chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extremely watery bowel movements; Very unpleasant smell when belches; Arm pain; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Extremely watery bowel movements), ERUCTATION (Very unpleasant smell when belches), PAIN IN EXTREMITY (Arm pain), PYREXIA (Fever) and CHILLS (Chills) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), PYREXIA (Fever) and CHILLS (Chills). On 20-Jan-2021, the patient experienced DIARRHOEA (Extremely watery bowel movements) and ERUCTATION (Very unpleasant smell when belches). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO-BISMOL) ongoing since an unknown date at an unspecified dose and frequency. On 20-Jan-2021, PYREXIA (Fever) had resolved. On 21-Jan-2021, PAIN IN EXTREMITY (Arm pain) had resolved. At the time of the report, DIARRHOEA (Extremely watery bowel movements) was resolving and ERUCTATION (Very unpleasant smell when belches) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications were not provided.
CAN'T EAT ANYTHING; BODY IS SORE; NAUSEA; VOMITING; HEADACHE; This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, expiry: 20-MAR-2022) dose was not reported, administered on 13-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 14-OCT-2021, the patient experienced can't eat anything. On 14-OCT-2021, the patient experienced body is sore. On 14-OCT-2021, the patient experienced nausea. On 14-OCT-2021, the patient experienced vomiting. On 14-OCT-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, vomiting, can't eat anything, body is sore and headache was not reported. This report was non-serious.
shingles but early stages; This case was reported by a consumer and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient just had vaccine shot and unknowingly actually had the Shingles, but early stages so had no idea.  The reporter asked should he or she need to be concerned.
I had a blood clot develop in the left circumflex artery of my heart. There wasn't any cholesterol or anything. I went to the ER and they did and ECG and diagnosed a heart attack and had a heart catheter with a placement of a stint.
Insomnia  After my second vaccine I started having instant pain in my  left arm. The next day,  inside my elbow at the joint was swollen and still is a month after. I thought this would go away and it hasn't
No further AE details; PROQUAD was improperly stored and administered to a patient; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 06-APR-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant human albumin) (PROQUAD) subcutaneous injection, 0.5 milliliter, once (lot number W016357 has been verified to be valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA [PROQUAD], expiration date reported and confirmed as 16-NOV-2023) (route of administration and anatomical location were not provided) as prophylaxis. The vaccine administered was stored at a temperature of 19.6 degree Fahrenheit (F), during a time frame of 7 Hours 20 Minutes 0 Seconds, and did not suffered previous temperature excursion (Product storage error). No further adverse event (AE) details nor product quality complaints (PQC) were reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2306USA001063:
Immediate localized Rxc welts, at site, redness approximately 4" in diameter. Hep B also given in L leg IM no rxn. MMr given RL- slight redness at inject site. However, not as dramatic as varivax rxn.
Pt. had hives and rash that looked like a severe sunburn from the neck down. Had heacaches, swelling and numbness of hands and arms, myalgias, and lethargy. A few days after his rash began his son had a similar rash and was diagnosed with Fifth's disease. As of July 8 2010 symptoms improves but not fully resolved.
Body aches,  coughing,  runny nose, Heavy congestion,  sneezing.   Head aches, .Aggresive and irritable. Poor appetite.  Sinus pressure.
Sinus headache; Intermittent dry heaves; Temperature of 101.3F; Threw up yellowish-orange fluid which tasted bitter and might have been bile; This spontaneous case was reported by a consumer and describes the occurrence of SINUS HEADACHE, FEVER of 101.3F, Intermittent dry heaves, and VOMITING in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 9399902 and 014F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, the patient experienced SINUS HEADACHE, FEVER of 101.3F, Intermittent dry heaves, and VOMITING. The patient was treated with ASPIRIN for Sinus headache and Fever, at an unspecified dose and frequency. At the time of the report, SINUS HEADACHE, FEVER of 101.3F, Intermittent dry heaves, and VOMITING had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Sep-2021, Body temperature: temperature of 101.3f (High).          No concomitant information was reported. He took aspirin which did not provide any relief. An hour before they called (1:00pm, EST), he had a temperature of 101.3F. He took a couple of aspirin.
DIZZINESS; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and other pre-existing medical conditions included patient had on beta blocker. The patient experienced drug allergy when treated with acetylsalicylic acid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: not reported) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-APR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness. This report was non-serious.
feeling headachy; his stomach is not feeling real great; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 11Mar2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient said that he had no side effect but on unspecified date of Mar2021, patient had been feeling headachy and his stomach was not feeling real great. Patient specified that was normal for him and stated it could be related to caffeine or diet. Patient asked if the mild side effects last more than a day or two after vaccination. The clinical outcome of both the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
@ the time of clinic visit pt had a wheal on side of neck; no mention to PHN; 30 mins p/vax broke out w/wheals all over body;
Fever x2 days post vaccination, erythematous / papular rash, after fever subsided for one day erythematous on trunk, papular on extremities.
This spontaneous report as received from a Registered Nurse refers to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions and drug reactions or allergies were not provided. On 28-JUL-2016 the patient was vaccinated with a improperly stored dose of VARIVAX 0.5 ml, lot # L043620, expiration date 07-NOV-2017, subcutaneously (anatomical location were not provided). No other suspect or concomitant therapies were reported. Temperature: 7.7 Fahrenheit degrees. Time frame: 40 minutes. Digital data logger was involved (reported as "Yes, log tag"). No prior temperature excursions. No product quality complain was involved. The patient's twin brother was vaccinated at the same time, then, this is one of two reports from the same reporter. Additional information has been requested.
Red eyes; Puffy, tender, itchy around the eyes; Puffy, tender, itchy around the eyes; Itchy around the eyes/eyeballs itchy; This is a spontaneous report from a non-contactable consumer, the patient. A 13-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 30Aug2021 at 14:45 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. Medical history included epilepsy. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 30Aug2021 at 16:30, within hours of vaccine, the patient experienced red eyes, puffy, tender and itchy around eyes and after 36 hours, the patient experienced eyeballs itchy. The symptoms did not subside until over 55 hours after vaccination. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events red eyes, puffy, tender, itchy around the eyes and itchy around the eyes/eyeballs were itchy were resolved on an unknown date in Sep2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine 3/30/10 felt chills tired and lethargic 3/31 developed headache, stomach ache 4/1 developed hives rash thru 4/2
Patient had fever, Myalgia-  Described as FLU-like symptom few hours, after IM administration, lasted for 1 day
pt recvd vax; moaning noise & "central jerking" observed by mom;lasted 10 mins;asleep at onset of episode; awoke w/ sxs;
Severe pain in both ankles and inability to stand on them. No injury occurred during time frame to justify the pain and swelling.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patients might have been vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date 17-SEP-2016) (dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effects were reported. Additional information has been requested.
Injection site swelling, redness, tightness sensation  Headache, body chill, flush facial region Took extra strength Tylenol and introduced fluids.  COVID arm remained for twelve days. I took pictures with my cell phone.
Redness, swelling around injection site next morning 1" wide x 2 1/2". Hives, bumps inside red area - 11:00 AM 8/14/14 - 4" x 4 1/2". Itching, burning - 11:00 AM 8/14/14. Prednisone 20mg taken 8/15/14 in AM, 8/15/14 in PM and ice. CLARITIN 10mg taken 8/15/14 in AM.
Soreness when moving and touching, intermittent pain, heat at site, small red bump at injection site
1 WEEK AFTER VACCINE, DEVELOPED "COVID ARM" RED INFLAMED CIRCLE AROUND INJECTION SITE.
Female patient age 44, at the time of vaccination, no PMH was mentioned. Patient was her daughtrer. After receiving the vaccine dose at 10:05, patient being waving her hands and yelled for help at 10:12. Clinician went over to waiting area about ten feet away from the vaccination are. Patient began shaking, drooling, and was unable to speak. This continued for 4 minutes until 10:16. 911 was called and clinician was put on hold. Patient had slurred speech and was able to shake her head to answer yes or no questions to conduct a quick assessment. Patient's daughter stated that patient has a history of of seziures in the past, but was unaware of her last experience. Pulse ox was noted to be at 95%. (continued)
Severe neck and headache.  Started at shoulders and went to top of head.  Lasted approximately 15 hrs.  Hard to lift head.  Experienced chills, sweats and nausea.  Had muscle joint discomfort and all over body fatigue.  Called Health Department and Dr. both said to take ibuprofen.  I took the ibuprofen and headache and body ache subsided for several hours.  When it started to come back I took ibuprofen again and the headache and body ache got better.  The following day I felt foggy and dizzy.
Became very ill around 6 hours after the shot. It started with growing pain and swelling at the injection site the turned into full blown illness. I developed an intense headache, fever, chills, body aches, nausea, and fatigue that lasted for a period of about 36 hours.
Administered Anthrax vaccine at event and patient reported left arm tingling, sweating and then he fainted in chair. Upon arousing seconds later he reported a headache. He was treated by medical staff on the scene and recovered fully within 15-20 min.
Severe flulike symptoms including shaking, chills, fever (100.8 oF), palpitations, exhaustion for 36 hours. 36-48 hours symptoms abated except for extreme exhaustion. Necessitated bedrest for 2 days.
Fever of 102.8 F; Body aches; Nausea; Headache; A spontaneous report was received from a Healthcare professional, concerning a 52 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever of 102.8, body aches, nausea, headache, fever of 103", and had to go to the ER and received a bag of fluid and was 80% better.  The patient's medical history as provided by the reporter includes asthma. No relevant concomitant medications were reported.    On 29 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: O25620A) for prophylaxis of COVID-19 infection.  On 29 Dec 2020, the patient experienced fever of 102.8, body aches, nausea and headache. On 30 Dec 2020 the patient experienced fever of 103" and had to go to the ER and received a bag of fluid and was 80% better.  The patient was treated with Children's medication.  Action taken with mRNA-1273 in response to the events were not reported.   At the time of this report, the outcome of the events was recovered.; Reporter's Comments: Based on the current available information, a strong temporal association between the use of the product and the onset of the reported events, and the known safety  profile of mRNA-1273  a causal relationship cannot be excluded
After the vaccine I had the normal response of muscle aches, headache, fatigue, etc for a couple days.  Then on 04/02/21 sitting at my desk at work I had a sharp stabbing/throbbing pain in the back of my head about two inches up from my neck and two inches behind my ear.  I have had this excruciating pain about 5 more times and my neck and back of my head are staying sore.  This pain wakes me from my sleep.  It happens for about 10 seconds then my neck and head are sore.
This case was reported by a healthcare professional (Chief Executive Officer of a home healthcare agency) and described the occurrence of shortness of breath in a 76-year-old subject of unspecified gender who was vaccinated with Flulaval (GlaxoSmithKline). Concurrent medications were not specified. On an unspecified date (15 November 2007 or later) the subject received 1st dose of Flulaval (unknown) with expiration date March 2008. In November 2007, at an unspecified time after vaccination with Flulaval, the subject experienced shortness of breath, fever, weakness and vomiting. The reaction was classified as systemic. The healthcare professional considered the events were disabling. The reporter suspected a safety and quality issue with the vaccine. At the time of reporting the outcome of the events was unspecified. It was indicated that these events occurred with multiple subjects. Nine specified at the time of the report. It was noted that 2 or 3 subjects had to be treated in the emergency room for these events. Most of the subjects recovered from the events after 2 to 4 days. Some subjects had not yet recovered at the time of reporting. Specifics on each individual subject were not provided.
t102, pains in back & legs gave APAP was very weak for 3 days;
1900 hours - started "just feeling bad. I went to bed because I felt terrible". Approx. 2300 hours fever of 104 degrees. Had fever of between 99 degrees and 104 degrees until fever free at approx. 1100 hours on 12/20/15. Red at injection site but no swelling.
Pt recvd vax in 1990 & lab eval showed a neg rubeola titer; No further details were provided;
nose bleed; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (nose bleed) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Nose bleed. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-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 EPISTAXIS (nose bleed). At the time of the report, EPISTAXIS (nose bleed) outcome was unknown.            This case was linked to MOD-2021-131250, MOD-2021-131250 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: form added - related to first dose
After second dose on March 19, 2021 I started getting shocking sensations in my lower legs and feet, mostly on the left side then shortly thereafter I started getting extremely painful left hip pain when in a sitting position and trying to stand. It started occasionally and then progressed to happening more often.  I went for therapy and seemed to improve but now is worse than even and an almost constant ache.  No amount of medications or exercise seem to help long term. Seems to be getting worse.  Never had these issues before the vaccine.
LEFT DELTOID AREA RED AND HOT TO TOUCH HAS NO FEVER MOTHER STATES ON DAY CHILD WAS VACCINATED CHILD WAS VERY TIRED AND SLEEPY.  OTHER WISE CHILD FINE.
Itching, skin rashes, red and black balls, numb tongue, fever, sore throat, stomach pain, swelling in the body,no energy and difficulty breathing
0900 - Pfizer Shot 1000- noticed eyes looked puffy 1100- rash started on left arm below bicep in the elbow area 1115- rash now showing on right arm in the same area Around 1230 - 1300 seen by EMT - at that time I was given a shot of Epinephrine and IV of Benadryl transported by ambulance to  ED to be evaluated for allergic reaction. was released from the ED around 1545 no other treatment needed
PATIENT DEVELOPED SWELLING AND BRUISING APPROXIMATELY 24 HOURS AFTER VACCINATION WAS GIVEN. PATIENT'S DAUGHTER REPORTED THAT SHE WAS TAKING HER TO HER PRIMARY CARE PHYSICIAN FOR FURTHER WORK UP
No adverse effects were reported; one patient was administered an improperly stored dose of ROTATEQ; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not provided.     On 13-AUG-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R033252, expiration date 29-JUN-2020; dose and route were unknown) for prophylaxis.         The storage temperature of the vaccine was reported as 15.5 degrees Celsius for a time frame of 17 hours and 30 minutes. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. The call was due to a data logger.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Positive, notes: I am still testing positive as well. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: After taking paxlovid the patient felt back to normal after experiencing very very bad sore throat, fever, cough and significant aches and pains. 2 days later the infection attacked my sinuses with fever and more coughing. These symptoms have now persisted for 5 days and patient still have them. Patient was still testing positive as well. Other medication in 2 weeks product was Mucinex, start on 11Dec2022 and stop on 13Dec2022. Patient had not known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Patient was mistakenly given a lesser dose of Pfizer Covid-19 booster. Instead of the correct dose of 0.3ml, she was given the child dose of 0.2ml. We are in the process of informing the patient that a lower dose was given.