chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Migraines, earache, tinnitus; Migraines, earache, tinnitus; Migraines, earache, tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04May2021 11:00 (Lot number: 6347) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Peri menopause" (unspecified if ongoing), notes: Other medical history: Peri menopause; "Hypothyroidism", start date: 11Nov1999 (ongoing), notes: Other medical history: Hypothyroidism. Concomitant medication(s) included: LIOTHYRONINE; LEVOTHYROXINE; CITALOPRAM; LEVOXYL taken for hypothyroidism, start date: Nov1999 (ongoing); CELEXA [CITALOPRAM HYDROBROMIDE] taken for anxiety, start date: Aug2011 (ongoing). Vaccination history included: Covid-19 vaccine (product=COVID 19, brand=Pfizer ,, lot unknown=True,, lot unknown reason=Unable to locate or read the details,, dose number=1,, vaccine location=Left arm, Time(24hrs):11:00, Anatomical site of injection: Left arm, Route of Administration: Intramuscular, Lot number: 6347), administration date: 06Apr2021, when the patient was 50 years old, for Covid-19 immunisation.  The following information was reported: TINNITUS (non-serious) with onset 05May2021, outcome "recovered" (18Jun2021), MIGRAINE (non-serious) with onset 05May2021, outcome "recovered" (15Jun2021) and all described as "Migraines, earache, tinnitus"; EAR PAIN (non-serious) with onset 05May2021, outcome "recovered" (20Jun2021), described as "Migraines, earache, tinnitus". The event "migraines, earache, tinnitus", "migraines, earache, tinnitus" and "migraines, earache, tinnitus" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of tinnitus, ear pain. Therapeutic measures were taken as a result of migraine.  Additional Information: The Facility where the most recent COVID-19 vaccine was administered Pharmacy or Drug Store. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient not tested for COVID-19. The Patient took OTC, Pain reliever for migraine.  No follow-up attempts are possible. No further information is expected.
Symptoms include headache Tues eve, Wed morning pressure by eyes. Does get sinus infections off and on. starting on 9/28/21 2018 half of Thyroid removed. Exposures reported: Grown kids were at a reception -people tested positive along with their kids test was Wed. Wife also positive on 10/1/21
RESTING HEART RATE OF 150 ABOVE GOING ON LIKE 10 DAYS; This spontaneous report received from a consumer via a company representative via social media concerned a male of unspecified age. 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: Unknown, expiry date: unknown) dose was not reported, 1 total, start therapy date not reported 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 an unspecified date, the patient experienced adverse reaction to the covid-19 vaccine ad26.cov2.s which further descried as heart rate was above 150 going on like 10 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of resting heart rate of 150 above going on like 10 days was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211133748-Covid-19 vaccine ad26.cov2.s- Resting heart rate of 150 above going on like 10 days. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Approximately one minute after patient received the Shingrix vaccine he started to become very pale and sweaty. He stated not feeling well . Next he started gasping for air and jerking his body.  Patient drop his head and continue gasping for air. One dose of Epinephrine 0.3 mg was administered to his right upper leg immediately.  Patient then started to breath normal again and started to talk normal. 911 was contacted and paramedics arrived about 10 minutes after later. Patient was taken to the emergency room from where he was release home several hours later.
COVID 19 Treatment; COVID 19 Treatment; Pavloxid Rebound. Came back 2 days after testing negative.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 20Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; FLOMAX [MORNIFLUMATE]. Past drug history included: Statin, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment"; DISEASE RECURRENCE (medically significant), outcome "not recovered", described as "Pavloxid Rebound. Came back 2 days after testing negative.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Pavloxid Rebound Came back 2 days after testing negative; Positive, notes: Pavloxid Rebound Came back 2 days after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
cardiac arrest; This is a spontaneous report from a contactable consumer.  An elderly ( older that 65-years-old) male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), via an unspecified route of administration on 20Jan2021 as the second single dose for covid-19 immunization.  The patient's medical history and concomitant medications were not reported. He was reported as with unspecified  health issues, and no known allergies.   The patient previously received BNT162B2 for immunization, on an unspecified date. The patient experienced cardiac arrest on 23Jan2021, at 20:30, which was serious as it was life-threatening and involved hospitalization (in the intensive care unit (ICU)).  Details were as follows: after the patient received the  2nd dose of the vaccine on 20Jan2021. The reporter indicated that he was released to go on 23Jan2021. The patient went into cardiac arrest. Therapeutic measures were taken as a result of cardiac arrest. The patient was reported as in the ICU, and critical on life support. There was no note of COVID prior to vaccination.  It was unknown if the patient has had a  COVID tested post vaccination. The outcome of cardiac arrest was not recovered.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
During the night after her mist was given she c/o sore throat. In am woke still c/o sore throat and fever 99.2, went up to 101.5 with MOTRIN 11-6 mom noted rash on torso, face swollen, red circles below eyes (lg); rash went to arms, butt, legs. Mmom gave BENADRYL which helped. Continued to give thru Sun. Fever better as well as swelling and redness on Mon.
Unexplained rising in heart rate almost daily, heart rate monitor goes nuts, chest tightens. Major stomach issues daily, gas, bloating, nausea, acid. Bones ache sometimes. Constant headaches/migraines, blurred vision, brain fog. Extremely low iron. All of this began after the 2nd dose. Was healthy and running 10 miles and now can't do one due to pain amd exhaustion. Been to Cardiologist, Hematology, and GI doctors.
Nausea, chills, fever, headache, fatigue; started at 6:30 am, was better by mid-afternoon. Fatigue lasted another 24 hours
My son received the Flumist vaccine on November 7th at 4:30pm.  On November 8th at approximately 2:30 am, he had a grand mal seizure.  He was not ill at the time and was afebrile.  We went to the ER, and his labs and CAT scan were normal.  The next week he had an MRI and EEG, both of which were also normal.  He has not had another seizure since.  He has no past history of seizures.
About 24h after vaccination, child developed 11cm diam red tender indurated lesion on right deltoid centered at varicella injection site. By 48h, increased tenderness. By 72h - almost completely resolved.
No adverse symptoms reported; vaccinated wilh improperly stored VARIVAX; This spontaneous report was received from a physician referring to 10 unspecified patients of unknown age and gender. Information about concomitant medications, pertinent medical history, drug reactions or allergies was not provided.    On 14-NOV-2019, the patients were vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S019581, expiration date 25-JUN-2021, dosage detail, route, anatomical location and strength were not provided) for prophylaxis (product storage error). Administered doses of vaccine experienced temperature excursion from -50 degrees Celsius (C) to -15 C (-14.67C) for 3 hours. Total time in the range from 6 degrees Fahrenheit (F) to 14 degree F (-14 degree C to -10 degree C) (-14.4C) for 3 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.  The outcome of product storage error was considered as unknown. No product quality complaint (PQC) was involved with this report.     This is a non-valid case due to lack of patient identifier.  As of 19-MAY-2020, all telephone attempts trying to obtain additional information has been unsuccessful.  Follow up information has been received from the physician on 21-MAY-2020 refers to a 5 year old male patient. On 18-NOV-2019, the patient was vaccinated with one dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX).  This is one of the multiple reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA007663: US-009507513-2005USA007664: US-009507513-2005USA007662: US-009507513-2005USA007661: US-009507513-2005USA007660: US-009507513-2005USA007665: US-009507513-2005USA007658: US-009507513-2005USA007659: US-009507513-2005USA007526:
COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Heart disease, unspecified and Heart failure.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID). At the time of the report, COVID-19 (COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         No concomitant medication was reported. The patient had been vaccinated and boosted with the Moderna Covid-19 vaccine and was Covid positive. Patient was suggested by doctor to take Paxlovid however several doctors had told that they do not know where to get it. Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment:  This is a spontaneous case, reported by a consumer, concerning a male patient of an unknown age with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, supported by a positive COVID-19 test, in the context of the 3 doses of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. No further details about the clinical course and treatments were provided. Outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case, reported by a consumer, concerning a male patient of an unknown age with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, supported by a positive COVID-19 test, in the context of the 3 doses of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. No further details about the clinical course and treatments were provided. Outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
pt recv vax 15MAR96 & 16MAR96 pt devel chicken pox w/100 vesicles over body;tx w/acyclovir;
Shortness of breath, nausea, syncope. Called 911. Transported to Emergency Room.
Numbness in skin and face; Bouts of heat on whole body; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in skin and face) and FEELING HOT (Bouts of heat on whole body) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LOSARTAN, OMEPRAZOLE and HYDROCHLOROTHIAZIDE for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced HYPOAESTHESIA (Numbness in skin and face) and FEELING HOT (Bouts of heat on whole body). At the time of the report, HYPOAESTHESIA (Numbness in skin and face) and FEELING HOT (Bouts of heat on whole body) had resolved.            Other concomitant mediations included: Hormone replacement. No treatment information was provided. Action taken with respect to mRNA-1273 was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Additional information received and Outcome of the events Numbness in skin and face,Bouts of heat on whole body were changed from Unknown to recovered
Patient is 12 years old and received the Pediatric Pfizer vaccine for 5-11 years old.  No adverse reaction reported.
Got the first dose of the vaccine yesterday. About an hour after is when her arm starting getting sore; This is a spontaneous report from a contactable consumer (patient).  A 70-year-old female patient received bnt162b2 (BNT162B2), lot number not reported, via an unspecified route of administration from 21Jan2021 to 21Jan2021 as SINGLE DOSE (first dose) for COVID-19 immunisation.  Medical history included none.  There were no concomitant medications. The patient is a 70/yo female who is very concerned that she 'took half of a Tylenol Migraine' yesterday morning before receiving her first dose of Pfizer-Biontech Covid19 vaccine.  She stated she came home, started reading on the internet, and is worried now that the dose won't be efficacious.  She also reports a sore arm and wants to know 'if that's a good sign' of immune response. She also stated that her doctors 'don't know, and told me to call you'.  Got the first dose of the vaccine yesterday. About an hour after is when her arm starting getting sore. It got progressively more sore throughout the day. This morning it has improved but is still sore when she raises her arm. Treatment: Took Tylenol. This was before she read this article. The nurse was the one who told her to take Tylenol. She goes for her second dose on 11Feb2021. The patient got the first dose of the COVID Vaccine yesterday. Before she went to get her shot she was getting a migraine so she took half of a Tylenol Migraine. She read that if you take Tylenol before getting the vaccine that it can effect the efficacy, the patient was asking if this was true.  The outcome of the event was recovering.
pt received 1st dose on 4/7/2021, 2nd dose on 4/22/2021
2 hours after receiving my second Moderna shot I had a fever and body aches. But the the numbness and burning in BOTH of my hands was troubling. It was severe enough that my husband wanted to take me to the ER. I waited it out and eventually the pain and burning did subside but the numbness and tingling in BOTH hands never disappeared. Until this day I still have numbness and pins and needles in my hands along with brain fog.
This spontaneous report as received from a licensed vocational nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with a dose of PROQUAD (dose, frequency, strength and route were not reported), lot number reported as K003820, expiration date reported as 14-SEP-2015. Co-suspect and concomitant therapies were not reported. The licensed vocational nurse reported that PROQUAD were expose to -14C for 30 minutes and they were administered on an unspecified date to a patient. No adverse effects were reported. Additional information has been requested. This is one (1) of two (2) reports from the same reporter (MARRS 1406USA001137 and 1406USA008023).
Robust take 7.5 cm with lymphangitis consistent with viral cellulitis. Possible bacterial cellulitis. Treated with cephalexia 500 mg po qid for 5 days.
Approximately 3 minutes after vaccination patient felt tingling all over and itchiness. No raised red areas noted to body. Pt also felt dizziness. Denied any chest pain, shortness of breath or other respiratory issues. 11:14 pt was given benedryl 25mg. Vials 138/72 99% room air HR 100. 11:18 Pt states she is feeling better.  PT denied need for EMS transport.
Pt began to feel warm, high pitched frantic crying, parent states was delerious, glassy eyed & inconsolable; Given APAP then to ER-t101R;
states woke up 3/18/20 with right arm burning and in pain and red swollen area extending from injection site down to elbow. states ran 101 fever and up to 102 today.
temperature excursion, temperature: 8.3C, time frame: 12 minutes; This spontaneous report was received from a registered nurse referring to 10 unspecified patients of unknown age or gender.  The patients' concurrent conditions, medical history and concomitant medications were not reported.  On unknown dates, the patients were vaccinated with hepatitis b vaccine (recombinant)(RECOMBIVAX HB) for prophylaxis (doses, frequencies, routes, lot#s and expirations dates were not reported). The reporter said that the product had undergone temperature excursion at 8.3°C, with a time frame of 12 minutes, digital data logger: "yes". There were no previous temperature excursions.
Temp 102-102 x 3 days, some site pain and fussiness x 2 days. No swelling or edema.
1. Constant Ringing in ears - It never seems to stop.  Makes it hard to focus and often keeps me awake at night.  Never had this before. 2. Get tired out much more quickly than I used to, and I am usually a very active person.
Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves 11-year-old a patient who received an 0.5 ml expired vaccination with MENACTRA (batch number U5746AD, expiry date 14 Oct 2018, route and site of administration were not reported) on 15 Oct 2018. Concomitant medications included FLUZONE QUADRIVALENT for Immunisation; ADACEL for Immunisation; and GARDASIL for Immunisation, the same day as the MENACTRA. It was a case of actual medication error due Expired vaccine used. It was unknown if any adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. 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. Documents held by sender: none.
Chest pressure, severe headache, aches all over, exhaustion. Mostly  concerned with the chest pressure because of possible pericarditis or myocarditis.  Went to cardiologist. Insurance company would not approve an ultrasound to check.
shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunocompromised (immune system was slightly compromised).   On 21st May 2019, the patient received the 2nd dose of Shingrix. On 23rd May 2019, 2 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient's oncologist wanted the patient to receive Shingrix to prevent the patient from shingles. The patient experienced shingles.
Fever; Chills; Headache; she blew a blood vessel in her right eye; This spontaneous case was reported by a consumer and describes the occurrence of CONJUNCTIVAL HAEMORRHAGE (she blew a blood vessel in her right eye) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced CONJUNCTIVAL HAEMORRHAGE (she blew a blood vessel in her right eye) (seriousness criterion medically significant). On 12-Apr-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, CONJUNCTIVAL HAEMORRHAGE (she blew a blood vessel in her right eye) and HEADACHE (Headache) outcome was unknown and PYREXIA (Fever) and CHILLS (Chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment details were reported. This case concerns a 63-year-old female with a serious unexpected event of conjunctival hemorrhage, and nonserious expected pyrexia, chills, and headache. Event onset the same day as after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 63-year-old female with a serious unexpected event of conjunctival hemorrhage, and nonserious expected pyrexia, chills, and headache. Event onset the same day as after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.