chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Positive COVID-19 PCR test; Positive COVID-19 PCR test; This is a spontaneous report from a contactable consumer or other non-health care professional. A 78-year-old male patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch number: not reported/ Lot Number: EN6202) via intramuscularly, administered in arm left (reported as left arm) on 03Mar2021 (at the age of 77-year-old) as dose 2, single and received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch number: not reported/ Lot Number: EM9809) via intramuscularly, administered in arm left (reported as left arm) on 10Feb2021 (at the age of 77-year-old) as dose 1, single both for covid-19 immunization administered in public health clinic/facility. Patient's relevant medical history included lung disorder (reported as ling) from an unknown date and unknown if ongoing. Prior to vaccination, patient was not diagnosed with covid-19 and post vaccination, patient was tested for covid-19. Patient's concomitant medications included inhaler (unspecified) for an unspecified indication. The patient did not receive any other vaccine in four weeks. On 08Nov2021, patient had positive COVID-19 PCR test (captured as vaccination failure and asymptomatic covid-19) (medically significant). The patient underwent lab tests and procedures which included COVID-19 PCR test (sars-cov-2 test) resulted as positive (nasal swab) on 08Nov2021. It was unknown if patient received any treatment for adverse event. Outcome of the event COVID-19 PCR test (asymptomatic covid-19) was not recovered and outcome of the other event was unknown.  No follow-up attempts are possible. No further information is expected.
It was reported that a 42-year-old male patient received a TD Adult vaccination on 5/15/01. Reportedly on 5/16/01 the patient developed a fever 102F, fatigue, muscle aches, headache, decreased appetite and muscle jerking. A physician evaluated the patient and prescribed Ibuprofen. Patient is to be re-evaluated in one week. From correspondence received on 7/26/01, it was reported that the patient recovered from this experience. This case is closed.
7APR95 pt recv vax & had t106-febrile sz; all test were neg; no more pertussis to be given; red inc
VASOVAGAL SNCOPE, PATIENT FAINTED WHILE SITTING A LARGE CHAIR WITH ARMS. PT REMAINED IN CHAIR, (DID NOT FALL), DID NOT RESPOND TO  A TAP ON ARM AND VOICE COMMANDS. SMELLING SALTS WERE ADMINISTERED AND PT QUICKLY REGAINED CONSCIOUSNESS. HE REMAINED UNDER OUR IMMEDIATE OBSERVATION FOR 20 MORE MINUTES, REGAINED COLOR WAS ABLE TO STAND AND LEFT WITH HIS WIFE.
Arm felt like on fire red blotchy rash arm itchy at sight of shot, shortness of breath when walking or house work.
Pt recvd vax on 07MAR90.On approximately 25JUL90 pt miscarried & reported to MD was 5 1/2 months pregnant.
redness and swelling at site of injection within 5 minutes. Entire body became red within 7-8 minutes
Information has been received from a nurse concerning an 11 years old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 12-JAN-2017, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (lot # L024993, expiration date 17-OCT-2017, dose and route unspecified) for prophylaxis. The vaccines were stored at 11.6 degree centigrade for 1 hour and 50 minutes. Data logger was involved in the case. There was previous temperature excursion at 9.3 degree centigrade for 50 minutes. No adverse effect was reported. It was reported that the excursion involved a total of three lots of GARDASIL 9. Two lots (L024993 and M024261) were involved in the event "doses of GARDASIL 9 administered after 13-DEC-2016 temperature incident". This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA008047: US-009507513-1703USA002793: US-009507513-1703USA002794: US-009507513-1703USA002795: US-009507513-1703USA002796: US-009507513-1703USA002797: US-009507513-1703USA002798: US-009507513-1703USA002799: US-009507513-1612USA007442: US-009507513-1702USA010448:
24 hours after injection experienced fever 99.1-101.2, chills, muscle soreness in neck and lower back, upper abdominal pain, diarrhea, severe fatigue, night sweats.  This has been going on for 6 days now.  Muscle soreness and diarrhea have subsided recently.  Low grade fever, mild upper abdominal pain, fatique and night sweats still persist.
Shingles; products liability - defective design/ manufacturing defect; Information has been received regarding a case in litigation from a lawyer and refers to a currently 79-year-old patient of unspecified gender. No information was received regarding medical history, concurrent conditions, or concomitant medications.  On approximately 27-DEC-2013 (reported as on or about December 27, 2013), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, strength, route and site of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions.  On an unknown date, the patient experienced shingles. On an unspecified date, the patient was treated due to the event at a medical center. The patient claimed damages as a result of: Injury to themselves; Loss of consortium; Loss of services; Economic losses. The following claims were asserted: negligence; products liability - defective design; products liability - manufacturing defect; products liability-failure to warn; breach of express warranty; breach of implied warranty; fraudulent misrepresentation; fraudulent concealment; negligent misrepresentation; unjust enrichment; strict liability; consumer fraud; loss of consortium; punitive damages. The outcome of the events was not provided. The causality between shingles and the suspect therapy was reported as related. The causality between the product quality issue and zoster vaccine live (ZOSTAVAX) was not provided.
unstated serious reaction 3 hrs p/vax; hospitalized; 2MAY94 no response for request for addtl info;
HYPOTENSION 7/31/2022 DISCITIS OF CERVICAL SPINE    ESRD (END STAGE RENAL DISEASE)  ACUTE RESPIRATORY FAILURE 9/1/2022 DISCITIS OF CERVICAL SPINE    ESRD (END STAGE RENAL DISEASE)  RESPIRATORY FAILURE, UNSPECIFIED ACUITY 8/22/2022 DISCITIS OF CERVICAL SPINE    ESRD (END STAGE RENAL DISEASE)  HYPOTENSION 7/31/2022 ESRD (END STAGE RENAL DISEASE)  ACUTE RESPIRATORY FAILURE 9/1/2022 ESRD (END STAGE RENAL DISEASE)  RESPIRATORY FAILURE, UNSPECIFIED ACUITY 8/22/2022 ESRD (END STAGE RENAL DISEASE)  HYPOTENSION 7/31/2022 ESRD (END STAGE RENAL DISEASE)  ACUTE RESPIRATORY FAILURE 9/1/2022 ESRD (END STAGE RENAL DISEASE)  RESPIRATORY FAILURE, UNSPECIFIED ACUITY 8/22/2022 ESRD (END STAGE RENAL DISEASE)
I got my booster shot at 4:45pm on a Friday.   The next morning I woke up at 4am feeling nauseous and I vomited. At 6am I woke up and vomited again. I had a fever of 102.4, body aches, and a headache. At about 8am I vomited again.  By 2pm I felt well enough to eat a little and I took 1000mg Acetaminophen.   At 8pm (27 hours after my booster shot) my fever peaked at 104 degrees. I was shivering under five blankets. I took 1000mg Acetaminophen at 8pm. At 9pm my fever had reduced to 102.3. At 11pm my fever was down to 100.2 and I took 600mg ibuprofen.   The third day my fever peaked at 5pm at 101.3 (I had taken 1000mg Acetaminophen one hour before).   The fourth day I had no fever and felt back to normal.   (I had a nearly identical experience with nausea/vomiting after my second shot of Pfizer, but my fever got much higher after the booster shot.)
booster; nauseous; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program (141003).  A 53 year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for COVID-19 immunization.  The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; NAUSEA (non-serious), outcome "recovered", described as "nauseous".  The lot number for COVID-19 Vaccine - Manufacturer Unknown was not provided and will be requested during follow up.
booster dose; I have developed a large lump in my left armpit the size of a baseball, lymph nodes very swollen.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Dec2021 14:15 (Lot number: FL3198) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PROBIOTICS; DIGESTIVE ENZYMES. Vaccination history included: Bnt162b2 (Previous dose details: , Previous dose product=COVID 19, Previous dose brand=Pfizer, Previous dose brand unknown=False, Previous dose lot number=ER8729,, Previous dose lot unknown=False,, Previous dose administration date=02Apr2021, Previous dose number=2, Previous dose vaccine location=Left arm), administration date: 02Apr2021, when the patient was 41 years old, for Covid-19 immunization, reaction(s): "I have developed a large lump in my left armpit the size of a baseball, lymph nodes very swollen"; Bnt162b2 (Previous dose product=COVID 19, Previous dose brand=Pfizer, Previous dose brand unknown=False, Previous dose lot number=EN6306,, Previous dose lot unknown=False, Previous dose administration date=12Mar2021, Previous dose number=1, Previous dose vaccine location=Left arm), administration date: 12Mar2021, when the patient was 41 years old, for Covid-19 immunization, reaction(s): "I have developed a large lump in my left armpit the size of a baseball, lymph nodes very swollen". The following information was reported: IMMUNISATION (non-serious) with onset 30Dec2021 14:15, outcome "unknown", described as "booster dose"; LYMPHADENOPATHY (non-serious) with onset Dec2021, outcome "recovered with sequelae", described as "I have developed a large lump in my left armpit the size of a baseball, lymph nodes very swollen.". The event "i have developed a large lump in my left armpit the size of a baseball, lymph nodes very swollen." was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient went to pharmacy or Drug Store for the Facility type vaccine. The patient did not receive other vaccine in four weeks. After each Covid vaccine the patient developed a large lump in her left armpit the size of a baseball, lymph nodes very swollen. Lump took weeks to go down. Got an MRI of the area in Aug2021, no cancer detected. The patient did not have Covid prior vaccination. The patient tested Covid post vaccination. The patient did Nasal swab for Covid test post vaccination. Covid test result was Negative. No Known allergies. No Other medical history.  No follow-up attempts are possible. No further information is expected.
Nauseous; Loose stools; Sick ever since; Arm started hurting; Felt achey; Fatigue; A spontaneous report was received from a 57-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced "sick ever since", arm started hurting, felt achey, fatigue, nauseous and loose stools.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 23 Dec 2020 around 2pm, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 24 Dec 2020, at 2 am, the patient stated that her arm started hurting, she felt achey, fatigue and thought nothing of it. She took paracetamol for the achiness.   On 25 Dec 2020, the patient started to feel nauseous, had loose stools and felt more fatigue. Treatment information was not provided.   On 28 Dec 2020, the patient took a "cold test" that came back negative.    On 29 Dec 2020, she still feels fatigued.   Action taken with mRNA-1273 in response to the events were not reported.   The outcome of events, "sick ever since", arm started hurting, felt achey, nauseous and loose stools, were unknown. The outcome of the event, fatigue, was not resolved.   The reporter did not provide an assessment for the events.; 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.
Pain when raising arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain when raising arm) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain when raising arm). At the time of the report, PAIN IN EXTREMITY (Pain when raising arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Woke up on the morning of May 26, 2021 with complete hearing loss in my right ear.  I was experiencing extreme vertigo and collapsed - was taking to Emergency Room. where I was diagnosed with BPPV and had a CT scan which was normal.  I was released with a prescription of Prednisone (50 mg) to take for five days with the hope that my hearing would be restored.  On June 1 I visited the Emergency Dept. because I still had no hearing in my right ear - I was completely deaf.  I was diagnosed almost immediately with Sudden Sensoineural Hearing Loss (SSHL) or "sudden deafness."  I was put on 19 days of high-dose steroids, 14 days at 60 mg. then taper off.  I visited a specialist at the hospital when I was on Day 13 of the therapy, and he began a series of 4 injections of steroids directly into the ear.  I have now completed that series of injections with no change in my hearing.
My daughter had her 18 month well baby and received DTAP, Flu and HEP A around 0930. My wife noticed spots on her tongue, lips and around her mouth. We took her to the ER for a quick look. She had no airway issues; however, her tongue seemed to be irritating her. After almost 3 hours in the ER waiting room I decided to take her home and continue BENADRYL and TYLENOL.
No additional AE details or Pqc; administered expired vaccine of MMR II; This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.   On 26-AUG-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II) lot # S015961, expiration date: 23-MAY-2021, 0.5 milliliter (strength, dosing schedule and route of administration was not provided) for prophylaxis. Administered dose of vaccine was reconstituted in a sterile diluent, lot# S016862, expiration date reported as: 20-SEP-2022, but upon internal validation established as 09-FEB-2022. There was no previous temperature excursion noted. No additional adverse event details provided.
little reaction around his arm; This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th December 2019, the patient received Shingrix. On 9th December 2019, 1 days after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was recovering/resolving.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were received as follows: This case was reported by the reporter for her husband. The reporter stated that the patient had a little reaction on his arm after his Shingrix injection. The reporter did not consent to follow up.
both legs were red and very swollen.; both legs were red and very swollen.; was extremely irritable crying.; Initial information received on 13-Oct-2021 regarding an unsolicited valid serious case received from a physician under reference number: US-SA-SAC20211018000115.  This case involves a two months old and unknown gender patient who was experienced both legs were red and very swollen (peripheral swelling), (erythema) and was extremely irritable crying (crying). while receiving DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE [PENTACEL], ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.  It was unknown if the patient had any concomitant disease or risk factor.  On an unknown date, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number and expiry date not reported via intramuscular route in unknown administration site, a dose of suspect ROTAVIRUS VACCINE not produced by Sanofi Pasteur lot number and expiry date not reported via oral route in unknown administration site and a dose of suspect PNEUMOCOCCAL VACCINE produced by unknown manufacturer lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination respectively.  On an unknown date the patient developed a serious events both legs were red and very swollen. (peripheral swelling), (erythema) and extremely irritable crying. (crying) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE, ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE.   These events were leading to congenital anomaly.  It was unknown if there were lab data/results available.  It was unknown if the patient experienced any additional symptoms/events.  It was not reported if the patient received a corrective treatment from the events.  At the time of reporting, the outcome was unknown for the events.  There was be no information on the batch number for this case.; Sender's Comments: This case involves a two months old and unknown gender patient who experienced peripheral swelling, erythema, crying (unknown latency) after vaccination with PENTACEL, ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE The time to onset is unknown. There is no further information regarding patient's medical condition at the time of vaccination and laboratory tests ruling out other alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Fever of 101.1,  soreness, exhaustion, diarrhea for approximately the first 36 hours; rash at injection site after 48 hours
His leg has been burning and aching/Legs started to burn and ache after second vaccine; His leg has been burning and aching/Legs started to burn and ache after second vaccine; Sleep problems after second vaccine; he got delusional at night.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 76 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 (Lot number: EW0162, Expiration Date: 31Jul2021) at the age of 76 years as dose 2, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Verbatim: high blood pressure" (unspecified if ongoing); "Covid long haulers" (unspecified if ongoing), notes: The first vaccine took away some of his long-haulers symptoms. Concomitant medication(s) included: OLMESAR taken for hypertension; AMLODIPINE BESILATE taken for hypertension. Vaccination history included: Bnt162b2 (First vaccine: Pfizer Bio-NTech COVID19 Vaccine, 0.3 mL.  LOT number which the internet would not let him fill in to report online is ER8727 and expiration 31Jul2021.), administration date: 19Mar2021, for COVID-19 Immunization. The following information was reported: BURNING SENSATION (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "His leg has been burning and aching/Legs started to burn and ache after second vaccine"; SLEEP DISORDER (non-serious), outcome "unknown", described as "Sleep problems after second vaccine"; DELUSIONAL DISORDER, UNSPECIFIED TYPE (non-serious), outcome "unknown", described as "he got delusional at night.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: He reports taking his first Pfizer Covid vaccine dose on 19Mar2021 and his second Pfizer Covid vaccine dose on 09Apr2021. On 11Apr2021 he reports that his leg has been burning and aching. He reports having a history of Covid long haulers. Caller states he is calling about the Pfizer Covid-19 Vaccine because he got the shot 2 weeks ago last Friday. He had Covid once in August and once again in December. Then, he waited 90 days after December after he tested negative. Patient description, he would go to sleep and sleep an hour and then would wake up and would count jellybeans. Caller adds he is lying, and means he would count 1 to 10, and 1 to 10, for the next 7 hours. Caller adds that the second vaccine gave him this same symptom. It was very, very bad the first night and he only slept for one hour. The second night, it was very very slight. Then, by the end of the second day he had leg pains but no more sleep problems. Tylenol and extra strength arthritic tylenol were taken as treatment, no other vaccinations within four weeks prior to the first administration date of the suspect vaccine.  No follow-up attempts are possible. No further information is expected.
5 hours following the administration of the Flu Mist, the child began to vomit approximately every 20 minutes which lasted about 8 hours.  Fever started at night, was about 101 degrees and lasted about 10 hours.  She also started to cough.  The rash developed on 11/23/07, about 7 days after the shot was given. Rash began at the ankles, was bright red with what looked like bruising underneath the rash in some areas on her legs.  It continued from her belly button to her elbows.  The rash had very little itching.  When the rash began, patient's mother treated her with benedryl and the redness of the rash faded.  The family was on vacation so the patient was taken to the Clinic.  Blood work was done and her urine was checked.  Mother was told they felt the rash was associated with the Flu Mist nasal vaccine due to the bruised look under the rash on her legs.  The Clinic consulted with a hospital who agreed.  Although the rash has faded, it is still very visible and covers her legs. On the rest of her body, it has almost disappeared.  03/07/2008 MR received for ER visit 11/23/07 with DX: Hypersensitivity vasculitis 2' to FluMist vaccine. Infant presented to ER with rash which was spreading.  Infant had developed vomiting and fever on the day of vax which subsided. PE(+) for confluent, purpuric petechial rash from the waist down.  Impression of Henoch-Schonlein purpura.
A couple of hours after my son got his 1st Pfizer covid vaccine, he had a breakout of hives on his chest, neck, back, chin, and thighs. The hives lasted for 3 days. We gave him Xyzal before bedtime, it helped him feel better.