chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mild Tingling in upper left arm left side of neck and face for a few hours, which remitted  After 11pm: low grade fever, body aches and chills, headache
Uncontrollable crying lasting 2-3hrs; No fever; Mom reported leg was swollen & tender @ inject site; 3rd DTP w/no prior adverse rxns;
Patient was in clinic for physical and to receive a covid vaccine on the Providers schedule, the correct Pfizer Covid vaccine was ordered by the provider and the wrong dose was administered to the patient by the nurse. Patient received the 6mo-5 year vaccine
Screaming and fever present that evening and treated with Tylenol. Low grade fever persisted for 6 months accompanied by constant runny nose. 6 months after shots, she had near-miss SIDS and was revived. Followed by 3 more SIDS episodes in hospital requiring resuscitation. Now has untreatable seizure disorder and mental retardation.
Systemic: Exhaustion, Systemic: described by the EMT as a vasovegal reaction. patient passed out and had seizure like reactions. was unresposive and given epi pen. after EMT arrived, patient was monitored and allowed to leave; symptoms lasted 1 day
I had my vaccination on 09/25/2022. I woke up on 09/26/2022 with a temperature cough and headache. I took an home test that was COVID-19 Negative. I went to Urgent Care on 09/27/2022 and tested COVID-19 Positive. I was told I could possibly take Plaxovid but was recommended by a friend to not take just yet due to recent vaccination.
a little bit of sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-MODERNATX-MOC20230519000021.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5, as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Hypertension but controlled with meds. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "a little bit of sore arm"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "a little bit of sore arm"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "a little bit of sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "a little bit of sore arm".  Additional information: Patient received Moderna Covid-19 Vaccine, Bivalent (Original and omicron BA.4/BA.5), Davesomeran, Elasomeran on 09May2023 (Batch/lot number: 016H22A) via intramuscular route for COVID-19 prophylaxis and experienced achy and arm hurt/a little bit of sore arm (vaccination site pain), chills, fever/Low grade fever on 09May2023, which were not recovered at the time of this report. Note to Case Processing Team: "Specific product able to be determined from information provided, the decision tree was not utilized to determine the product. Did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Caller stated that he had his 6th shot last 09May2023, lot number 016H22A. He had the 1st 4 (Pfizer) and the last 2 were Moderna. He stated that he had no reaction after his previous shots except for "a little bit of sore arm". But the last dose of Moderna which he had 8 days ago, in about 7 hours he had a reaction. He stated it was nothing significant - "little chills, fever, achy and my arm hurt, and I expected that and it was okay because I knew that my body was working". After a day or two almost all of them went away except for a low-grade fever. It had been 8 days and he still had fever which is a little less high than it used to be. He had already consulted with his doctor, but he could not give him an explanation. Had there been reports of fever lasting for about a week after getting the vaccine? The caller was in a rush, so he only provided the details of the last bivalent dose, but he agreed with Safety follow up. Preferred method of contact: email. For the reported dose field as Unknown was selected as there is no 6th dose option.  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.
Nausea and vomiting continuously for three hours that afternoon of receiving the vaccine. Felt bad the next day but nothing horrible. A week later experienced what they call Covid arm. So far that has lasted about four days but it is better.
This spontaneous report was received from a vaccine coordinator referring to multiple, unspecified patients of unknown age. The patients' medical history, concurrent conditions and concomitant therapies were not provided. From 18-JAN-2019 to 30-JAN-2019, these patients was vaccinated with improperly stored doses of M-M-R II (strength, dose and frequency were not reported) lot # N025891/ N024698, expiration date 19-SEP-2019/08-SEP-2019. RECOMBIVAX HB (lot # R004185, expiration date 06-NOV-2020), LIQUID PEDVAXHIB (lot # R005118/ R013571, expiration date 28-NOV-2020/19-MAR-2021) and ROTATEQ (lot # R002521/ R013861, expiration date 18-SEP-2019/04-DEC-2019) for prophylaxis. The sterile diluent used to reconstitute M-M-R II was properly stored. The vaccines were exposed to temperature of 47.3 Fahrenheit (F) for 15 minutes and the data logger was involved. There was no previous temperature excursion. This is a non-valid report with no patient identifiers.
Pt developed erythematous papules on soles of feet & palms of hands within minutes of receiving PREVNAR vaccine - resolved with IM BENADRYL.
Upset stomach, no appetite, chills, headache, disorientated.  Temp went as high as 104.6, given Tylenol and put cold rags on extremities, Pulse oximeter read as low as 85and varied to 90.  Applied CPAP and pulse Oximeter began to register 91 Pulse was as high as 103 and blood pressure was 152/92.  This occurred over a time from 4:30 P.M. to approximately 6:40 when temp dropped to 102.8, and 7:45 temp was 101.8, Pulse oximeter was 86-89.  By 9:05 pm Pulse oximeter went to 90 and rose to 92 and then 93 in the next couple hours. Patient had aching all over and felt disorientated the next day.
Chills began approximately 11 hours following dose followed by body aches/pain and fever of 102 for approximately 48 hours, immediately followed by swollen lymph nodes and pain in left arm and left side of neck for approximately 36 hours. All treated with Tylenol per package directions.
Eight days following second administration, rash appeared at injection site along with itching.  This progressed to generalized itching and hives type of rash on the inner surfaces of both arms, head and neck  This pattern of hives and puritis continues until this day  (approx. 25 days post injection.  Itching is relieved by 25-50 mg of benedryl.
Information regarding Prevnar was received from a healthcare professional regarding a 2 month old female patient who experienced elevated white blood cell count and fever of 103 degrees F. At 2 months of age, the patient received a dose in April 2005. The patient also received a dose of haemophilus influenzae type B conjugated vaccine and the first dose of Pediarix in April 2005. At the time of immunization, the patient had an upper respiratory tract infection but no fever. The indication for Prevnar was immunization. Product was administered in April 2005. The dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. Within 24 hours of vaccine administration, the infant experienced an elevated white blood cell count of 36,000 and a fever of 103 degrees F. The child was hospitalized where a septic work up was negative. The fever resolved within 24 hours after the onset. No additional information was available at the time of this report.
2 relatives died; This is a spontaneous report received from a non-contactable reporter (consumer).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), 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: DEATH (death), outcome "fatal", described as "2 relatives died". The date and cause of death for the patient were unknown. It was unknown if an autopsy was performed. Clinical course: The reporter asked why Pfizer COVID-19 vaccine was being recommended while people were dying and what was the content of the vaccine. The reporter then mentioned that her 2 relatives died when they took the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300141692 same reporter, drug, and event; different patient;; Reported Cause(s) of Death: 2 relatives died
W/in 24 hrs p/receiving vax, pt experienced bruising, swelling & redness in her leg.  Seen in ER. Warm soaks to her leg were recommended. Sx did resolve.
Patient fell forward in his chair, briefly lost consciousness and started seizing for about 3-4 seconds. Patient stated he had not eaten all day. Company has an in-house safety/medical team that came over to observe and examine the patient. EMS and fire department arrived as well to further examine patient. He did not want to go to hospital despite EMS recommending it. Patient stated he felt fine as if nothing had happened afterwards.
For days afterward - my arm was swollen, red , hot itchy and sore and that lasted that for about 5 days. I had a slight fever on Saturday night (the night after). It was gone the next day. Then  vaginal bleeding started on the date marked on this report in April. I went to the Clinic. I was fine after taking the Nitro Furatoin. I had another bleeding episode - approximately a month later I went to ER at hospital - May 25, I think. Bleeding has stopped - it wasn't continuous. Have had several doctor visits.
Loss of feeling in left leg and foot; Foot drags when walking.; Nausea; shortness of breath; This is a spontaneous report from a contactable consumer, the patient. A 16-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection: Batch/Lot number: unknown), via an unspecified route of administration, administered in Arm Right on 18Jun2021 09:15 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient's medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 27Jun2021 13:00 Hour, the patient experienced loss of feeling in left leg and foot. Foot dragged when walking. Leg shook when still. Nausea and shortness of breath. The adverse event result in doctor or other healthcare professional office/clinic visit. The patient received treatment for the events. The outcome of the events was not recovered.   Additional information has been requested and will be provided as it becomes available. ; Sender's Comments: Based on current information available, the events mostly represented intercurrent condition in this patient with young age, unrelated to Bnt162b2. Relevant medical history, concurrent disease, trauma history are missing for a medically meaningful assessment.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate
Herpes simplex virus reactivation with every dose.Reactivation with in hours and up to 3 days following each dose. Upper lip; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Nov2022 at 14:30 as dose 5 (booster), single (Lot number: GH9693) at the age of 59 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Batch/Lot No: FJ6369, Location of injection: Arm Left), administration date: 06Aug2022, when the patient was 58-year-old, for COVID-19 immunization, reaction(s): "Oral herpes"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: FE3592, Location of injection: Arm Left, Vaccine Administration Time: 03:30 PM), administration date: 30Nov2021, when the patient was 58-year-old, for COVID-19 immunization, reaction(s): "Oral herpes"; BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: EP6955), administration date: 07Apr2021, when the patient was 57-year-old, for COVID-19 immunization, reaction(s): "Oral herpes"; BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: EP6955), administration date: 17Mar2021, when the patient was 57-year-old, for COVID-19 immunization, reaction(s): "Oral herpes". The following information was reported: ORAL HERPES (non-serious) with onset 17Nov2022, outcome "recovered", described as "Herpes simplex virus reactivation with every dose. Reactivation with in hours and up to 3 days following each dose. Upper lip". Therapeutic measures were not taken as a result of oral herpes.  Additional information: Herpes simplex virus reactivation with every dose. Reactivation with in hours and up to 3 days following each dose. Upper lip.
RASH STARTED 8/14 WITH SEVERE FATIGUE AND BLOODY NOSE. SEEN BY URGENT CARE AND R/T MEASLES VS REACTION TO VACCINE NOTED.
flu; Initial information regarding an unsolicited valid non-serious social media case received from a consumer or non-healthcare professional on 08-Nov-2020.  This case was linked to case 2020SA314739 (same reporter).  This case involved patient (with unknown demographics) who got the flu (influenza), when received INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concurrent condition, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number not reported) via an unknown route at an unknown administration site prophylactic vaccination.  On an unknown date it was reported that, the patient caught the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Night Of Vaccine : Cold Sweat Starting Night, continuing for two days :  102+ Fever Body Aches Shivers  All reactions subsided by third day.
Lower back spasms, 24 hours later paresthesia of rt. foot for 12 hours, 72 hours post-vac muscle fasciculations all over body still happening currently with additional muscle pains esp. in legs and aroms and back starting 2 weeks post vac.
IMMEDIATELY AFTER SECOND SHOT, I HAD A 102 FEVER FOR 2 DAYS. AUG 26, 2021, I WAS HOSPITALIZED FOR LARGE IMPASSIBLE KIDNEY STONE.
Case number PHEH2013US025599, is an initial spontaneous report received from the pharmacist on 10 Dec 2013. This report refers to a 69-year-old female patient. Her medical history and concomitant medications was not reported. She as vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on an unspecified date. On 09 Oct 2013, she experienced shingles outbreak. It was reported that she experienced the same event after getting vaccinated with FLUVIRIN (see case number: PHEH2013US025600). The event outcome was unknown. The seriousness and causality was not reported. No additional information was available.
16JUL 3AM pt woke up w/jerking arm & leg movements, t101 ax; given APAP-jerking cont for aobut 1/2 hr p/APAP administered; cont APAP thru Saturday when no longer had elevated temp
Getting admitted to ICU for suspected (not confirmed) Guillain-Barré syndrome 6 days after flu shot.
THERE WERE NO ADVERSE EFFECTS,  PATIENT RECEIVED AN EXTRA DOSE OF VACCINE, BECAUSE HE DID NOT REMEMBER GETTING A DOSE AT A VACCINATION SITE WHILE HOMELESS
Information has been received from a healthcare worker concerning a 63 year old male patient, who was scheduled to receive ZOSTAVAX (Oka/Merck), received a dose of VARIVAX (Oka/Merck) and had not experienced any known symptoms. Follow-up information was received from a physician reported that the patient received a dose of VARIVAX (Oka/Merck) in September 2008, 9 weeks ago at another clinic and was told to come back in 2 months for another dose of ZOSTAVAX (Oka/Merck). When the patient called the clinic he received the vaccine at, the clinic said they were out of ZOSTAVAX (Oka/Merck), but to call another clinic. The patient called the clinic where the reporting physician was working at. The physician told the patient that ZOSTAVAX (Oka/Merck) was a one time shot. The physician looked into the situation and determined that the patient received VARIVAX (Oka/Merck). The physician recommended that the patient should receive ZOSTAVAX (Oka/Merck), but the clinic had it on backorder until December. The physician was not sure what the patient would do. Additional information has been requested.
EMS brought pt to ED with difficulty breathing; O2 supplementation; pt has dementia; positive for COVID; transferred to ICU; AKI; DNR/DNI; pt's condition worsened and she was transitioned to hospice care with comfort measures; pt passed away in the hospital
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Nov2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in right arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "sarcoidosis" (unspecified if ongoing); "dermatomyositis" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "penicillin allergy" (unspecified if ongoing); "allergies: tomatoes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Allergy"; Erytab, reaction(s): "Allergy"; Ciprofloxacin, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19: the patient received Paxlovid from 30Sep2023 to 04Oct2023 for COVID-19 treatment.  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.
arm pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number G72ZD, expiry date 24th November 2020) for prophylaxis.   On 10th April 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient had arm pain that resolved in a few days. The batch number reported for Shingrix(d72zd) did not exist and was updated to G72ZD, as per sales database. This case has been linked with the case US2019099069, reported for patient's wife.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Apr2021 as dose 1, single (Lot number: er8736) and on 18May2021 as dose 2, single (Lot number: ew0185) at the age of 32 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 04Jan2022 as dose 3 (booster), single (Lot number: 070h21a) for covid-19 immunisation. The patient's relevant medical history included: "chronic sinusitis" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "overweight" (unspecified if ongoing); "Known allergies: cipro (antibiotic)" (ongoing); "Known allergies: azo" (ongoing). Concomitant medication(s) included: ZOLOFT, start date: Mar2020; ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: Nov2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Information: Other medications in 2 weeks were Women's multi vitamin (start date: Mar2020), Mupirocin saline rinse (start date: Apr2022). Patient received Paxlovid from 30Jun2022 for treatment of COVID-19 and experienced Metallic taste in mouth like others report constant smell like boar taint/high alcohol/racid lingering but much more pronounced around warmed foods.; Sender's Comments: Based on possible temporal association the causal role of suspect  cannot be excluded for the reported events.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Local left deltoid edema, erythema and had systemic affect, 2 days, post vax, of larynx.
Information has been received from a company representative concerning approximately one out of ten of a physician's southeast Asian patients who were vaccinated with Hepatitis B vaccine recombinant and Varicella Virus Vaccine Live concomitantly. The patients experienced a painful papular vesicular rash on the bottoms of their feet. The rash appeared in rings. Medical attention was sought. No further information is available.
Red, tender, swollen (L) arm with fever. Treated with KEFLEX and BENADRYL.