chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative:  93yo patient died at home in home hospice on 9/14/2021. Pt admitted to hospice on 9/8/21 with Terminal/Hospice Qualifying Diagnosis: Cirrhosis with liver mass likely HCC vs metastasis. Pt had received covid vaccines on 1/14/21 & 2/11/21. This death is likely not related to the vaccinations due to comorbidities, age, and length of time from vaccine administration.
Pt. states received Phizer vaccine 06/02/2021 experiencing  fatigue, nauseous. 06/10/2021 adverse event of vomiting, aspiration, heart attack, cardiac arrest, coma 4 days, ICU reporting slight brain damage.  Discharged 06/18/2021 to Rehabilitation Facility  discharged 07/07/2021.
Developed severe headache, posterior neck pain, body aches, chills fatigue fever 100.1 nausea, dry heaves started at 10 PM l/6
Received expired booster dose beyond 30-day Use By Date; Received expired booster dose beyond 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired booster dose beyond 30-day Use By Date) and PRODUCT STORAGE ERROR (Received expired booster dose beyond 30-day Use By Date) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired booster dose beyond 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received expired booster dose beyond 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired booster dose beyond 30-day Use By Date) and PRODUCT STORAGE ERROR (Received expired booster dose beyond 30-day Use By Date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  One dose was administered to the adult patient of age more than 45 year old.  On 11-Jun-2022 or 12-Jun-2022, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions.  Treatment information was unknown.
Client reported feeling nauseous and dizzy as well as having a headache and "heavy"right arm during the 15 minute waiting period after receiving her vaccine. Client's vital signs taken at 1545  and were BP 108/72, P 89, O2 99% and R 14. Client was given some water and animal crackers. Client was encouraged to drink fluids and stay hydrated. Client continued to report feeling dizzy  and tired, but reported her heavy arm had improved. Blood pressure was reassessed at 1600 and was 126/82. PHN encouraged client to rest and stay hydrated and if her symptoms did not improve or resolve she should be seen in the walk in or by a medical provider. Client verbalized understanding. Client left clinic with her husband who was giving her a ride. On 6/18/2021 at 1022 PHN placed call to client to see how client was feeling today. Call went straight to voicemail. PHN requested call back. Client returned call just before 1400 and reported symptom improvement and that client was only feeling tired today.
This spontaneous report was received from a medical assistant concerning an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of VAQTA, for prophylaxis (dose number, route, lot # and expiration date were unknown), which were improperly stored at 1 Celsius degree for 17 minutes. There was no previous temperature excursion. A digital data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA013334: US-009507513-1704USA013571:  US-009507513-1704USA013572:
hardened softball size reddened area (hot) itchy/sore/hard @ site of inj;still obvious sore;
9/13/18 - Around 1:00pm patient went to the eye doctor. Her eyes were dilated using and eye drop called TROPI-PHEN. Patient received vaccination around 4:10pm and drove home. As soon as she arrived at home around 4:45pm she noticed that the floor felt as if it were shaking and her legs were shaking. She then developed a severe headache with sinus pressure and pain around her eyes, teeth and ears. She stated she had trouble keeping her eyes open. She also developed pain all over her body that felt different from her fibromyalgia pain. 9/14/18 - Patient stated she continues to have a headache and pains all over her body. She also developed a severe sharp pain that started under her arm and felt as if it were moving towards her chest which she felt about 4 times. She stated that she feels weak and developed a fever in the morning. She took TYLENOL 650mg (2 tablets) around 10:30am and checked her temperature at 11:30am (101 degrees F). A repeat check of her temperature around 1:15pm was 99 degrees F. She has an appointment scheduled today 9/14/18 at 3:30pm with Associate who works in the same office as her primary care physician.
Case number PHEH2014US019858 is an initial spontaneous report received from a medical assistant on 01 Oct 2014 and a follow up report from the medical assistant received on 24 Nov 2014. This report refers to a 11 year-old male patient. He was allergic to hydrocodone. He tolerated the previous vaccinations (unspecified). He concomitantly received BOOSTRIX vaccine (other manufacturer) at a dose of 0.5 ml intramuscularly on 16 Sep 2014. On the same date, he was vaccinated with MENVEO (batch number: M14067) intramuscularly in the left arm at a dose of 0.5 ml. It was reported that the patient received MenCYW-135 liquid component of MENVEO and did not received MenA lyophilized conjugate. No adverse events were reported following the maladministration. Follow up report from the medical assistant received on 24 Nov 2014: Added information related to previous vaccination, current condition (allergy), concomitant vaccine (BOOSTRIX) and updated the MENVEO vaccination site.
Information has been received from a license vocational nurse (LVN) concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX (lot # not reported). The patient had inflamed swollen arm for 1.5 weeks. No further information was provided. This is one of several reports received from the same source. Additional information has been requested.
Patient received Covid shot on 4/22/2021; experienced injection site pain, chills, joint pain, felt unwell.  On 4/25/2021 has swollen lymph nodes in neck.
Information has been received from a 23 year old female who on 15-FEB-2007 was vaccinated with the first dose of GARDASIL. Concomitant therapy included MICROGESTIN. As soon as she received the vaccination, the patient became very dizzy and her blood pressure became very low. The patient continued experiencing dizzy spells that came on all of a sudden for approximately 6 months post vaccination. Additional information has been requested.
sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031D21A) for COVID-19 vaccination.     The patient's past medical history included Exposure to chemical pollution and Open heart surgery. Concurrent medical conditions included Hypertension.    On 16-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Oct-2021, the patient experienced VACCINATION SITE PAIN (sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm) outcome was unknown.            Concomitant medication of the patient was not reported.   The patient received his booster dose in his left arm shoulder deltoid muscle.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-461997, MOD-2022-461985 (Patient Link).
Woke with high pitched scream from nap. Calmed down but has presented with same high pitched scream and restless sleep numerous times since. Otherwise appears in good health.
Patient refers dizziness, paresthesias, diaphoresis and nausea after receiving the Pfizer COVID vaccine.
Fatigue; dyspnea; chest pain; cough; This is a spontaneous report from a contactable consumer (patient himself). A 48-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER0170, Expiry date: not reported), via an unspecified route of administration, administered in Arm Right on 27Apr2021 at 07:30 (age at vaccination was 48 years) as Dose 2, Single for COVID-19 immunization. Facility of the most recent COVID-19 vaccine was administered was reported as Hospital. The patient's medical history included diabetes. The patient's concomitant medications were not reported. The patient had not received any other vaccines are received within 4 weeks prior to the Covid vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8729, Expiry date: not reported), via an unspecified route, administered in Right Arm on 06Apr2021 at 07:30 (age at vaccination was 48 years) as Dose 1, Single for COVID-19 immunization. On 28Apr2021 at 07:00 the patient experienced fatigue, dyspnea, chest pain, cough. Since the vaccination, the patient has not been tested for Covid-19. Device date was 03May2021. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Information has been received from a licensed practical nurse concerning an unknown number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with doses of VARIVAX lot # M034583 (expiration date 27-JUL-2018) administered subcutaneously for prophylaxis (dose was not reported). The doses were stored at temperatures >14 degrees Fahrenheit and <46 degrees Fahrenheit (26.7 degrees Fahrenheit) for a total of 30 minutes as identified by a digital data logger. It was reported that there were no previous temperature excursions. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004183.
Aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches) and CHILLS (Chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Concomitant products included EMPAGLIFLOZIN (JARDIANCE), LISINOPRIL, HYDROCHLOROTHIAZIDE, MONTELUKAST, SIMVASTATIN, GLIMEPIRIDE, LEVOTHYROXINE, LEVOTHYROXINE, METOPROLOL, DILTIAZEM, GABAPENTIN and VITAMIN B12 NOS for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PAIN (Aches) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (Aches) and CHILLS (Chills) 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.   This case was linked to MOD-2021-425592, MOD-2021-425599 (Patient Link).
Information has been received from a health professional concerning a her 7 year old son who in January 1997 was vaccianted with varicella virus vaccine. In approximately January 2001, the pt developed moderate to severe chicken pox, hundreds of pox all over including the throat. The reporter was concerned about the effectiveness of the vaccine. The reporter's youngest son, did not develop the chicken pox. The reporter noted that one of her son's required acyclovir during the outbreak to minimize it as much as possible. The mother also reported that her oldest son also developed the chicken pox. Additional info has been requested.
Patient was seen on 31 May with complaints of red spots on chest and back. Received smallpox vaccine two weeks prior. Pt noticed mild red lesions on chest & back. Provider stated it was a mild reaction from smallpox vaccine & prescribed antihistamine for itch.
Using ECG feature on my watch showed inconclusive results and later showed atrial fibrillation.  Still showing inconclusive but not atrial fibrillation since.
No difference in condition since being of Humira; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (No difference in condition since being of Humira) and ARTHRALGIA (Joint pain) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    There was no reported medical history.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced DRUG INEFFECTIVE (No difference in condition since being of Humira) and ARTHRALGIA (Joint pain). At the time of the report, DRUG INEFFECTIVE (No difference in condition since being of Humira) and ARTHRALGIA (Joint pain) outcome was unknown.            No Concomitant product use was reported.  It was unknown if the patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the events of JOINT PAIN and NO DIFFERENCE IN CONDITION SINCE BEING OF HUMIRA was not reported for Humira.  No treatment information was provided.  Company Comment: This is a spontaneous case concerning an adult female patient with no reported medical history, who experienced the unexpected, non-serious, event of Drug Ineffective, (reported No difference in condition since being of Humira) and Arthralgia which occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine and co-suspect, non-company product Adalimumab (Humira). No further information on risk factors, co morbidities, clinical course and management of the events was available in the report. The event of Drug Ineffective is in relationship with the co-suspect drug Humira based on the narrative. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.Sender's Comments: This is a spontaneous case concerning an adult female patient with no reported medical history, who experienced the unexpected, non-serious, event of Drug Ineffective, (reported No difference in condition since being of Humira) and Arthralgia which occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine and co-suspect, non-company product Adalimumab (Humira). No further information on risk factors, co morbidities, clinical course and management of the events was available in the report. The event of Drug Ineffective is in relationship with the co-suspect drug Humira based on the narrative. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
At daycare the day after vaccines were given, child had an episode where she vomited after becoming pale. Her knees buckled and she fell to the floor from a standing position. She did not have loss of consciousness.  She was alert.
Mother reports child not self soon after shot, started running a fever and throwing up later in the day and through the night.
Chest Pressure  left side  164 /96 82 16 pain 4/10 BS 114
Immediately after injection with fine rash to deltoid region, then 5 days later with bright red rash to ankles which was less in 2 days-non pruritic-8 days after injection with fine maculopapular rash to anterior deltoid/chest. No acute allergic event.
I have had a really bad rash that comes and goes over various parts of the body, legs, arms, stomach, back hands, feet etc.  started day 7 after vaccine and is still here day 10.  Seems to be the worst these last two days.
COVID; COVID; This is a spontaneous report from a contactable consumer reporting same events under the same suspect product for 3 patients. This is the third of 3 reports.  A patient of unspecified age and gender received unknown dose number of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that 3 people died from COVID after getting Pfizer's Vaccine. Three (3) individuals had the Pfizer's shot and died from COVID. The patient died on an unspecified date. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101441253 Same reporter/vaccine/event, different patient;US-PFIZER INC-202101441264 Same reporter/vaccine/event, different patient; Reported Cause(s) of Death: covid; covid
Received vaccine 07/18/12 began having lethargy and myalgias about 24 hours later. Headache, fatigue, lethargy, myalgias, and bilateral orbit soreness for 4 1/2 days. Then red papular skin eruption on limbs, hands, feet, face, slightly pruritic, no fever.
Patient reported pain on left side of neck and a visual disturbance. Vital signs obtained: At 1400: 230/115 pulse, 140 pulse ox of 92% on room air. The medic was called. At 1415 BP 260/120 apical pulse of 180. At 1430 BP 266/118. The patient was transported.
Patient was given the entire vial contents of non- reconstituted Covid 19 Pfizer vaccine. Error was discovered the next morning. Pfizer called. Patient called. Appropriate physicians notified of event. Patient stated the symptoms that she was displaying was pain/tenderness to injection site and mild dizziness. Patient in clinic for office visit. Per provider, patient vitals WNL, area at injection site noted to have  some redness and mild swelling consistent with a local vaccine reaction. Per provider, no further follow-up at this time. May receive 2nd Pfizer dose on schedule. Patient to call with questions and/or concerns. Advised to use a cold pack, ibuprofen or APAP as needed for pain/ swelling..
BODY ACHES; INJECTION SITE ARM PAIN; PAIN IN FINGERTIPS; NECK PAIN; CHEST PAIN; BACK PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, and batch number: 1802070 expiry: UNKNOWN) dose was not reported, once a total in left deltoid administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced body aches. On 11-MAR-2021, the subject experienced injection site arm pain. On 11-MAR-2021, the subject experienced pain in fingertips. On 11-MAR-2021, the subject experienced neck pain. On 11-MAR-2021, the subject experienced chest pain. On 11-MAR-2021, the subject experienced back pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches on 11-MAR-2021, and had not recovered from injection site arm pain, pain in fingertips, neck pain, chest pain, and back pain. This report was non-serious.
Fever overnight. Febrile seizure on 03/31. Vomiting 04/01. Temperature was up to 105 degrees.
An hour after vaccine 6/25/21 fell into extreme and uncontrollable nervous system tremors, unable to talk for 20 minutes, went to emergency room. Same event occurred on 6/30/21 and 7/1/21 in which I had to go to the emergency room and now referred to neurologist for further testing.
Started feeling terrible the day after the vaccine. Very tired, not feeling well, off balance. Symptoms got so back she had to go to the ER. She ended up being transferred to another hospital because they couldn?t treat her. She has a blood clot in the carotid artery and acute strokes and brain tissue damage and numbness and loss of strength to right arm and hand
Cold sore roughly 3 day s after and then sore throat about 7 days after and still sore and fairly sever and only on right side.  Right side throat feels swollen and some pain all the way up to behind my right ear.  Slight chills and tired.
Fever, NauseaVomiting, exhaustion Narrative:  missed work following first dose due to symptoms  Other Relevant History:
Muscle spasms; Body pain in my back and legs; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 01May2021 at 18:30 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic acid reflux disease, esophagitis, non-alcoholic fatty liver disease, asthma and microcytic anemia. Concomitant medications included pantoprazole sodium sesquihydrate (PROTONIX) from unknown date for unknown indication. The patient previously took Codeine, Vicodin, triptan, steriods and penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03May2021 at 07:00, the patient experienced muscle spasms and body pain in back and legs. The clinical outcome of the events muscle spasms and body pain in back and legs was unknown at the time of the report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.