczema.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe
8/19/21 history of developmental delay, DM type 2 not on insulin, HLD, hypothyroidism, venous insufficiency who presents for evaluation of lower extremity edema and dysuria
Received Hepatitis A vaccination on Fri 6/29 am. Began around 3pm Sat. with rash on ankles and extending up legs. Had hives on right ankle and left upper thigh
A non-serious spontaneous report of "29 patients received expired FLUMIST" was received form a physician concerning a 16-year-old female. The patients' medical history included no history of asthma. Concomitant medications were not available. On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008). The reporting physician was concerned regarding efficacy and loss of potency due to the expired product. Sine the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to include all their concomitant medications). There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and events are considered resolved. On 05-Feb-2009, the physician confirmed that there were no adverse events with the medication error.
12 hours after the second COVID vaccine was received I had chills for two hours and then started vomiting.  Only took two Tylenol and water. We had to spend the night because my husband had his second shot the next day. We had a two hour drive home and almost home I started to feel nausea light headed very hot. I passed out in the car so my husband pulled over to assist me. After five or so minutes I decided I could make it home but started vomiting again. I had nothing to eat but did drink sips of Sprite. He wanted to take me to ER but I said no. Worse sickness I?ve had in 72 years
heart palpitations; low grade fever; nausea; This case was reported by a pharmacist via call center representative and described the occurrence of palpitation in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number DK9L5, expiry date 4th September 2021) for prophylaxis.   On 4th May 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 5th May 2019, 1 days after receiving Shingrix, the patient experienced palpitation, low grade fever and nausea. On an unknown date, the outcome of the palpitation, low grade fever and nausea were recovered/resolved.   It was unknown if the reporter considered the palpitation, low grade fever and nausea to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that palpitations developed later in the day than the other symptoms. The patient visited the emergency room for the palpitations, but the physicians were not able to determine a cause. As of 8th May 2019, the patient's symptoms were completely resolved, but it was not certain when exactly the patient's symptoms resolved. The pharmacist stated that she was uncertain about causality, but that the patient seems to think that her symptoms were caused by the Shingrix. The reporter consented to follow up. Emergency visit was Required. The vaccine administration facility was the same as primary reporter.
pt recv vax 19AUG96 & 20AUG96 pt exp gen rash on stomach & back;
Pain in arm, body aches, chills, nausea, dizziness, headache, irritated throat
Patient received 0.5ml for his third dose back in 09/15/2021. Per CDC guideline, he is supposed to receive 0.25ml as his fourth dose today 4/4/2022, however patient was given 0.5ml instead. No immediate complaint or side effect observed at time of administration.
When at home experienced lip and facial tingling and then swelling of the lip and face.  Developed problems with taking a deep breath.  Took Benadryl and in about 45-60 minutes it became easier to breathe.
Wrong Vaccine given. Pediarix was given instead of DTAP alone. This resulted in two IPV doses administered simultaneously and an unnecessary fourth dose of Hepatitis B Vaccine. No immediate side effects.
pt brought to Hospital 1/24/22 with AMS, progressive weakness, FTT; positive COVID test; O2 saturations WNL on RA; sinus tachycardia and HTN; urinary retention and hematuria; cystoscopy with bx done, no malignancy; UTI, treated with ABX; PEG tube placed due to inability to swallow; DNR/DNI; dc'd to home on hospice 2/11/22 (hospice name not in medical record) where she passed away
Given 2015 flu vaccine, within 5 minutes compaint of numbness and tingling down arm into fingers, and up into shoulder area and left side of neck, c/o headache. Treated w/ NSAID, ice, gentle ROM exercise/limited use-rest of left arm.  Has visit several times, report sx gradually decreasing.  Last contact 11/24, some pain in shoulder and slight headaches.