chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SORE LEFT ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included broken shoulder, and other pre-existing medical conditions included patient did not have any known drug allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested.  On 14-MAY-2021, the subject experienced sore left arm. The action taken with covid-19 vaccine  was not applicable. The patient recovered from sore left arm on 17-MAY-2021. This report was non-serious.
Information has been received from a newspaper article concerning a 17 year old "healthy" female with no reported problems with shots, allergies, or fainting who on 03-JAN-2008 was vaccinated with a first dose of Gardasil. The patient was concomitantly vaccinated with three unspecified vaccines. It was reported that approximately 20 seconds after receiving the vaccinations, the patient felt nauseous and dizzy. She fainted and began to display "seizure-like symptoms" of eyes rolled back in her head and she started shaking. After that, she was unconscious for 3 to 5 minutes. She had a severe headache the entire day and soreness where she received the HPV shot. The patient's outcome was not reported. additional information is not expected.
Possible afebrile seizure, patient was lethargic, turned blue. Seen at OVMC.
Lump under right arm pit in lymph node. It is tender,  especially when stretching arm.
Narrative: Pt is a 86y.o male who died on 05/02/2021 with a h/o COPD (3-4L O2 at home), R lung cancer s/p chemo/XRT and R lobectomy, Chronic diastolic HF with EF 54%, T1DM, HTN, CAD s/p PCI w/ DES to RCA. PPt received Moderna Covid-19 vaccination 2/2 on 02/17/2021. On 02/25/2021 pt presented to ED with c/o increased SOA. cough with yellow sputum, and dyspnea that started 3 days ago. Pt was discharged from ED on 02/25/2021 with physician noting patient has been with non-Hospital hospice for ~2 years. Pt presented for inpatient hospice admission on 04/30/2021. Physician reported in Death Note "Death was caused by: hypoxic respiratory failure secondary to end stage COPD" . Unlikely Moderna Covid-19 vaccine caused/contributed to pt death.
This case was reported by a nurse via call center representative and described the occurrence of hearing loss in a 53-year-old male patient who received FLULAVAL quadrivalent (batch number 93T79, expiry date unknown). On an unknown date, the patient received FLULAVAL quadrivalent .5 ml. On an unknown date, 3 hrs after receiving FLULAVAL quadrivalent, the patient experienced hearing loss (serious criteria GSK medically significant). On an unknown date, the outcome of the hearing loss was not recovered/not resolved. The reporter considered the hearing loss to be unlikely related to FLULAVAL quadrivalent. Additional details were provided as follows: The patient experienced hearing loss in his right ear. The patient went to an urgent care facility. They stated there is no correlation from receiving Flu shot. The patient followed up with physician and his physician stated that there was a correlation. On 7th October 2015, the hearing loss was ongoing. This case was a reported as a follow-up report of a case reported on 6th October 2015. However the initial report was not traceable so a new case was created.
Swelling, redness, hot lump at injection site began on the 8th day after injection @ approximately 7:30-7:45 pm. Headache, fatigue also began on 7th day with runny nose. Taking Benadryl for arm swelling, Tylenol for arm pain.
about 3-4 hours after getting the second dose of Moderna, she started having swelling of her hands and the swelling extended down to her feet.  She also said she had some shortness of breath.  She did not report the reaction until about 24 hours later.  I told her to go to urgent care/emergency room.  she said she had doctors appointment the next morning at 9am.  I encouraged her to go anyway or at least call her doctor.  She did call and md said ok to come in the next morning .  MD confirmed allergic reaction and she called me about 1 hour after appt to tell me.  she did say she was better and I told her to watch closely and go back to md if not better.
Arm redness, tightness in chest. S/s started 10 days after vaccination.  Pt was given naproxen 500mg twice daily and Zantac 150mg twice daily.  Consults pending for pulmonary clinic and 4 week follow-up with cardiology.  6/18/09 Hospital and outpatient records received DOS 3/23/09 to 5/4/09. FINAL DIAGNOSIS: Acute Myopericarditis after Smallpox Vaccination. Patient presented with chest tightness, substernal pain, painful knees, rash on shoulder, red papules around vaccination site.
felt tired within 30 minutes of receiving the vaccine; later that night had extreme chills and could not sleep, the next day on 4/24 throwing up stomach acid and then went to hospital after having chest pain, received fluids and when testing came back okay, I was discharged and felt better
next day arm swollen & black & blue;pain like tooth ache in arm treated by at least 8 MD, finally MD  dx breakline plex 9 years later still pain;
Patient received an expired MENACTRA with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health professional via Global Medical Information (GMI) (Reference number- 00571643) and transmitted to Sanofi on 21-Apr-2021.  This case involves an 11 years old male patient received an expired 0.5 mL dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6543AA and expiry date: 23-Feb-2021) via intramuscular route in the right deltoid (expired product administered) for prophylactic vaccination on 20-Apr-2021.  Medical history, past medical treatments, past vaccinations and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) and HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) for Immunisation.  It was an actual medication error case due to expired vaccine used (latency: same day).   The reporter stated that the mother was concerned about what possible adverse outcomes could come from this. Mother is aware that patient will need need to be revaccinated. Initial response provided: Provided response from the SRD, however, physician assistant was not satisfied. Offered to escalate to TA for the question on what possible adverse outcomes could come from receiving an expired vaccine. Physician assistant requested a response by the end of the week.    At the time of reporting, the patient experienced no specific adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
pt recv vax  24JUN96 pt devel a fever of 102;28JUN96 pt devel a fever of 102;28JUN96 pt exp nausea & vomiting;28JUN96 to 30JUN96 pt hosp for dehydration;
Roughly 5.5 hours after receiving the vaccine, I felt extreme fatigue (5:00 pm). This was followed by sudden diarrhea (9:00 pm), nausea (9:00 pm), and cold/chills (11:30 pm). The next day a sore/scratchy throat was present (8:00 am)
Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 4 (booster), single (Lot number: GH9703) at the age of 58 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 and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 2023, outcome "not recovered"; DRUG INEFFECTIVE (medically significant) with onset 2023, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included: Anti viral from 18May2023 to 23May2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300206998 same patient, different drug/AE.;
site had local reaction of swelling warmth, erythema & soreness treatment recommended-cold pack to site, OTC Benadryl
have had 5 of my wife's friends who had miscarriages; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABORTION SPONTANEOUS (medically significant), outcome "unknown", described as "have had 5 of my wife's friends who had miscarriages".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200684313 mother/baby case;US-PFIZER INC-202200684312 mother/baby case;US-PFIZER INC-202200684320 mother/baby case;US-PFIZER INC-202200684318 mother/baby case;US-PFIZER INC-202200684314 mother/baby case;US-PFIZER INC-202200684317 mother/baby case;US-PFIZER INC-202200684316 mother/baby case;US-PFIZER INC-202200684319 mother/baby case;US-PFIZER INC-202200684315 mother/baby case
patient complains of pain and stiffness in right arm near injection site. recommended ibuprofen, ice, possible doctor visit.  patient visited doctor 10-25-2019 received prescriptions for prednisone, cyclobenzaprine, and tramadol
After 3 minutes of observation in a chair, he got up to move to the observation area in clinic and then fainted.  He fell backward against a closed door and slid down.  He quickly regained consciousness and his vitals were stable.  within 10 minutes he was no longer dizzy or hot.  He was able to sit up right without issues.   Per dad, this is the same reaction he had to the flu vaccine in fall of 2020.
This spontaneous report was received from a pharmacist refers to a currently 65 years old male patient with cirrhosis and allergy to etodolac who in June 2012 was vaccinated in the left upper arm with the first dose of PNEUMOVAX 23, (lot # (H010661), Exp date 02-FEB-2014) (dose and route not reported). No other co-suspects were reported. Concomitant medications included lisinopril (manufacturer unknown), COREG, hydrochlorothiazide (manufacturer unknown), amlodipine and NAPROSYN. The pharmacist reported that the patient was vaccinated in the right upper arm with a dose of PNEUMOVAX 23 yesterday, on 25-OCT-2012 around noon. After injection yesterday (on 25-OCT-2012), patient stated he experienced arm soreness and a "strange feeling". Patient stated this morning (on 26-OCT-2012), he woke up with headache, nausea, arm soreness and swelling around the injection site. The pharmacist reported that the patient's physician had left the hospital and can no longer be reached. Patient was treated with TYLENOL and sought medical attention, but how was unknown. There were none lab diagnostics studies performed. At the time of reporting, patient's outcome was not recovered. Action taken with PNEUMOVAX 23 was not applicable. The relatedness between the events and PNEUMOVAX 23 was unknown. Additional information is not expected.
Patient had fainted after receiving the vaccine and when I came to saw him, he was back on the chair. He said he felt faint. I asked if his breathing was alright, his sight and hearing was ok; he said everything was fine, but he still felt faint. Then I saw his eyes closing again and he slouched down on the chair and became unconscious. I helped him onto the ground, where he started shaking, so I rolled him onto his side. He felt clammy. It was a few seconds before he stopped shaking and opened his eyes again. I asked him to stay laying on the ground and asked him again regarding his breathing, hear rate, vision, how he felt. He asked if he passed out again and I told him yes and we're going to keep him on the ground until paramedics arrive. He said he felt better; his breathing and speech was fine, there wasn't any sound of shortness of breath, but he was sweating in cold sweats and he asked us to fan him. He said that he felt better and that he has a big phobia of needles, which his wife who was there, confirmed. He informed me that he's fainted several times at doctor's office and hospitals when they stick a needle in him. When the fire fighters arrived, they spoke to him prepared to get a EKG on him, to which he immediately told them that he doesn't want them to stick any needles in him and he became frightened that the EKG pads were needles. When paramedics came, they determined that they had to take him to the hospital because they said he wasn't able to stand up on his own without falling over and his heart rate was increasing.
Seen a rise in blood clots in younger individuals; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of THROMBOSIS (Seen a rise in blood clots in younger individuals) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Seen a rise in blood clots in younger individuals) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Seen a rise in blood clots in younger individuals) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.  Based on the 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.   This case was linked to MOD-2021-003812 (Patient Link).; Sender's Comments: Based on the 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.
the unspecified patient did not had positive antibody titers after either dose; the unspecified patient did not had positive antibody titers after either dose; Information has been received from a nurse, referring to a 12 years old female patient. The patient's medical history, concurrent condition and concomitant medications were not provided.  On an unknown date, when the patient was 12 years old, the patient was vaccinated with one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, strength, route, lot # and expiration date were unknown) for prophylaxis. On an unknown date, when the patient was 22 years old, the patient was vaccinated with a second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, strength, route, lot # and expiration date were unknown) for prophylaxis.   On unknown dates, after both doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), the patient did not have positive antibody titers. It was unknown if the patient received any "measles, mumps or rubella containing vaccine" prior to age of 12 years old. The outcome of antibody test negative was unknown. The causality assessment was not reported.
I woke up about 3 weeks after the second dose with a lot of jaw pain and pressure in my jaw. I went to my PCP and they gave me antibiotic thinking that it was sinus pressure. It did not help and I see a dentist in a couple weeks, I still have a lot of jaw pain.
About 2 weeks after the 2nd Pfizer dose, began experiencing neurogenic bowel disorder. Lower colon motility contractions had stopped. Sensory nerves also affected. This has continued to present, July 2021.
A non-serious spontaneous report of Flu-like symptoms has been received from a consumer/mother concerning her 10-year-old daughter, subsequent to FLUMIST. The patient's past medical history and concomitant medications were not reported. About two months ago in approximately September 2009, the patient received FLUMIST. The same night after the vaccine was administered, the patient experienced a fever and other mild flu-like symptoms. The event resolved within 24 hours of onset.
Moderna COVID-19 Vaccine EUA. Minor and expected tenderness the day after injection. Noticed 9 days after vaccination that the injection site is getting swollen and very itchy. Increasing redness. Taking OTC antihistamines and ibuprofen as needed. No need for additional intervention yet, but felt obligated to report and help provide information. Currently on injection day +10,  increased redness, swelling, and itching.
Case number PHEH2014US003831 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a 17 year old male patient. Past medical history and concomitant medication were not reported. He vaccinated with FLUCELVAX (batch number: 005021A and expiry date: JUN 2014), at dose of 0.5 intramuscularly on 20 NOV 2013. No adverse event was reported following this administration error.   Following an internal review on 18 AUG 2014, a signficant correction was done for the information received on 21 FEB 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second inidcation as Drug use in unapproved population.
This spontaneous report as received from a consumer refers to her daughter who on an unknown dates was vaccinated with the three doses of GARDASIL (dose, route and lot numbers not reported) but they were administered not in the correct time frame. This is one of several reports from the same source. Additional information has been requested.
multiple outbreaks of herpes zoster; postherpetic neuralgia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unspecified age and unknown gender. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On 02-NOV-2015 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date (reported as shortly after the vaccination), the patient suffered multiple outbreaks of herpes zoster and postherpetic neuralgia. As a result of these symptoms, patient was seen and treated by medical providers and was still under their care. As the result of vaccine live(ZOSTAVAX), 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 injury. He also suffered medical expenses, the loss of accumulations and other economic and non-economic damages. The outcome of herpes zoster and postherpetic neuralgia was considered as not recovered. The reporter considered the events to be disabled and related to Zoster Vaccine Live(ZOSTAVAX).
23SEp or 24SEP mild, brief, shaking 10-15 seconds while being nursed, cont sporadically 1 wk; seen by MD heart murmur, sz 1OCT92; pt physically imparied;
This spontaneous report was received from a physician, via Pfizer and refers to a 59-years-old patient of an unknown gender. The patient's concurrent condition included immunodeficiency. There was no information about the patient's concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (exact dose, lot#, expiration date or route of administration not provided). On an unknown date, the patient had no response for 20 of the 23 antibodies of PNEUMOVAX 23. The outcome of the event was unknown.
obtained a positive test for covid approx 6 months after vaccine; obtained a positive test for covid approx 6 months after vaccine; This is a spontaneous report from a contactable consumer, the patient.  A 43-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was unknown), via an intramuscular route of administration, in the left arm, on an unspecified date in Feb2021 (at the age of 43-year-old), as DOSE 1, SINGLE, for COVID-19 immunization. The patient's medical history was none. No known allergies. The patient received other medications within 2 weeks of vaccination included bupropion, sertraline hydrochloride (ZOLOFT) and tadalafil. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Aug2021, obtained a positive test for COVID approx. 6 months after vaccine. Since the vaccination, patient has been tested for COVID-19 and covid test type post vaccination was nasal swab/ PCR Covid Test and result was positive on 16Aug2021. Prior to vaccination, patient was not diagnosed with COVID-19. The patient underwent lab tests and procedure which included SARS-CoV-2 test/ PCR test/ Nasal Swab and result was positive on 16Aug2021. No treatment for AE. Outcome of the events was recovering  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
The day after receiving the 2nd dose of the Pfizer COVID-19 vaccine, I experienced heavy abdominal cramps, nausea, and fatigue. I was not on or nearing my period. These symptoms lasted for one day. I had no symptoms after the 1st dose.
Febrile seizure, 104f temp, 26.2 WBC, admitted with possible UTI, Later found out to be pneumonia from titers through immunologist. Kidney xrays were normal. She also lost some motor functions.
Numbness and tingling down arm and up neck into face, face swelling, rash on face, migrane, fever, swelling and pain at injection site, fatigue, disorientation, general feeling of unwellness.
This spontaneous report as received from a registered nurse at a health center, refers to unspecified patients of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 21-JUN-2016 or thereafter, it is possible that these unspecified patients received improperly stored VARIVAX (lot #M007287 and exp date 12-FEB-2018, lot#M002064 and exp date 12-JAN-2016) subcutaneously. The reporting nurse stated that she noticed several doses of VARIVAX from two different lots removed from their boxes after it was determined that those lots had undergone a temperature excursion of 4 hours and 6 minutes at a maximum temperature of 45.3 degrees Fahrenheit, but nurse reporter was not certain if the product had been administered prior to or after the temperature excursion had occurred. No adverse effects were reported. No product quality complaint was involved. Additional information is not expected as the reporter did not wish to be contacted.
The RN who administered the vaccine administered an expired dose. Patient did not report any adverse effects from the vaccine.