chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I became infected with Covid from a gathering of 6 thousand people; I became infected with Covid from a gathering of 6 thousand people/Suspected COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "I became infected with Covid from a gathering of 6 thousand people"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "I became infected with Covid from a gathering of 6 thousand people/Suspected COVID-19". Clinical course: patient write to say thank you for the vaccine. patient family and patient became infected with Covid from a gathering of 6 thousand people. If it were not for the vaccine, patient family and patient would have possibly lost several family members.  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.
Mother called health dept. requesting manufacturer and lot # for rabies vaccine daughter rec'd yesterday. States she was questioning symptom's following injection were a possible reaction and questioned if she should receive any more doses. Reports daughter experienced vomiting approx. 1 1/2 hours, post vax. Vomited X 3; no complaint of diarrhea. Temperature to 104F. Tepid tub bath taken and ibuprofen given and took Tylenol in between. Temperature decreased to 99F this AM and complaining of feeling weak. Also, complained of headache. Questioned mom if daughter had complained of any symptoms of illness prior to coming to clinic and she said only to meds. Only reaction to any previous vaccines was a mild fever with 1st baby shots. Mom stated with present vaccine, she complained of soreness, no redness or swelling. She relates temperature still down and still complaining of headache. Now also states muscles sore and experiencing dizziness when gets up out of chair. Vomited X 1, today when she tried to eat a banana; has kept down other fluids and soup. Had consulted with health pharmacist & he had recommended mom talk with daughter's physician and let PMD make the call if she should continue series. Works for vet and discussed risk for exposure on the job. Mom states if pt continues to feel ill tomorrow, she will follow-up with PMD. Mom called and stated pt went to MD on Thursday and got a shot of antibiotics and started on Bactrim for kidney infection. She returned to PMD on Friday and was no better and was hospitalized for kidney infection. Hopes daughter will be discharged from hospital today. Says she ran a temperature of 102F in the hospital X1 and had complained of her side being sore last week but thought is was just a pulled muscle. Rabies shot cancelled today as pt still in hospital. Will contact health dept. when she is ready to resume. Mom did say that the pt's doctor did say that pt's symptoms were not due to Rabies pre-exposure vaccine; she did not have a vaccine reaction.
pt recv vax;devel minimal periorbital edema in area of rt eye lid;erythema in area of face & neck;dph given & pt was observed;
low platelet count; This spontaneous case was reported by a consumer and describes the occurrence of PLATELET COUNT DECREASED (low platelet count) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PLATELET COUNT DECREASED (low platelet count). At the time of the report, PLATELET COUNT DECREASED (low platelet count) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: low (Low) Low.         No concomitant medications were reported. No treatment medications were reported.
I developed pericarditis shortly after my 2nd shot on 4/11/2021. The symptoms were similar to covid but when I tested, the test always came back negative. After 6 months of off/on(April, July, August) symptoms and repeated negative covid test. I developed severe shortness of breath, chest pains, feet swelling and fatigue in October 2021. I went to the emergency room and required a pericardial window to drain fluid from my heart sac. The heart sac and severed inflammation.
Diarrhea; Lots of pain; Fever; Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), PAIN (Lots of pain), PYREXIA (Fever) and VACCINATION SITE PAIN (Soreness at injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), PAIN (Lots of pain), PYREXIA (Fever) and VACCINATION SITE PAIN (Soreness at injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), PAIN (Lots of pain), PYREXIA (Fever) and VACCINATION SITE PAIN (Soreness at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) 100.6 F..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was on other medication.
Very sore left arm  10:00 PM 4/16/21 Chills/Shivering 1:15 AM 4/17/21  Extreme tiredness 4/17/21
Passed out; Low heart rate; Possible pneumonia; A spontaneous report was received from a consumer concerning an 84-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced passed out, low heart rate, and possible pneumonia.    The patient's medical history was not reported. There were no concomitant medications provided.  On 15 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot # unknown) intramuscularly, for prophylaxis of COVID-19 infection.  On 17 Jan 2021, the patient was hospitalized for passed out, low heart rate, and possible pneumonia. The reporter's mom found the patient passed out on the floor. It was thought he may have passed out about 4 or 5pm. The patient was taken to the emergency room (ER) via ambulance. At that time his heart rate was 20 bpm. Physicians said he may have pneumonia. It was noted the patient still works and walks miles every day. The patient was still hospitalized at the time of this report. There was no treatment information provided.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome for the events of passed out, low heart rate, and possible pneumonia was unknown at the time of this report.; Reporter's Comments: This case concerns a 84 year old male patient who experienced a serious unexpected events of passed out, low heart rate, and possible pneumonia.The event occurred 2 days 7 hours after first dose of the vaccine. Very limited information regarding the events has been provided at this time.  Based on temporal association between the use of the product and the start date of the event/s, a causal relationship cannot be excluded.
Previously diagnosed with Covid PNA in 11/2020 that was treated with course of Remdesivir and steroids, has 2 negative covid tests in the interim. He received his first Moderna COVID vaccine on 1/4/2021, but did not get the second dose. He had recently been hospitalized at a healthcare provider for COPD/CHF exacerbation was discharged 4/13/2021, returned this morning with URI symptoms, found to by hypoxic with O2 sats in the 80s, encephalopathic, and Covid test was subsequently positive (4/15/2021).  Pt transferred that evening to our hospital for ICU level care.
My wife fed our daughter Enfamil formula and within minutes she developed hives on the face and neck; she also vomited twice and had diarrhea. The hives continued to cover her entire body. Within 15-20 minutes of the feeding we took her to the emergency room where she was injected with Epinephrine. They also gave her through an IV Benadril, steroids, and something to settle her stomach. Before the IV they first attempted to administer the Benadryl and steroids through the mouth but she vomited it up. It should be noted that for the first two months of our daughter life she took Enfamil daily without any problems as my wife's milk was delayed in coming in. We are reporting this because we are unsure if there is a correlation, if not a causation, between the vaccination she received just two days before and the adverse reaction to Enfamil, which had not previously been a problem.
Hallucinations; He seems impaired mental and emotionally; He became unruly, hostile, angry, indignant; Unreasonable dreams; Belligerent, lost all sense of decorum, couldn't figure out where he was; Cried; This is a spontaneous report from a contactable consumer reporting for himself.   A 80-years-old male patient received bnt162b2 (BNT162B2; Lot #ENS318) vaccine , via an unspecified route of administration in the left arm on 30Jan2021 11:15 at single dose for covid-19 immunisation .  Medical history included Parkinson's disease, mobility decreased .  Concomitant medication included thyroid (THYROID), carbidopa, levodopa (RYTARY).  The patient previously took codeine and experienced drug hypersensitivity.  One hour after receiving the vaccine, the patient  experienced hallucinations on 30Jan2021 12:15 with outcome of recovering , he seems impaired mental and emotionally on 30Jan2021 12:15 with outcome of recovering , he became unruly, hostile, angry, indignant on 30Jan2021 12:15 with outcome of recovering , unreasonable dreams on 30Jan2021 12:15 with outcome of recovering , belligerent, lost all sense of decorum, couldn't figure out where he was  on 30Jan2021 12:15 with outcome of recovering , cried on 30Jan2021 12:15 with outcome of recovering.  All the reported events were considered Important Medical Events.
My tongue and lips have being itching; Swelling a little bit my lips and tongue; my 'place' is swell little bit.; My tongue and lips have being itching; Swelling a little bit my lips and tongue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: CVS6738, Expiration Date: 22Dec2021, Batch number: Unknown) at the age of 48 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE :1), for Covid-19 immunization. The following information was reported: LIP PRURITUS (non-serious), TONGUE PRURITUS (non-serious), outcome "unknown" and all described as "My tongue and lips have being itching"; SWOLLEN TONGUE (non-serious), LIP SWELLING (non-serious), outcome "unknown" and all described as "Swelling a little bit my lips and tongue"; SWELLING (non-serious), outcome "unknown", described as "my 'place' is swell little bit.".  Additional Information: Consumer stated, "Since I taken the Pfizer, my tongue and lips have being itching and my 'place' is swell little bit." No other medical conditions.  Follow-up attempts are completed. No further information is expected.
Received vaccination the morning of August 25th, began experiencing a headache the afternoon of the 25th.  Went to bed, woke up the morning of August 26th with 10/10 headache throbbing frontal headache.  Associated symptoms include extreme photophobia, scotomas, phonophobia, dizziness, and nausea.  Headache has been constant and unrelenting in nature.  Currently on day 17 of the headache.  Was seen twice in labor and delivery triage for the pain.  Was given percocet and fioricet for pain.  Chose not to take percocet.  Fioricet decreased pain level to 3/10.  Admitted to hospital 9/09/2014 for further work up of headache.  MRI negative, all blood work negative, blood pressures normal range.  No previous history of migraines or headaches.  Unable to attend work for last 17 days due to debilitating headache and associated symptoms.
Had fever p/vax of 99.4 & then to 101 lasted 2 days; never higher than 101; both upper & lower legs were swollen;
Information has been received from a physician concerning a 22-week-old female who on 14-MAR-2007 and 21-MAY-2007 was vaccinated PO with the first and second 2.0 mL doses, respectively, of Rotateq (Lot numbers not available). The physician reported that on 10-JUN-2007 the patient developed intussusception. Unspecified medical attention was sought and the patient was subsequently hospitalized (duration unknown). An "intussusception" test was noted to be negative, however, an Emergency Room (ER) physician believed that the intussusception had a spontaneous resolution without the need for surgery. The patient subsequently recovered. Additional information has been requested. 9/20/07-records received for DOS-6/10-6/11/07- DC DX: Vomiting. Acute onset of emesis ranging from dark green to coffee ground in color, decreased energy, perioral cyanosis with one episode.
Rash on arms and legs, swelling around eye, nauseous. Day 7: vomiting and seizure. The discharge summary received on 3/30/04 states new onset focal seizures w/ likely secondary generalization.
REVACCINATION WITH DIFFERENT COVID-19 VACCINE; ALLERGY; GOUT; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypothyroidism, kidney stones, low testosterone, enlarged prostate, sleep apnea, and statins allergy (patient had muscle weakness when treated with statins.). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on 2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 7 decade old. No concomitant medications were reported.  No adverse event reported post vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received non-company suspect vaccine included: Moderna covid-19 vaccine (elasomeran) (dose number in series 2) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered on 03-MAY-2022 for covid-19 prophylaxis. Patient was revaccinated with different covid-19 vaccine (dose number in series 2). On an unspecified date in 2022, the patient developed gout, and allergy (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The outcome of the gout, allergy and revaccination with different covid-19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20221121516.
Immediate nausea, left arm pain, tingling in left arm, sweating, loss of vision, loss of hearing, stomach pain, tingling in fingers after approx. 10 minutes.
Patient was admitted and being treated for covid.  She was receiving maximal therapy (see my progress note from today), but unfortunately underwent a cardiopulmonary arrest.  Patient started to be resuscitated, but discussions with family revealed that she did not want to be put on a machine.  She was made a DNR and comfort medications (morphine) were administered given pain of CPR.  Patient passed shortly after stopping CPR.
Significant amount of blood in urine from 23Jun2021 to 07Jul2021. Massive bleed in first few days with blood clots...over the duration the appearance slowly diminished. Soreness in right side, No urgency, pain or infection. No previous history of urinary or kidney issues.  09Jul2021 - UroScan and Scope of bladder - normal
Urticaria, dermatographia, GERD and feeling as though there is something stuck in my throat. Emergency room visit.. IV solumedrol, benadryl, and famotidine. Then 5 days of oral prednisone, Zyrtec, Benadryl, and famotidine. Symptoms continue without improvement greater than one week at this time.
Received flu shot on 11/13/06 at a community clinic at approximately 11:30 am. At bed time (10 pm) patient noticed itching from waist down. by 12 midnight itching intensified. Patient denies seeing any rash. Patient denies any other symptoms. He reported that by morning itching had resolved and no further problems noted.
testicles swelling; experienced a rash three hours after the vaccine; fever; chills; diarrhea; Malaise; they gave him a quick test that said he had covid; This is a spontaneous report from a contactable consumer (patient). A 63 -year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown) via an unspecified route of administration in left arm on 15Apr2021 at 10:30 (at the age of 63 years old) as single dose for COVID-19 immunization. Patient's medical history included asthma and it was diagnosed years ago. Concomitant medications were not reported. On 15Apr2021, the patient experienced fairly, fever, chills, testicles swelling, and diarrhea, malaise, COVID-19 and rash three hours after the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient reported symptoms went on for several days and began on 15Apr2021 about three hours after he was administered the 1st dose of the Pfizer COVID vaccine and the symptoms resolved probably 7 days later. Patient do not have prior vaccine side effects. Patient did not require treatment but for one thing he did call to HCP and was sent for a COVID test and it came back negative, and it was the one that takes three days, states patient still did not feel good so that same day patient first COVID test on 23Apr2021 patient went to another COVID test at and they gave him a quick test in that result patient had COVID. Outcome of the events fever, chills, diarrhea, malaise was recovered and testicular swelling, rash, COVID-19 was unknown.    Information on the lot/batch number has been requested.
Redness, swelling at site on evening of 8/5/10 and noted also on 8/6/10.
This spontaneous report has been received from a pharmacist concerning to a 64 year old male patient. The patient's concurrent condition included connective tissue disease. None drug reactions/allergies. On 26-SEP-2013, the patient was vaccinated with ZOSTAVAX lot # J001690, expiration date: 08-MAY-2014 in the right arm deltoid region, (dose and route not reported). Concomitant therapy included methotrexate (manufacturer unknown). On 27-SEP-2013 (reported as within 24 hours of receiving the vaccination), the patient experienced swelling and redness at the vaccine administration site, fever (unspecified temperature), a whole area swelled all the way down her arm and her arm ached. On 21-OCT-2013, the patient reported that the initial swelling and redness had settled in her elbow. On an unknown date, the patient stated that her right elbow still hurt real bad and clicked when she moved it. It was also reported that she experienced elbow joint pain after certain movements. The patient was given MOTRIN (manufacturer unknown) as a treatment for fever and it resolved within a day or two. None laboratory diagnostics were performed. At the time of the report, the outcome of right elbow clicks when she moves it, redness had settled in her elbow, elbow joint pain after certain movements and swelling had settled in her elbow was unknown. The outcome of the whole area swelled all the way down her arm ached, her arm ached, redness and swelling at the vaccine administration site was resolving. The outcome of a fever (unspecified temperature) was recovered and the outcome of the right elbow still hurt real bad was reported as not recovered. The reporting pharmacist considered the event to be as significant disability or incapacity. Additional information has been requested.
Pt reports rosacea like rash in half crescent shape showing up on her back the next day that was very itchy.  Last approximately 2 days.
Stomach ulcer; A lot of histamines in the body; Headache; A spontaneous report was received from a Consumer concerning a female patient age unspecified who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events a lot of histamines in the body/histamine level increased, headache/headache and stomach ulcer/gastric ulcer.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 24-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On 09-MAR-2021, the patient experienced the events a lot of histamines in the body, headache and stomach ulcer.  The event stomach ulcer was considered to be serious with criteria of important medical event.  Laboratory details were not provided.  Treatment details included none.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events a lot of histamines in the body, headache and stomach ulcer was unknown.; 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.
Developed rash within 12-24 hours of getting vaccine. About 8 months after getting my vaccine I contracted COVID. Began as a sinus headache and turned into a migraine that lasted 5 days. Mild fever 99 degrees, body aches, nausea, swollen throat and difficulty swallowing. Lot of coughing and congestion. Around day 3 I developed hives similar to what I had when I received vaccine. Around day 5 I reached out to allergist because I was beginning to show signs of a sinus infection. Most symptoms lasted one to two weeks with cough persisting for four weeks.
Approx. 16 hrs after vaccination. C/O increase heart rate; "not feeling normal" and increase B/P. To local hospital ER with heart palpitations, B/P 189/97, P=89, Resp 18 but reg heart rate on exam and cardiac monitor. Observed and sent home with s/sx resolved. Next 24 hr client rested with no problems. 2-3-10 c/o "(R) blue hand" (no pain, no heat, no swelling). 2-5-10 4 pm fullness in neck and body "not feel right". Increased B/P sent to PMD.
A report was received from a health care professional on 24 October 2003 concerning 3 vacciness of unknown gender less than 4 years of age who inadvertentl received Fluvirin on an unspecified date. On an unspecified date, 3 vacciness less than 4 years of age inadvertently received Fluvirin.  It was unknown at the time of the report whether or not the vacciness had exhibited my signs or symptoms of an adverse reaction. There was insufficiant information to determine the reporter's causality assesment. Update 1, 24 November 2003: Follow up information was received from a health care professional on 24 November 2003 indicating that the vaccinee was a 6 month old female. the vaccinee experienced fever on 23 October 2003 after receiving 0.25 ml Fluvirin vaccine on 22 October 2003. The fever resolved 2 days later. Follow up pending. Cross reference with: PJP200300889,PJP200301210, PJP200301211, PJP200301212, PJP200301213.