chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tinnitus/has it in the left ear; Sounds are distorted; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown manufacturer), for COVID-19 Immunization. The following information was reported: TINNITUS (medically significant), outcome "unknown", described as "tinnitus/has it in the left ear"; HYPOACUSIS (medically significant), outcome "unknown", described as "Sounds are distorted". Therapeutic measures were taken as a result of tinnitus, hypoacusis including steroid shots (unspecified). Additional information: The patient wanted to know if tinnitus was a symptom after the second vaccination. The patient has it in the left ear. The sounds are distorted and steroid shorts from the ENT did not help.   The lot number for bnt162b2 was not provided and will be requested during follow up.
break out; had a flare up; my right hip was hurting; This is a spontaneous report received from a contactable consumer (patient, self-reported). A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number: EW0158 and expiry date was unknown), via an unspecified route of administration, on 08Apr2021, as a single dose for COVID-19 immunization. The patient also received  pain relieving patch (CAMPHOR, MENTHOL, METHYL SALICYLATE, TOCOPHERYL ACETATE, lot number and expiry date were unknown). Patient's medical history and concomitant medications were not reported. It was reported that the patient did not have any reaction until Sunday morning. At Sunday morning patient's right hip was hurting so patient put some pain patches on lower back and within 3 minutes patient was having a breakout. The patient had used those patches for years and never had break out before. The patient immediately took them off to rinse them in drill. Two of them back there because patient kept having flare up. On Monday, the patient had a flare up. The patient had not used any patches since then. The patient was just wondering if it was in relationship with COVID-19 shot. The patient was unwilling to share further information. Hence further probing could not be done. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
The patient experienced no symptoms; A patient was administered an improperly stored dose of PROQUAD; This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history and drug reactions/allergies were not provided. The patient's concomitant therapy included sterile diluent.     On 25-JUN-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (therapy type: digital data logger) (PROQUAD) (lot # S012533, expiration date reported as 20-OCT-2020) (dose, frequency and anatomical location were not provided) via subcutaneous route for prophylaxis (product storage error). The vaccine was reconstituted with sterile diluent (lot# N035974 and expiration date reported as 25-AUG-2020) that was stored properly. The patient had not experienced any symptoms (no adverse event). The administered dose of the vaccine experienced temperature excursion of 10 degree Fahrenheit for 1 hour and 30 minutes as recorded by a data logger. The vaccine had no previous temperature excursion. Product quality complaint (PQC) was not associated with this report.
2/8/21 approx 4 hours after shot: Fatigue, chills, fever, muscle aches, headache, brain fog. 2/8/21 approx 10-13 hours after shot: nausea, vomiting , chills, fever, abdominal pain,  muscle pain everywhere, injection site pain/heat/swelling/redness.  2/9/21, all day: fever, severe muscle aches and chills, general discomfort,  brain fog, fatigue, sleepiness, restlessness, injection site whole arm pain, swelling, heat, hard/raised, red, itchy rash. 2/10/21: abdominal pain, arm pain/symptoms about the same, rash now raised, intense itch. 2/11/21 abdominal pain, diarrhea, arm pain, itching, red/hot, swollen rash, mild brain fog, no chills, occasional fever
Soreness, heat and 3x5 in swelling at injection site from about 8 hrs after through next two weeks, gradually reducing. Fever up and down of 101 to 103 for day 1.5 thru day 4.  Soreness and 2x2 in swelling of lymph gland in left arm pit from day 2 thru day 8.  Soreness of rest of arm pit and left breast.  Lack of apetite from 24 hrs to about day 7.  Tiredness and excessive sleeping for about 1 week after.
Stroke 02/11/2021 after confusion since vaccine.  Was  never diagnose with hypertension, nor treated for this
Information has been received from a registered nurse referring to a 12 year old patient of unknown gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On 16-AUG-2016 the patient was vaccinated with an adult dose of VAQTA (lot # L048222, expiration date 19-DEC-2016, intramuscular, dose unknown). It was the first dose in the patient's series. No adverse effects were reported. Additional information has been requested.
Pt recvd 2-1cc injections of Recombivax 12DEC90 & 14JAN91; 10JUN91 recvd Engerix-B; pt "did not develop immunity";
CHILLS, FEVER, HEADACHE, MUSCULAR ACHES, SEVERE JOINT PAIN, NAUSEA, LIGHTHEADEDNESS, DRY HEAVES.  LASTED ABOUT 18 HOURS.  TOOK 800 MG IBUPROFEN 1 TIME AFTER ABOUT 12 HOURS.  COULDN'T EAT OR DRINK BECAUSE OF SYMPTOMS AND FOR FEAR OF VOMITING.
The patient's spouse stated that after receiving the Moderna booster the patient was feeling ?just fine and there were no signs of any issues.? The patient?s spouse further stated that ?by 3AM, she was feeling dizzy and dehydrated. By 4AM, I was calling 911.? The patient's spouse indicated that the patient had passed away.
received full 2-dose series of CV19 vaccine #1 on 27Jan2021 and #2 on 15Feb2021. Was PCR tested CV19 positive on 25Aug2021; received full 2-dose series of CV19 vaccine #1 on 27Jan2021 and #2 on 15Feb2021. Was PCR tested CV19 positive on 25Aug2021; This is a spontaneous report from a contactable other HCP. A 38-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL3247), via intramuscular route of administration, in the left arm, on 15Feb2021 (at the age of 38-year-old), as single dose and received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL3247), via intramuscular route of administration, in the left arm, on 27Jan2021 (at the age of 38-year-old), as single dose, both the doses for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Unknown if other vaccine in four weeks and Unknown if other medications in two weeks. Unknown if COVID prior vaccination. On 21Aug2021, reporter staes patient received full 2-dose series of CV19 vaccine #1 on 27Jan2021 and #2 on 15Feb2021. patient was PCR tested CV19 positive on 25Aug2021. Event resulted in doctor or other healthcare professional office/clinic visit. Unknown if patient received treatment for events. The patient underwent the lab tests and procedure which included the rapid test (Nasal Swab): result was positive on 23Aug2021 and PCR test (Nasal Swab): result was positive on 25Aug2021. Outcome of the event was recovering.  No follow-up attempts possible. No further information expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events vaccination failure, COVID-19 and suspect drug BNT162B2 cannot be excluded.
right cheek redness; right cheek redness and rash with burning; right cheek redness and rash with burning; itching; tingling sensations; felt hot; dizzy; This is a spontaneous report from a contactable consumer. A 67-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, lot EL3247, expiry date not reported), via an unspecified route of administration, administered in the left arm on 28Jan2021 as a single dose for COVID-19 immunisation. Medical history included hypertension and hypothyroidism, both from an unknown date and unknown if ongoing. The patient had COVID prior vaccination (dates unspecified). The patient was not pregnant at the time of the vaccination and report. The patient's concomitant medications were not reported. The patient had known allergies to aspirin, codeine, metoclopramide, morphine, hydromorphone, tramadol, hydrocodone, and prochloperazine maleate (COMPAZINE). The vaccination was done in the hospital. In Jan2021 (also reported as 18Jan2021), patient experienced right cheek redness and rash with burning, itching, tingling sensations. The patient also felt hot and dizzy. The events caused hospitalization from an unspecified date in 2021. The patient was not tested for COVID post vaccination. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Chills, shortness of breath (mild) joint and muscle pain, fatigue Essentially similar symptoms to when I had covid, towards the end of my illness. So like immune system symptoms.  I had covid 3/15/20-4/30/20.  I?m a long COVID sufferer, I still have resp pbs, arrhythmia, fatigue. I would like to get the second shot but am concerned about my over reactive immune response
Information has been received from Pfizer and was assigned manufacturer report number 2010056103. A male consumer was vaccinated with a dose of PNEUMOVAX on an unknown date. The consumer had a bad reaction to PNEUMOVAX. The patient had lost his spleen and needed yearly vaccines. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Upon internal review, lost his spleen was determined to be an other important medical event. This was originally reported by a consumer to a sales representative. Additional information has been requested.
Had MMR, Varivax, and Prevnar on 10/11/2005.  Presented on 10/24/2005 with rash all over body - no fever.  Treated with Benadryl as needed.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about July 2015, the patient was inoculated with ZOSTAVAX, (lot number and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles but caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX the patient was admitted to an intensive care unit for a transient ischemic attack, viral encephalitis, pneumonia and herpes zoster. Thereafter, the patient was diagnosed with transient ischemic attack, viral encephalitis, pneumonia and herpes zoster. As a direct and proximate result of these injuries, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient suffered significant medical expenses, severe pain and suffering, other damages, and ultimately death on 05-JUL-2016. The patient sustained severe and permanent personal injuries. Further, as a tragic consequence the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and ultimately death. Upon internal review transient ischemic attack, viral encephalitis, pneumonia and death were considered medically significant events. Transient ischemic attack, viral encephalitis, pneumonia and herpes zoster were reported to be disabling. Additional information has been requested. Reported Cause(s) of Death: death.
morphea; Information has been received from a lawyer, and refers to a patient (pt) of unknown gender who at the time of vaccination with zoster vaccine live (ZOSTAVAX) was approximately 54 years old. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. On or about 03-JUN-2014, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the was treated by a healthcare provider for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: morphea. The outcome of the event was not provided. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
fever 101.4 began early morning, vomiting started at 7am and lasted for 8 hours, migraine began midmorning and lasted for half a day, was in bed resting  starting at 7am, and was not able to hold down tea or food until 7pm.
I got the COVID-19 Booster shot on 10/28/2021. The symptoms occurred starting the next day. I had a sore and tight heart muscle. Every time I coughed or lifted something my heart muscle felt soreness. I was extremely exhausted and just felt tired all day and night. My arm hurt for 5-7 days. It took around 45 day mark. I stayed in contact with my doctor on occasion and she said everything would be fine and to just take ibuprofen or something similar.
Painful, red and white, blister like bumps all over the hands and feet. Began as a single bump (01/22/2021) then spread throughout both hands and feet the next day (01/23/2021). No other symptoms. (I had coxsackievirus as a young child)
Pt. had a fainting (vasovagal-like episode) Turned pale/clammy and Pulse was thready although VS were stable Pulse approximately 60/Needed O2 for about 10 mins/Laid supine/got better. Discharged with father stable VS.
Information has been received from a medical assistant concerning an unspecified number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of LIQUID PEDVAXHIB, lot # M014926 with expiration date of 17-FEB-2019 administered intramuscularly for prophylaxis (dose was not provided). It was reported that the vaccine had been stored for 5 hours at 59 degrees Fahrenheit as recorded by a digital data logger. There were no previous temperature excursions. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA008023: US-009507513-1702USA008024: US-009507513-1702USA002933:
Patient was given the vaccine and then about 2 minutes later he started to vomit and was light headed. Gave the patient some saltine crackers and water. I checked with the patient to see if the water and crackers were helping and he said yes. The vomiting stopped after having some water and saltine crackers. Took vitals at 10:02 am heart rate 82, o2 100%, and BP 116/61. I checked to see how the patient was doing and he stated that he was doing better. We released the patient with parents who were here to get there second vaccines. Patient was released at 10:14 am.
I was diagnosed with Bells Palsy  on the right side of my face. - September 29th, 2021 at ER . I am reporting that change in my health - currently no change in symptoms since that time. My Primary care doctor confirmed the diagnosis in a follow up appt. On a treatment plan now of various medications - some have changed by this point. I have complete facial paralysis on the whole right side of face.  Those symptoms started the evening Sept 28th.  Note: I had a flu vaccine on Sunday, September 26th, 2021  - injection on my left arm - prior to the third dose of COVID - . I had the 3rd dose of COVID on October 4th -  (after I had the Bells Palsy symptoms begin).
Within minutes of shots, went very red, flushed, legs swollen with purple blotches, extremely erythematous. Breathing normal. Sats 99% on room air. HR-150. Given Benadryl and resolved within 15 minutes. Left with pin-point rash on trunk. OK the following morning.
(L) upper arm red, swollen, tender, hot to touch x 2days. Started to decrease on 3day post vaccination.
Narrative: STATES FOR >1 WEEK HANDS AND ARMS HAVE BEEN SO SORE THAT HE CAN'T PICK UP THINGS WITH THEM.
This is a spontaneous report from a non-contactable pharmacist via Pfizer sales representative, who reported for her/his daughter. A 18-year-old female patient received the second dose of TRUMENBA on an unspecified date at single dose in arm for immunization. The patient medical history and concomitant medications were not reported. Patient was otherwise healthy and not feeling sick when vaccinated. Previously on an unknown date, she received the first dose of meningococcal group b rlp2086. On an unspecified date, after the administration of the second dose of the vaccine, the patient experienced a large baseball-sized welt at the injection site on her arm and flu-like symptoms for two days. Final outcome of the events was reported as unknown. Patient did not have these reactions with the subsequent third dose of meningococcal group b rlp2086. No follow-up attempts are possible. No further information is expected.
shingles episode happened a year after receiving the second dose; shingles episode happened a year after receiving the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, 1 year 4 months after receiving Shingrix and 1 year after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The reporter mentioned that the shingles episode happened a year after receiving the second dose and that the second dose was given four months after the first dose. The reporter asked information and recommendations on giving another dose or dose series to a patient that had already completed the dosing schedule for the Shingrix vaccine. The dates for the doses and more patient information were not available at the time of reporting. The reporter consented to follow up. The case was considered as suspected vaccination failure since the details regarding laboratory confirmation was not given.
My b/p shot up as well 180/107; My heart started racing....noted at 133/I had strong heart palpitations; Feeling of lightheadedness; This is a spontaneous report from a contactable nurse reporting for herself. A 50-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, via an unspecified route of administration in the right arm on 29Dec2020 at 12:15 pm, at 50-years of age, at single dose for COVID-19 immunization. The patient received the vaccine in Hospital and didn't receive any other vaccine in the previous four weeks. Medical history included hypertension from an unknown date (controlled) and no known allergy. Concomitant medication included amlodipine besilate 10 mg (NORVASC). The patient reported that, on 29Dec2020, within 6 minutes after receiving the vaccine dose, her heart started racing, it was noted at 133, her blood pressure shot up as well to 180/107, she had strong heart palpitations with feeling of lightheadedness. Prior to the vaccine the patient was at work, feeling well and taking care of her patients. Emergency Room visit and Physician Office visit were required, moreover fluids and potassium were administered to the patient as a result of the events. She reported she spent 8 hours in the ER. The events were reported as non-serious but they were assessed as important medical events by the Company. At the time of the report the reported events were resolving.  Information about Lot/Batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Hypertensive crisis, Palpitations, and Lightheadedness cannot be excluded.  The case will be reassessed if additional information becomes available.  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.
Pt. states that after receiving the 1st dose of Moderna 10/03/2021, started experiencing symptoms 10/11/2021 of blotchy and itchy area at injection site continuing to swell throughout the left arm up to the shoulder. Pharmacist communications recommendation of Reporting and Follow-Up with Primary.
Migraines lasting all day, sometimes waking up with a migraine, after dealing with them for 3 weeks I received medical help Currently on Sumatriptan 100 MG as needed, still have migraines