chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; sore right arm; little fever; nausea; heartburn; chills; muscle aches; mild dizziness; This is a spontaneous report from a Pfizer-sponsored program. A contactable 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was not reported, Expiry date: unknown, at the age of 62 years), dose 1 via an unspecified route of administration, administered in Arm Right on 10Feb2021 14:00 as dose 1, single for covid-19 immunisation. Medical history included covid-19 (The day he received the dose he was cleared 28 days on 10Feb2021 form previously having Covid 19). The concomitant medications were not reported. The patient experienced headache, sore right arm, little fever, nausea, heartburn, chills, muscle aches, and mild dizziness on 11Feb2021 02:00. He took Benadryl and Advil 25 hours after receiving the first dose. Since he took meds for headache and symptoms, will this effect the efficacy of the vaccine? He wished he had been told about not taking NSAIDs or medication after the vaccination, he would have pushed through the discomfort. He was now asking since he took this medication is the vaccine that he got is still effective or if he messed up and needs to get another vaccine. Outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
I have had my period twice in the last four weeks since my vaccine and three times in the last six weeks.
Tested positive for covid; Tested positive for covid; This is a spontaneous report received from a 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 08Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 years, in left 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 covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergy: Sulfa" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. No other medication in 2weeks. Tested positive for covid. Prescribed Paxlovid due to serious asthma. Did not help make patient felt better and still coughing with terrible congestion 6 days after finishing the 5-day Paxlovid treatment. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Narrative: 07/11 2020 COVID swab, result: not detected COVD infection following COVID vaccine series 02/23, Pfizer, dose #1 03/23, Pfizer, dose #2 08/06 pt c: fever, cough, headache, exposure: co-worker 08/09 COVID swab, result: detected 08/09 SARS-COV-2 LINEAGE B.1.617.2 08/09 SARS-COV-2 CLADE 21A DELTA 08/23 COVID swab, result: detected 08/24 08/24 CXR impression: No focal consolidation. Please note a viral pneumonia may not have significant radiographic findings. Clinical correlation is recommended.
Immediate effects - severe headache, diarrea, muscle & joint pain, fatigue, low level depression, mood problems. Long term effects - headaches, bowel problems, muscle & joint pain, chronic fatigue, low level depression, mood problems.
Chest tightness, shortness of breath, itchy rash (quarter size bumps).
managed to make it to bed to lay under A/C and passed out; all of a sudden my Body broke out into a real bad sweat that soaked clothes; felt real nauseous like I was going to vigorously vomit; was light headed; This is a spontaneous report from a contactable consumer (patient). A 27-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Right on 27Sep2021 19:45 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization at a pharmacy. The patient's medical history was not reported. The patient previously took clindamycin and azithromycin and experienced drug allergies. No other vaccines in four weeks and no other medications in two weeks. No COVID prior to vaccination. On 28Sep2021 12:45, the patient reported that she was folding clothes and felt fine when all of a sudden her body broke out into a real bad sweat that soaked clothes, felt real nauseous like she was going to vigorously vomit, was light headed, managed to make it to bed to lay under A/C and passed out. The patient had a doctor or other healthcare professional office/clinic visit. The patient received an unspecified treatment for the events. The patient underwent lab tests and procedures which included blood test: unknown results and COVID Nasal Swab: negative on unspecified date. The blood work was used to determine if she can receive the 2nd dose. The outcome of the events was unknown.   The lot number for BNT162B2, was not provided and will be requested during follow up.
This is a spontaneous report from a contactable pharmacist (patient). A 65-year-old female patient received PREVNAR 13, (lot number and expiration date unknown) via an unspecified route of administration in left upper arm on 09Jan2019 at about 9 or 10 in the morning at a single dose for immunization in the physician's office. Medical history included ongoing blood cholesterol from an unknown date. The patient had no previous vaccinations and family medical history. Concomitant medication included CENTRUM MULTIGUMMIES. On 11Jan2019, a couple days after vaccination, the patient had pain at the injection site and was not warned this could happen. She was very upset that she was not told to expect this. The patient called the doctor as she was not warned about the pain. She feels the doctors should warn patients to expect this and that the drug company should tell the doctors to tell the patients to expect pain. The patient had very severe pain and discomfort and was surprised as she had shots in the past with no problems. The patient also stated that the pain started a couple days later and is ongoing though it is better. The patient was treated with menthol cream. When the patient called the doctor, they told her that maybe she shouldn't get the pneumonia injections; that is ridiculous and she is going to call them about that to. The patient was recovering from pain at the injection site. The following information on the batch number has been requested.
Headache, Myalgia, Fever, Diarrhea, NauseaVomiting, injection site reaction, fatigue Narrative: Employee reports injection site pain/discomfort, swelling and redness, in addition to fever (102 F), headaches, body aches, fatigue, nausea, and diarrhea. Reports saw her doctor who prescribed "steroids." No dose, duration or frequency provided to employee occupational health. Reports symptoms have resolved as of date of entry.
needle was not totally connected to syringe.  upon administering, vaccine leaked out onto patient's arm. incomplete dose administered. Sanofi contacted and advised to offer patient another dose. patient contacted on 10/17/2023 at 11:55 and was offered another dose of vaccine. patient agreed to come to health department and received full dose at approximately 1:15pm on 10/17/2023
Starting 1 week after second dose;  ear ringing, just getting better Starting from 3 weeks after second dose to now: swollen hands, feet, ankles,  tingling pain along tibia bones, brain fog, joint pain whole body,  nuscle weakness and twitching
Swelling at injections site, no redness, left arm, shoulder, armpit very sore for about a day.
Mononucleosis, Inflamed tonsils, sore throat, fever, headache.
Information has been received from a physician via medical records, concerning a 2 months old male with diaper rash, allergies, plagiocephaly, hyperbilirubinaemia, and history of cephalohematoma and hospitalization, who on 07-MAR-2008, was vaccinated with ROTATEQ (657989/1838U). Concomitant therapy included diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3-comp vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (PEDIARIX) (Lot # AC21B1AB), (PREVNAR) (Lot # 808702E) and (ACTHIB) (Lot # UF341AC). On 07-MAR-2008, the patient experienced intestinal gas. On 09-MAY-2008, the baby experienced eczema in face and trunk with excoriations in face (cheeks and forehead), and it was noticed that he had a flat occipital, plagiocephaly. The baby was vaccinated according to protocol with PEDIARIX, ACTHIB, PREVNAR and ROTATEQ. The baby was 4 months of age. The patient was treated with Vaseline + 1% Hydrocortisone. On examination on 10-JUL-2008, it was noted that the baby still had Plagiocephaly. The baby was vaccinated according to protocol with PEDIARIX, ACTHIB, PREVNAR and ROTATEQ. The baby was 6 months of age. No additional information is expected. The patient was also reported in WAES: 0707USA00777.
Developed arrhythmia after COVID-19 vaccine. Started noticing it after the first shot. After second shot, ended up in ER. Started medication in June. Each time, had more arrhythmia after vaccination.
Red, itchy rash spread from the just above the injection site and below the injection site. Approximately 6 inches long and 3 inches wide. Area is hot and slightly swollen to touch but does not actively hurt or is sore. Developed 24 hours after 2nd dose of vaccine along with chills, low fever and body aches. Those resolved in 24 hours but the red, itchy rash is still active 72 hours after shot.
Tachycardia (HR 100 on arrival, was higher at home), numbness/tingling of lips and mouth, ? mouth swelling started at 5pm on day of vaccine. Took Benadryl 50mg PO prior to arriving at ED. Felt improved compared to home. Was given Ativan in ED X 2 doses and Benadryl 25mg IV  3 hours after arrival for complaints of eye swelling and itching. Symptoms resolved.
Left arm just below the injection site has rash and it is swollen and warm to touch; Left arm just below the injection site has rash and it is swollen and warm to touch; Left arm just below the injection site has rash and it is swollen and warm to touch; This is a spontaneous report from a contactable consumer or other non hcp.   A 53-years-old female patient received bnt162b2 (BNT162B2), (Formulation: Solution for injection, Batch/Lot Number: EW0158; Expiration Date: Unknown) dose 2, single via an unspecified route of administration, administered in Arm Left on 21Apr2021 (age at vaccination 53 years old) for covid-19 immunisation. The patient medical history was not reported. Concomitant medication was not reported. The historical vaccine was bnt162b2, (Formulation: Solution for injection, Batch/Lot Number: ER8733; Expiration Date: Unknown) dose 1, single via an unspecified route of administration, administered in Arm Left on 31Mar2021 for covid-19 immunisation. On 23Apr2021 and it was persisting patient stated that I am having a reaction to it; My left arm just below the injection site has rash and it was swollen and warm to touch. Treatment received was Benadryl, patient reported that I started it yesterday and I took four times yesterday. The outcome of all events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Nauseated, dry "heaves", dyspnea, paleness wife called EMT transported to ER; stay approx 2 hrs-released home saw pvt MD later same day;
EXCRUCIATING PAIN IN BONES; PRODUCE PAIN ON DEEP BREATHING; EXCRUCIATING PAIN IN JOINTS; EXCRUCIATING PAIN IN MUSCLES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced excruciating pain in bones. On 2021, the subject experienced produce pain on deep breathing. On 2021, the subject experienced excruciating pain in joints. On 2021, the subject experienced excruciating pain in muscles. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from excruciating pain in joints, excruciating pain in muscles, excruciating pain in bones, and produce pain on deep breathing. This report was non-serious.
respiratory distress  Narrative:  Moderna Covid 19 vaccine on 3/12/2021 Developed  respiratory distress one hour after the vaccine On 3/15/2021 BP 100/67 sat  69 ct chest angiogram negative for PE 3/18/2021
While sitting five minutes after shot, pt turned white, eyes rolled back. Mother called for help. Reaction walking by an immediately laid pt on floor. Within approx. 10 seconds pt was awake, coherent, and speaking. Was mildly diaphoretic. Remained on floor for five min before sitting up. Still feeling fine up sitting up pt was AOx3. As precaution and at mother's urging pt was taking in wheelchair  for brief observation and vitals check.  5:29 SEATED HR 77 RESP 12 BP 165/112 SPO2 99 5:30 LYING HR 69 RESP 12 BP 151/95 SPO2 98 5:35 LYING HR 70 RESP 12 BP 149/95 SPO2 98
I feel like I have very light prickles like a needle on my skin in one arm and then moved to the rest of my body and my face. its not painful, its itchy and funny feeling that comes and goes.
Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a patient (age and gender not reported) who had pain, large red raised area warm to touch and pins and needles to her lips, while she received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number: QFAA1827 and 30-Jun-2019) (dose, dose in series, route and site of administration was not reported). On an unknown date, following the vaccination the patient experienced pain, large red raised area warm to touch and pins and needles to her lips. (Other relevant tests included no lab data.) Final diagnosis was pain, large red raised area warm to touch and paraesthesia oral. It was not reported if the patient received a corrective treatment. The outcome of the events was reported as unknown. List of documents held by sender: none.
Vaccine was administered to a patient following a temperature excursion; Excursion, max temp 47.14 F; This spontaneous case was received on 31-Oct-2023 from other healthcare professional via Communications (reference number: SEQW23-03894) and concerned a patient of unreported age and gender.  The patient's medical history and concomitant medications were not reported.     On an unspecified date, Fluad Quadrivalent (influenza vaccine inact sag 4v) vaccines were exposed to a temperature excursion peaking at 47,14 degrees Fahrenheit (F) for 45 minutes (explicitly coded as 'Product storage error temperature too high'). The batch numbers reported were 371622 with the expiry date 30-Jun-2024, 374243 and 374228.  On 30-Oct-2023, after the temperature excursion, the patient was vaccinated with Fluad Quadrivalent (dose: 0.5 ml, route of administration and anatomical location: not reported) for active immunization against influenza disease (explicitly coded as 'Product administration error').   At the time of initial reporting, it was not reported whether the patient experienced any adverse events after the Fluad Quadrivalent administration.  Company comment: A patient of unreported age and gender was vaccinated with Fluad Quadrivalent an unknown amount of time after it suffered a temperature excursion peaking at 47.14 degrees of Fahrenheit (F) that lasted for 45 minutes (explicitly coded as: 'Product storage error' and 'Product administration error'). It was not reported if the patient experienced any side effects following vaccination. Product storage error and product administration error were assessed as not related as per company's specific guidelines.; Sender's Comments: A patient of unreported age and gender was vaccinated with Fluad Quadrivalent an unknown amount of time after it suffered a temperature excursion peaking at 47.14 degrees of Fahrenheit (F) that lasted for 45 minutes (explicitly coded as: 'Product storage error' and 'Product administration error'). It was not reported if the patient experienced any side effects following vaccination. Product storage error and product administration error were assessed as not related as per company's specific guidelines.
This spontaneous report was received from a registered nurse and refers to an multiple unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with an unknown amount of improperly stored doses of PROQUAD lot numbers: M048201, M044575, M042500 and N010247, reconstituted with properly stored diluent. No adverse effects reported. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1707USA012945:
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 16-MAR-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (incorrect product storage) lot # M040141 for prophylaxis. Concomitant therapies included sterile diluent. No adverse event.
While receiving Pfizer Covid 19 vaccine, needle malfunctioned in the patient's arm resulting in premature needle retraction.  It is estimated the patient received less than half the dose.  A full dose was then administered in the patient's other arm.  Patient was counseled on potential side effects.
This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731; Expiration Date: Jul2021) via an unspecified route of administration in the right arm on 12Apr2021 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included exercise induced Exercise induced asthma, polycystic ovarian syndrome and scoliosis. Concomitant medications included birth control (unspecified), salbutamol (ALBUTEROL) and paracetamol (TYLENOL) taken within two weeks of vaccination from unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204; Expiration Date: Jun2021) via an unspecified route of administration in the left arm on 22Mar2021 (at the age of 33-years-old) as a single dose for COVID-19 immunisation and reported that on 06Apr2021 lymph node on left clavicle swelled, reduced by 15Apr2021. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Apr2021, the patient experienced painful swelling in right armpit, pain had continued for 4 days, extending into muscles of right arm on an unknown date in Apr2021. On 28Apr2021, the patients lymph node on right clavicle swelled. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events was not recovered.No follow-up attempts are needed. No further information is expected.
My sister is recovering from cancer and she was given a flu vaccine and a "pneumonia" shot at her oncologist's office.
Headache, body aches, nausea, fever, sweating, chills, fatigue
Myocarditis; This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Myocarditis) in a 52-year-old male patient 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 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 MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Ejection fraction: 54% (normal) 54%. In 2021, Troponin I: 6.77 ng/ml (High) 6.77 ng/mL.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDITIS (Myocarditis) to be possibly related.    Concomitant Medications were not reported.  Therapy for event was not reported.  This literature-study case was reported in a literature article and describes the occurrence of Myocarditis  in a 52-year-old male patient who received mRNA-1273. Based on the current available information and reporter´s causality , a causal relationship cannot be excluded.   This case was linked to MOD-2021-317848, MOD-2021-317975, MOD-2021-317976, MOD-2021-317978 (Patient Link).; Sender's Comments: This literature-study case was reported in a literature article and describes the occurrence of Myocarditis  in a 52-year-old male patient who received mRNA-1273. Based on the current available information and reporter´s causality , a causal relationship cannot be excluded.
Case number PHEH2015US001398, is an initial spontaneous report from a pharmacist received on 15 Jan 2015. This report refers to a 19-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was administered only MenCYW-135 liquid component of MENVEO (batch number: X14089) without being reconstituted with MenA intramuscularly on 15 Jan 2015. No adverse event was reported following the administration error (inappropriate preparation of medication).
Pfizer vaccine was given to patient when vaccine was not indicated for the patient. Patient's mother knowingly gave the nurse the wrong birthdate for the patient.
The following day she was at the clinic (she said to make sure you knew she was a cancer patient) and experienced uncontrollable cold & shaking, they took her temperature at clinic which registered 101 degrees, and she was disoriented and unable to move to get out of her vehicle.  She then reported the day after the side effects she woke up and was fine.
HYPERGLYCEMIA INTO THE 500S WITH CONFUSION, WENT TO THE ED FOR EVALUATION AND RECEIVED INSULIN TO HELP BRING IT DOWN SAFELY.
Corneal ulcers; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ULCERATIVE KERATITIS (Corneal ulcers) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ULCERATIVE KERATITIS (Corneal ulcers) (seriousness criterion medically significant). At the time of the report, ULCERATIVE KERATITIS (Corneal ulcers) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Fever 101-102 degrees 24 hours after - body aches, saw MD, gave IM inj ceftriaxone & started MACROBID for presumed pyelonephritis - condition resolv. 5-8 days later.