chrisvoncsefalvay/vaers-outcomes huggingface dataset:
all her pain was gone/the pain disappeared again; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 21Oct2021 (Lot number: FF2590) at the age of 74 years as dose 3 (booster) single, administered in arm right, administration date 06Feb2021 (Lot number: EL9262) as dose 2, single and administered in arm right, administration date 16Jan2021 (Lot number: EL8982) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (ongoing), notes: Verbatim: Diabetes; "Asthma" (ongoing), notes: Verbatim: asthma; "Overweight" (ongoing), notes: Verbatim: Overweight; "lipids were elevated for years" (unspecified if ongoing), notes: states the lipids were high prior to her receiving the Pfizer COVID Vaccine and the lipids were elevated for years. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 2021, outcome "recovering", described as "all her pain was gone/the pain disappeared again". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller said she had chronic pain even before the Pfizer COVID Vaccine and mentioned she already received both doses of the vaccine and her booster dose. States she received the 1st dose of the vaccine and the next morning all her pain was gone; states the pain came back gradually in Oct2021 and after she received the booster dose in Oct2021 the pain disappeared again; states she can walk more, her hands are usable and she can do more and whatever is in the vaccine is helping her with the pain and she can still feel the pain but it is not as severe. Caller states the pain came back in Sep2021 and Oct2021 gradually and she had the booster vaccine in Oct2021 and by then the pain was full back. States other than a blood test done she did not start any new medications and states she does not have cancer; states her lipids were high and they had been high for a long time so that was the reason she went to see if there was something going on and her nurse practitioner didn't want to miss anything and her lipids were high all the time; states the lipids were high prior to her receiving the Pfizer COVID Vaccine and the lipids were elevated for years and did not want to take a chance; states she went to Cancer # and they did a blood workup and there was not anything to be worried about and for her to come back in a year for more blood work; states she had the extensive blood work done and if there is anything that might help she will turn over the blood work results.  Follow-up attempts are completed. No further information is expected.
Nursing Home resident given Janssen COVID-19 vaccine during On-Site clinic and Rehab.  Sponsor consented to resident receiving vaccine and resident/facility denied resident receiving any prior dose of COVID-19 vaccine.   After vaccination completed upon reporting  it was noted that a dose of Janssen COVID-19 was given at a Dialysis clinic the week prior.  Pharmacy reported to facility to verify accuracy. Facility nor sponsor were aware or notified about a prior dose of COVID-19 vaccine.  Dialysis clinic verified dose was given.  Doctor notified.  Resident had mild nausea the day after vaccine, but resolved and no other side effects noted.
Patient reported that she began to notice hives in the afternoon. She took one dose of benadryl and noticed a difference.  She mentioned that she didn't have any swelling of the lips, tongue, or throat.
patient said they felt that they were experiencing increased migraines, body aches and runny/stuffy nose at 1 week post vaccination
Arm pain, rash, redness, chills, streaking to axilla, infection, treated with ibuprofen and Augmentin.
Herpetiform (zoster) eruption localized to L upper arm at site of previous Shingrix inoculation ~ 2 years ago; This is a spontaneous report from a contactable physician (patient). A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 16Feb2021 10:00 (batch/lot number and expiration date were not reported) at the age of 67 years old, as single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included losartan; amlodipine; acetaminophen; and omeprazole; all taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicillin and experienced allergies. Historical vaccination included Shingrix given 2 years ago. No other vaccines received in four weeks. On 18Feb2021 08:00, the patient experienced herpetiform (zoster) eruption localized to L (left) upper arm at site of previous Shingrix inoculation 2 years ago. No treatment was given for the event. The patient was recovering from the event. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 post vaccination.   Information on the lot/batch number has been requested.
At this time provider of this patient feels the only reasoning behind patient's low platelet count could be in possible relation to COVID19 vaccine given 01/05/21. Patient is not having any other concerns and health status has not changed (besides platelet result) since before vaccine on 01/05/21. Patient was not given vaccine by our facility but by the pharmacy. At this point provider plans to advise patient does NOT get 2nd dose.
Patient reports stabbing pain in Right hand, including thumb and second finger. Patient reports stabbing pain in Left hand including thumb, 1st and second finger. Onset occurred in the middle of the 2nd night post vaccination. Numbness and poor coordination of hands followed. States she has seen a chiropractor and talked to heart doctor but no one has diagnosed specific issue.
Diarrhea 27JAN92 t103 27JAN92; had cold about 1-2 wks prior to immun; 28JAN92 temp went on up to 105 ax; pt seen in ER;
The place where they put the vaccine in the left arm is aching; Next day morning it is reddish and the side of a quarter; This is a spontaneous report from a contactable consumer (reported for herself). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in arm left on 11Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, on an unspecified date as dose 1, single for covid-19 immunisation. On an unspecified date, the consumer stated that, she received her second dose of the Covid 19 vaccine on 11Mar2021 and last night the place where they put the vaccine in the left arm was aching and that morning it was reddish and the side of a quarter. Patient requesting, what she should take or what she needs to do. The case assessed as non-serious. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
101 degree fever, aching joints, aching muscles, constipation, fatigue.  Starting at 3:00 am, approximately 12 hours after vaccination.  Diarrhea occurred all day the following day and into the next, though fever subsided, fatigue remains.
AIN - Anterior Interosseus Neuropathy - Parsonage Turner Syndrome. Tested by facility over several weeks to determine the AIN with Electrical needle measurements - painful arm, sharp back pain (like knife in shoulder) & chest, 50% loss of pinching strength between thumb and first two index fingers. Numbness in fore arm. Weakness spread at time progressed. Waking up several times a night with severe arm pain, sometime chest pain.
severe diarrhea; This is a spontaneous report from a contactable consumer or other non-health care professional via Pfizer-sponsored program. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 17Feb2021, patient experienced severe diarrhea. Patient also took medication for his diarrhea. The patient wanted to know if this was a possible side effect. The outcome of the event was unknown.
Low grade fever (99.4); Flu like symptoms. Treated w/Tylenol Extra Strength. Lasted two (2) days.
Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patient fainted in chair for a few seconds. She knew her name and was responsive but felt dizzy. She said things looked green and hazy. EMS came and checked vitals/assessed pt. She declined going to the ER.
1st: Mild arm soreness with first shot that went away in a few hours. Loose stools beginning a couple days after shot and lasting three days. 2nd: Mild arm soreness X 1 day. Unformed stool beginning four days after shot and continuing four days to present. Uncertain how long it will continue. Severe whole body edema beginning day five. Particularly pronounced in L arm that received Moderna Vaccine. Also aches in Left shoulder, and whole body muscle aches. She has had some edema in her lower legs and feet, but NEVER in her hands, face and torso. In retrospect, we should have avoided using her left arm to vaccinate due to lymph node removal.
Fever x 2 days, severe dizziness, headache, nausea, fatigue. Dizziness, fatigue, and headache, while reduced, are still present on day after vaccine administration.
Bronco spasms, racing pulse, anxiety Treatment was Xanax, nebulizer, prednisone
COVID Vaccine Breakthrough Case  J&J Dose 7/23/21 (206A21A) COVID Positive 10/27/21  10/26/21: Patient is an African American male with past medical history of hypertension not on any medication, asthma, history of gun shot who presented to the ED with fatigue, shortness of breath cough, chills and body ache.  Patient reports he has been sick for the past 6 days.  Patient has also been having abdomen pain, nausea vomiting.  Two days ago patient reports he was vomiting and he passed out.  Patient also reports left-sided midclavicular to chest pain, intermittent, 5/10, nonradiating, worse with coughing and no alleviating factor.  Patient took the J&J COVID 19 vaccine in July 2021. Patient smokes marijuana intermittently.  Patient reports he has not been taking blood pressure medication for some years.   Patient did test + COVID 19 4 days ago. Family history significant for both parents dying from MI in the 50s, cousin dying from MI 3 weeks ago at age 40.At this time patient endorses headache have but denies fever, abdomen pain, blurred vision, dizziness or any focal deficits.   Initially in the ED blood pressure 193/125, heart rate 97, RR 22, 100% room air, temp 99.8°.  Chest x-ray did not show any acute process, official read pending.  CT head negative for acute intracranial abnormality, did note sinusitis. Lab works not remarkable.  Patient received nitro in the ED.  10/28/21:  40-year-old man presented with complaints of chest discomfort, nausea, generalized malaise following recent COVID diagnosis.  He is fully vaccinated,  apprehensive about COVID diagnosis as both parents died of COVID last year.  Blood pressures were noted to be markedly elevated on presentation to the emergency department, known history of hypertension noncompliant with medications and has lost primary care provider.  He was admitted to the hospitalist Service, has remained minimally symptomatic and hemodynamically stable with no oxygen requirements.  At this time he does not meet criteria for inpatient treatment for COVID infection with antiviral therapy, steroids or Actemra.  He was started on oral antihypertensive with improvement in blood pressures, medication compliance and the need to establish care with primary care has been counseled.  He has been discharged in stable medical condition to be followed up by the COVID safe at home program.
Vax - Shingrix (system won't allow me to enter in box 17)  Symptoms include teeth chattering chills, flu-like symptoms, fatigue, dizziness, poor balance, extreme tiredness, and inability to work. No medical attention sought. Waiting for symptoms to pass so that I can return to work. Warn everyone!
After the J&J vaccine- I started my cycle, 11 days before my cycle should start with a much heavier flow, (use a super absorbing tampon every 2 hours) extreme pain. Like when I started my cycle as a kid.
Developed shortness of breath after these multiple vaccines, while on travel. Diagnosis never made. Thought now to be the beginnings of dysautonomia or the beginning of mast cell activation syndrome. In 2009 developed dysautonomia in the form of postural orthostatic tachycardia syndrome after receiving radiation for breast CA. She also went on to develop multiple symptoms of mast cell activation including flushing episodes, urticaria and increase number of episodes of SOB. Was treated partially with H1 and H2 blockers and mast cell stabilizer medications.
Pt received Covid vaccine injection in L Arm on Thursday 1/28/21. It became red and swollen so she had it evaluated at ED, was told injection site was not properly cleaned and was placed on an antibiotics (changed 1x d/t ineffectiveness). She reports redness has decreased but swelling remains, no other side effects noted.. Encouraged patient to submit a patient report through our website and assured her I would also submit a report. Pt declined FU assessment with provider. Agreed to phone call check in ~1 week. flag placed for follow up. Report submitted.
Mobility decreased; Off-label use; This spontaneous case was reported by a physician and describes the occurrence of MOBILITY DECREASED (Mobility decreased) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product CARBIDOPA, LEVODOPA (DUOPA) suspension for an unknown indication.    The patient's past medical history included Alcohol use (Quit/Wine beer mixed drinks), Jejunostomy tube insertion (INTESTINAL TUBE (JEJUNAL) PLACEMENT) on 01-Nov-2016 and Percutaneous endoscopic gastrostomy (ORIGINAL PEG TUBE PLACEMENT) on 01-Nov-2016. Previously administered products included for Product used for unknown indication: AMANTADINE, Probiotic pearls, Miralax and azilect. Concurrent medical conditions included Seasonal allergy. Concomitant products included LORATADINE for Allergy, AMOXICILLIN and CIPROFLOXACIN (CIPRO [CIPROFLOXACIN]) for Bladder infection, METFORMIN for Diabetes, ATROPINE and BOTULINUM TOXIN TYPE A (BOTOX BTX A) for Drooling, CICLOSPORIN (RESTASIS) for Dry eyes, ONDANSETRON for Nausea, PRAMIPEXOLE and ISTRADEFYLLINE (NOURIANZ) for Parkinson's disease, GABAPENTIN for Restless legs, TRAZODONE for Sleep problem, CYANOCOBALAMIN, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE (FOLBEE) for Supplementation therapy, CALCIUM CITRATE, COLECALCIFEROL (CALCIUM VITAMIN D3 [CALCIUM CITRATE;COLECALCIFEROL]), VITAMIN D3, NAPROXEN SODIUM (ALEVE), CINNAMOMUM BURMANNI, CINNAMOMUM SPP. (CINNAMON [CINNAMOMUM BURMANNI;CINNAMOMUM SPP.]), CARBIDOPA, LEVODOPA (RYTARY), VITAMIN B NOS (B-COMPLEX [VITAMIN B NOS]) and PARACETAMOL (TYLENOL) for an unknown indication.   On 01-Nov-2016, the patient started CARBIDOPA, LEVODOPA (DUOPA) (Percutaneous) 1 dosage form. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced MOBILITY DECREASED (Mobility decreased) (seriousness criterion hospitalization prolonged) and OFF LABEL USE (Off-label use). At the time of the report, MOBILITY DECREASED (Mobility decreased) and OFF LABEL USE (Off-label use) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  For the event Off label use, causality is assessed as Not Applicable; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  For the event Off label use, causality is assessed as Not Applicable
Fatigue after booster dose; Fever after booster dose; Chills after booster dose; Nausea after booster dose; Swollen lymph node in left arm pit; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (Fatigue after booster dose), PYREXIA (Fever after booster dose), CHILLS (Chills after booster dose), NAUSEA (Nausea after booster dose) and LYMPHADENOPATHY (Swollen lymph node in left arm pit) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue after booster dose), PYREXIA (Fever after booster dose), CHILLS (Chills after booster dose), NAUSEA (Nausea after booster dose) and LYMPHADENOPATHY (Swollen lymph node in left arm pit). At the time of the report, FATIGUE (Fatigue after booster dose), PYREXIA (Fever after booster dose), CHILLS (Chills after booster dose), NAUSEA (Nausea after booster dose) and LYMPHADENOPATHY (Swollen lymph node in left arm pit) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product used was reported.  No treatment information was provided.   This case was linked to MOD-2022-511201, MOD-2022-511195 (Patient Link).
Pt recvd vax 28JUL92 & cried; mom did not give pt APAP until 29JUL92 when still crying; t103.4 ax; mom also gave pt tepid bath; later t102.1 mom called MD; pt seen by MD t103.4 MD adm pt to hosp w/inconsolable crying & would not eat;
Sore arm for 12 hours (Like a golf ball had been injected inside the muscle). Nausea. Insomnia. Body aches. Cold extremities. Lack of energy for about 16 hours after onset of symptoms, I could not perform any ordinary activities--it felt like a bad case of flu.
Patient called 6 days after receiving vaccine c/o of pain that radiated up her neck; she saw her PCP and he said that it probably aggravated her fibromyalgia and pinched nerve that she had surgery on in 2/2017; she feels better now, but does have some pain still.
A non-serious spontaneous report of nosebleed has been received from a health professional concerning a four-year-old male, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 03-Oct-2011. On 03-Oct-2011, 12 hours after receiving FLUMIST, the patient experienced a nosebleed. The outcome of event nosebleed was resolved.
PATIENT DEVELOPED CELLULITIS AND ABCESS OF BACK AND HERPES ZOSTER OF NECK AND BACK STARTING THE NEXT DAY AFTER RECEIVING COVID 19 VACCINE.
got sick; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program (159558). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got sick". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Period of confusion; Her memory cleared up; This is a spontaneous report from a contactable Nurse. A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL3247, Expiration Date: not reported), via an unspecified route of administration in left arm on 20Jan2021 11:30 as dose 1, single for COVID-19 immunization (at the age of 70-year-old). Patient historical vaccine included 20 days prior to COVID shot had Shingles shot, NDC/Lot/exp for shingles shot was not reported. Patient had no AEs follow prior vaccinations. Medical history included depression and had COVID last March before it was even being tested. Knew she had COVID because she couldn't taste her food. It was like the flu but she couldn't taste. History of all previous immunizations was not provided. Additional vaccines was not administered on same date of pfizer suspect. Family medical history included patients mother was 91 when she died. Patient was sure her mother had memory problems. There was no early onset Alzheimer's or Parkinson's in the family. No further details provided. Concomitant medication(s) included fluoxetine hydrochloride (PROZAC) taken for depression and was on very little medicine. Had no NDC/Lot/exp for the Prozac. The patient experienced period of confusion and her memory cleared up on an unspecified date. It was reported that, patient got the Pfizer shot and was getting the second one tomorrow on 10Feb2021. Patient had period of confusion. Couldn't remember where she put her credit card. It happened four times. It felt crazy. Had misplaced her credit card, but never lost her credit card like that. Didn't know if that had anything to do with the COVID shot. Worked as an RN and LPN. Patient wanted to know if the period of confusion was related. Occurred four time almost within a couple hours. It was a block of confusion and quite scary. Was in a store, put her credit card away and then couldn't find it. Was asked her phone number and couldn't remember her phone number. A couple days later was driving down the road and didn't know where she was. Her memory cleared up when she was at an intersection and could name areas she knew. Stated that experience was different. Just thought it was an offshoot of the memory problem. Period of confusion began a week and a half to two weeks ago. Reported seriousness was not serious. It was concerning when that happened and wondered how long it will go on. Didn't call her doctor. Patient was just paying attention to how often it was happening. Relatedness for period of confusion was unknown. Causality was reported as patient was under stress with work and wasn't sleeping and wanted to just check it out before receiving second dose. The outcome of the events was unknown.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.