chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very high pitched loud tinnitus in my right ear; This is a spontaneous report from a contactable other HCP (healthcare professional, patient). A 60-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: ER8737) via an unspecified route of administration on 02Apr2021 at 15:15 (at the age of 60-years-old) as a single dose in the right arm for COVID-19 immunisation. Medical history included Ehlers Danlos Hypermobility, known allergies: Sulfa drugs and known allergies: narcotics, all from unspecified dates and unspecified if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications ("other medications in two weeks") included levothyroxine sodium (LEVOXYL), fexofenadine hydrochloride (ALLEGRA), gabapentin and escitalopram oxalate (LEXAPRO), all taken for unspecified indications on unspecified dates. The patient did not receive any other vaccine within four weeks prior to receiving the COVID-19 vaccination. On 02Apr2021 at 15:15, the patient experienced very high-pitched loud tinnitus in my right ear. The event was serious for disability or permanent damage. The clinical course was reported as follows: "immediately after receiving the injection, I began experiencing very high-pitched loud tinnitus in my right ear. It has not resolved and awakens me at night. I am afraid to receive the second shot." The patient had not received treatment for the adverse event. The clinical outcome of the event very high-pitched loud tinnitus in my right ear was not recovered/not resolved. Since the vaccination, the patient was not tested for COVID-19.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Information has been received from a 69 year old female with hypertension who on 10-SEP-2007 was vaccinated with Zostavax (Oka/Merck).  Concomitant therapy included loratadine (Claritin), vitamins (unspecified), aspirin, amlodipine besylate (Norvasc) and lisinopril.  On 11-SEP-2007 the patient had an increase in her blood pressure from the 120's to the 160's.  The patient's increase in her blood pressure persisted.  The patient did not seek medical attention.  No further information is available.
Extreme chills and severe shaking lasted 4hrs tapering off after 230AM without medicine.  Body aches and severe headache (not migraine) lasted almost 24hrs; took 500mg Tylenol at 5am with little relief, took 240mg baby Aspirin approx 8am, took 10mg Maxalt at 9am with some more relief, but headache persisted.  Took 325mg Aspirin about 3pm and felt near total relief by 5pm.  Body aches also relieved by afternoon.  No issues the next day (Sunday).
Patient was accidently given an empty syringe.  We realized quickly & called the patient who came back in within a few hours & received the moderna covid19 vaccine.
red; itches terribly; 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 VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (itches terribly) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (itches terribly). At the time of the report, VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (itches terribly) outcome was unknown.            No concomitant medication  was reported.  No treatment history was reported.   This case was linked to MOD-2021-298586, MOD-2021-298603 (Patient Link).   Reporter did not allow further contact
Fever - 24 hours Headache - 18 hours Fatigue - 40 hours
Fever and lethargy 102-103 degrees, irritable, lethargic onset 7/28/11.
This spontaneous report as received from registered nurse refers to 6 month old patient (gender not reported). Nurse reported that an expired dose of ROTATEQ lot # 0210AE (exp. date 29-SEP-2013) (route and dose not reported) went through unsupported temperature excursion from 30-SEP-2013 to 04-OCT-2013 and was administered to the patient on 07-OCT-2013. No adverse effect reported. This is one of several reports from the same source (MARRS # 1310USA004161, 1310USA006563). Additional information has been requested.
This spontaneous report was received from a medical assistant regarding a female patient of unknown age with no pertinent medical history reported. In August 2012 (unspecified date) the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (dose, route and anatomical location not reported) for prophylaxis. No other suspect therapies or concomitant medications were reported. The medical assistant reported that the patient was at the physician's office to be administered her second dose of GARDASIL on 06-JUN-2013. No adverse effects were reported. Additional information has been requested.
Information has been received from a physician concerning a female who on 15-JAN-2008 was vaccinated with her first dose of GARDASIL (lot# 660387/1967U). On an unspecified date the patient was vaccinated with her second dose of GARDASIL (lot# not provided). Subsequently the patient experienced nausea, vomiting, headache and stuffy nose since she was given the second dose. The patient was recovering from nausea, vomiting, headache and stuff nose. She sought medical attention by calling the nurse. Additional information has been requested.
no additioanl adverse events; inappropriate schedule of vaccine administered; This spontaneous report was received from an other health professional and refers to a female patient of unknown age. The patient's concurrent conditions, medical history, concomitant medications, drugs reactions or allergies were not provided.  On unspecified date in August 2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0,5 ml (route of administration, lot # and expiration date were not provided) for prophylaxis. On 10-FEB-2021, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0,5 ml (route of administration, lot # and expiration date were not provided) for prophylaxis, past the recommended 2 months. No additional adverse events were reported.
Began swelling 3-4 hours after returning from getting the vaccine. No difficulty breathing at first. Had fever, arm ache, and weakness as expected on day after and the next day. Remained fatigued after normal vaccine response subsided.   For the next week, had severe brain fog and difficulty processing/remembering/communicating; dry eyes; facial swelling; extreme fatigue; difficulty breathing.  After first week, brain fog lessened and became able to have short conversations. Fatigue lessened but continues (difficulty walking more than ~0.25 miles, difficulty breathing, get tired going up stairs).
Skin eruption over that past few days which appears to be consistent with Pityriasis rosea. It is benign and not needing intervention
About 15 minutes after injection c/o bump and slight itching. Slight reddness around injection site (L) deltoid. Observed x 20 min B/P 128/83 at 845A and 120/82 at 905A. Applied ice x 10 min. States itching relieved. 12/19/14 reports feels better, arm only a little sore.
Fever (100+); body & joint aches; body & joint aches; headache; slight nausea; weakness; extreme fatigue; feeling unwell; muscle pain; injection site pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A non-pregnant female patient of (Age: 72, Unit: unknown) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN6208), via an unspecified route of administration, administered in arm right on 13Mar2021 at 14:00 (02:00 PM) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. The patient received concomitant medications in two weeks which included metformin; glipizide; triamterene; irbesartan, all drugs taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine in four weeks. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EL9266), via an unspecified route of administration, administered in arm left on an unspecified date in Feb2021 at 02:00 PM as dose 1, single for COVID-19 immunization. On 13Mar2021 at 19:00 (07:00 PM), the patient experienced fever (100+), body and joint aches, headache, slight nausea, weakness, extreme fatigue, feeling unwell, muscle pain, injection site pain. Began 5-6 hrs after injection. Lasted 36+ hours and began to subside on Monday after injection. The patient underwent lab tests and procedures which included fever was 100+ on 13Mar2021. The patient did not receive treatment medication for all the events. Outcome of all the events was recovering.  No follow-up attempts are possible. No further information is expected.
LONG-TERM DIZZINESS; This spontaneous report received from a consumer 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced long-term dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of long-term dizziness was not reported. This report was non-serious. This case, from the same reporter is linked to 20210755402.
Back pain; Tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID) and BACK PAIN (Back pain) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced COVID-19 (Tested positive for COVID). On 07-Apr-2021, the patient experienced BACK PAIN (Back pain). At the time of the report, COVID-19 (Tested positive for COVID) and BACK PAIN (Back pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included unspecified thyroid medication.   Patient had throat ache, mild chest pain and headache due to COVID-19. Treatment medications included Vitamin C, Vitamin D, Magnesium, Ibuprofen, Robitusin since 01-Apr-2021 and started by taking the vitamins and then on the following days, started adding some medicines.
Significant arm and shoulder pain in the injection arm that has lasted over a month. Still have not regained full mobility of my arm despite stretching and massaging the area.
Pt recvd Engerix-B on 27APR90, 29MAY90, & 25OCT90 subsequently was found neg anti-HBS p/3 doses @ 1mo, 2mo, & 6mo intervals;
Event occurred after 2nd dose. Patient was diagnosed with Covid Tylenol Discharged home
Patient had flu-like symptoms while deployed at start of pandemic (approx. Jan/Feb 2020), but testing was unavailable. His symptoms (URI-like) completely resolved. He received Moderna dose 1 on 02 Feb 2021 without incident, and Moderna dose 2 on 02 Mar 2021. Approximately one week later, he developed mild, dull, diffuse chest pain and shortness of breath which has persisted since.   He was seen in clinic for chest pain and dyspnea on 15 Mar 2021. Patient noted his chest hurt ?all over? especially with deep or with normal inspiration. Reclining, laying down, and sleeping on his right side increased his pain (he did not trial sleeping on his left). Leaning forward decreased pain. He endorsed feeling short of breath, and stated he felt light headed twice while going up stairs, without passing out. He denied recent illnesses and other symptoms. He is a very physically fit Active Duty Marine, who has continued running despite his symptoms. During this encounter and later f/u encounter, he expressed he did not believe running made his symptoms significantly worse.  Vital signs were within normal range and he did not appear in distress. Cardiac and lung exam were normal, and no friction rub or murmur was appreciated. EKG showed sinus bradycardia, with HR consistent with his known, athletic-type normal variant heart rate. No other abnormalities were detected. Due to limited ancillary services within clinic, he was sent to USNHO ED for evaluation. There, he had basic labs (including Trop I) drawn, which were normal. EKG and portable chest xray were also unremarkable, and he was discharged with Motrin 800mg PO TID.  He was seen in clinic again 29 Mar 2021 for continued, unchanged symptoms, and reported he had been taking his Motrin only in the mornings and afternoons. Vital signs were unchanged (normal limits). Exam, including heart and lung, were normal. EKG again demonstrated sinus bradycardia, consistent with his normal resting heart rate. He was started on empiric therapy for pericarditis. He was released from clinic and will follow up in several weeks.
SORENESS IN SHOULDER  AND NECK FORM ELBOW; BUMP UNDER NEATH INJECTION SITE; PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned an 81 year old female. The patient's height, and weight were not reported. The patient's past medical history included heart failure, stent placement, heart attack, breakout in hives, and itching, and concurrent conditions included type 2 diabetes, hypertension, anxiety, penicillin allergy, iodine contrast dye, sulfur allergy, non smoker, and non alcohol user, and other pre-existing medical conditions included patient had no drug abuse or illicit drug. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: 05-AUG-2021) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. Concomitant medications included insulin for type 2 diabetes. On 26-MAY-2021, the subject experienced pain at injection site. On 27-MAY-2021, the subject experienced bump under neath injection site. On an unspecified date, the subject experienced soreness in shoulder and neck form elbow. Laboratory data (dates unspecified) included: Pain scale (NR: not provided) 8 to 9 out of 10, 5 out of 10. Treatment medications (dates unspecified) included: lidocaine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain at injection site, bump under neath injection site, and soreness in shoulder and neck form elbow. This report was non-serious.
Pt reported rash, hives, swelling (L) deltoid at injection site. Swelling in her neck on the (L) side which has not resolved. She also has hoarseness since.
Swollen injection site, warm and reddened to elbow. She could not sleep on Rt side. She felt feverish (temp not taken) x 3 days.
Headache, Myalgia & Arthralgia Narrative:  dose 1: my right shoulder is extremely sore and unable to work day 1 to 2/9 dose 2: muscle aches, chills and headaches ; chills; sweating  Other Relevant History:
Child birthday was 10/18/15 baby turned three and was given a two year old dose, mother notified and will bring child in for second half asap.
Received shingles vaccine from my doctor at his office on 02/12/2022. By Monday, 02/14/2022, I developed what looks like "covid toe", an extremely painful condition. Lab performed a Covid PCR test which has come back negative. No Covid. Shingrix vaccine made me very sick. I'm in a lot of pain in my left foot. I have photos of my "covid toe" which I will upload as well the lab test results for covid. I stupidly listened to my doctor's advice.
For the first time in decades, my period is 2+ weeks each month and extremely irregular, despite being on birth control.  This has never happened before and started soon after my 2nd dose of the Moderna Covid vaccine.
prescribed paxlovid after vaccination; prescribed paxlovid after vaccination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Batch/Lot number: unknown), in left arm and as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing). Concomitant medication(s) included: TOPIRAMATE taken for migraine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "prescribed paxlovid after vaccination". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Narrative case summary and further information: Reason for no lot number: of Paxlovid: Other: LOT#: Consumer stated, "PAA183750 or may be not. Sorry, I see GA5765. I see that's 5, hold on. So, the GA5765 or 6765. I can not count (Not confirmed hence not captured in tab). Expiry Date of Paxlovid: Jan2023. Other Products: Yes. Additional Context: Consumer stated, So, I have been taking Paxlovid and I was on a hold with my doctor this morning and I had a side effect and they wanted me to call and let you know what it was. When asked for the side effect: Consumer stated, "I am actually having pain, where I got my vaccine shot in my left arm. Name of the medication: Paxlovid. When paraphrased the concern: Consumer stated, That is correct, at the injection site where I had my vaccine, I had 3 shots in the same arm for my covid vaccine and I am experiencing pain in the arm, at the site of the injection. Consumer was informed about the role of Pfizer Drug Safety. When asked if consumer is HCP: Consumer stated, Doctor. Oh! no. Me? I am a patient. Product details: (LOT#, NDC#, UPC#, Expiration date) LOT#: Consumer stated, PAA183750 or may be not. Sorry, I see GA5765. I see that's 5, hold on. So, the GA5765 or 6765. I cannot count(Not confirmed hence not captured in tab). Expiration date: Consumer stated, I do have expiration Jan2023 (Confirmed as Jan2023). Pharmacy details: Name: Consumer stated, (pharmacy name) in (city, state name). Dose: Consumer stated, Repeat that one more time. So, Thursday I took the morning and the night dose, and then Friday I took morning and night dose and this morning I took morning dose. So, I guess 5 doses. Treatment for adverse events: Consumer stated, I took Tylenol for cover my covid symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt reports that apprx 1 hr after being vaccinated she had the following reactions: felt "an intense heat t/o my body,all over"; Rash/hives on my hands, face & neck that lasted apprx 1/2 hr & then went away; fever; chills; nausea & "tickle in my throat.  Pt reports these symptoms lasted t/o the night. Pt reports she did not sleep well.
the injection site was very red/the size of an orange; did not feel well for about two weeks; had headache; whole arm was significantly bruised; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   On 23rd January 2020, the patient received the 1st dose of Shingrix and PNEUMONIA VACCINE. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site erythema, malaise, headache and bruising of arm. On an unknown date, the outcome of the injection site erythema and malaise were unknown and the outcome of the headache and bruising of arm were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, malaise, headache and bruising of arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in her left arm and the injection site was very red, the size of an orange and the whole arm was significantly bruised.  She also had headache and did not feel well for about two weeks.  She also stated that she got the pneumonia vaccine in the right arm on the same day. The reporter consented to follow up.
Pt started with symptoms of facial paralysis approximately 2wk after vaccination, pt was diagnosed with mild case of L bell?s palsy
That evening, my left arm became extremely touch sensitive at the injection site and my throat began to feel scratchy requiring me to take 10 mg Cetirizine Hydrochloride (Allergy Relief). The following day (1/13/21) at approximately 6 a.m., a large red, raised, warm welt had formed on my left upper arm, measuring approximately 1 inch by 1 inch. By 1/14/21, the welt had grown to 1 inch by 1.5 inches and continued to be extremely touch sensitive, raised and warm with a hardness to it. By 8:30 a.m. on 1/14/21, all visual reaction was gone, but from 1/14/21 to 1/24/21, the injection site remained periodically itchy.