chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm for next 3 days after vaccination/ Sore left arm after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm for next 3 days after vaccination/ Sore left arm after 2nd dose) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Arthritis. Concomitant products included MELOXICAM for Arthritis, METFORMIN for Diabetes.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Sore arm for next 3 days after vaccination/ Sore left arm after 2nd dose). On 19-Feb-2021, PAIN IN EXTREMITY (Sore arm for next 3 days after vaccination/ Sore left arm after 2nd dose) had resolved.            Patient stated that no treatment had given for her symptoms.   This case was linked to MOD-2022-465200, MOD-2022-465155 (Patient Link).
Daughter of patient reported that she was having trouble breathing and felt "extremely sick" after getting the booster.  She was taken to  the hospital and was told by the doctors at the hospital that this was a heightened inflammatory reaction to the booster dose of Moderna because she had received monoclonal antibodies within 90 days of receiving the booster dose on 1/19/2022.  Daughter states patient was sent to hospital, was given oxygen and steroids, was stabilized.
Rash all over body triggered exactly 2 weeks after booster dose of Moderna with no prior reactions to dose 1 & 2 of Moderna shot. Rash breaks through daily 24 hour loratadine 10mg.
Patient reported to the pharmacy at 5:00 p.m. on 3/31/2019 that she was feeling very sick, nauseous, weak, and had a headache and that she'd been feeling that way all night and all day. When asked if she felt feverish, she said yes. She said she had not been able to eat all day. I encouraged her to try to eat something and take some TYLENOL and if she didn't feel better soon she should go to the ER.
Swelling at injection site approx.4-5 cm in size.Small pustual at both injection sites.Patient started on Augmentin.
Blood clots in colon; 2nd dose 07Jan2021; This is a spontaneous report from a contactable other hcp (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19), second dose at the age of 61-years-old via an unspecified route of administration, administered in arm left on 07Jan2021 (Batch/Lot Number: Ek5730) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient has no known allergies. Concomitant medication included unspecified medication. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in the left arm on 22Dec2020 (lot number: Ek5730) at the age of 61-years-old for covid-19 immunisation. The patient experienced blood clots in colon on 14Jan2021. It was noted that the patient received the second dose on 07Jan2021. The patient was hospitalized for blood clots in colon for 30 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 21Jan2021. Therapeutic measures were taken as a result of blood clots in colon which included surgery. The patient was recovering from the event.; Sender's Comments: Based on event-vaccine chronological association a causal relationship between event blood clots in colon and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), cannot be completely excluded. . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Mom previously presented to ED on 5/23 concern of vomiting sent home. Triage call to RN on 524/17 mom concerns of vomiting, swollen hands and feet, not eating or drinking, lethargic. Disposition patient to present ASAP. Patient presented to clinic the afternoon of 5/24/17 sleeping in moms arms in the lobby. Nurse brought patient back to exam room. Patient awake and alert, crying during height and weight. Mom holding child in lap, child began lip smacking and black stare at ceiling. Patient unresponsive to stimulation, provider was contacted to come into room and code was called. Patient transferred on oxygen to ICU for seizure management. Patient currently still admitted on 5/25/2017.
dizziness; diarrhea; headache; nausea; fever; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), DIARRHOEA (diarrhea), HEADACHE (headache), NAUSEA (nausea) and PYREXIA (fever) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history reported.  Concomitant products included ATORVASTATIN, olmesaitan, METHENAMINE and hippurate for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced DIZZINESS (dizziness), DIARRHOEA (diarrhea), HEADACHE (headache), NAUSEA (nausea) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 26-Feb-2021, DIARRHOEA (diarrhea), NAUSEA (nausea) and PYREXIA (fever) had resolved. At the time of the report, DIZZINESS (dizziness) and HEADACHE (headache) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.
A couple days after receiving the 2nd dose of shingrix the patient reported having sores on her right buttock.
Hard, warm swelling shoulder to elbow, painful.  Painful to raise arm.  Next day red patches same area.  Took AMOXICILLIN 875 MG 2 X a day for five days.  Also took CLARINEX 5 MG 1 X a day for five days.
Soreness at injection site Full arm pain of injection arm Body aches muscular and joint pain throughout body Nausea
Got the vaccine, went home and didn't have any problems.  He woke up this morning to use the bathroom and his legs were aching.  His wife came in and said that he was warm with a fever, and also has a headache, no energy.  He has not taken anything for the symptoms.  He has not notified his doctor.  The arm where the vaccine was given is a little sore, but not too bad, just the achiness and fatigue.
I had a sore arm at the injection site for about a day. I had a fever, headache and extreme fatigue on 02/23/2023. I tested positive for COVID-19 on 02/25/2023. I contacted my provider and got a prescription for Paxlovid.  I completely the prescription and developed a urinary tract infection.  I got an antibiotic for the urinary tract infection. As of today, I am feeling better with no lingering COVID-19 symptoms.
Within 2 hours of vaccine administration patient began to experience body aches, chills, low grade fever, and injection site swelling , pain, and heat. About 4 hours after vaccine administration patient experienced several episodes of vomiting that resolved within two hours. Re-evaluated in office 7 hours after vaccine administration and given 50mg IM Benadryl. Blood work done to evaluate CBC and ESR.
This vaccine was stored at room temperature outside of 2 hours. The vial was opened around 3PM and the vaccine was administered around 530PM. I did not realize this was incorrect until 11/5/21. I have contacted my managers and the manufacturer who did not have stability data past 2 hours and advised to use clinical judgement.
80 yo male received first dose of Moderna COVID-19 vaccine on 1/22. Received second dose on 2/19. He also had COVID in December 2020. Around 3/18, patient presents to the hospital with chief complaint of 3-4 days of dyspnea on exertion. He denies fever and cough. Nasopharyngeal swab obtained 3/18 at 1847. Coronavirus PCR test resulted positive a few hours later.  Rapid nasopharyngeal test was done on 3/19 and resulted back negative. Patient was diagnosed and treated for community acquired pneumonia with hypoxia.
From telephone contact with reporting physician, it was stated that the patient was administered Tripedia (lot # UO311DA) on 07/31/01. It was reported to the physician on 08/01/01 that a local reaction of redness and swelling and knot formation developed at the injection site. Symptomatic treatment was given per physician. These symptoms resolved quickly.
Pt c/o rash on torso and hips after Typhoid vaccination.  Pt states rash resembles heat rash. Pt states rash was first noticed upon arriving home, roughly 6 hrs after immunization.  Pt has received immunization previously with no side effects.
Pt described itching 2 days post vaccination and now hives to MD. MD called us on 9/27/18. 15 days post vaccination.
p/vax pt exp face c/large red blotches then blotches on chest & back; mom states there were red circles around inj sites; no fever; no other symptoms; took pt to urgent care
Menstrual irregularity, spotting. Periods had been normal and always on time, like clockwork.  No spotting, ever. Spotting/Bleeding began at almost two weeks past first dose of Pfizer. Bleeding not particularly heavy but lasted long. After third dose of Pfizer, booster shot, in December,  I experienced heavy, heavy bleeding, fora week, again out of sync with my usual cycle. My gynecologist who conducted a thorough exam, including ultrasound,  said there was no indication of perimenopause nor any indication of another gynecological isssue. He conjectured that the immune response from the vaccine affected the lining of my uterus. My periods did not fully return to their normal, clock work timing post my vaccination.
Dose 1 given 2/24/2021 Lot # EN6198 Pfizer Patient died at Hospital on 1/2/2022 Pt tested positive for Covid 19 on 12/24/2021, died from covid complications
received dose one of Shingrix on August 2, 2018  / never returned for the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 2nd August 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient never returned for the second dose of Shingrix, which led to incomplete course of vaccination. The reporter stated that, the patient was now interested in completing the series. No additional details provided at the time of reporting. The reporter consented to follow up.
Inlarged and sore lymph gland left armpit. If I lay on left side experienced numbness in left arm and hand.
Extreme tinnitus and substantial loss of hearing (have not seen ENT/Audiologist yet..expected it to go away or at least decrease in intensity.)  Others included headache, fatigue for several days, ongoing nausea and dizzy spells, light headed, all of which basically went away after a couple of weeks.   Noises and ringing in the ears has NOT improved and will therefore seek professional help/advice.
CLOT IN LEG; CLOT ON THE LEFT SIDE OF THE BRAIN; STROKE ON THE LEFT SIDE OF THE BRAIN; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was very healthy before the vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced clot in leg, and clot on the left side of the brain. On 13-JAN-2022, the patient experienced stroke on the left side of the brain, and was hospitalized (date unspecified). Patient spent 9 days in the ICU (Intensive care unit). It was reported that after the vaccine patient had pain in his legs and it was hard to walk after the vaccine shot. Reporter stated that after an ride, maybe a day or two later, a clot hit the patient on the left side of the brain and that the clot must have been in his leg. Patient had a stroke on the left side of the brain and was paralyzed on the right side due to a blood clot on the left side. Patient has aphasia and can hardly talk and had to pay for occupational therapy, physical therapy and speech therapy. Reporter stated that a wheel chair, a hospital bed and a lift had been provided for the patient. Patient was unhooked from the ICU after 9 days and with his eyes were rolling in the back of head and they put him in the corner room, he could not feed himself, they trained him how to work a lift and change diapers, wash him and roll him. Patient came home from hospital in a bed and had been in a bed since last year. Duration of hospitalization and discharge information were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stroke on the left side of the brain, and the outcome of clot in leg and clot on the left side of the brain was not reported. This report was serious (Hospitalization Caused / Prolonged). This case is a duplicate of 20230321273.  It was determined that deletion was required for Manufacturer Report Number 20230321273 as it was duplicate of Manufacturer Case Number 20230320406. All relevant information regarding Manufacturer Report Number 20230321273 will be submitted under Manufacturer Case Number 20230320406.; Sender's Comments: V0: 20230320406- stroke on the left side of the brain, clot in leg, clot on the left side of the brain. The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.
Face is irritated; Face is red; Hardness at the injection site; Swollen at the injection site; Redness at the injection site; Soreness in the arm, at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SKIN IRRITATION (Face is irritated), ERYTHEMA (Face is red), VACCINATION SITE INDURATION (Hardness at the injection site), VACCINATION SITE SWELLING (Swollen at the injection site) and VACCINATION SITE PAIN (Soreness in the arm, at the injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis rheumatoid.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. In March 2021, the patient experienced VACCINATION SITE PAIN (Soreness in the arm, at the injection site). On 22-Mar-2021, the patient experienced SKIN IRRITATION (Face is irritated), ERYTHEMA (Face is red), VACCINATION SITE INDURATION (Hardness at the injection site), VACCINATION SITE SWELLING (Swollen at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). The patient was treated with AMMONIUM CHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ORIGINAL) for Adverse event, at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) for Adverse event, at an unspecified dose and frequency. In March 2021, VACCINATION SITE PAIN (Soreness in the arm, at the injection site) had resolved. At the time of the report, SKIN IRRITATION (Face is irritated), ERYTHEMA (Face is red), VACCINATION SITE INDURATION (Hardness at the injection site), VACCINATION SITE SWELLING (Swollen at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was seen in the ER on 22-MAR-2021.  Patient was treated with a (STEROID) (NOS). No hospitalization was reported.
This spontaneous report as received from a medical assistant refers to an 8 year old female patient. The patient's medical history was not reported. On 01-AUG-2015, the patient was vaccinated outside the prescribing information with a dose of GARDASIL lot # K016966, expiration date reported as 10-MAY-2017 (dose, route and site of administration were not reported). Concomitant medications were not reported. No adverse effect was reported. Additional information has been requested.
temperature excursion; This spontaneous report was received from a licensed practical nurse referring to a 1-year old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions or allergies were not provided.    On 02-NOV-2020, the patient was vaccinated with dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength and route of administration were not reported; 0.5 milliliter, lot # S035125, expiration date was reported as 04-NOV-2022, but upon internal review, it was established as 04-NOV-2021) for prophylaxis (product storage error). The vaccines were exposed to the following temperature excursions: -13.9 degrees Celsius to 14.7 degree Celsius; -14 degree Celsius to -10 degree Celsius, with an average of -13.9 degree Celsius for 30 minutes. -14 degree Celsius to -10 degree Celsius, with an average of -14.2 degree Celsius for 15 minutes; -14 degree Celsius to -10°C, with an average of -14.7 degree Celsius for 20 minutes and -14 degree Celsius to -10 degree Celsius, with an average of -14.6 degree Celsius for 5 minutes. Information regarding previous temperature excursions was not provided. The call was due to digital data logger.  The outcome of the event was unknown.
Little cough; This is a spontaneous report from a contactable Nurse.  A female patient of an unspecified age started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 20Dec2020 to 20Dec2020 single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced little cough on an unspecified date. The action taken in response to the event for BNT162B2 was not applicable. The outcome was recovered  Information on the lot/batch number has been requested.
Moderna COVID-19 Vaccine EUA - Mild tinnitus starting approximately 12 hours after dose 2 and continuing to the next day.
Headache going on three weeks. Went to the Dr 4 times given pain medication, and UNK medication for migraines. I do not have migraines. The Dr. has now sent me to a Neurologist. I have also went to the ER once for the Headache.
Gardasil adverse reaction resembling RA pauciarticular joint pain  elevated sed rate, elevated RF, anemia
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 11-MAR-2015 the patient was received improperly stored VARIVAX (lot # K007979, expiration date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Appx 30min after shot. Pt reported back to pharmacy with husband citing; overheated, dizziness, chest pain, breathlessness. I (pharmacist) provided a chair, helped pt take off sweater and surgical mask (covid mask). I also recommended she let me call her ambulance on account of age and symptoms. Her husband reported that the chest pain and breathlessness are "nothing new." I once again advised them to let me call them an ambulance. Being of sound mind and body and oriented X 3 the pt refused but assured me she was headed to the nearest urgent care. There was nothing on vaccine consent form that indicated reason to refuse vaccine and shot was indicated according to vaccine registry. Attempted to reach out to pt at 6:00 pm -- phone rang w/out answer and again at 8:00pm and I was sent to voice mail. Outcome is unknown at this time.
My menstral cycle is now 10 days late and it has never been more than 1 day late. I don?t know if it?s related to the vaccine, but I?m not pregnant.
mom stated pt arm was painful, was swelling over large area of upper arm;pt had lump in axilla & more swelling;mom advised to use warm compresses;no fever areas still swollen;
Started getting muscle pain in hip flexor(s) then shoulders June 10 and then grew bilaterally.  July 16 stated feeling it in my shoulders.  By evening of July 29 was in excruciating bilateral pain in shoulders, neck, hips, knees and even in hands.  Went on predinsone on Aug 13 diagnosed with PMR on August 18 from RA doctor.
Terrible chest conges; No energy; Hurt everywhere; Nauseous; Feeling ill; Sick; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY TRACT CONGESTION (Terrible chest conges), ILLNESS (Sick), ASTHENIA (No energy), MALAISE (Feeling ill) and MYALGIA (Hurt everywhere) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RESPIRATORY TRACT CONGESTION (Terrible chest conges), ILLNESS (Sick), ASTHENIA (No energy), MALAISE (Feeling ill), MYALGIA (Hurt everywhere) and NAUSEA (Nauseous). At the time of the report, RESPIRATORY TRACT CONGESTION (Terrible chest conges), ILLNESS (Sick), ASTHENIA (No energy), MALAISE (Feeling ill), MYALGIA (Hurt everywhere) and NAUSEA (Nauseous) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient received their Moderna vaccines in January and three months later the patient began to feel ill. The patient also reported that it was now 5 weeks into this feeling and the patient can't take it anymore.  Reportedly, the patient hurt everywhere and felt nauseous, having no energy and had a Terrible chest conge.  No Concomitant product use was reported. No treatment information was provided.