chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ear pain; Tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 24Mar2021 (Batch/Lot Number: ER2613) (at the age of 67-years-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications the patient received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 29Mar2021, the patient experienced ear pain and tinnitus. All the events were reported as serious, seriousness criteria as disability. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered.
She got home and did not have any reactions until last night around 10:00  PM when she got a bad headache, fever last night that was 100.1.  Her back is killing her, her legs hurt and her left arm hurts as well.  Her eyes are also watering.   She has not taken anything for the symptoms.   She tired to go to work, her husband said that she did not look good.  She was sent home from work, she went to the nurses station at work, had a fever of 100.2 who told her to go home, it was a reaction from the vaccine, and to call us.
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender from which their concurrent condition, medical history or concomitant medications were unknown. On an unknown date, the patients were vaccinated with PROQUAD doses unspecified in series (dose, route and dose number not provided) (lot no. K019102 with expiration date of: 15-APR-2016), the reporter also stated that the aforementioned vaccine was inappropriately stored. At the time of this report, no adverse events were reported and the outcome of the patients was unknown. The physician also reported that another unspecified number of patients were vaccinated with inappropriately stored VARIVAX (please refer to MARRS No. 1504USA005042 and MARRS No. 1503USA012150). The physician reported that the earliest dose administered was on 21-FEB-2014, however it was unknown which vaccine was administered in this date. Additional information has been requested.
Sleepy after covid vaccination; Tiredness after covid vaccination; Fever after covid vaccination; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy after covid vaccination), FATIGUE (Tiredness after covid vaccination) and PYREXIA (Fever after covid vaccination) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (Moderate to severe chronic plaque psoriasis).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced SOMNOLENCE (Sleepy after covid vaccination), FATIGUE (Tiredness after covid vaccination) and PYREXIA (Fever after covid vaccination). At the time of the report, SOMNOLENCE (Sleepy after covid vaccination) and FATIGUE (Tiredness after covid vaccination) was resolving and PYREXIA (Fever after covid vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment medication reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of tiredness after covid vaccination and sleepy after covid vaccination with humira(adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of fever after covid vaccination with humira(adalimumab) was no reasonable possibility.  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.
Wed 5/13/20: around midnight, ~13-15 hrs after late 4-mo shot series was given at age 6 mos 1 day, he woke w/an emesis, mom felt tactile temp, checked him & had a mild temp of 101. Gave Tylenol & slept. Thursday 5/14/20: Tmax 101.8, controlled w/Tylenol. Afeb off Tylenol by evening of 5/14 w/temp 98 around 1800 hrs Thursday, 5/14. Friday 5/15/20 around 1400 hrs: was being fed when mom noted arms out akimbo w/shaking in a vibratory manor of arms, less so in bilateral legs, & eyes rolled up & was unresponsive for ~45 secs. No gagging or emesis prior to sz & no cyanosis of perioral area.  Sz activity stopped, eyes were closed but tried to feed again. After a few secs had recurrent seizure type, but just lasted 5-10 secs. Slept thereafter for 10-20 mins & has been fine since as of parent calling me at ~1530 hrs. Told to take to Immediate Care for recurrent fever over 100.4, or a recurrent seizure of >=60 secs.
Symptoms started immediately after vaccination. Reported extreme pain to doctor on 11/23/16. Surgery was scheduled then carried out on 2/24/17. Note: symptoms were intolerable pain in right shoulder and arm.
One week to the day after patient's first vaccine he died of a heart attack; This is a spontaneous report from a contactable consumer and from a contactable physician. A 71-year-old male patient (husband) received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 at single dose on the right arm for COVID-19 immunization. The patient medical history included past heart conditions. No known allergies. Patient took other medications in two weeks. Facility type vaccine was doctor's office/urgent care. No other vaccine received in four weeks. One week to the day after patient's first vaccine he died of a heart attack on 19Jan2021 18:30. Cause of death was heart attack. No COVID prior vaccination. No COVID tested post vaccination. It was unknown if an autopsy was performed. The physician  reported that the patient arrived DOA. Physician signed the death certificate based on the patient's prior diagnosis. Physician would not provide additional cause of death medical background without consent. He was not aware of any adverse events experienced from the time of vaccination to the date of death.   Follow-up (05Feb2021): This is a follow up spontaneous report from a contactable physician. This physician reported in response to HCP telephonic follow up activity which the following: patient death and cause of death were confirmed.  Follow-up attempts are completed. No further information is expected. Information about Lot number is not available.; Sender's Comments: Based on the temporal relationship, the association between the event fatal heart attack with BNT162b2 can not be fully excluded.  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.; Reported Cause(s) of Death: One week to the day after patient's first vaccine he died of a heart attack
This spontaneous report was received from a male consumer of an unknown age reporting on him/her self via a company representative. The patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies were not provided. On 04-FEB-2019, the patient was vaccinated with the first dose of GARDASIL 9 (lot #, expiration date, strength, dose, route and anatomical location were not provided) for prophylaxis. The patient reported that he was concerned that the liquid that was in the syringe was "clear", it was cloudy and white. The patient reported that "the unidentified pharmacist at the pharmacy shook the GARDASIL 9 a couple of times and the administered GARDASIL 9 was clear".
Round red circle and tenderness on arm at site of shot; severe lower back and muscle strain making necessary to stay in bed all day; Could not lift or bend  for 2-3days.
Patient received Pfizer COVID vaccine on 5/13/21 and 6/10/21. On 1/3/22 and 1/9/22, patient tested positive for COVID. On 1/9/22, patient admitted to our inpatient facility for acute appendicitis with COVID-19 pneumonia and acute COPD exacerbation. On 1/12/22, patient underwent laparoscopic appendectomy and biopsy of liver nodule.  As of today (1/12/22), patient is still admitted in our med/surg unit.
Approximately 5 inch round rash developed at vaccination site 8 days after receiving it. Light in color, but distinctly circular. Slightly itchy, raised/swollen, warm to the touch. No pain.  It is now day 3 after irritation was noticed, looks about the same, however little to no itchiness. Round rash still present, warm to the touch, slightly raised.
Power outage, vaccine administered after temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Power outage, vaccine administered after temperature excursion) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Power outage, vaccine administered after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Power outage, vaccine administered after temperature excursion) 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 product use was not provided by the reporter. No treatment information were reported.
Burning sensation in mouth from day one until today. 4/19/21. Not getting any better; Headaches; Migraine; Muscle pain; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 06Apr2021 at 13:15 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included migraine and food allergy to garlic. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received codeine (MANUFACTURER UNKNOWN) on an unspecified date for an unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included rizatriptan benzoate (MAXALT), diclofenac sodium (CATAFLAM), docusate sodium (STOOL SOFTENER), curcuma longa (TURMERIC) and VITAMINS; all of them started from an unknown date for unspecified indication and unknown if ongoing.  On 06Apr2021, the patient experienced burning sensation in mouth which was not getting any better, headaches/migraines for 6 days and muscle pain for 5 days. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event- burning sensation in mouth was not recovered at the time of this report. The clinical outcome of the events- headaches/migraines was recovered on 12Apr2021. The clinical outcome of the event- muscle pain was recovered on 11Apr2021.   No follow-up attempts are needed. No further information is expected.
Child who is 22 months old came in needing 4th DtaP, 3rd HIB, 4 Prevnar, 1st  Hep A and a flu which mom declined. When the clerk did data entry she discovered an error on HIB lot number. Investigation determined I had administered DTaP-HIB rather than just plain HIB. I didn't realize there was still any of this in the house. I called and spoke with father who said both of his kids did well after the shots except this one had a little diarrhea but that's all. Explained the error I made resulting in him getting 2 doses of DTaP. Reassured him that his son is very well protected but the concern was it could cause a very swollen left leg. He reports he is fine. I apologized for my mistake.
Positive breakthrough case of COVID-19 post vaccination.  Symptoms: stuffy nose, slight cough, loss of smell
No additional adverse event reported; one dose of improperly stored VARIVAX was administered to the patient; This spontaneous report was received from an office manager, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.      On 12-MAR-2020, the patient was vaccinated with an improperly dose of varicella virus vaccine live (oka/merck)(VARIVAX) injection as prophylaxis (strength, dosage regimen, route of administration, and anatomical location were not reported; lot number S021322 has been verified to be valid, expiration date reported and validated as 09-JUL-2021). The sterile diluent (MERCK STERILE DILUENT) that was used to reconstitute the vaccine was stored properly. No additional adverse event reported.     The temperature excursion reported was of -8.3 degrees Celsius for 24 minutes. No previous temperature excursion as recorded by a data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2003USA005839: US-009507513-2003USA005888: US-009507513-2003USA005896: US-009507513-2003USA005961:
Moderna COVID-19 Vaccine EUA  Swollen arm (same arm as injection site). Swollen lymph nodes in left armpit (same side as injected arm).
Loss of energy; Sleepiness; Recurrent falls; Losing his balance; After falling he was unable to pick himself up and even with assistance had issues; issues getting his feet under him and walking; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Loss of energy), SOMNOLENCE (Sleepiness), FALL (Recurrent falls), BALANCE DISORDER (Losing his balance) and DYSSTASIA (After falling he was unable to pick himself up and even with assistance had issues) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received 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 ASTHENIA (Loss of energy), SOMNOLENCE (Sleepiness), FALL (Recurrent falls), BALANCE DISORDER (Losing his balance), DYSSTASIA (After falling he was unable to pick himself up and even with assistance had issues) and GAIT INABILITY (issues getting his feet under him and walking). At the time of the report, ASTHENIA (Loss of energy), SOMNOLENCE (Sleepiness), FALL (Recurrent falls), BALANCE DISORDER (Losing his balance), DYSSTASIA (After falling he was unable to pick himself up and even with assistance had issues) and GAIT INABILITY (issues getting his feet under him and walking) outcome was unknown.            No concomitant medication were reported.   It was reported that the feet did not seems to listen to his head and was lucid and responsive throughout.   No treatment drug were reported.   This case was linked to MOD-2022-549164 (Patient Link).
About 48 after dose 4 I began to feel fatigued, and I had shortness of breath. I let my doctor know about my symptoms. I had lab work done and my blood work showed that my platelet levels had dropped.
About 3:30 she began to feel pain in the injection site, slight itching and nausea. This progressed to diffuse headache, nausea, chills, throat tightening and sensation of shortness of breath. She notified her mom 8 PM and they came to the emergency department. No history of prior allergic reactions or anaphylaxis.
Information has been received from a physician concerning her 21 month old male son who on 27-JUL-2009 (also reported as 26-JUL-2009) and on 02-OCT-2009 was vaccinated with the first and second doses respectively of VARIVAX (Merck) (route and lot # unknown).  Concomitant therapy included DTAP on 02-OCT-2009.  The physician was concerned because not 3 months apart but her physician said that the initial dose in July did not count, "unknown why".  The physician said that beginning on 02-OCT-2009 her son had a fever and runny nose.  The patient sought medical attention at the physician office.  At the time of this report the patient's outcome was not recovered.  Follow-up information was received from a physician via pediatric medical records concerning the 21 month old patient with no pre-existing allergies, birth defects or medical conditions, who on 29-JUL-2009 at 14:30 (previously reported as 27-JUL-2009 and 26-JUL-2009), received a first dose of VARIVAX (Merck) (lot # 65898/1338U) subcutaneously into his right thigh, and concomitantly received a dose of PCV (unspecified) (manufacturer unspecified).  On 01-OCT-2009 at 14:23 (previously reported as 02-OCT-2009), the patient received the second dose of VARIVAX (Merck) (lot # 664725/0861Y) subcutaneously into his right thigh, and concomitantly received a dose of DTAP (manufacturer unspecified), IM into his left thigh.  There was no illness at time of vaccination.  It was reported by the physician that the patient's first dose of VARIVAX (Merck) was given within 30 days of previous vaccines MMR II (unspecified) and Hep A (manufacturer unspecified) (both given on 07-JUL-2009).  This was considered "not valid".  Due to the VARIVAX (Merck) being a "live virus", the patient was very far behind on his vaccines.  The physician reported that the VARIVAX (Merck) needed to be repeated.  There were no ordered tests and laboratory data.  No further information is available.
Pt recvd vax on 27AUG93 &  felt funny; started to faint; very stiff; had a sz;
Patient developed chest pain c/w myopericarditis, troponin elevated. transferred to tertiary care facility
25mins post vaccination, pt reports that she has a lump in her throat but she was able to swallow. Called at 12:12 pm for patient complaining of scratchy throat and unable to clear throat after receiving Moderna Booster vaccine. Patient's V/S: BP-109/69, HR-86, RR-18, O2 sat on RA-100%. Continued to observe patient. Patient states, she can swallow without problems, encouraged patient to drink water. Per patient, she is allergic to peanuts and shellfish, NKDA.  At 12:18 pm, Benadryl 50 mg PO administered by RN.  Patient was able to swallow Benadryl 50 mg capsule without any problem. Continued to monitor patient.  12:19; V/S: BP-117/68, HR-89, RR- 19, O2 sat on RA -99%,  patient is talking in full sentences, denies any sob or itching, no rashes, per patient, her mom is waiting in the car, her mom is driving, encouraged patient  to drink more water and ambulate around the hallway. Patient will ambulate with RN and will go home when stable. Patient was able to drink more water without any problem. 12:27 V/S: BP-118/71, HR- 83, RR- 18, O2 sat- 99%RA.  At 12:50, patient is stable and discharged home.  Pt had a scratchy throat w/ prior Moderna vaccinations.  Was not reported at the time of booster vaccination.
I had a large red spot at the injection site for over 3 1/2 weeks and a hard bump underneath the skin. About one week ago I noticed that the injection site was still hard and was turning black and blue. I contacted my doctor's office regarding it and they said it sometimes takes a while for it to go away. Now the black and blue area has the skin peeling as a scab would. The redness and swelling and heat are gone but I still have that hard bump underneath and it's slowly going down.
chills; temperature; ache all over; she has been sicker/really sick; This is a spontaneous report from a Pfizer sponsored Program. A non-contactable consumer reported for female patient. A 75-year-old female patient received bnt162b2 (BNT162B2 Formulation; solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included allergic to everything, bee stings from an unknown date and unknown if ongoing. Concomitant medication included epinephrine (EPIPEN) taken for an unspecified indication, start and stop date were not reported. The patient experienced chills, temperature, ache all over and she has been sicker/ really sick on an unspecified date. It was reported that patient feels a little bit better today and patient always carries any EPIPEN. The outcome of events reported as recovering.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Headache-Mild, Additional Details: Mom stated pt felt lightheaded, her eyes rolled back, and fainted for a few seconds.  When we observed her, pt was ok but a little shaky.  The paramedics came and checked on her, but mother declined going to ER
This spontaneous report as received from a register nurse refers to unspecified number of patient (age and gender were not reported), that on an unknown date were vaccinated with GARDASIL (dose, strength, route and lot number were not reported) which on an unknown date experienced an incorrect product storage. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
SIRVA: severe Left shoulder pain experienced <24 hours after injection that has not resolved to present day. Completed Ortho evaluation x 2 visits, cortisone injection x 2 - refractory to treatment. MRI completed. FU with Dr. diagnosed me with SIRVA from influenza vaccination.