chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Blood clot in her leg; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot in her leg) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clot in her leg) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood clot in her leg) outcome was unknown.            Concomitant product use was not provided by the reporter.  The patient had a blood clot in her leg.  Company Comment: This case concerns a  female of unknown age  with  no reported medical history , who experienced Non-serious , unexpected event of thrombosis which occurred on an unknown date with an unknown dose of mRNA-1273 vaccine (Moderna Covid 19 vaccine ) . The re-challenge is unknown since the outcome of the event is unknown. The benefit-risk relationship of mRNA-1273 vaccine ( Mdoerna Covid 19 vaccine ) is not affected by this report. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow up received on 10-NOV-2021 contains no new information.; Sender's Comments: This case concerns a  female of unknown age  with  no reported medical history , who experienced Non-serious , unexpected event of thrombosis which occurred on an unknown date with an unknown dose of mRNA-1273 vaccine (Moderna Covid 19 vaccine ) . The re-challenge is unknown since the outcome of the event is unknown. The benefit-risk relationship of mRNA-1273 vaccine ( Mdoerna Covid 19 vaccine ) is not affected by this report.
Burning in calves and involuntary twitching of feet and toes.  Nausea.  Heart palpitations.  These symptoms still exist 4 months after receiving the vaccine.
I had a pain in my right leg behind my knee. I could not bend that leg and almost wondered if it was a blood clot. After 30ish minutes or so it vanished. I had never felt anything like that before.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    Concomitant medication was not provided. Treatment medication was not provided
The shot don't work/Suspected vaccination failure; The shot don't work; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Covid-19 vaccine.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 31-OCT-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient stated that the shot did not work just like Covid shot, more bull and more bull and so on. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible, as no contact, details were available.
Alopecia universalis; This is a spontaneous report from a contactable physician. A 51-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via intramuscular route of administration on 20Dec2020 (at the age of 51 years-old) as a single dose for COVID-19 vaccination.  Medical history included erectile dysfunction and GERD. The patient had no known allergies. The patient's concomitant medications were not reported.  It was unknown whether the patient received any other vaccine within 4 weeks prior to the vaccine.  The patient was not diagnosed with COVID prior to vaccination. The patient was tested for COVID post vaccination on an unknown date and the COVID test result was negative. On 21Dec2020 the patient experienced alopecia universalis- onset after 1st shot, mild. The event alopecia universalis resulted in a physician office visit. The patient was treated for the alopecia universalis with Minoxidil, allegra, prednisone started on 08Feb2021. The clinical outcome of the alopecia universalis was not recovered.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. The patient's relevant medical history was not reported. On 04-NOV-2014, the patient was vaccinated with a dose of M-M-R II (therapy type, route, dose, frequency and lot # were not reported) which underwent an excursion. This is one of several reports received from the same source. Additional information has been requested.
mom noted elevated temp the following morning;t104 ax;temp lasted approx 12-18hrs;no temp following day;not particularly fussy;slept well;used APAP;
Next day patient called -> chief complaints: soreness/pain injection site, redness/swelling more than 2'" diameter. No other symptoms, localized to injection site.
On 3/29/99, the pt received her 1st Lymerix. In April, 1999, the 2nd dose was given and some time after either the 1st or 2nd dose, she experienced mid to lower back pain (moderate to severe) and progressed quickly. In May, the pt reported she had a sudden onset of sciatic nerve pain which radiated down her left leg. She went to an othopod and had an MRI of her back which revealed "arthritis and inflammation". She had physical therapy until August, 1999. From July to August, 1999, she had a sudden onset of right heel pain and was dx'd with plantar fasciitis treated with supportive shoes and she was not to go barefoot. The back pain continued despite physical therapy. In 1/00, she saw a different orthopod and was noted to be "walking funny". Walking was painful, and she was prescribed Celebrex which relieved the pain and enabled her to walk better. A second MRI in 1/00, again showed inflammation and arthritis of her spine. In 3/00, the pt received the 3rd Lymerix. The most recent information received on 8/4/00 reports the pt's pain intensity increases with activity.  A follow up report received 2/2/2001 adds: This report was received from a pt and has been verified by the primary care physician. Concurrent medical conditions included a penicillin allergy, foot arthropathy, a narrowing of lumbar 5 and sacral 1 of back due to osteoarthritis, and hypercholesterolemia. Concurrent medications included atorvastatin (Lipitor) and estradiol (Estrace). On 03/29/1999 the pt received her 1st injection with Lymerix. On 04/26/1999 the 2nd dose was given.... Follow up from the primary care physician revealed confirmation of back pain and right heel pain only. These symptoms were not considered permanently disabling. To the reporting physician's knowledge, the joint complaints were not evaluated by a physician nor have any lab tests been performed for arthritis. The info received on 08/04/2000 reported the pt's pain and ability to walk has been manageable with the use of Celebrex but the pain intensity increases with activity. The plantar fasciitis "is not bad if she wears supportive shoes and has minimal intense activity when barefoot". The latest info on 10/17/2000 from the physician did not provide an outcome. The events of arthritis, inflammation, back pain, sciatic nerve pain, plantar fasciitis and heel pain do not meet ICH serious criteria but are being submitted as an expedite report by special FDA request per the 6/28/2000 letter.
ACCORDING TO SIIS PATIENT GOT PFIZER COVID 19 VACCINATION AT SAMS CLUB ON MAY 5, 2021.  PATIENT CAME TO OUR PHARMACY ON 05/19/2021 AND GOT A JANSSEN VACCINATION.  PATIENT MARKED ON OUR FORM THAT HE HAD NOT HAD ANY OTHER COVID VACCINES PREVIOUSLY.  WE CALLED THE SAMS CLUB AND THEY VERIFIED PATIENT DEMOGRAPHICS THAT HE GOT THE PFIZER VACCINE FROM THEM.  CALLED PATIENT AND ASKED HIM AND HE STILL SAYS HE HAS NOT PREVIOUSLY GOTTEN ANY OTHER COVID VACCINATIONS AND DENIES GETTING A DOSE OF PZIFER ON 5/5/21.  NO ADVERSE REACTIONS REPORTED.
Inflamed upper arm deltoid 40 x 40 mm, red, temp 98.4, child c/o no pain.
received first dose , Moderna feb 5th - symptoms onset was friday  2/12, experiencing skin pain , she states that anything that touches her skin, it hurts, she states its not pain, but more sensitivity.
PT DEVELOPED A RASH IN EACH ARMPIT. PT SAID RASH WAS BURNING.  THE RASH WAS CIRCULAR WITH THE CENTER NOT INVOLVED. RASH LOOKED DRY A  LITTLE SCALY. PT STATED SHE HAD NEVER HAD THIS RASH BEFORE. PT DID NOT SEEK MEDICAL TREATMENT.
Dizziness and feeling faint, nausea, fever, chills, tingling in my arms and hands, tingling in my tongue, extreme weakness. Every time I opened my eyes, the room would spin.  All occurred for the full night starting around 10:30 pm the evening of the vaccine and ending by 8:00 am the next morning. The following day I still had a fever, had a headache, fatigue, and felt like I'd been hit by a bus.  From the third day on, just some tiredness and a sore arm. It's been thirteen days since my vaccine and my arm is still sore but all other symptoms have gone.
VACCINE GIVEN AFTER FROZEN; VACCINE ACCIDENTALLY STORED IN FREEZER FOR APPROXIMATELY 4 TO 5 DAYS; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. 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,and batch number: 207A21A expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced vaccine given after frozen, and vaccine accidentally stored in freezer for approximately 4 to 5 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine given after frozen and vaccine accidentally stored in freezer for approximately 4 to 5 days was not reported. This report was non-serious.
Tonight after a movie she complained that her face was tingling she got very scared and didn?t u set stand why she had pins and needles feeling in her cheeks eyes nose and face but not her forehead. Waited made her drink water watched her checked her pulse sitting at 67bpm standing about 80 bpm after 30 mins it went away and now she?s tired and wants to sleep.
pt recvd vax; 26oct95 exp approx 30 lesions & low grade fever;
This spontaneous report was received from a licensed practical nurse and refers to a 27-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date (at 1 year of age), the patient was vaccinated with the first dose of M-M-R II (dose, route of administration, lot# and expiration date were not provided). On an unknown date (at 27-years of age), after prolonged interval, the patient received the second dose of M-M-R II (dose, route of administration, lot# and expiration date were not provided). No adverse effects were reported. Additional information has been requested.
SUPER ILL; REALLY HIGH FEVER IT WAS TERRIBLE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unknown) dose was not reported, administered on 02-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 02-JUL-2021, the subject experienced super ill. On 02-JUL-2021, the subject experienced really high fever it was terrible. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the super ill and really high fever it was terrible was not reported. This report was non-serious.
Fever 102.5 fahrenheit/fever from 99.4 to 102.5 Fahrenheit; Headache; Chills; This is a spontaneous report from a contactable consumer (patient)  A 34-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot EL9262) on 27Jan2021 at 17:00 at single dose in Right arm for COVID-19 immunization.  Medical history included migraine from 2016 (reported as from 5 years).  Concomitant medication included propranolol. Previously, on 06Jan2021 at 19:00 patient received the first dose of the vaccine (lot EL1685) at single dose  in left arm for COVID-19 immunization and he had no effects to report. On 17Dec2020 patient received Flu vaccine for immunization.On 28Jan2021 at 17:00 the patient experienced fever 102.5 Fahrenheit/ fever from 99.4 to 102.5 Fahrenheit; on 28Jan2021 he also had headache and chills. No treatment given for fever; patient has taken three 650 mg Tylenol, one every few hours, but his headache was still the same. Final outcome of all the events was reported as not recovered. Patient asked if the temperature 102.5 was normal or should go to the hospital.
Pt's arm became red after injection. One hive appeared shortly after. PT was given BENADRYL and stayed at office for observation for 30 minutes. Pt developed scattered hives the next day. All resolved.
We did not discard the extra volume in the vial during our initial clinics.  I came to realize this was not authorized under the EUA after the fact and ceased pooling doses after the first four clinics on 3/10, 3/11, 3/12 and 3/13/21. When we reported the extra doses, we were advised to cease pooling doses and report to VAERS, citing EUA guidelines.  We noticed that some of the vials had enough residual volume to pull a full 6th dose and did so from 6 vials at our clinic 3/16/21. When we reported that information, we were then advised to cease pulling any residual volume from any vial, so we have not done so since.
I had a strange reaction to the first COVID Vaccine; 2 weeks after shot arm swelled and injection site a large lump in arm; 2 weeks after shot arm swelled and injection site a large lump in arm; The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on [10Aug2021], this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (Lot Number: EN6251), via an unspecified route of administration, administered in left arm, on 15Feb2021 11:00, as dose 1, single for COVID-19 immunisation.  The patient medical history was not reported. Prior vaccinations and concomitant medications were reported as none. On an unspecified date, the patient had a strange reaction to the first covid vaccine, also 2 weeks after shot, on 01Mar2021, arm swelled and injection site with a large lump in arm. It lasted for 2 weeks. No relevant lab tests were done in response to the event. The outcome of the event had a strange reaction to the first COVID vaccine was unknown and of other events was recovered in Mar2021.  Follow-up attempts are completed. No further information is expected.  Follow-up (10Aug2021): New information from a contactable consumer (patient) includes: the case was updated as valid, new events added.  Follow-Up (18Aug2021): Follow-up attempts are completed. No further information is expected.
This case was reported by a consumer via other manufacturer and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 1st June 2018, the patient received the 2nd dose of SHINGRIX. On 2nd June 2018, 1 days after receiving SHINGRIX, the patient experienced fever. On 3rd June 2018, the patient experienced chills. On 4th June 2018, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the fever, chills, injection site pain and injection site erythema were unknown. It was unknown if the reporter considered the fever, chills, injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On an unspecified date in 2018, two months before the date of reporting, the patient received 1st dose of SHINGRIX. Two days after receiving SHINGRIX, the patient experienced chills. Three days after receiving SHINGRIX, the patient experienced soreness and redness at the injection site. The patient refused to provide their full contact information and their physician's contact information. No further information was reported.
VARIVAX administered post temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown gender and age. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 27-AUG-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, 0.5 milliliter (lot number S032355 which has been verified to be valid, expiration date 14-OCT-2021) (route of administration and anatomical location were not reported), for prophylaxis. The vaccine was reconstituted with sterile diluent (dose reported as 0.5 milliliter, frequency reported as once and it was unknown if it was improperly stored as well). The vaccine was exposed to temperature of -2.8 degrees Celsius for 5 hours 2 minutes. Digital data logger was involved. There was no previous temperature excursion.
1.5 days after vaccines give pt began being dazed, inactive - only responding for basic needs - to eat sleep. 1 week later she began hitting self in head, crying for no reason. Symptoms gradually resolved 3.5 weeks after vaccine given.
THE PATIENT PRESENTED TO THE ED WITH NAUSEA/VOMITING/CONFUSION. SHE TESTED POSITIVE FOR COVID.
made my husband and I sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK receipt date: 05-AUG-2022 Reporter's comment: The case was reported by the consumer via interactive digital media. The patient was sick and did not took second dose.  The follow-up could not be possible as no contact details were available The case had been linked with US2022AMR116795 reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2022AMR116795:Same reporter
Pt hospitalized for COVID19 on 6/20/21.  Sick for about 1 week prior to hospitalization.  Exposure to family member that was positive.
Gave Novartis H1N1 vaccine (4 yrs and older) 0.5ml IM. Should have given Sanofi Pasteur H1N1 vaccine (6 months and older) 0.5ml IM. No signs or symptoms of distress noted.
1.  Acute thromboemboli within the distal right middle cerebral artery M1 segment and proximal right middle cerebral artery M2 segment with intermediate collateral flow. 2.  Moderate hypoenhancement of approximately one half of the right middle cerebral artery distribution parenchyma, compatible with oligemia/infarct.  Treatment was tPA  Discharged from hospital 2/27/2021
i developed deltoid bursitis per the urgent car Dr i saw. He prescribed steroids for 5 days. pain and discomfort resumed after finishing the steroids
Temp 98 degrees F on 4/19/04. Erythematous macules, vesicles, some scabs seen on scalp, trunk, legs, penis.
Patient presented about 48 hours later with morbilliform exanthem and fever to 101. Increasing fussiness and poor oral intake over next 24 hours. Now with diagnosis of Kawasaki Disease.
Intermittent fevers for past 24 hours. Max temp 102. Temp does respond to tylenol. Excessive irritability. Twitching with falling asleep. Vomited x3 on 4/16/19 Received Dtap Hib Prevnar 13 4/16/19. Mom reports an hour after vaccines started with excessive irritability. Temp intermittent since vaccines - high 102. Temp does respond to tylenol. 4/16 -3 episodes of vomiting 4/17 seen in office for symptoms.
Immediately after the injection I was having right pectorals and sub scapular pain. Two days after, I began developing numbness in right arm. Three days after I began to experience numbness and tingling in bilateral feet as well. Four days later I began to experience left hand and arm numbness and tingling as well. Six days after I am now developing bilateral axilla tingling as well as tingling up into the medial thighs and occasionally into the right mandibular region.
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: where patient points to inject being made and where redness and swelling appears is approximately 2" from the top of shoulder, patient is a nurse at local outpatient facililty and was concerned about the injection as soon as it was given, said it sseems rather high to her. patient also noted large amount of fluid leaked back out down arm.
Mother called and stated that patient had hives and stiff arms and legs within 24 hours of getting immunizations. Mother called Dr.'s nurse and she advised mother to give benedryl and call and report to the Health Dept.