chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; This is a spontaneous report received from a Pfizer sponsored program from a contactable consumer (patient). A female patient of unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot# and expiration date were not reported), via an unspecified route of administration on unspecified date at as a SINGLE DOSE for COVID-19 vaccination. Medical history and concomitant medication were not reported. Patients want to change the time to go appointment for second dose. She got a headache after first dose and still has a headache and it's getting better. The clinical outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Initial common pain at the injection site began within 5 minutes around 3:15. After returning home about 30 minutes later I felt lethargic and took a nap until about 10 pm. When I woke up from my nap, I still felt extremely lethargic and started feeling a tingling sensation and numbness in my left arm (vaccine administered in left arm). I did not pay attention to it and thought that would be common. I went back to bed and slept through the night until I woke up around 10 am. The tingling sensation and numbness continued from the injection site to the tips of my fingers. Both arms now felt the sensation, but the left arm was worse (similar to the irritation, discomfort, and pain of when your foot falls asleep). My left eye lid to my eyebrow started to twitch 5-10 times per hour for about 36 hours. The arm reactions settled down after a 50mg dose of Benadryl orally directed by my doctor after about 1 hour. The Benadryl only weakened the tingling sensation and numbness. I was directed to continue taking the Benadryl every 4-6 hours as needed. I had an increased heart rate of about 132 bpm when I woke up at 10 am (potentially due to anxiety about the vaccine reactions). I was directed to rest, and I had to call out of work. The facial twitching and arm reactions slowly settled down on 4/26 around 7 pm.
The patient had swelling in his arm and pain. It went to lower arm. The pt was taking TYLENOL and it didn't help. The pt went to the ER a few days later and they gave him antibiotic which the pt stated help and swelling is going down.
Examined on 11/23/2001 at 3 PM. Red, slightly swollen, warm to touch area 5" by 7.5' on lateral interior aspect right forearm. Pt states swelling had decreased in last 24 hours.
patient had tingling all over her body then her feet got really hot like they were on fire. called paramedics and she was stable and refused to go to hospital. patient said would follow up with doctor
sweats; she just does not feel great; she can hardly lift her arm; her arm is so sore; chills; fever of 99.4; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweats), VACCINATION COMPLICATION (she just does not feel great), VACCINATION SITE MOVEMENT IMPAIRMENT (she can hardly lift her arm), PAIN IN EXTREMITY (her arm is so sore) and CHILLS (chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 20-Jan-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced HYPERHIDROSIS (sweats), VACCINATION COMPLICATION (she just does not feel great), VACCINATION SITE MOVEMENT IMPAIRMENT (she can hardly lift her arm), PAIN IN EXTREMITY (her arm is so sore), CHILLS (chills) and PYREXIA (fever of 99.4). At the time of the report, HYPERHIDROSIS (sweats), VACCINATION COMPLICATION (she just does not feel great), VACCINATION SITE MOVEMENT IMPAIRMENT (she can hardly lift her arm), PAIN IN EXTREMITY (her arm is so sore), CHILLS (chills) and PYREXIA (fever of 99.4) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Body temperature: 99.4 f High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Hives, rash, swelling of most of arm where injection was given, seen in ER next day given Rx for ORAPRED.
swelling & irregular erythematous rash around inj site, started soon p/vax & cont to worsen locally;
This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. On 10-MAR-2014 the patient was vaccinated with ROTATEQ (dosing regimen unspecified). No concomitant medications were reported. On an unknown date medication error was reported as the patient received doses on 10-MAR-2014 that were exposed to temperatures outside of the recommended storage range noted in the prescribing information. No adverse effect reported. No product quality complaint involved. The outcome of medication error was unknown. This case is linked to: 1403USA005417, 1403USA011256, 1403USA011262, 1403USA011268, 1403USA011301, 1403USA011335, 1403USA011343, 1403USA011350, 1403USA011353, 1403USA011356, 1403USA011363, 1403USA011414, 1403USA011416, 1403USA011418, 1403USA011420, 1403USA011422, 1403USA011424, 1403USA011425, 1403USA011427. (same reporter link) Additional information has been requested.
sudden severe onset of vertigo; dizziness; syncope; vomiting; This is a spontaneous report from a contactable consumer (patient, self-reported). A 51-Year-old female patient (who was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6204 and expiry date was not provided) via an unspecified route of administration, in left arm on 12Mar2021 at 13:30 as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis and immunotherapy. The patient had allergies to penicillin, sulfa drugs and peanuts. The patient's concomitant medications were not reported. The patient previously took ibuprofen and had allergy. The patient stated that On 18Mar2021 at 12:30, the patient experienced sudden severe onset of vertigo and dizziness with syncope and vomiting. The patient was hospitalized for 3 days. On an unknown date in Mar2021, the patient was hospitalized, and a week and a half later still had dizziness which prevents patient from performing daily tasks. Patient received unspecified treatment for the adverse event. Seriousness of the events was reported as hospitalization. Outcome of the events vertigo, syncope, vomiting and loss of personal information was recovering, and for the events dizziness it was not recovered.
onset p/27hr post vax, itching, pain, redness, induration of 30mm, warmth & soreness;ice applied @ 48-72hr;resolving, still reddened w/20mm induration p/4 days;
Gave Novartis H1N1 vaccine (4 yr & older) 0.5mL IM. Should have give Sanofi Pasteur H1N1 (6 months & older) 0.5mL IM. No signs or symptoms of distress noted.
Chronic Spontaneous Urticaria; no food, environment, or other triggers; flare ups every 4-6 hours at random locations on entire body.
As mentioned earlier, I had been previously diagnosed with chronic urticaria and had been on a regular regimen of Allegra for over a year. I was in the process of weaning off the Allegra and was almost done with it. I was advised by my Allergist, to take Allegra (180mg) daily during the week of my Covid-19 shots. The first Covid-19 dose came and went without any effects, however, roughly a  week or so after the second dose, I noticed that my hives became more aggressive and I had to go back to taking Allegra more frequently again.
injection site soreness in my left arm.; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 24Feb2021 at 13:45 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes, hypertension, pet dander allergy, dust allergy, eggs allergy, pollen allergy and apples allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID -19 vaccine. Concomitant medications included metformin (MANUFACTURER UNKNOWN), olmesartan (MANUFACTURER UNKNOWN), colecalciferol (VITAMIN D3) and metoprolol (MANUFACTURER UNKNOWN); all for unknown indication from an unknown dates and unknown if ongoing.  It was reported that the patient was a Pfizer colleague and had received the first dose of the vaccine at the Pfizer clinic. On 24Feb2021, the patient experienced injection site soreness in his left arm. It was mild on the previous day more intense on the day of report. The patient did not  experienced any further adverse events. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were taken as a result of the adverse event which included the treatment with TYLENOL. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event injection site soreness in left arm was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
I have not slept more than 2-3 hours since the vaccine. I tried melatonin last week for 2 nights to no avail, and I went to my doctor who prescribed Trazodone and recommended 50mg a night. That didn't work, so the next night I took 100mg and I slept for 4 hours or so on and off. I'm apprehensive and scared to take it every night. Please help me!
This spontaneous report as received from a healthcare worker refers to a 5 year old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 10-AUG-2015, the patient was vaccinated with the improperly stored dose of PROQUAD (Merck) (lot number L005297 and expiration date 23-SEP-2016; dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04May2021 at 09:00 as dose 1, single (Lot number: EW0175), in right arm, on 25May2021 at 14:15 as dose 2, single (Lot number: EW0168), in right arm and on 23Dec2021 at 15:30 as dose 3 (booster), single (Lot number: FL3197) at the age of 57 years, in right arm for covid-19 immunization. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "ocular hypertension" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "depression" (unspecified if ongoing); "constipation" (unspecified if ongoing); "vaginal dryness from menopause" (unspecified if ongoing); "Known allergies: Sulphate drugs" (unspecified if ongoing), notes: Known allergies: Sulphate drugs. Concomitant medication(s) included: LEVOTHYROXINE (Brand:), start date: 01Oct2007; BUPROPION HCL  (Brand:), start date: 25Dec2021; BIMATOPROST ( (Brand: Somerset Therapeutics LLC), start date: 01Jan2021; METHYLPHENIDATE ( (Brand:), start date: 27Sep2021; MIRALAX (Brand:), start date: 30Sep2016, also reported as other medication in two weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 included Paxlovid (Anti-viral) started on 20Apr2022 and stopped on 24Apr2022. Clinical course was reported as, Covid symptoms returned on 29Apr2022, 5 days after finished patient last dose of Paxlovid. Runny and plugged nose, coughing, sore throat, heavy/tight chest. Patient never had the cough and sore throat when patient symptoms started before the Paxlovid, only the extremely runny nose, headache, chills, fatigue and tight chest. Patient was not recovered from symptoms and no treatment received for symptoms.
2 days after my son received MMR and Hep A on 10/28/08 he had high fever, inconsolable, listless, lethargic for two weeks. He is now receiving therapy for Expressive/Receptive speech delay.  9/2/09 PCP medical records received DOS 10/28/09 to 4/28/09. Assessment: Delayed expressive language per state developmental service. Patient developed congestion coughing, fever, fussy, screaming, crying and lots of mucus. Disrupted sleep. Rash on back not vaccine injection site. URI. Parent concerned that child does not communicate, just cries, not expressing himself or verbalizing. Modified Checklist for Autism in Toddlers - several non-critical items of concern.
hot flashes; nausea; I could not get out of bed; fatigue; headache; upper arm sore; This spontaneous case was reported by a physician and describes the occurrence of HOT FLUSH (hot flashes), BEDRIDDEN (I could not get out of bed), FATIGUE (fatigue), HEADACHE (headache) and NAUSEA (nausea) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse reaction (Medical History was not provided).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced HEADACHE (headache) and VACCINATION SITE PAIN (upper arm sore). On 16-Jan-2021, the patient experienced BEDRIDDEN (I could not get out of bed) and FATIGUE (fatigue). On 17-Jan-2021, the patient experienced HOT FLUSH (hot flashes) and NAUSEA (nausea). At the time of the report, HOT FLUSH (hot flashes), BEDRIDDEN (I could not get out of bed), FATIGUE (fatigue), HEADACHE (headache), NAUSEA (nausea) and VACCINATION SITE PAIN (upper arm sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication were not reported by the reporter. Treatment included Zofran 4mg for nausea.
Vertigo came on suddenly 6 days after the first dose of the Pfizer covid vaccine and I have now had the vertigo for 3 days and some new knee pain today on day 8.
A rash and redness on the arm and it's tender to the touch; A rash and redness on the arm and it's tender to the touch; A rash and redness on the arm and it's tender to the touch; Golf ball size swelling at the injection site; This spontaneous case was received on 21-Oct-2020 from other health professional (nurse) via Med Communications (reference number: SEQW20-04047) and concerned a patient of an unreported age and gender.  The patient's medical history and concomitant medications were not reported.  On an unspecified date in Oct-2020, reported as within the last week from initial reporting, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: arm and route of administration: not reported) for prevention of seasonal influenza. The batch number reported was 283852 and expiration date 30-Jun-2021.  On an unspecified date in Oct-2020, an unknown amount of time after receiving Flucelvax QIV, the patient developed a golf ball size swelling at the injection site on arm. The patient also developed a rash and redness on the arm, and it was tender to the touch. The reporter stated it was not life threatening.  The outcome of the events was unknown.  The reporter assessed the events to be related to Flucelvax QIV. Pharmacist reported 4 patients who had an adverse event to Flucelvax Quad MDV.  This case is linked with cases 202005387, 202005388 and 202005389 (due to same reporter).  Additional information received on 05-Nov-2020 from pharmacist via Med Communications (SEQW20-04786): Reported provided causality. Causality changed from not reported to related. New reference number added. New reporter added. Narrative amended.  Company comment: The patient developed erythema, tenderness, rash and vaccination site swelling on an unspecified date after vaccination with Flucelvax QIV. Although onset date for these events was not provided, narrative suggested plausible temporal relationship. No information regarding concomitant medications and medical history was provided. Considering all above mentioned, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Reporter's Comments: Pharmacist reported 4 patients who had an adverse event to Flucelvax Quad MDV.; Sender's Comments: The patient developed erythema, tenderness, rash and vaccination site swelling on an unspecified date after vaccination with Flucelvax QIV. Although onset date for these events was not provided, narrative suggested plausible temporal relationship. No information regarding concomitant medications and medical history was provided. Considering all above mentioned, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).
About 3-4 hours after the vaccine was administered she became very tired and had a very sore arm.   The hives started last night (Wed) 5/5.
droopy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 9-year-old female patient received BNT162b2 (BNT162B2), in 2022 as dose number unknown, single (Lot number: FL8094) at the age of 9 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious) with onset 2022, outcome "unknown", described as "droopy".  Additional information: The report was not related to study or programme. The reporter stated that her daughter got Pfizer vaccine, clarifying that it was the Pfizer covid vaccine. She was not a doctor obviously, her daughter did not have a crazy reaction with the covid vaccine, she was just droopy but no reaction. She did completely different day, she was 10 years old, she was 9 at the time, but this has nothing to do with her, it was a different time when she got it, she did it in Mar2022 or Apr2022, whenever they authorized vaccines for kids. When probed for her daughter Lot and Expiry of the Covid vaccine, reporter declined as she does not feel it was relevant to provide.
Pt received Pfizer vaccines on 03/01/21 and 03/22/21. Pt presented to the ED on 11/24/21 with complaints of SOB and hypoxia after being exposed to a spouse with COVID. Pt was found to be COVID positive on 11/24/21. Pt required BiPAP.
My cycle started 6 days early and I had vaginally bleeding for 18 days straight until my physician gave me a prescription for progesterin to stop the bleeding. I am not sure if I will continue to bleed if my cycle comes on again?.now I am currently 7 days late for it to start.
Breakthrough case admission after 4 vaccines Pfizer 4/2/21 lot# ER8730;  Pfizer 4/3/21 lot# Ew0162;  Pfizer 11/24/21 lot# FJ1620;  Pfizer 6/24/22 lot# FN2908
ON 3/18/2021 I had a    massive stroke    due to several    blood clots    in the caratid artery and in the brain.  I survived and am now in the process of rehab to regain full mobility.
Covid; Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Mar2021 at 07:30 as dose 1, single (Batch/Lot number: unknown), in left arm, on 05Apr2021 at 07:30 as dose 2, single (Batch/Lot number: unknown), in left arm, on 26Oct2021 at 15:30 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 12Apr2022 at 15:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive, notes: After 3 days, I tested positive for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was nauseous and headachy. When she first started feeling sick, she was experiencing only a bronchitis-like cough. After 3 days, she tested positive for Covid, so she asked her doctor to prescribe Paxlovid. Patient was not having Known allergies and Other medical history. Patient didn't took other medication in 2weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Fever over 100.2 degrees for two days following vaccination, treated with tylenol.  Rash on chest and back and "pox" like bumps on butt.  No treatment for rash.
sore arm; Fever; headache; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PYREXIA (Fever), HEADACHE (headache) and MYALGIA (muscle aches) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 048A121A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PYREXIA (Fever), HEADACHE (headache) and MYALGIA (muscle aches). On 07-Mar-2021, PYREXIA (Fever) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and MYALGIA (muscle aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Body temperature: 101.2 (High) 101.2.         No corrective treatment was reported
PATIENT HAS PAIN IN UPPER ARM AREA AND ALSO COMPLAINS OF NUMBNESS IN THE HAND THAT HAS CONTINUED 6 DAYS AFTER SHOT.
This spontaneous report has been received from a Pharmacist Intern, concerning a 12 month old patient of unknown gender. The patient's medical history, concurrent condition or concomitant medication were not provided. On 19-APR-2017, the patient was vaccinated with and expired dose of M-M-R II rHA Albumin status with a lot # L012482 and expiration date 10-APR-2017 (dose, route of administration were not provided) for prophylaxis. No adverse events were reported. Product quality control was no involved. Additional information has been requested.