chrisvoncsefalvay/vaers-outcomes huggingface dataset:
prior to vaccine she had very regular periods for 12 months.  After second dosage of vaccine, she is having cramping, clots, and periods about every 2 weeks
12/16/07 - PM - injection site left arm became red, increased over next couple days to about 2 inches in diameter.  Seen in doctor's office 12/20/07.  Redness had started to fade by then, and completely resolved by 12/28/07.
mixing YF-VAX with a different diluent and administrating it to a patient with no reported adverse event; Initial information received on 28-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves patient of unknown age and gender who took Yellow Fever Vaccine [YF-VAX] mixed with a different diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received 0.5 mL dose of suspect Yellow Fever Vaccine  Solution for injection(Strength = standard) (lot number, route, batch lot: requested, expiry date was unknown) for immunization and mixed with a different diluent with no reported adverse event (product preparation error) (unknown latency). Information on the batch number was requested.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
TD was expired in Jan 2019. I didn't realize this when it was given. Expired vaccine was in the Refrigerator.
pt recv vax 23OCT97 & 5 days later sudden onset of acute lt arm numbness & weakness & pain from triceps down-has to think to move arm;MD suspects post vax plexus inflammation;
Chills, 102 degree fever, nausea, headache,  (lasted 3 days) swelling of injection site, warmth and large knot at injection site (this is 4th day and still happening).
11/08/21 presents to  ED "for altered mental status" "confused, fatigued, generalized weakness, and decreased activity" PMHx "HLD, CAD, CHF GERD, DM2, asthma, stage 3 CKD, and CHF POD7 from a revision laminectomy fusion T10-L3 c/b acute blood loss anemia on chronic anemia s/p 2UPRBC"
This spontaneous report was received from a physician via a company representative concerning an approximately 88 year old female patient. Approximately on an unknown date in October 2008 (reported as about 5 years ago), the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. Approximately on 10-SEP-2013 (reported as 6 weeks ago), the patient developed shingles in the right side of the eye and on the top of the head to the back of the head. The patient was in extreme pain from the developed shingles. The patient sought medical attention (doctor visit). The patient had taken unspecified steroids and Gabapentin (manufacturer, dose and frequency unknown). It was unspecified if any lab tests were performed. The outcome of shingles in the right side of the eye and on the top of the head to the back of the head was reported as not resolved as the patient was in discomfort at the time of report. The relatedness for of shingles in the right side of the eye and on the top of the head to the back of the head was unknown for ZOSTAVAX. Additional information has been requested.
light headed/dizzy; eyes sensitive to light; warm sensation; foggy/strange sensation; I was feeling fatiqued; Fell asleep; Headache; Legs tingling/ cold at down my legs; burning sensation; pain in my chest and right arm; pain in my chest and right arm; Heart racing; Legs tingling/ cold at down my legs; This is a spontaneous report from a contactable consumer (patient). A 58-years-old male patient received first dose of BNT162B2 (FIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number; EW0175 and expiry date was not reported), via an unspecified route of administration in Arm Right on 29Apr2021 at 11:00 PM (age at vaccination: 58-years-old), as DOSE 1, SINGLE for COVID-19 immunisation at School or Student Health Clinic. The patient medical history included Gunshot wound to the left hemisphere of the brain, chronic sleep issues, minor paralysis to the right side of body as result of TBI and Penicillin allergy (all from an unknown date and unknown if ongoing). Concomitant medications included vitamin C (ASCORBIC ACID) and zinc taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was allergic to penicillin. It was unknown whether, the patient diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Apr2021 at 16:00, the patient experienced light headed /dizzy, eyes were sensitive to light, warm sensation in upper right arm, and foggy. After dinner, at about 7pm, he laid down because he was feeling fatigue and then fell asleep. He woke up a few times in the night with a strange sensation running up and down his legs. Legs tingling/cold at times. He had burning sensation and pain in his chest and right arm, chest felt like he had a rubber band wrapped around him. He experienced heart racing, bad headache and legs were cold. He woke up next morning basically unable to do anything for a several hours. He felt foggy, stumbling around and dizzy and felt better in afternoon. He still felt foggy headed but it got better as days pass and he was very tired. He felt a lot better after a few days. The patient had visited to physician's office for the events. The patient did not receive any treatment for the events. Outcome of the events was recovered on an unspecified date in 2021.  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
passed out; blood clots; heart inflammation; kidney troubles; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out), THROMBOSIS (blood clots) and CARDITIS (heart inflammation) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), THROMBOSIS (blood clots) (seriousness criterion medically significant), CARDITIS (heart inflammation) (seriousness criterion medically significant) and RENAL DISORDER (kidney troubles). At the time of the report, LOSS OF CONSCIOUSNESS (passed out), THROMBOSIS (blood clots), CARDITIS (heart inflammation) and RENAL DISORDER (kidney troubles) outcome was unknown.            No concomitant medication were reported. No treatment medication were reported. No lab data reported.   This case was linked to MOD-2021-376600 (Patient Link).; Sender's Comments: This case concerns patient of an unknown age and gender with no relevant medical history reported, who experienced the unexpected serious events of loss of consciousness, thrombosis (AESI) and carditis. The event occurred at an unknown date after the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable since the events happened after the second dose and no additional dosing is expected. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report. Case was assessed as serious due to important medical event and medical judgement.
This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247) via an unspecified route of administration on 28Jan2021 at 12:00 in left arm as a single dose for COVID-19 immunization. The patient's medical history (including any illness at time of vaccination), family medical history relevant to adverse events, concomitant medications, other products and investigation assessment were not reported. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. The patient did not receive any additional vaccines on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccines included flu vaccine and tetanus vaccine which caused sore arm. It was reported that the patient received the COVID vaccine around noon at 12:00 on 28Jan2021 at work and had swelling and redness at the injection site the size of a golf ball. The site of injection was red, a little raised, and warm to touch. She asked if it was normal and was there anything she could look out for. She stated it had been really sore, but she did not look at it because she had long sleeves on. She first noticed it around 16:00 on 29Jan2021. There was no emergency room or physician office visit. Relevant tests were not reported. The outcome for the event vaccination site pain was unknown and for all other events was not recovered/not resolved.  Follow-up attempts are completed. No further information was expected.
BLOOD IN STOOL; TENDER LUMP ABOVE HIS LEFT EYEBROW; FACIAL CONTUSION; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported.  The patient's concurrent conditions included Human immunodeficiency (HIV) infection, seasonal allergy, medical marijuana, alcohol use (glass of wine with dinner), non smoker, and bleeding issues.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042AV1A expiry: UNKNOWN) dose was not reported, 1 total administered on 09-APR-2021 19:30 to right arm for prophylactic vaccination. Concomitant medications included atazanavir sulfate for antiviral, emtricitabine/tenofovir alafenamide fumarate for antiviral, cetirizine hydrochloride for seasonal allergies, amlodipine besilate, and topiramate. He stopped his antivirals medications two days prior to this report and three days after vaccination. On APR-2021, the patient experienced injection site pain. On 10-APR-2021, around noon he noticed a lump above left eyebrow/facial contusion, described as a raised portion the size of a pea, with a red portion an inch by and half. It was tender. It was still present at the time of this report but improved. On 11-APR-2021, after a bowel movement, he noticed fresh blood in the stool around the faeces and afterwards he wiped. On 13-APR-2021, he contacted his healthcare professional (HCP) and they did a coagulation test (NR: not provided) and it was within normal range. He mentioned that the bleeding was a little worse but his HCP was going to retest in a few days.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 12-APR-2021, was recovering from tender lump above his left eyebrow, and facial contusion, and had not recovered from blood in stool.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210431872-Covid-19 vaccine ad26.cov2.s-Blood in stool. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY
Chills & light-headed/dizziness/fatigue started the evening of shot and lasted through the night; next had cold-like symptoms; now is recovered.
Sneezing; Runny nose; Body aches; Fatigue; Moderate nausea/vomiting; Moderate nausea/vomiting; Soreness at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (Sneezing), RHINORRHOEA (Runny nose), MYALGIA (Body aches), FATIGUE (Fatigue) and NAUSEA (Moderate nausea/vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, the patient experienced SNEEZING (Sneezing), RHINORRHOEA (Runny nose), MYALGIA (Body aches), FATIGUE (Fatigue), NAUSEA (Moderate nausea/vomiting), VOMITING (Moderate nausea/vomiting) and VACCINATION SITE PAIN (Soreness at the site of the injection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Runny nose, at an unspecified dose and frequency. At the time of the report, SNEEZING (Sneezing) and RHINORRHOEA (Runny nose) had not resolved, MYALGIA (Body aches), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Soreness at the site of the injection) outcome was unknown and NAUSEA (Moderate nausea/vomiting) and VOMITING (Moderate nausea/vomiting) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Pt recvd 3rd in a series of Engerix-B doses & on 16MAR91 Hepatitis B immune titer indicated no immu A;
Pfizer Dose 1 1/15/21 (NA) Pfizer Dose 2 2/4/21 (NA) Pfizer Dose 3 10/27/21 (FF2593) COVID Positive 3/6/22  3/6/22: A 94-year-old gentleman presented to hospital from nursing home with a history of increasing shortness of breath and hypoxia noted by the nursing staff.  As per medic, patient was noted to desaturate in the 80s on room air.  In the emergency room, he was started on oxygen via nasal cannula that rapidly increased to 15 L high-flow.  He is a poor historian.  Reports shortness of breath.  He was previously on hospice. That was discontinued just about 2 weeks ago.  Patient reports increasing generalized fatigue over the past week as well as exertional dyspnea.  He was apparently complaining of an abdominal pain 2 days ago.  He has a history of Alzheimer disease and pancreatic mass.  3/14/22: A 94-year-old male with dementia with COVID-19 pneumonia and hypoxia requiring oxygen.He is s/p remdesivir ,antibiotics and dexamethasone though did not complete 10 day course steroids as he clinically improved . He is DNR DNI. He needs to be prompted to eat because he would not eat on his own. Otherwise he is hemodynamically stable on room air. He will discharge back to facility.
This was my third shot/a booster.  No effects until Tuesday evening after vaccination.  Chills, Fever, and low grade temperature.  Also had diarrahea and stomach issues.  This is day and symptoms persist.  Highest fever today November 25, 2021 is 99.9.  Normal temperature for me is 97.1.  Cough that is productive today but had cough for 3 days.  Overall feel awful.  Took a home Covid test and it came back negative.  Today seems to be the worse day so far.
Scraped their left sheen; Left sheen swelled a little/swelled a little around the ankle; Was bruised; This spontaneous case was reported by a consumer and describes the occurrence of SCRATCH (Scraped their left sheen), SWELLING (Left sheen swelled a little/swelled a little around the ankle) and CONTUSION (Was bruised) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A, 030L20 and 034F21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included LEVOTHYROXINE, LISINOPRIL, ATORVASTATIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Oct-2021, the patient experienced SCRATCH (Scraped their left sheen), SWELLING (Left sheen swelled a little/swelled a little around the ankle) and CONTUSION (Was bruised). At the time of the report, SCRATCH (Scraped their left sheen), SWELLING (Left sheen swelled a little/swelled a little around the ankle) and CONTUSION (Was bruised) outcome was unknown.            Concomitant medication also included one a day vitamin over 50.  Treatment medication included antibiotic .  Patient states that they had took the antibiotic since 29-Oct-2021, for a week.
SOB, dizzy, O2 Sats dropped, assisted to bed, red blotchy spots, swelling to face, itching abdomen. Medications given. Pt to ICU overnight - not responding to question for 30 min.
10/17/21 BROUGHT TO ER BY FAMILY DUE TO WORSENING SOB, , GENEREALIZED PAN. FOUDN TO HAVE COVID 19 PNEUMONIA PLACED ON BIPAP. WAS ADMITTED TO HOSPITAL AND WAS TRANSITIONED TO COMFORT CARE  AD FAMILY REQUEST. PATIENT DIED 10/18/21.
Two weeks of Flu like symptoms, with extreme bone and joint pain, fatigue, vomiting and headache. Random sharp stabbing pain in random places. Can last for a few seconds or an hour. Tested negative for covid. At end of two weeks, left foot has started going numb in the bottom left side and is spreading. Still extremely tired and feel like upper body strength has decreased.
Patient reports that she received her shot for COVID on 12/30 and within a day it was sore, painful at the injection site with an area of redness and induration. Progressed into a decrease range of motion and pain in neck, arm, and back. PCP prescribed muscle relaxant and icy hot to affected area. It is improving as of today the redness and swelling have improved but still decrease ROM in R arm, shoulder, and hand.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received SHINGRIX for prophylaxis. On 31st October 2018, the patient received the 1st dose of SHINGRIX. On 31st October 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 1st November 2018, the patient experienced injection site erythema. In November 2018, the patient experienced injection site swelling and injection site itching. The patient was treated with TYLENOL, BENADRYL and BENADRYL Cream. On 31st October 2018, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site itching were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling and injection site itching to be related to SHINGRIX. Additional details were reported as follow: The age at vaccination was not reported. The same day of vaccination, the patient experienced pain at the injection site and she treated it with TYLENOL. The next day after vaccination, the patient had the injection site started turning red. Over the next few days, the patient experienced really red, itchy and swollen. The patient was uncomfortable and the patient treated with oral BENADRYL, but it did not really help. About to a day 5, the patient used BENADRYL cream and that was really helped to the patient. It was mostly went away in 7 days. The patient had concerned because she interpreted the literature to expect only 2 to 3 days of discomfort. The patient felt GlaxoSmithKline should do a better job of informing people about these effects and how to treat them. The reporter declined to provide further information and requested to remain anonymous. The reporter declined to provide the physician information. The reporter had not given consent for follow up.
Less sleepy the following day after; Extreme sleepiness; Still tired the next day; This is a spontaneous report received from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534), via an unspecified route of administration in the left arm on 20Mar2021 at 13:30 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history included suffered with chronic system neurological Lyme disease (10 years ago) and concurrent condition included hypothyroid. The patient did not have any allergies to medications, food, or other products. The patient's concomitant medication included levothyroxine sodium (LEVOXYL) for an unknown indication from an unknown date. The patient previously received the first dose of BNT162b2(PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot no: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 21Mar2021, the patient experienced extreme sleepiness and tiredness. On 22Mar2021 the patient experienced less sleepy. The patient reported that she had extreme sleepiness the following day, was still tired the next day, but less so and less sleepy the following day after that. The patient did not received treatment for the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the extreme sleepiness, tired and less sleepy were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
6-7cm erythema of which 3-4 cm is indurated, paresthesias, thrombotic thrombocytopenic purpura throughout. Treated with top. steroids, tylenol.
The patient received a vaccine that had not been stored properly. Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
7/16 developed enlarged lymph nodes and muscle aches. 7/23 developed sore throat, rash on face, back of neck upper chest and upper back. 7/25 both eyes developed conjunctivitis but left eye worse. No fever.
heart went into ventricular tachycardia causing serious motor vehicle accident giving drugs to slow heart rate and icd installed
Sternal, non-radiating chest pressure and pain with associated shortness of breath, fatigue and dry cough
Moderna vaccine inadvertenly given instead of Pfizer vaccine. Both were available at this clinic site, simply wrong vaccine picked up and administered.
I contracted COVID 19 on 3/28/21. I came down with symptoms on 3/27/21. My 3 children tested positive starting on 3/22/21. Symptoms for me have included congestion, sore throat and fatigue
12:00 to 12:30, Welts, red blotches, across chest and now redness is spreading to legs. No dyspnea, but nervous. BP and lung sounds by EMS staff. ER kit with Epi to us at 14:30.