chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Stomach ache (very minimal); could not eat the entire day; change in taste; Chills; headache; Terrible back ache; stabbing feeling in my left cheekbone; This is a spontaneous report received from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the left arm on 23Mar2021 at 10:00 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. Medical history included chronic lyme and bartonella (bartonellosis). The patient had no known allergies. The patient received doxycycline (MANUFACTURER UNKNOWN), ceftriaxone sodium (ROCEPHIN) and unspecified herbal anti-inflammatories (MANUFACTURER UNKNOWN) within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 04Mar2021 at 10:00 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 at 01:00 (15 hours after the second dose), the patient woke up in the middle of the night with chills, headache, terrible back ache and a stabbing feeling in the left cheekbone and change in taste. On 25Mar2021 at 09:00 (next day), the patient had stomach ache and could not eat the entire day. The patient did not receive any treatment for these events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events chills, headache, terrible back ache, could not eat the entire day and stabbing feeling in left cheekbone was resolved on 25Mar2021 at 21:00 (all symptoms resolved), whereas for events stomach ache (very minimal) and change in taste was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
5 days after my FIRST COVID shot, I experienced symptoms identical to what others have reported following the second shot:  extreme fatigue, headache, achiness, night sweats, and fever.  I did have a UTI at the time but I believe the symptoms are unrelated to that.  It was a mild UTI and cleared up quickly on antibiotics, while the other symptoms persisted for 3 days.
Pt presently in hospital diagnosed with Guillain Barre after given flu vaccination. Hospital called for this office to report flu vaccine to CDC. 12/29/08-records received for DOS 10/18-10/25/08 and 10/31-11/10/08-DX GBS-Leucopenia. Presented on 11/17/08 with slurred speech and right LE weakness and numbness and gait disturbance. Subsequent admission on 10/31/08-presented with weakness and cyanosis, abdominal discomfort. treated with IVIG. Bilateral facial palsy. Mid to moderate oral dysphagia.Subsequent admission for fever and flank pain.
local reaction to left thigh. large insize. redness and swelling. ~ 5 inch
Unconscious; Felt a bit sore at the injection site; A spontaneous report was received from a consumer and healthcare facility staff member concerning a 69 years old, female patient who experienced little bit sore at the injection site, unconscious and passed away.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 22 Feb 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.   The patient experienced sore at the injection site and unconsciousness both since 22 Feb 2021. The husband of the patient performed CPR as instructed by 911 and EMT's and police performed medical procedure which included injections and electrical shock both on 22 Feb 2021. The patient died on 22 Feb 2021.  Treatment information was not provided.   The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The patient died on 22 Feb 2021. The cause of death was unknown. Plans for an autopsy were not provided.; Reporter's Comments: This is a case of death of a 59-year-old, female patient who experienced injection site sore and became unconscious on the same day after mRNA-1273 administration and subsequently expired. Although critical details such as the patient's medical history and actual cause of death is lacking, based on the current available information which shows a strong temporal association with the product use, thus, a causal relationship cannot be excluded. injection sore is consistent with product safety profile and cannot be excluded.; Reported Cause(s) of Death: Unknown cause of death
30 minutes post vax, the pt's right deltoid became swollen and blotchy. Parents called from home, were instructed to return to clinic. No hives anywhere else on body. Improved while in clinic. No dyspnea. Instructed to use cool compresses and sitz bath.
This spontaneous report was received from a medical assistant referring to an unknown number of patients of unknown age and gender. The patients medical history and concurrent conditions were not provided. Since 01-NOV-2016, an unknown number of patients were vaccinated with improperly stored doses of PEDVAX HIB lot number not reported. Other vaccines improperly stored included VAQTA, RECOMBIVAX HB, GARDASIL 9, M-M-R II, and ROTATEQ. No adverse effects reported. No further information provided. This is one of several reports from the same source. Additional information is not expected. No contact information provided.
A non-serious spontaneous report of twenty-eight patients received expired FLUMIST was received from a health professional concerning an eight-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 20-Feb-2011. The patient received the expired FLUMIST on 02-Mar-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
pericarditis; recurrent nonexertional, positional chest pain; SOB; dry cough with evidence of pericardial effusion and bilateral pleural effusions; dry cough with evidence of pericardial effusion and bilateral pleural effusions; dry cough with evidence of pericardial effusion and bilateral pleural effusions; This is a spontaneous report from a contactable Physician. A 56-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number not provided), via an unspecified route of administration on 01Mar2021 (at age of 56 years old) at single dose for COVID-19 immunisation. Medical history included Asthma. There were no concomitant medications. No COVID prior vaccination. No COVID tested post vaccination. No other vaccine in four weeks. The patient previously took first dose of BNT162B2 (lot/batch number not provided) for COVID-19 immunisation, tioconazole and had Known allergies to Tioconazole. On 02Mar2021, the patient presented with recurrent nonexertional, positional chest pain, SOB (Shortness of breath) and dry cough with evidence of pericardial effusion and bilateral pleural effusions on CTA (Computerised tomogram). ECHO (Echocardiogram) confirming pericarditis. Labs and additional workup negative for AI or malignancy, all lab test in 2021. No. of days hospitalization was 2. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. Treatment received (Colchicine, Ibuprofen) for all events. The outcome of the events was Recovering.  information on the lot/batch number has been requested.; Sender's Comments: Based on data provided, the reported events are assessed as possibly related to BNT162B2. This case will be reassessed upon receipt of further information. 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.
Patient developed a raised, splotchy, red rash on her chest that spans across her upper chest from armpit to armpit. She says it does not hurt, burn, or itch. She says she does not know when it occurred, outside of the fact that it started after she received her first dose of her Shingrix vaccine series. It has been two months since her first dose and the rash is still present.
rash 1 day followed by 1+ redness, swelling, warmness, itchy, below site circumferally rt upper arm;no fever, no sz or severe problem;
Dizziness; Nausea; Clammy; This is a spontaneous report from a contactable consumer (patient).  A 22-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: not provided), via an unspecified route of administration on the left arm on 30Dec2020 10:30 at SINGLE DOSE for COVID-19 immunization. Medical history was none and there were no concomitant medications.  The patient stated that she got the vaccine at 10:30AM on 30Dec2020, and started to have a feeling of dizziness, nausea, and being clammy about 20 minutes after receiving the vaccine. The patient hasn't done any treatment for these yet. It was also mentioned that dizziness, nausea, and being clammy has pretty much gotten worse (not recovered).   Information on the batch/lot number has been requested.
shaking; chills; total body aches; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose,MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: TREMOR (non-serious), outcome "unknown", described as "shaking"; CHILLS (non-serious), outcome "unknown", described as "chills"; PAIN (non-serious), outcome "unknown", described as "total body aches". 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-202101772862 same patient and drug, different dose and similar event
This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 75-year-old female patient who received Herpes zoster (shingrix) (batch number CZ455, expiry date 16th September 2022) for prophylaxis. Co-suspect products included Herpes zoster (shingrix) (batch number 295S7, expiry date 9th October 2022) for prophylaxis. Previously administered products included shingrix (1st dose received on 1st July 2020). On 22nd August 2021, the patient received the 2nd dose of shingrix. On 10th January 2022, the patient received Shingrix. On 22nd August 2021, unknown after receiving shingrix and not applicable after receiving shingrix, the patient experienced drug dose administration interval too long. On 10th January 2022, the patient experienced extra dose administered. On an unknown date, the outcome of the drug dose administration interval too long and extra dose administered were unknown. Additional details were provided as follows: The age at vaccination was not reported. The first dose was administrated on 1st July 2020. The patient received a late second dose of shingrix on 22nd August 2021, which led to lengthening of vaccination schedule. On the 10th January 2022,at the time of reporting a dose of Shingirx was inadvertently administrated to a same patient, which led to extra dose administered. The reporter informed that no further events were reported and agreed to be contacted for follow-up. The reporter consented to follow up.; Sender's Comments: US-GLAXOSMITHKLINE-US2022004286:Same patient and reporter.
BRIEF OVERVIEW: Admission Date: 9/1/2023 Discharge Date: 9/12/2023 Discharge Disposition:  home or self care  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Generalized weakness [R53.1] COVID-19 [U07.1] COVID-19 with multiple comorbidities [U07.1]   HOSPITAL COURSE: 80M with HTN Hypothyroid chronic back pain, wheelchair bound at baseline, post polio syndrome. He resides at LTCF. He reported increased weakness, tiredness,  and dry cough. No fever nor diarrhea   He presented to emergency department workup revealed that he is  COVID positive. CXR showed prominent vascular hila and interstitial markings. He completed 5 days of remdesivir. IV lasix given to facilitate a negative fluid balance. Echo with EF of 55% LVSF nromal no pericardial effusion   Patient did well. His cough improved. He was out of COVID isolation 9/12. He remained asymptomatic while waiting isolation completion. He was discharged on 9/12/2023 back to his living facility in stable condition. It is recommended that patient follow up with his PCP as an outpatient.
5/8 Seen for fever, cough, respiratory symptoms 2 weeks post covid. Improved on antibiotics. ID following and will be discharged home on antibitics with ID follow up.
Developed pain and erythema at the site of yellow fever injection.  Diameter approximately 10cm.  Had reactive pain in muscles, shoulder and side.  Had mild, occasional, residual pain at site one month afterwards. Did not seek medical attention.
PERSISTENT NON-GOING FEVER OF 37.5 WITH PEAKS OF 38.8 AND 39.6, REACHING 40 ON SOME OCCASION, IT IS TREATED WITH ALTERNATING PARACETAMOL AND SPIDIFEN.
TESTED  POSITIVE FOR COVID 9-7-22 , DECEASED 10-10-2022.    WE DO HAVE A REPORT FROM 9-29-22 THAT SAYS SHE WAS ADMITTED TO A HOSP 9-25-22 BUT HAD NO SX OF COVID AT THAT TIME.  HAD A COVID VACCINE J AND J   4-2021  , NO OTHER VACCINES ON THAT DATE.  i ACCIDENTALLY MARKED A BOX IN ITEM 17.
Pt received vaccine and when needle pulled began bleeding small amount. Pressure held. Escorted to observ.ation. Noted on arrival to observation to have large hematoma around puncture site, Pressure held x 5 min. Ice pack applied. Upon questioning, stated that he took ASA daily. Held for 30 min observation. Advised to seek further advice from primary care physician. On final inspection, swelling had subsided. No redness noted
left arm is /Swelling on arm "volume is one of a small egg - perhaps 60 cm^3"; liquid filled under the skin, accumulation of lymphatic fluid on arm; Soft to touch; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left arm is /Swelling on arm "volume is one of a small egg - perhaps 60 cm^3"), SKIN INFECTION (liquid filled under the skin, accumulation of lymphatic fluid on arm) and SKIN SWELLING (Soft to touch) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No  medical history was provided.     On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (left arm is /Swelling on arm "volume is one of a small egg - perhaps 60 cm^3"), SKIN INFECTION (liquid filled under the skin, accumulation of lymphatic fluid on arm) and SKIN SWELLING (Soft to touch). At the time of the report, PERIPHERAL SWELLING (left arm is /Swelling on arm "volume is one of a small egg - perhaps 60 cm^3"), SKIN INFECTION (liquid filled under the skin, accumulation of lymphatic fluid on arm) and SKIN SWELLING (Soft to touch) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Significant follow up appended
Fever; chills; insomnia; felt like had a stomach virus; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Apr2021 (at the age of 19-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other medications (unspecified) within 2 weeks prior to vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 31Mar2021(at the age of 19-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Apr2021 at 00:00 the patient experienced fever, chills, insomnia and felt like he had a stomach virus. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever, chills, insomnia and felt like he had a stomach virus was recovering at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 4/17/21, I had the first dose (Lot EW0164).  Here is a summary of my symptoms following the first dose: ~3 hrs after the vaccine, I had numbness and tingling on left side of my face, including the left side of my tongue (followed by 1st trip to ER). The next day, I had unilateral numbness on the entire left side of my body from the top of my head to the bottom of my foot (followed by 2nd trip to ER that included a CT scan and MRI). The numbness lasted about 3 days, turned to tingling (similar to when your leg ?falls asleep? and starts to ?wake up?), and then pain before the symptoms mostly subsided. A few hours later (this is now 4/20), I had a migraine (I get headaches often, but this was the 3rd migraine that I?ve had in my life ? ibuprofen/Tylenol rotation did not help and only when I was able to finally sleep was there some relief). Following the migraine, the unilateral numbness returned (4/21). A neurologist started me on a 5-day Prednisone treatment; symptoms mostly subsided, but the unilateral numbness returned on the 3rd day of the treatment (4/23). Over the first two weeks following the shot, I logged my daily symptoms as they occurred. In addition to the numbness and the migraine, my log included at various times: other headaches, pressure behind eyes, pressure in one ear, pounding heart (yet normal heart rate), pain in left chest, cramps (legs, feet, side ? noted well hydration), short/sharp pain in side, forgetfulness, body aches, pressure in chest with deep breaths, tired, etc. Weeks 3-4 after the shot, I noted a rash on left leg.   Yesterday, I received my second shot. The symptoms seem to be coming on a quicker timeline. ~75 min after the shot numbess in left face (I was sure to get the shot on the right arm this time, first shot was in  the left arm with left side numbness...this one right arm shot , but still left side numbness). Quickly spread to numbness on full left side of the body. The numbness was present when I woke up this morning and turned to tingling (similar to when your leg ?falls asleep? and starts to ?wake up?) and now pain. I've also noted on my log: forgetfulness (my wife called me loopy), pressure behind left eye, pressure in left ear, pain in right chest (where my heart would be but other side - rather brief)... if I'm on the same path as the first shot with just a faster timeline, the migraine is up next. Plus I've had a few blood tests: 1 was ordered by the neurologist (4/20/21 - no concerns on his end he only noted slightly elevated vitamin D) and another blood test order by primary dr near end of July 2021 to check if i had indicators for Gilbert's syndrome (which my dad has but my blood test results and past blood test results indicate that I don't have it).
Patient reports numbness to left thumb-the same side she had the vaccine administered. Patient denies chest pain, shortness of breath, abdominal pain, dizziness. Vital signs obtained: BP 182/110, 160/98, HR 84, 78; RR 18, 18, SpO2 98% on RA. Patient monitored for 15 minutes with no changes reported.
This spontaneous report as received from a 79-year-old male patient with a pertinent history of atrial fibrillation. In approximately 2010 (reported as 6 years ago), the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml administered subcutaneously (strength, lot # and expiry date were unspecified). Concomitant therapies included warfarin and losartan potassium (manufacturer unknown). On 29-MAR-2016, the patient came down with a case of shingles and also nerve pain at night. The patient sought unspecified medical attention (however, he was not hospitalized), he was given VACLOVIR and gabapentin for the treatment of the events. No laboratory tests were performed. The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported.  Additional information has been requested.
feverishly; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (feverishly) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (feverishly). At the time of the report, PYREXIA (feverishly) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were provided.   This case was linked to MOD-2022-592455 (Patient Link).
Red, raised, itchy papular plaque at site of injection, 12 days later.
Cholesterol level went high after moderna vaccine administration; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD CHOLESTEROL INCREASED (Cholesterol level went high after moderna vaccine administration) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD CHOLESTEROL INCREASED (Cholesterol level went high after moderna vaccine administration). At the time of the report, BLOOD CHOLESTEROL INCREASED (Cholesterol level went high after moderna vaccine administration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported  Treatment information were not provided
mom recv vax &  12MAY97 or 13MAY97 child devel a diffuse chickenpox-type rash;this considered a possible case of secondary transmission;