chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dizziness; severe fever; severe headache; severe muscle aches; booster; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 04Dec2021 14:30 (Lot number: F63527) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: INFLUENZA VACCINE, administration date 11Nov2021; and an unspecified contraception pill (received within 2 weeks of vaccination). Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0150, Location of injection: Arm Right), administration date: 06Apr2021, when the patient was 40 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0170, Location of injection: Arm Right), administration date: 27Apr2021, when the patient was 40 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 04Dec2021 14:30, outcome "unknown", described as "booster"; DIZZINESS (non-serious) with onset 06Dec2021, outcome "recovered" (07Dec2021), described as "dizziness"; PYREXIA (non-serious) with onset 05Dec2021 07:00, outcome "recovered" (06Dec2021), described as "severe fever"; HEADACHE (non-serious) with onset 05Dec2021 07:00, outcome "recovered" (08Dec2021), described as "severe headache"; MYALGIA (non-serious) with onset 05Dec2021 07:00, outcome "recovered" (06Dec2021), described as "severe muscle aches". Therapeutic measures were taken as a result of pyrexia, headache, myalgia and included ibuprofen 400 mg. Clinical course: The following morning after receiving the vaccine severe fever, severe headache and severe muscle aches started. 30 minutes after taking 400 mg ibuprofen, these events got better but restarted an hour later. This was repeated 3-times during that day. The following day moderate headache was still ongoing and mild dizziness started. The fever and muscle aches resolved. By the 3rd day only mild headache was ongoing, the dizziness was resolved. Recovered fully from all events by the 4th day after the vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Patient complained of throat tightening within 5-10 minutes of receiving the Moderna vaccine IM in her left arm.  Pharmacist administered diphenhydramine  and patient began to feel relief within 5 minutes. Patient waited approximately 30 minutes and felt okay to leave. Patient was asked to contact us with any problems and she appears to be okay now.
Severe vertigo that starts with spinning and nausea. Over the two weeks, symptoms have begun to subside considerably but have not completely disappeared.
Moderna Vaccine First shot Administer March 10  Thursday March 18th In the afternoon Temperature began to rise reached 104.8 during the night. Tired fatigue weakness. In the morning it came down to 99.9 Started to feel better Friday March 19th In the afternoon Temperature began to rise again it reached 104.8 during the night. Tired fatigue weakness. Also, at 2 in the morning I started to shake uncontrollably. I can only describe it as an addict on with drawl, it ended at 4. To weak to get to the phone in the other room, and call for help In the morning my temperature was down to 99.8 again. Feeling better, thought the worst was over. Saturday March 20th Temperature began to rise again in the afternoon by nighttime it was back up to 104.9 Took some Ibuprophin At some point in the night the sheets were soaked in sweet. Pull the sheets and put down new ones. This happened twice. I was running out of sheet. Ibuprophin By morning my temperature was down to 98.6. I was tired, but I felt my strength coming back Sunday March 21th By midmorning my temperature began to rise again. To 103.9 It is now dropping and is at100.1 At three in the morning my temperature was normal. And it has remained there/   I better be immune from the plague after this.
Moderna Covid-19 vaccine administered to unauthorized age group.  Patient was only 17 years of age.  No reactions or symptoms to report. No pregnancy complications to report at th is time.
Patient reported disruption of menstrual cycle.  It was difficult to say specific times or dates but it started after receiving the COVID vaccine.  Second dose received on June 17, 2021 lot EP7533.  Advised by vaccine clinic nurse to see primary provider.
Shortly after leaving doctor office, patient was not feeling well, lack of appetite, coughing, fast heart rate, hives and itching all over, nausea, vomiting. Returned to doctor's office. He was given oral medicine and injected with steroid. Still giving a steroid and Benadryl by mouth at home for 3 days. On the afternoon of the 19th, he became extremely pale, absolutely no color in face except darkness under eyes. Then Saturday face became red.
HIDRADENITIS SUPPURATIVA FLARE; Psoriasis flare; COVID DIAGNOSIS; This spontaneous case was reported by a consumer and describes the occurrence of HIDRADENITIS (HIDRADENITIS SUPPURATIVA FLARE), PSORIASIS (Psoriasis flare) and COVID-19 (COVID DIAGNOSIS) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Hidradenitis suppurativa.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced HIDRADENITIS (HIDRADENITIS SUPPURATIVA FLARE), PSORIASIS (Psoriasis flare) and COVID-19 (COVID DIAGNOSIS). At the time of the report, HIDRADENITIS (HIDRADENITIS SUPPURATIVA FLARE), PSORIASIS (Psoriasis flare) and COVID-19 (COVID DIAGNOSIS) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. On unknown dates, the patient experienced COVID DIAGNOSIS, HIDRADENITIS SUPPURATIVA FLARE and PSORIASIS FLARE. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was reported.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of COVID DIAGNOSIS with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of HIDRADENITIS SUPPURATIVA FLARE and PSORIASIS FLARE was not provided.   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.
Got exposed to Covid infection after receiving the 1st dose of Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (Got exposed to Covid infection after receiving the 1st dose of Moderna vaccine) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (Got exposed to Covid infection after receiving the 1st dose of Moderna vaccine). At the time of the report, EXPOSURE TO SARS-COV-2 (Got exposed to Covid infection after receiving the 1st dose of Moderna vaccine) outcome was unknown. Not Provided      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.   No concomitant medication information provided. No treatment information provided.
pt recv vax 1OCT96 9AM & c/o of chills, fever & thirst inc as day progressed;c/o rt arm being sore, red, swollen & warm to touch;c/o arm being red & tender to touch from shoulder to elbow;c/o extremities being cold;
had hives at site on 1/4/21 in the pm none when in the office on 1/5/21
Sore arm at injection site; This is a spontaneous report from a non-contactable consumer, the patient. An 18-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in left arm on 29Mar2021 at 11:30 as a single dose (at the age of 18-years-old) for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient had not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Mar2021 at 16:00, the patient had sore arm at injection site (vaccination site pain). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the event sore arm at injection site. The clinical outcome of vaccination site pain was unknown at the time of report.  No follow-up attempts are needed; No further information is expected.
Patient received the vaccine on 10/25/2017 in the evening, the patient felt feverish, area was sore and painful and very red.
This case was reported by a physician via a sales representative and described the occurrence of cellulitis in a 4 year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included unspecified vaccines (multiple other childhood vaccines - manufacturer unspecified) given on the same date as KINRIX. On an unspecified date the subject received unspecified dose of KINRIX at 0.5 ml in an unknown thigh. Within a couple of days of vaccination with KINRIX, the subject experienced cellulitis. Signs included injection site redness, hot (injection site hot to touch) and swelling. The physician considered the events were clinically significant (or requiring intervention). The subject was treated with KEFLEX. The subject resolved on therapy. Product complaint was noted. The site claimed good aseptic technique was followed and there was no change in the appearance of the vaccine administered. It was reported that cellulitis was probably related to treatment with KINRIX. A note was made that other childhood vaccines were given at the same time, but infections have occurred only at either INFANRIX or KINRIX injection sites or that leg affected. Four subjects received INFANRIX from lot number AC14B126AA with expiration date 03 March 2013 and one subject each received KINRIX from lot number AC20B168AA with expiration date 02 December 2012 and lot number AC20B164BA with expiration 13 October 2012 (six subjects affected in total ranging in age from 15 months to 8 years). Additionally, no other subject have received these vaccines from these lots and "not" had cellulitis with the exception of three subjects the site is still trying to locate.
Day 2 was fatigue, low grade fever.  Day 3 Body aches -neck, lower back, thighs.  Symptoms subsided on Day 4.  Day 8 itchy lump on arm at injection site.
non urticarial rash on chest and around neck that occurred 48 hrs post vaccine. No sob, wheezing.  Pt only took zyrtec the night before. No medications this morning when she noticed the rash.
Symptoms:  Chills, Rigors, Cough, Shortness of breath, Headache, Fatigue, Diarrhea, Difficulty breathing, irritable and agitated
Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 52-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided The vaccine was administered after being stored in a refrigerator for 33 days.
doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  The vaccine was removed from freezer on 18-Oct-2021 at 8am. No treatment information was provided by the reporter.
Secondary vaccinia reaction adjacent to primary Smallpox vaccination site.  Continue to monitor site and perform more meticulous hand washing.
Mom calls in PM after shot, area red and swollen. On 11/18/2004: left arm red with edema, warm to touch. Patient complained of itching. Benadryl Allergy as directed.
positive COVID-19 test; This is a spontaneous report received from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 02Apr2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated he received Pfizer's COVID vaccine on Friday, 02Apr2021, and got tested for COVID today (Apr2021) with a positive test. He is asking if the vaccine may cause a positive test. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on Apr2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
have been sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not applicable for this report. The reporter briefly mentioned that so many of her friends received the Shingrix vaccine and couple of them had been sick. No other information was provided.
mom states 1 day p/vax was given; pt was unresponsive; also change in appetite;
Patient received vaccine during the morning of 05/20/2021. The vaccine was given by the pharmacy manager. The patient reported no symptoms and waited the required 15 minutes prior to leaving. The patient called the pharmacy on 7/20/2021 complaining of a sore arm. He stated that his arm has been hurting since the vaccine was given and the doctor told him that the pharmacy gave the vaccine wrong. He stated he was not looking for compensation or to get anyone in trouble, but that he wanted to let us know. He stated that his doctor told him that they probably hit the nerve and that there was nothing they could do to help.
allergic reaction; hives; itchy rash; rash in the lower back that spread to the body over the course of 3 days.; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for an COVID-19 immunization. The patient medical history and concomitant medications were not reported. A Physician called for information about if a patient that developed an allergic reaction to the first dose of the Pfizer's COVID-19 vaccine. The Physician reports that there was a patient that developed hives and an itchy rash in the lower back that spread to the body over the course of 3 days. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Phone call from county coroner's office that pt died yesterday (4/13/03). Autopsy pending. 4/16/03 autopsy showed death no relation to immunizations.
Extreme head ache, nausea, body aches and extreme fatigue. Most concerning though, three massive nose bleeds. The first one took 30 minutes to stop and I lost a lot of blood, paramedics were called. The second bleed was  4 days after the vaccine and the third was 6 days after the vaccine. Both were excessive bleeds but not as bad as the first one. I have also been having unusual bouts of high blood pressure. 911 was called for the first bleed. The bleed was stopped and transport was not needed.
Tested positive for COVID 3 days PTA; arrived with worsening SOB, O2 requirements; acute on chronic respiratory failure 2/2 COVID-19 pna. Given Toci, steroids, singulair, pepcid, zinc, remdesivir, lovenox, zithromax. Progressed from HFNC to vent. Expired in hospital.
Five minutes after receiving the COVID vaccine, patient reported itching on the L shoulder.  Patient received 25 mg diphenhydramine and was monitored
Patient c/o excessive soreness in left shoulder joint beginning 1 week after injection and persisting to date. Most painful with forward mvmt vs. lateral lifting. Patient states she has impaired muscle movement.
This spontaneous report was received from a register nurse, concerning an unspecified number of patients, of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with a dose of VARIVAX (Merck) (dose, strength, lot number were not reported), intramuscular. Co-suspect and concomitant therapies were not reported. The register nurse reported that an unknown number of patients had received VARIVAX (Merck) since 19-MAY-2014, that had went through a supported temperature excursion. No adverse effects reported. Additional information has been requested. These case is one (1) of two (2) reports from the same reporter. (MARRS 1405USA015715 and 1406USA000619).
Information has been received from a nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of 0.5 ml GARDASIL (lot # K004204, expiration date 12-JAN-2017), (lot # was reported as K006960, expiration date 19-FEB-2017), (lot # J015378, expiration date 09-APR-2016), (lot # K005881, expiration date 14-JAN-2017), intramuscular which were exposed to 32.5F for 2 hours. This event was considered as incorrect product storage. No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
Extreme pain in upper arm where vaccinated made worse by any movement.  OTC pain med minimally helpful. I?ve not at all. Ten days later pain lessened but ache remains especially upon movement.
Information has been received from a nurse concerning an unspecified patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with improperly stored PNEUMOVAX 23(lot # R009408, expiration date 07-MAR-2020) (dose, frequency, route of administration were not reported) for prophylaxis (product storage error). The product was stored in an unmonitored refrigerator (temperature was unknown by reporter) for 7 hours. No adverse symptoms reported. Follow up information was received on 04-OCT-2018: This spontaneous report was received from a registered nurse refers to a 56-year-old female patient. On an unknown date, the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # R009408, expiration date 07-MAR-2020) (dose and frequency not reported) intramuscularly for prophylaxis. It was reported that temperature monitor was not tracking the temperatures. There was no reason to believe the temperatures were out of normal range. No temperature excursion was suspected. The call was due to protocol.
About 15 min after getting vaccine my lower lip started to feel a little tingly.  About 45 min after that my chin started to feel a little numby/tingly.  Within another hour the numby/ tingly feeling went up the left side of my face stopping at my eye.  The feeling was similar to when nova cane is wearing off after dental work.   I had this facial sensation until midnight when I went to bed.  It also appeared that about an hour after the shot I noticed my tongue looked purpled which did not last long before it appeared to return to normal color.  Exactly 2 weeks after the vaccine, my chin became numb and tingly and I felt a funny feeling in my right eye, almost like an allergy feeling.   This lasted approximately 2 hours before dissipating.   I have never had this happen to me before.  On day 4 after the vaccine I did feel like I was getting sick and was fatigued this lasted for  about 4- 5 days before feeling better and back to myself.
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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown 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 was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 21-Aug-2022 Reporter's comment: The patient got the vaccine and still got shingles.  The patient was still dealing with them, the patient had them for 5 months now. The patient stated that hope you feel better soon. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Diarrhea appeared fairly quickly and lasted about 18 hours. Used Pepto Bismol and generic Immodium roughly 6 hours apart. Second symptom is exhaustion. Still ongoing. I just want to sleep.