chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I was definitely sick in the bed; Couldn't even function; Hurt; Horrible headache; I can hardly get to the bathroom infact I had to call my daughter she came to take care of me now; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 78 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s): "the first one put me in the bed"; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious) with onset 01Oct2021, outcome "unknown", described as "I was definitely sick in the bed"; MOBILITY DECREASED (non-serious) with onset 01Oct2021, outcome "unknown", described as "Couldn't even function"; PAIN (non-serious) with onset 01Oct2021, outcome "unknown", described as "Hurt"; HEADACHE (non-serious) with onset 01Oct2021, outcome "unknown", described as "Horrible headache"; GAIT INABILITY (non-serious) with onset 01Oct2021, outcome "unknown", described as "I can hardly get to the bathroom infact I had to call my daughter she came to take care of me now".  Additional information: The patient received her COVID booster on Monday. She was fine to see on Tuesday. She was definitely sick in the bed couldn't even function and hurt and had horrible headache, she could hardly get to the bathroom infact she had to call her daughter and she came to take care of her now, she works in the health field and she advised her not to get the shot but she did. The patient have had her other two shots and they didn't bother her the first one put her in the bed as far as the concern.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swelling of elbows; Pain in elbow; Hand pain; hand swelling; COVID-19; COVID-19; Discomfort in right elbow; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4265254-00 (Agency).  A 63-year-old male patient received BNT162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Batch/Lot number: unknown), on 12Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 31Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Batch/Lot number: unknown) at citrate free and second regimen (Batch/Lot number: unknown) at citrate free, all subcutaneous for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "recovering" and all described as "COVID-19"; MUSCULOSKELETAL DISCOMFORT (non-serious) with onset 2022, outcome "unknown", described as "Discomfort in right elbow"; JOINT SWELLING (non-serious), outcome "not recovered", described as "Swelling of elbows"; ARTHRALGIA (non-serious), outcome "not recovered", described as "Pain in elbow"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Hand pain"; PERIPHERAL SWELLING (non-serious), outcome "not recovered", described as "hand swelling". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. The action taken for adalimumab was dosage permanently withdrawn. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter considered "covid-19" and "discomfort in right elbow" related to BNT162b2. The reporter's assessment of the causal relationship of "swelling of elbows", "pain in elbow", "hand pain" and "hand swelling" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment and causal relationship of "discomfort in joints" and "COVID-19" with the suspect product(s) BNT162b2 was possible.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of Swelling in right elbow, Pain in right elbow, Pain in right Hand, Swelling in right hand, Discomfort in right elbow and Covid-19 with HUMIRA(ADALIMUMAB) was no reasonable possibility.  The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events drug ineffective, covid-19, musculoskeletal discomfort, joint swelling, arthralgia, pain in extremity and peripheral swelling cannot be excluded.
HEADACHE; LOW-GRADE FEVER; MUSCLE PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 07-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced low-grade fever. On 07-APR-2021, the subject experienced muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, low-grade fever, and muscle pain. This report was non-serious.
After receiving flu shot patient passed out hitting his head on pharmacy counter and received a laceration. Emergency personnel was called. After attending to patient he was transported to area hospital for stitches.
Patient experienced a severe chest tightness a day after providing the vaccinations. Patient describe it as she was able to breathe but the tightness was very painful as she though twice about calling emergency number. She got headache, feverish and chills. She felt tired/exhausted and lasted for 4 days after the providing  the vaccines.
Pt received shot in pharmacy for second covid pfizer vaccine.  She sat down for 15 minutes, but then got up and felt lightheadness.  However, she continued shopping in store with her family.  On the way out, she was still feeling lightheadness and her vision was lessened so she sat down at the food court area.  Pharmacist was alerted to come attend to her.  Pharmacist suggested that she put her head between her legs and offered wet towel for her neck.  After about 5 minutes, she said she was fine to go with her family.
Rash all over body starting about a week ago after immunizations. He had a low grade temperature. Raised irregular blanchy rash on chest and back, has a few on his arms.
First dose of Moderna Covid-19 Vaccine was administered to person under the recommended age under the EUA .  No adverse outcome for this patient. 2nd dose not given.
on evening of 10NOV95 had a rectal temp of 106;parent stated that the pt also exp a sz;was taken to ER that evening;went to pvt MD on 15NOV95;
Soreness injection site; The initial case was missing the following minimum criteria: unspecified product and adverse event. Upon receipt of follow-up information on 04Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable healthcare professional, the patient, from a Pfizer sponsored program. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the arm on 23Dec2020 (at the age of 63-years-old) as a single dose for COVID-19 immunization.   Medical history included penicillin allergy and anaphylaxis to a penicillin type drug. The patient's concomitant medications were not reported.  The patient previously took ampicillin (MANUFACTURER UNKNOWN) from an unknown date to an unknown date for an unknown indication and experienced drug allergy.  On 23Dec2020, the patient experienced soreness at injection site. The patient did not receive any treatment for the event. The clinical outcome of the soreness at injection site was recovered in Dec2020 after about 48 hours. The reporter considered that there was a reasonable possibility that the soreness at the injection site was related to the vaccine.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Case number PHEH2014US025262, is an initial spontaneous report received from a nurse on 12 DEC 2014. This report refers to a 17 years old female patient. Past medical history and concomitant medication were not reported. She received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: M14025), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 13 NOV 2014. No adverse event was reported following this administration error (inappropriate preparation of medication).
1. my throat started to close within 10 minutes, plateaued at 15 minutes, went away at 40 minutes 2. face and neck and upper chest swelled and flushed red for 4 days 3. severe nausea--I'm still mildly nauseous 4. vomiting --1 day 5. diahhreah--I still have mild diahhreah 6. migraine headaches that didn't respond to Tylenol or Aspirin initially and woke me out of sound sleep at 2 am; lasted for 4 days 7. dizziness- 8 days 8. extreme fatigue--I'm still moderately fatigued 9. sever sore arm--arm is slightly sore now 10. chest pain in the middle of my chest, went away upon lying down, upon getting up came back, lasted 3 days, I still feel it occasionally 11. inability to eat solid foods for 4 days due to vomiting and nausea 12. severe chills at night and in the day--I still get chills at night occasionally
10 minutes after injection, dizzy spell and vasovagal reaction.  Diaphoretic, pulse rate 48, BP 107/71.
Monday night 9/22/14 Rt arm swell up Tuesday got worse warm to the touch went to ER given IV antibiotics discharged on 10 day high dose oral antibiotic, went back Wed IV saline fluids originally diagnosed as cellulitis then when f/u they felt it resolved too quickly and they don't think it was cellulitis but a bad rxn to shots given together same day same arm.
the powder portion of Pentacal was incorrectly diluted with sterile water diluent and the diluent that was erroneously used with no reported adverse event; the liquid portion of Pentacel was not administered with no reported adverse event; Initial information was received on 07-Feb-2023 regarding an unsolicited valid  non-serious case received from an other health professional.  This case involves a 2 months old female patient and reported that the powder portion of pentacal was incorrectly diluted with sterile water diluent and the diluent that was erroneously used and the liquid portion of diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] was not administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included rotavirus vaccine (Rotavirus vaccine) for prophylactic vaccination; pneumococcal vaccine 13v (Pneumococcal 13 valent vaccine) for prophylactic vaccination; and hepatitis b vaccine (Hepatitis b vaccine) for Prophylactic vaccination.  On 07-Feb-2023, the patient was received the powder portion of the suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine was incorrectly diluted with sterile water diluent and the diluent that was erroneously used with no reported adverse event (product preparation error) (latency: same day) (lot number: UJ788ABA, expiration date: 18-Sep-2023, dose, formulation, strength: Unknown) via unknown route in the right upper thigh for Immunization (Immunisation) and the liquid portion of pentacel was not administered with no reported adverse event (wrong technique in product usage process) (latency: same day).  It was reported that "The powder mixed with sterile water and then administered is lot UJ788ABA. The liquid portion, not administered, is lot U7440BA. She commented that the liquid vial has a smudge on the lot number and she is unsure if the zero is a zero or the letter D. The carton is lot UJ788ABA."   No lab data reported.  Action taken: not applicable.  Outcome: Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Vomiting, chills, body ache, fever, headache About 6 hours after getting the Tdap and the inactivated flu vaccine, I experienced nausea and headache and chills. About two hours after that vomiting occurred. Fever and headache are still present 16 hours later.
A non-serious spontaneous report of administration to 21 month old and runny nose was received from a public health nurse/healthcare professional concerning a 19-month-old female, subsequent to H1N1, Intranasal. The patient had no relevant medical history and no concomitant medications was administered to the patient. On 10-Nov-2009 the patient received H1N1, Intranasal for an unspecified indication. On 10-Nov-2009 after vaccination the patient developed runny nose which lasted till 13-Nov-2009. No laboratory studies and no treatments were needed for the event of runny nose. The patient was fine with no flu-like symptoms and no adverse effects from the vaccination. The outcome of the event of administration to 21 month old and runny nose was resolved. Additional information was received on 10-Dec-2009 and incorporated into the narrative: Medical history, concomitant medication, cessation date and outcome of the event, reporter's information.
Hyperirritable, nonconsolable, hyper crying episode for over 1 1/2-2 hrs; shrill cry-t104 devel rxn w/ a few hrs of vax;
Severe flu-like symptoms.  Uncontrollable shivering with cold for 2.5 hours.  Then fever of 102 degrees.
Pt developed s/s of COVID 3/29/2021 and tested positive 4/9/2021
This spontaneous report as received from a physician, via company representative, refers to a female patient of unspecified age. On an unspecified date, patient started therapy with ZOSTAVAX, subcutaneous injection (dose and lot number not reported). Co-suspect or concomitant therapies were not reported. On an unspecified date, physician reported that the patient, that was also a physician, had received ZOSTAVAX at an unspecified pharmacy, and experienced a severe neuropathy in the injection arm. Reported stated that patient missed a lot of work because of this. At the time of the report, the patient was not recovered and the causality for the event was unknown. Severe neuropathy in the injection arm was considered as disability by the reporting physician. Additional information has been requested.
Fatigue, chills, nausea, headache. Next morning, felt dizzy. Tried to get up.  Sat at table, felt dizzy again, passed out,  felt like she was deep sleep, was told she was foaming at the mouth. Felt better afterwards.
soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at the injection site) 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 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (soreness at the injection site) outcome was unknown.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   No Concomitant Products were reported. No Treatment information was reported.   This case was linked to MOD-2021-427849, MOD-2021-427028 (Patient Link).
PATIENT HAS MIGRAINE SINCE GETTING VACCINE. PATIENT IS SUSCEPTIBLE TO MIGRAINES
On 4/17/00, the pt received his 1st IM, left deltoid dose of Havrix. Subsequently, on 4/17/00, he felt like fainting, he felt as if he could not breathe, he experienced pallor, red ears, palpitations, chest tightness, light-headedness, difficulty concentrating and fatigue. His BP was 140/90 (high for him). Physician thought it might be a vasovagal reaction. The pt noticed that his beard was growing more slowly; he shaved every day, but since yesterday, he didn't have his usual 5 o'clock shadow. After the initial events, the pt reported feeling generally unwell with episodic palpitations and "disequilibrium". This latter symptom was described as a feeling of spatial disorientation that lasted for "a second" after a rapid change in head position; there was no sensation of the room spinning, loss of consciousness or diplopia. This symptom gradually resolved approx. 10 days, post vax. The pt also reported developing a sore throat and fever on 4/22/00. He reportedly, experienced episodes of sweating and palpitations. The fatigue and malaise continued and were accompanied by an episodic, pounding headache. The pt denied myalgias, rhinitis, otalgia, fever or chills, and was reportedly, examined by his PCP on 4/26/00. The pt's physician did not obtain an ECG or 24 hour Holter study. No treatment was given. The pt stayed out of work during the week of 4/24/00. His symptoms largely abated by the end of the week and he was back at work by 5/1/00. He was able to drive. The most recent information, received on 5/1/00, reports the condition of the vaccinee as resolved.
No additional AE's reported; Improperly Stored; Administered; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 16-JUN-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot number: T000698, expiration date: 07-JAN-2022; dose and route of administration were not provided). The vaccine was stored in temperature:  11.3 degrees Celsius for 15 minutes. There was no previous temperature excursion. Digital data lodger was involved.  No adverse event was reported. The patient was asymptomatic.  This is one of the four reports from the same reporter.; Sender's Comments:  US-009507513-2106USA005206: US-009507513-2106USA005204: US-009507513-2106USA005205:
Swelling of the site in a 4-5cm radius around the injection, redness, heat, inflammation
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was refrigerated packaging tote to maintain a temperature of 36 F - 46 F. However, that is not approved by State for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Important Hair Loss; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the right arm on 15May2021 as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) taken for an unknown indication on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Apr2021, the patient underwent COVID-19 test Polymerase Chain Reaction (PCR) and the result was negative. On 17May2021, the patient experienced hair loss which was important. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event hair loss was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
3 days of fever and muscle aches; muscle aches/1 day of muscle aches; 3 days of intestinal infection (diarrhea); 3 days of intestinal infection (diarrhea); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Oct2021 15:45 (Lot number: FF2590) at the age of 74 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "other medical history= heart" (unspecified if ongoing); "other medical history= Liver" (unspecified if ongoing); "diabetes" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE taken for immunisation, administration date Sep2021; LANTUS; SYNTHROID; HUMALOG; LOSARTAN; ATORVASTATIN. Past drug history included: Amoxicillin for drug allergy; Sulfa for drug allergy. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8730, Location of injection: Arm Left), administration date: 26Mar2021, when the patient was 74 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6200, Location of injection: Arm Right), administration date: 01Mar2021, when the patient was 74 years old, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 07Oct2021, outcome "not recovered", described as "3 days of fever and muscle aches"; MYALGIA (non-serious) with onset 07Oct2021, outcome "not recovered", described as "muscle aches/1 day of muscle aches"; GASTROINTESTINAL INFECTION (non-serious), DIARRHOEA (non-serious) all with onset 07Oct2021, outcome "not recovered" and all described as "3 days of intestinal infection (diarrhea)". Therapeutic measures were not taken as a result of pyrexia, myalgia, gastrointestinal infection, diarrhoea.  Additional information: Facility type Vaccine= Pharmacy or Drug Store. Other medications taken within 4 weeks and two weeks taken was reported under concomitant section. Covid prior vaccination=No and tested post vaccination=No.  Follow-up attempts are completed. No further information is expected.
patient reports swelling at vaccine site 1 week after vaccine administered. swelling accompanied by itching, headache and nausea x 1 day. redness remained for 4 days
PRODUCT STORAGE ERROR; This spontaneous report received from a pharmacist concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and 041A21A expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced product storage error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of product storage error was not reported. This report was non-serious.
t105 3 days later, vomited x 1 23SEp92; 30SEP92 fever 101 w/ coughing;