chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Low grade fever; minor nausea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever) and NAUSEA (minor nausea) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 02BL2OA) for COVID-19 vaccination.     No medical history was reported by reporter.  Concomitant products included MELOXICAM, CITALOPRAM, TAMSULOSIN, ATORVASTATIN and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced PYREXIA (Low grade fever) and NAUSEA (minor nausea). On 12-Feb-2021, PYREXIA (Low grade fever) and NAUSEA (minor nausea) had resolved.            This case was linked to MOD-2021-008303, MOD-2021-099943 (Patient Link).   Reporter did not allow further contact
12OCT92 t101-102; temp by 15OCT92 105; 16OCT92 t104; hospitalized for dehydration; devel rash; discharged 18OCT;
No reported issues with vaccination. Patient received Pfizer BioNTech instead of Moderna as second dose. Patient did not have vaccine card, has dementia (not known by pharmacy in advance), and wife left him alone at the pharmacy for the vaccination. Wife called the next day to inform the pharmacy that the incorrect dose was received.
I FELT LIKE A TRAIN RAN ME OVER; BODY ACHE; FAST HEART RATE; HEADACHE; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 02-JUN-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 03-JUN-2021, the subject experienced I felt like a train ran me over. On 03-JUN-2021, the subject experienced body ache. On 03-JUN-2021, the subject experienced fast heart rate. On 03-JUN-2021, the subject experienced headache. On 03-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, headache, body ache, and fast heart rate, and the outcome of i felt like a train ran me over was not reported. This report was non-serious.
This spontaneous report as received from a physician via a company representative refers to a 71 year old female patient. The patient's pertinent medical history and concomitant medications were not reported. In approximately 2013 (reported as "2 to 3 years ago"), the patient received a dose of ZOSTAVAX one time injection (dose, route of administration, lot # and expiration date were not provided) and a dose of PNEUMOVAX23(dose, frequency, route of administration, lot # and expiration date were not provided) at the same time. On an unknown date (reported as "a couple of weeks later"), the patient was diagnosed with Miller Fisher Syndrome involving cranial nerve VI of the right eye (reported as "Miller Fisher Syndrome and with cranial nerve VI of the right eye"). The patient sought medical attention. The outcome of Miller Fisher syndrome involving cranial nerve VI of the right eye was reported as recovering at the time of this report. The reporter did not provide a causal relationship between the event of Miller Fisher syndrome involving cranial nerve VI of the right eye and the vaccination with ZOSTAVAX as well as with the vaccination with PNEUMOVAX23. Upon internal review Miller Fisher Syndrome involving cranial nerve VI of the right eye was determined to be medically significant. Upon internal review Miller Fisher Syndrome involving cranial nerve VI of the right eye was determined to be medically significant. Additional information is not expected as the reporting physician did not wish further contact.
Pfizer-BioNTech COVID-19 Vaccine EUA Erythema and pain noticed at injection site at 22:00 Pain worsened over night The next morning around 0700, noticed worsening Erythema, inflammation, tenderness, warmth No fever 12/21 borders of Erythema have expanded
cognitive dysfunction; a little funny in the head for a short period of time; sore arms; diminished strength for 10-12 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 61-year-old male patient received bnt162b2 (BNT162B2), administration date 05Apr2021 (Lot number: EN6206) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: Patient History: No. There were no concomitant medications. Vaccination history included: Bnt162b2 (LOT: EN6200, after their first vaccine dose they both had a little dizziness that was not bad, they were fine.), administration date: 11Mar2021, when the patient was 60 years old, for COVID-19 immunization, reaction(s): "little dizziness that was not bad". The following information was reported: COGNITIVE DISORDER (non-serious) with onset Apr2021, outcome "not recovered", described as "cognitive dysfunction"; FEELING ABNORMAL (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "a little funny in the head for a short period of time"; PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "unknown", described as "sore arms"; ASTHENIA (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "diminished strength for 10-12 days". Therapeutic measures were not taken as a result of cognitive disorder, feeling abnormal, pain in extremity, asthenia. Additional information: They had some cognitive dysfunction with the second dose but not as much. After their second vaccine dose they both felt a little funny in the head for a short period of time, and random stuff they don't care about like sore arms which doesn't concern him, and diminished strength for 10-12 days which didn't concern him.   No follow-up attempts are possible. No further information is expected.
Extreme neck pain, difficulty swallowing. Now she's getting better but the muscle pain has moved down to her legs she went to see doctor. She said her doctor thought it was just muscle spasms. Still has some pain in the neck, has difficulty sleeping from the pain. She is able to swallow ok. Doctor's office is closed til 2/1/10 so wasn't able to talk to the doctor yet.
Skin rash and urticaria pruritus. Diphenhydramine 50 mg prn, Hydrocortisone
(L) deltoid site erythema began 10-24-14. Vesicle appeared 10-25-14. 1 large vesivle - few small at the site. BENADRYL, ibuprofen.
Information has been received from a healthcare professional, concerning an unknown number of patients who were vaccinated with a prefilled syringe filled with a dose of GARDASIL, and experienced "very painful" reactions. The reporter indicated that the prefilled syringes "eject out" quickly, and are more painful  than when the syringes supplied to the office are used. Consequently, the office discontinued the use of the prefilled syringes, and the number of very painful reactions has decreased. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Patient had right arm redness, swelling, hot to touch, and blisters after receiving DTaP #5 after half of day of placement.  Patient returned 08/11/2006 and was prescribed. Aclovate to apply three times a day and Pre Lore 5mg/teaspoon
anaphylactic reaction; Product origin unknown; This spontaneous report was received from a pharmacist  and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drugs reactions or allergies were not provided.  On an unknown date, (reported as 5-10 years ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)(dose, strength, frequency, lot # and expiration date were not provided) for prophylaxis. The reporter stated that it could have been also pneumococcal 13v conj vaccine (crm197)(PREVNAR 13). On an unknown date, the patient experienced anaphylactic reaction. The outcome of anaphylactic reaction and product origin unknown was unknown.     The causal relationship between anaphylactic reaction and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not provided.  Upon internal review, the event of anaphylactic reaction was considered to be medically significant.
The vaccinee received injections of Engerix-B on 5/1/01 (lot ENG5178A4), 6/17/01 (lot ENG5178A4) and 11/20/01 (lot ENG5239A4). On 2/11/02, a "titer" (NOS) was "0". The reporter considered the negative titer to be probably related to Engerix-B administration.
Pt recvd vax on 8JUN92 & approx 4 hrs following the vax, devel jaw stiffness & seen in ER: MD stated that was only able to open mouth about 2 or 3 cm; tongue was thick & was exp body aches; t99.4;
Immediately following the injection and till the next morning, my arm was tender at the injection site.  The following morning my arm was more painful at injection site.  Around noon the day after the 2nd shot, I began to feel achy all over and couldn?t get warm.  By 2:00 a headache began.  At 3:01 I had a fever of 101.7*, at 4:02 it was 102.*, at 6:23pm it was up to 103.1*.  The body aches and headache worsened.  At 9pm I called a nurse advocate who said all symptoms were normal and to take 2 ibropfen for the fever.  I slept most of the afternoon and evening.  By 10:30, I woke up all sweaty and the fever had broken.  On Feb. 11th, my arm was only slightly painful, I had no fever or aches, just felt tired.  On the 12th, I was fine.
Erythema 100mmx50mms area inferior to injection site, trace pruritus Treatment: cold compresses
11/11/09 11 20/ Pt. arrived in the gyn clinic for a related gyn question. Upon standing up pt. felt faint & was helped to a chair. Fainted about 1 min - upon awakening she began having dyspnea. To Center, then to Medical Center via ambulance.
48 hours after vaccination in right arm - Pt developed rash, swelling, low grade fever, & sore arm. Rash is approximately 4 inches in diameter.
Pfizer-BioNTech COVID-19 Vaccine EUA Injection site pain Headach Chills Fever Injection site swelling Feeling unwell
This spontaneous report as received from a physician refers to a 4 year old patient of unknown gender. On 11-DEC-2013 the patient was vaccinated with an expired dose of PROQUAD injections (lot # H015791, expiration date 12-NOV-2013) in the right arm (dose unspecified). No adverse effect had been observed or reported. Additional information has been requested.
This spontaneous report as received from a certificate medical assistant (CMA) refers to a 63 years old female patient with allergy to aspirin and codeine. On 18-MAR-2014 the patient was vaccinated with ZOSTAVAX, lot # J006157 (exp. 30-AUG-2014), 0.65 ml, subcutaneous in the left arm. Patient called physician's office on 20-MAR-2014 and stated that the injection site was red and slightly puffy since an unspecified date after the administration of ZOSTAVAX. No treatment was given. No lab test was done. The outcome of injection site was red and slightly puffy was reported as not recovered/not resolved. Additional information has been requested.
Started out like first injection. Had fatigue. It continued for about 30 days. On the 29th day I felt like I had a stroke. I had sore muscles, and joints. I was Confused. Tried to get hold of my doctor. Would not respond. Called second doctor. He gave me medicine (pills). Still not a hundred percent but getting better. I still suffer from fatigue. Doctor ran tests on the brain because I felt I had a stroke. My immune system went at war with the vaccine.
Fever of 104; Tachycardia; Shortness of breath; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TACHYCARDIA (Tachycardia), DYSPNOEA (Shortness of breath) and PYREXIA (Fever of 104) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, the patient experienced TACHYCARDIA (Tachycardia) and DYSPNOEA (Shortness of breath). On 12-May-2021, the patient experienced PYREXIA (Fever of 104). At the time of the report, TACHYCARDIA (Tachycardia), DYSPNOEA (Shortness of breath) and PYREXIA (Fever of 104) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2021, Body temperature: 104 (High) High. On 13-May-2021, Body temperature: less than 100 (Inconclusive) Stayed under 100.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   On 11 May 2021, patient experienced tachycardia and shortness of breath after the first dose of vaccination and went to the emergency room. On 12 May 2021, patient had fever of 104 which went down later and didn't went higher than 100. Again patient went to emergency room and healthcare professional took her off work for week. No treatment information was provided.    This case was linked to MOD-2021-213244 (Patient Link).
I had sinus problems, cough, sickness, fatigue, and running nose. I tested positive for COVID-19 at home. I talked to my doctor, and they prescribed me Paxlovid. I still have a lingering cough. I tested negative for COVID-19 last week.
Parent called to say that child cried post vaccination and was unable to move (states he was stiff). Parent took child to ER at approximately 10 PM and he had a fever of 105; treated with Tylenol and Motrin throughout the night and was released by noon on 3/17/05. Follow up calls revealed child is doing well.
Patient reports redness close to the injection site (on the upper arm) but not at the injection site. Site affected has a circular redness that the patient reports is warm and sore. Patient reports the site has become more red since yesterday.
Initial and follow up information has been received from a physician concerning a 6 year old female who on 13-JUN-2007 was vaccinated subcutaneously in the left arm with a second dose of varicella virus vaccine live (Oka/Merck) (lot# 656576/0446U). Concomitant therapy included a first dose in the left arm of hepatitis A virus vaccine (HAVRIX) (Lot#AHAVR172AB). The patient also received a dose of loratidine 1-2 hours prior to vaccination. There was no illness at the time of vaccination. On 13-JUN-2007 within one hour after the vaccination the patient experienced hives, swelling of her lips and itchy hands and feet. The patient was evaluated at a local emergency room and treated with diphenhydramine hydrochloride (BENADRYL). The patient did not require hospitalization. The symptoms resolved within 2 hours and the patient completely recovered. The physician also added that the patient developed hives and lip swelling after vaccination with a second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) on 18-MAY-2005. (WAES# 0710USA00801). No product quality complaint was involved. Additional information is not expected.
Patient was brought to health center by parent for COVID booster. Patient had previously had 2 Pfizer doses. Moderna 0.25mL dose was given to patient. It was later realized that Moderna is not yet approved by CDC for booster in patients under the age of 18. Patient parent was notified and voiced no concerns at this time. Additional training, education and information sheets were provided to all staff at health center to prevent future errors.
rash, hives, failed topical steroids but ultimately responded to prednisone and IM steroid injection
lt brachial area swollen, tight, erythematous, hot-involved entire upper arm & into shoulder;tx w/ice pack only;APAP as needed;
This spontaneous report as received from a nurse refers to a female patient of unknown age. The nurse reported that a patient received her first dose of the GARDASIL on 23-OCT-2014 and then received a second dose of the HPV series which was GARDASIL 9 on 13-JUN-2016. No adverse effects were reported. No product quality complaint (PQC) was reported for the suspect products. Additional information has been requested.
The patient had received her first dose of the Pfizer COVID-19 vaccine (lot number EL 1283, exp 4/30/2021) and about an hour later, she began to experience chest tightness and throat tightness.  She took her albuterol inhaler, but did not feel better, and proceeded to go to the ER. She has a history of asthma, but regards it as mild and only takes albuterol as needed.  She denies having any cutaneous, gastrointestinal, or cardiovascular symptoms.  At the ER, she was administered diphenhydramine and corticosteroids--she began to subjectively feel better.  She denied a history of allergic reactions to medications or vaccines, and denied a history of anaphylaxis.  She was not taking any medications on the day of her reaction, and was at her baseline health.  She had no vaccines within the past 14 days.
That evening felt unwell the night of the vaccination and into the next day was feeling very fatigue and 05/14/2021, 05/15/2021 until June 1, 2021 felt fine. Then on June 02, 2021, miscarriage. June 3, 2021 regular Dr. appt with OBGYN for missed period. Appt. June Discovered after June 5, 2021 lab for pregnancy hormone.
3 hours after injection: Sore arm (where injected).  Symptoms faded within 24 hours. 7 days after the injection: a large (~3" diameter) raised circular red spot appeared at the injection site.  It was itchy but painless.  It disappeared 36-48 hours after it began. Not other side effects were noted.
Initial misuse report received from a healthcare professional on 04 March 2014. 5-year-old patient was given a dose of FLUZONE on 13 October 2013 and then again on 21 February 2014. (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
Body ache; Chills; Headache; This is a spontaneous report from a contactable consumer (patient) via Pfizer sales Representative. The consumer reported on three patients. This is the first of three reports. A female patient of an unspecified age received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, on the second dose of vaccination the patient experienced body ache, chills and headache. The patient was treated for body ache, chills and headache with ibuprofen and the symptoms went away in one day. The clinical outcome of the events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021117324 same reporter/product/event, different patient;US-PFIZER INC-2021117244 same reporter/product/event, different patient
PVC is on EKG; lethargy; headache; sore arm; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 80 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 25Jan2022 12:30 (Lot number: FJ1614) at the age of 80 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Elevated BP" (unspecified if ongoing), notes: Elevated BP; "Glaucoma" (unspecified if ongoing). Patient had no prior Vaccinations with in 4 weeks. Concomitant medication(s) included: LISINOPRIL taken for blood pressure increased, start date: 1980 (ongoing); LATANOPROST OPTIC taken for glaucoma, start date: 2021 (ongoing); TIMOLOL [TIMOLOL MALEATE] taken for glaucoma, start date: 2021 (ongoing). Vaccination history included: Bnt162b2 (dose:1, Time (24hr): AM, Anatomical site of injection: Left Deltoid, Route of administration: Intramuscular, Batch/Lot number: EL3242), administration date: 06Feb2021, when the patient was 79 years old, for COVID-19 Immunization; Bnt162b2 (dose:2, Time (24hr): AM, Anatomical site of injection: Left Deltoid, Route of administration: Intramuscular, Batch/Lot number: EN6202), administration date: 27Feb2021, when the patient was 79 years old, for COVID-19 Immunization.  The following information was reported: VENTRICULAR EXTRASYSTOLES (medically significant) with onset 28Jan2022, outcome "unknown", described as "PVC is on EKG"; PAIN IN EXTREMITY (non-serious) with onset 25Jan2022 13:00, outcome "unknown", described as "sore arm"; HEADACHE (non-serious) with onset 26Jan2022 06:00, outcome "unknown", described as "headache"; LETHARGY (non-serious) with onset 26Jan2022 13:00, outcome "unknown", described as "lethargy". The event "pvc is on ekg" was evaluated at the physician office visit. Therapeutic measures were taken as a result of ventricular extrasystoles included HCTZ to BP med. No relevant test for thromboembolic events with thrombocytopenia.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events due to temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
complained he is hot then he was passed out---he was sweating a lot . We called 911 . was back when ambulance came----they checked on him and saidis fine--and they left.  is fine after that then he left 30 min later.
My whole body felt unusually warm and sore; My whole body felt unusually warm and sore; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 14:15 (Lot number: EP6955) at the age of 53 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CALCIUM; VITAMIN D 3; ZINC; ZOLOFT; VITAMIN-C. Vaccination history included: Bnt162b2 (lot number=EL3247,, administration_time=02:00 PM,, vaccine_location=Left arm), administration date: 08Mar2021, when the patient was 53 years old, for Covid-19 immunization. The following information was reported: FEELING HOT (non-serious), PAIN (non-serious) all with onset 30Mar2021 08:00, outcome "recovered" and all described as "My whole body felt unusually warm and sore". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of feeling hot, pain.  Additional information: The patient was not diagnosed with COVID-19 prior the vaccination. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.