chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nausea; loose stools; aching; This is a spontaneous report from a contactable healthcare professional, the patient. A 83-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the arm left on 25Mar2021 at 12:00 (at the age of 83-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, high cholesterol and hypertension (HTN). Concomitant medications included simvastatin (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN), melatonin (MANUFACTURER UNKNOWN) and sertraline hydrochloride (SERTRAL) received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccines within 4 weeks prior to COVID vaccine. On 26Mar2021 at 14:00, the patient experienced nausea, loose stools and aching. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of the events nausea, loose stools and aching were not resolved at the time of report.   No follow-up attempts are needed. No further information is expected.
The patient came in 7-18-23 in the evening and said that she experienced some arm swelling, muscle pains, headache, and a slight rash on a small area on  her upper back from her vaccination on 7-10-23.  The symptoms resolved but she did let her doctor know at a doctor visit.
This spontaneous report has been received from a health worker and refers to some unspecified patients. Since 30-DEC-2014, doses of VARIVAX (Merck) which had been exposed to a temperature of 11 degrees F for 51 hours cumulatively had been administered to unspecified patients. Vaccine of VARIVAX (Merck) should be stored frozen between -58 degrees F and +5 degrees F. No adverse effects have been observed or reported. This is one of several reports from same reporter. Additional information has been requested.
Patient reported nausea in the first 30 minutes. while driving home this became so intense that she had to pull over in order to vomit.
Pt had received Hep B #2 and Hep A #2. Pt fainted about 5 minutes later. Non-responsive. O2 administered. Immediately some response. But deep breathing continued. 911 called. Paramedics were unable to get pt to reply to P.O. stimuli. Pt was taken to mobile unit. About 15 minutes later, pt out of unit walking and responsive. Discharged to mom per car.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-MAR-2016, the patient was inoculated at a physician's office with ZOSTAVAX (lot number, dosage, and route of administration not provided), for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. Later in 2016, she was treated at physician's office for a vesicular outbreak, which was diagnosed as herpes zoster. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
I had my vaccination on January 15.  Had low grade temperature, body aches, nausea, severe chills starting about 12 hours after injection.  Lasted 24 hours.  Third day after injection, my arm broke out in a rash around injection site, lasted  2 days.   Had 2 breast biopsies on January 20.   Started a breakout on both breasts on January 22.  On  January 27 rash started to spread over my torso.  Went to dermatologist on February 5, started prescription medications and cream.  By February 6, I had a full body breakout with red burning skin, rough red rash, welt/hives and pain.  On Feburary  6  went to the ER for treatment.  Received IV of Benadryl and Prednisone.  ER doctor said she believed the vaccination was the cause.  If it was from the biopsies it should have been contained to the breast area.
first shot on 7/21/20, did not get second yet; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received first Shingles shot on 21st July 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 8-MAY-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient did not get the second shot yet and asked could he/she still get the second shot now. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingles vaccine, which led to incomplete course of vaccination. The follow-up would not possible as no contact details were available.
Initially, sore arm. Then progressed to full body aches and persistent nausea. 2-3 inch diameter red area around injection site.
Brain fog; Nausea for weeks; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Brain fog), NAUSEA (Nausea for weeks) and MYALGIA (Sore arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not Provided) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced FEELING ABNORMAL (Brain fog), NAUSEA (Nausea for weeks) and MYALGIA (Sore arm). At the time of the report, FEELING ABNORMAL (Brain fog), NAUSEA (Nausea for weeks) and MYALGIA (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was mentioned. No treatment medication was mentioned.   This case was linked to MOD-2021-296133 (Patient Link).
Patient developed a fever to 102.3 and had a decreased level of responsiveness with rigors. An infectious evaluation including COVID 19 testing, respiratory viral panel, basic lab evaluation (including CBC and CMP), and physical exam were all unremarkable. She was provided PR acetaminophen which reduced her fever and she returned to normal. After clinical improvement, she mentioned that she has developed similar reactions to previous medications (PCN) and vaccines (unknown which type) that always improve with acetaminophen. She did not annotate this on her vaccine screening form. She was provided acetaminophen and had no further symptoms. Will plan to provide her with scheduled acetaminophen after dose 2.
Extreme shivers at bedtime, large area of rash two days later, doctor said it looked like cellulite-us, recommended  Claritin and ice pack .
Tachycardia/increased heart rate, also dizziness, both lasting approximately 24h
Patient complained drowsy and sweaty.  Patient reported drinking and  not eating breakfast this A.M.
Burning throughout my body is the chief compliant which we cannot find out why. Never recall having anything like this in my medical records.  Also had had pain, back pain as well but the inflammation is painful and my major compliant.
Rec'd MMR and Varivax 5/31/06. Rash over entire body on 6/9. No fever. Still has prominent rash on face, body and extremities but father states it looks better today. Has given Benadryl.
Pt developed rash on trunk; while playing stopped breathing, fell to ground, turned blue & was shaking all over; Rec'd cpr & was hospitalized; t105, dx feb sz & viral synd;
This spontaneous report was received from a nurse concerning to a 6 months old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 17-JUN-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # K023534, expiration date: 22-MAY-2016) (strength and dose were unspecified), the route was defaulted to oral. No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Patient resident of nursing home.  Patient had tested positive for Covid-19 on 12/16/2021.  On 01/05/2022 patient reported to nurse she was not feeling well.  Patients blood pressure was low, and blood glucose high.  No SOB noted on exam.  Edema noted on CXR.  Midodrine 5mg x 1 given.  Patient was then found unresponsive and expired at 1102.
3rd day post vax pt devel temp, neck sore, sneeze, cough, h/a, sinus stopped up, ache in neck;
Left office 10:30am after waiting 10 mins after shots. Baby was fine. Baby started getting irritable at noon. Daycare called mom when she saw baby twitching lower and upper extremities and eyes rolling back. Had three episodes each lasting 1 min then slept. Came to office, rechecked, referred neurologist,
Elevated temp/ fever reporting 101-103 degrees F - chills, nausea, dizziness, achy and shortness of breath.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 09Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 30Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: tested negative 7 days after first positive test; (unspecified date) Positive, notes: first positive test; (Jun2022) Positive, notes: 4 days after completing Paxlovid/tested very positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. No treatment taken for Adverse event.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events vaccination failure and COVID 19  and the suspect drug BNT162b2.
I regained my taste. I had Covid 31Dec-10Jan with both loss of smell and taste initially. My smell returned quickly but after the 2nd vaccine my taste returned the next day; I had Covid 31Dec-10Jan with both loss of smell and taste initially.; This is a spontaneous report from a contactable nurse (patient). A 48-years-old female patient received the first dose of  BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot-number: EL0104), via an unspecified route of administration in the right arm on 21Dec2020 at 03:00 at a single dose, and the second dose (Lot number: EL3249) via an unspecified route of administration in the right arm on 11Jan2021 at 03:00 at a single dose for COVID-19 immunization. Medical history included hypothyroidism. The patient was not pregnant at the time of vaccination, did not have any other vaccine within four weeks, and did not have COVID prior to the vaccination. The patient's concomitant medications were not reported. The patient previously took sertraline (ZOLOFT) and experienced drug hypersensitivity. The patient stated that she regained her taste. She had COVID from 31Dec-10Jan (also reported as on 12Jan2021 at 12:00) with both loss of smell and taste initially. Her smell returned quickly but after the second vaccine, her taste returned the next day. The patient underwent lab tests and procedures which included viral test (nasal swab; Sofia COVID test): positive on 04Jan2021. The patient received no treatment for the events. Outcome of the events was recovered.; Sender's Comments: A causal association between reported event and suspect BNT162B2 cannot be excluded.
Since the first vaccine, patient has not menstruated.  Patient was always regular prior to vaccine.
8/26/21: At 23 hours, general tiredness; fever of 101.3; fever dissipated in 8 hours 8/28/21: At 60 hours; severe night sweats
-Localized Redness, Pain, Swelling at injection site. -Headache daily since vaccine
High fever; Vomiting; This case was reported by a consumer via call center representative and described the occurrence of fever in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th October 2021, the patient received the 1st dose of Shingrix (intramuscular). In October 2021, 12 hrs after receiving Shingrix, the patient experienced fever and vomiting. On an unknown date, the outcome of the fever and vomiting were unknown.   It was unknown if the reporter considered the fever and vomiting to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient received Shingrix into his left deltoid.  Twelve hours after his dose, the patient started vomiting and reported having a high fever. The patient could not provide lot or expiration date of vaccine. The reporter was not asked about consent via email or consent to contact his doctor.
ONE PERCENT REACT BADLY TO THE VACCINE; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced one percent react badly to the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of one percent react badly to the vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20221005765, 20221005731, 20221003651 and 20221005834.
Information has been received from a health professional concerning a 2 month old female who on an unspecified date was vaccinated with a dose of ROTATEQ. The patient also received unspecified routine 2 month vaccinations. The next day, the patient had a fever of 104.5 Fahrenheit and was hospitalized. At the time of report, no outcome was reported. Additional information has been requested.
Client complained of lip tingling after receiving the 2nd dose of Pfizer vaccine. Post vaccination waiting period was 30 minutes due to history of severe allergy to peanuts. Client VS were stable. Lip tingling improved prior to discharge home.
Sluggishness x 1-2 days. Rash 15 x 4 cm on (L) deltoid, 1 cm below injection site, starting 3 days after injection.
PT. MOTHER PHONED OFFICE STATED PT. HAD REACTION FROM VARICELLA VACCINE. INSTRUCTED MOTHER TO RETURN TO OFFICE,TO HAVE CHILD EXAMINED. PT. LEFT ARM RED,SWOLLEN AND TENDER TO TOUCH, AREA 9X9 CM IN DIAMETER. PT.'S MOTHER DENIED ANY FEVER. PT. GIVEN HYDROXIZINE 25MG 1 TID PRN, AND LOCOID LC BID X7D. PER MD. PT. INSTRUCTED TO RETURN TO OFFICE IF CONDITIONS WORSEN. INSTUCTED TO USE WARM COMPRESSES AS NEEDED.
Information has been received from a physician referring to multiple unspecified numbers of patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were not reported. From January 2016, an unspecified number of patients were vaccinated with an improperly stored dose of M-M-R II (lot#, expiration date, dosage, frequency and route were not reported) for prophylaxis. No adverse effect reported. The vaccine was stored at unspecified high or low temperature excursions from January 2016. The reporter stated that one refrigerator experienced 2041 excursions and another experienced 230 excursions during this timeframe. There has previous temperature excursion. Data logger was involved. No product quality complaint was involved. No further information was provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA004633: US-009507513-1709USA004630: US-009507513-1709USA004631: US-009507513-1709USA004632: US-009507513-1709USA004628: US-009507513-1709USA004629: US-009507513-1708USA008490.
Tingling & numbness of my legs and arms; Joint pain; Weakness from my calf, feet, wrists, and to my hands came back & it has continued to progress up to my thighs; Cold sensation; Rheumatoid Arthritis (recently diagnosed in June 2021) flared up; My symptoms have worsened after taking each dose.
4/1/06, Donor had had complaints of a steady line of pain from his right shoulder down to his mid-forearm, described as an ache, since his TD shot which he received on 3/22/06. Also, complaints of right upper back and neck stiffness and pain, weakness in affected arm. Shot was given approximately 1 inch below corresponding axilla, in right upper arm, very small purple spot still visible at site. Donor went to Hospital last evening, was told by the doctor there, that shot was given too low, right next to nerve, toxoid bled into nerve sheath. Donor was told to take ibuprofen around the clock for the next week, have site re\-evaluated in a week. Donor has an appt with his PCP this coming week. 4/1/06; due to possible conflict of interest-this MSA called the donor and verified that the info on the DARR and attached sheet is true. The following is additional info donor rates right arm constant pain at 4-5 on pain scale 0 to 10. When at work and after a couple hours, the pain increases to 6 or 7. 4/1/06, Pt's job involves holding a saw with both hands. The left arm does most of the weight bearing initially-but as he tires, the right arm bears more weight. Told donor to seek HCP care if needed prior to scheduled appt. Management was informed 3/31/06 by MSA.                                                                                                                        Plasma Services 4/3/06-Examined donor 12 days after TD injection it still ecchymotic-about 2mm. No induration or erythema. Site caudal to deltoid, hand, wrist, elbow strengths/s. No sensory deficit throughout arm, hand. Assessment-injection placed (caudally) to belly of deltoid muscle. Pt had local reaction which caused pain which had to altered use of chain saw. No evidence of muscular or neural damage since injection.
I began having dizzy spells sometime following this shot. My records show that I went to see my Ear Nose and Throat doctor on April 22nd complaining but never making the connection at that time to the shot. We decided that neither of us thought it was vertigo since I have had that before - this was different. Discussed the possibility of menieres but again it wasn't a textbook case but decided to keep a watch and consider that possibility.  On Nov. 3rd I received the Moderna booster shot. Didn't feel great the next day and subsequent days after was having dizzy spells again. By Monday, November 8th I couldn't lift my head off of the pillow. It wasn't until this week that I began piecing together the timeline that I have had dizziness after the second shot and now the booster. It's pretty severe and a daily issue right now more than two weeks after the booster shot. There has to be a correlation.
Metallic taste in the mouth; thought it was thrush; burning of the tongue; dulled sense of taste; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 12Mar2021 (Lot number: EN6204) at the age of 50 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DYSGEUSIA (non-serious) with onset 16Mar2021, outcome "not recovered", described as "Metallic taste in the mouth"; ORAL CANDIDIASIS (non-serious) with onset 16Mar2021, outcome "not recovered", described as "thought it was thrush"; TONGUE DISCOMFORT (non-serious) with onset 16Mar2021, outcome "recovering", described as "burning of the tongue"; TASTE DISORDER (non-serious) with onset 16Mar2021, outcome "not recovered", described as "dulled sense of taste". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dysgeusia, oral candidiasis, taste disorder. Additional information: Clinical course:  The patient had the first covid19 vaccine on 12Mar2021 and the symptoms started with a metallic taste. The patient never lost her taste and they thought it was thrush. The patient also had burning of the tongue and a dulled sense of taste. She never lost her sense of taste. The patient was treated with Nystatin as they thought it might be thrush, but there is no whiteness of the tongue. Metallic taste in the mouth and Dulled sense of taste were reported as worsened. The reporter was querying if there have been other reports about these symptoms and if these symptoms are related to the vaccine as symptoms became apparent after the first dose of the vaccine. The relatedness of drug to reaction(s)/event(s): Metallic taste in the mouth, Burning tongue, Dulled sense of taste with primary source reporter as source of assessment and Global Introspection as method of assessment was unknown. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional administered vaccines. Patient had no prior vaccinations (within 4 weeks), no Patient medical history (including any illness at time of vaccination) and no family medical history relevant to adverse events. The patient does not have SARS-CoV2 antibodies at diagnosis. The patient did not display clinical signs at rest indicative of severe systemic illness. Events did not require the initiation of new medication or other treatment or procedure.  No follow-up attempts are possible. No further information is expected.
Pt developed fever, sore throat, runny nose and headache for 2 days following the pneumonia shot. He then developed congestion and cough .
pt recvd vax & exp 1 104-105; had sz & was cyanotic ems called - to hosp; pt resuscitated by mouth to mouth; had another sz & t 106; admitted to hosp; iv meds; exp rash & 23sep94 returned home but remained drowsy & draggy;