chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a hospital registered nurse, concerning a 65 year old female patient with diabetes, unspecified cardiac issues (for which patient has been hospitalized on 11-OCT-2012), and penicillin allergy. On 11-OCT-2012, the patient was vaccinated with a 0.5 ml PNEUMOVAX23 in the left arm (route and frequency were not reported) (Lot # and expiration date were not reported). On the same date, the patient was vaccinated concomitantly with a dose of unspecified Influenza Virus Vaccine (manufacturer unknown) in the right arm. In October 2012, the patient developed sore of the left arm, cellulitis, swollen and tender where the PNEUMOVAX23 was administered. The nurse stated that she was not sure if the PNEUMOVAX23 was administered below the deltoid site or not. She stated that client was chubby and had odd shaped arms and it was hard to define where the deltoid area was. Nurse stated that the patient also developed reaction of the right arm (MARRS #: 1210USA010519). Nurse stated that she believed the patient's hospitalization may have been prolonged because of the adverse reaction to the PNEUMOVAX23 and flu vaccine (manufacturer unknown). Unspecified antibiotics were given as treatment for the events. On 15-OCT-2012, the patient was released from hospital. At the time of the report, the outcome of the patient was unknown. The relatedness for sore, cellulitis, tender and swollen of the left arm where the PNEUMOVAX23 was administered was unknown for PNEUMOVAX23. This is one of two reports from the same source. Additional information has been requested.
Reporting administration error as per immunization system. We contacted Pfizer for expiration dates, Pfizer vaccine specialist advised expiration dates and deemed vaccine viable at the time of vaccine administration. Pfizer vaccine vials only include manufactaurer dates on the box and vials. Therefore, we contacted Pfizer to attain expiration dates directly from them.  No adverse reaction reported from the patietn at the time of the vaccination and no adverse reaction reported since given vaccine.
developed symptoms of COVID, tested positive for COVID after being fully vaccinated, 2 months later.
Extreme soreness at and around site of injection in left arm; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration, administered in Arm Left on 23Feb2021 at 10:30 (at the age of 41-year-old) as a single dose for COVID-19 immunization. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. Patient medical history reported as none. Concomitant medication included fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication. Patient had no Known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Feb2021 at 13:00 the patient experienced extreme soreness at and around site of injection in left arm. Patient did not receive any treatment for the event. The clinical outcome of the event was not recovered.  Follow-up attempts completed. No further information expected.
Extreme fatigue and "brain fog" for about 24 hours. Slept most of that time.
hacking cough that worsened with the 2nd dose; Dose number=1 Administration date=13Apr2021/ dose number=2 vaccine date=13Apr2021; Dose number=1 Administration date=13Apr2021/ dose number=2 vaccine date=13Apr2021; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 53-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: not reported) via an unspecified route of administration in left arm on 13Apr2021 (at the age of 53-years-old) as dose 2, single for COVID-19 immunization at hospital. The patient's medical history included chronic kidney disease, hypertension and COVID-19 from an unknown date and unknown if ongoing. Known Allergies: NA. Concomitant medications/other medications in two weeks included carvedilol (CARVEDILOL) and losartan (LOSARTAN); both were taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: not reported) via an unspecified route of administration in right arm on 13Apr2021 (at the age of 53-years-old) as dose 1, single for COVID-19 immunization and experienced hacking cough. The patient received dose number=1 administration date=13apr2021/ dose number=2 vaccine date=13apr2021 (off label use) and inappropriate schedule of product administration. On 14Apr2021, the patient's hacking cough worsened with the second dose. No COVID tested post vaccination. No treatment for adverse events. The outcome of the event cough was not recovered.No follow-up attempts were required; information about lot/batch number cannot be obtained. No further information was expected.
Headache, Fever, NauseaVomiting, sore arm, body aches, chills, hot flashes, sensitivity to light, fatigue , abdominal cramps Narrative:
About 30 minutes after my face got flush. It stayed flush, but no temperature on work gun 97.2. Woke up with fever 100.5, joint pain, headache, and little pain in the right side of my neck.
Woke up Tuesday morning with my bottom lip swelling. Took Benadryl around 1pm, as the swelling continued. Around 3pm, my tongue started swelling and I went to the Er
A parent on his daughter's robotics team passed away from Covid today; A parent on his daughter's robotics team passed away from Covid today; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (death, medically significant), COVID-19 (death), outcome "fatal" and all described as "A parent on his daughter's robotics team passed away from Covid today". The deceased was fully vaccinated. The patient date of death was unknown. The reported cause of death was covid-19. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Limited information precludes a comprehensive causality assessment of event COVID-19 infection post- BNT162B2 Vaccine,however its causal role cannot be excluded due to lack of efficacy  .Case will be reviewed further on receipt of FU information  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: passed away from Covid
Headache, Myalgia, Fever, Diarrhea, Fatigue Narrative:  Other Relevant History:
Alopecia Areata flare up/Patches of bald spots; This is a spontaneous report received from contactable consumer. The reporter is the patient.  A 39 year-old patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Feb2021 16:15 (Lot number: EL 9266) at the age of 38 years as dose 2, single and administered in arm left, administration date 22Oct2020 17:00 (Lot number: FH8020) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Known allergies: Latex" (unspecified if ongoing); "Known allergies: adhesives" (unspecified if ongoing); "Gastric Sleeve" (unspecified if ongoing); "Ana markers" (unspecified if ongoing); "lupus" (unspecified if ongoing); "RA marker" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "allergies" (unspecified if ongoing); "pulmonary embolism" (unspecified if ongoing); "c-sections" (unspecified if ongoing), notes: twice; "gallbladder removal" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; SERTRALINE; MONTELUKAST; BUPROPION; LISINO [LISINOPRIL DIHYDRATE]. Past drug history included: Cipro, reaction(s): "Allergy: Cipro". Vaccination history included: Bnt162b2 (Dose 1, lot number: EL 9262, in the left arm at 02:00 PM), administration date: 22Jan2021, when the patient was 38 years old, for COVID-19 Immunization. The following information was reported: ALOPECIA AREATA (medically significant) with onset 01Jun2021, outcome "recovering", described as "Alopecia Areata flare up/Patches of bald spots". The event "alopecia areata flare up/patches of bald spots" was evaluated at the physician office visit. Therapeutic measures were taken as a result of alopecia areata, possible steroid injections. Clinical information: The patient has not been COVID-9 tested since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had alopecia areata flare up with 3-6 months of dose. Had coming out in handfuls, patches of bald spots.  No follow-up attempts are needed. No further information is expected.
Patient presented to the office on 3/20/17 and reported feeling a sore left arm on 3/18/17 (one day after receiving the vaccination) that resolved in that one day. He presented to the office on 3/20/17 reporting a nosebleed, headache, and a feeling of malaise the morning of 3/20/17. The office checked his BP which was 124/66 and his temperature which was 96.8. He was instructed to rest and increase fluids and follow up with the office the following day. The office called him on 3/21/17 and he reported that all of his symptoms were resolved and he was actively able and well enough to play football the night before on 3/20/17. No further reactions have been reported from the patient since.
Received the Tb shot in the left arm Friday morning, by Friday evening, area where the shot was received was swollen and hot to the touch.  Next day, arm was extremely sore and I was unable to lift it above my shoulder and had muscle aches all over my body, not severe and not needing medical attention.  Called a 24 hour nurse hotline and was told it was a normal reaction to the TB shot and if condition got worse or didn't improve within 5-7 days, to see my doctor.  Sunday, muscle aches were still happening but improving, arm swelling was going down and arm was no longer hot to the touch but still couldn't lift it above shoulder.  Monday, aches were more of a dull pain and arm was tender but mobility in it was returning. Tuesday, was a little tired but no aches and could lift arm above my shoulders but felt tightness in it, same for Wednesday.  Thursday, I could move and lift my arm without feeling any pain.
no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 14-FEB-2023, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
headache; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), NAUSEA (Nausea) and VOMITING (Vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced HEADACHE (headache), NAUSEA (Nausea) and VOMITING (Vomiting). On 05-Mar-2021, HEADACHE (headache), NAUSEA (Nausea) and VOMITING (Vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information not provided
Information has been received from a health professional concerning a 4 year old male with no significant past medical history and no known allergies whose 2 year old sister was vaccinated SC on 09/04/2001 at approximately 10 in the left arm with the first 0.5 mL dose of varicella vaccine without reaction. The pt and his sister also received a 0.1mL tuberculin purified protein derivative on 09/04/2001. The pt was receiving no medication, and there were no illnesses at the time of his sister's vaccination. On 09/10/200, the pt developed shingles. He was seen in the ER on 09/11/2001 and diagnosed with shingles on his abdomen. On 09/12/2001 the pt presented to a clinic with a number of "fluid-filled pustules." He also had a fever of 100 deg F. Ibuprofen was administered as required. On 09/14/2001, the pt was seen again in the clinic and there were shingles on his back. It was reported that on his left mid torso, abdomen and back, there was pustular erythematous-based dermatitis in a dermatomal formation approximately 4-5cm wide both anteriorly and posteriorly without secondary infection. A specifen of a vesicular lesions was obtained for PCR analysis on 09/14/2001 and submitted on 09/20/2001. It was noted that the pt had never received varicella vaccine and his mother could not remember if he ever had chickenpox. It was reported that there was no recent exposure to chickenpox or herpes zoster. On 10/19/2001, the sample submitted for PCR analysis was found to be VZV positive and the presence of wild type VZV was identified. Follow-up info received from a completed questionnaire indicated that the pt recovered. No further info is available.
had chronic shingles, did get shingles shot, had exacerbation/Suspected vaccination failure; had chronic shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (patient had chronic shingles).   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 1-June-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had chronic shingles. One doctor suggested to get the shingles shot. The patient received shingles shot and three years later the patient only had one exacerbation. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, and laboratory confirmation of shingles was not provided.
fatigue; sore arm; shoulder pain in injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), INJECTION SITE PAIN (sore arm) and ARTHRALGIA (shoulder pain in injection site arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039k20a) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced FATIGUE (fatigue), INJECTION SITE PAIN (sore arm) and ARTHRALGIA (shoulder pain in injection site arm). At the time of the report, FATIGUE (fatigue), INJECTION SITE PAIN (sore arm) and ARTHRALGIA (shoulder pain in injection site arm) outcome was unknown. Not applicable      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided by Reporter.
Large lump at injection site; Large redness area almost half the top of arm; This is a spontaneous report from a contactable nurse (patient) or other Health Care Professional. A 69-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6203 and Expiry date: Unknown), via an unspecified route of administration in Arm Left, on 04Mar2021 at 12:00 PM (at the age of 69-years-old) as UNKNOWN, SINGLE for Covid-19 immunization. The patient medical history was not reported. The patient known allergies were not reported. The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient did not receive other medications within 2 weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. On 04Mar2021 at 16:00, the patient had experienced large lump at injection site, large redness area almost half the top of arm. The patient did not receive treatment for events. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On 29-AUG-2014, an unspecified number of patients had received improperly stored doses of ROTATEQ (dose, frequency and lot # unknown) orally. No symptoms reported. This is one of several reports from the same source. Additional information has been requested.
felt weak; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt weak) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (felt weak). At the time of the report, ASTHENIA (felt weak) outcome was unknown.            No Concomitant medications were reported. No Treatment information was reported.   This case was linked to MOD-2021-200997 (Patient Link).   Reporter did not allow further contact
Fever of 101, swollen lymph nodule in armpit , body aches and stiffness of joints and limbs.
A bad taste started immediately - seconds after the needle was put in my arm.  The taste is still there, some 4 hours after the vaccination - but not as srtong.  I have been eating and drinking to try to get rid of the taste
Experienced brain fog; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Experienced brain fog) in a female patient of an unknown age 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 FEELING ABNORMAL (Experienced brain fog). At the time of the report, FEELING ABNORMAL (Experienced brain fog) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported.  It was reported that patient experienced brain fog four months ago.  The treatment information was  not provided.   Reporter did not allow further contact
Quarter size raised welt at injection site several days after vaccine administered. ER visit - dr said cellulitis, gave KEFLEX for several days.
This spontaneous report has been received from a 66 year old female patient reporting on herself. The patient's medical history included hypotension and drug reaction hypersensitivity to vancomycin. In June 2011, the patient was vaccinated with ZOSTAVAX (lot number reported as 0358AA) (strength, dose and frequency were not provided). Concomitant therapies included NEURONTIN. On 05-JAN-2016, the patient developed a very severe massive shingles all over her back. The shingles are located on her "whole back on each side of her spine", they are very severe and she cannot go to work or put clothes on because of this. Treatment for the event according to her doctor included Acyclovir, famciclovir, DEMEROL and an unspecified shingles gel. The patient sought medical attention, she contacted her physician. At the time of the report the outcome of herpes zoster was reported as not recovered and the relatedness between the events and the ZOSTAVAX was not reported. Additional information has been requested.