chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; headache; body aches; muscle pain; tremors; weak; bone pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), HEADACHE (headache), PAIN (body aches), MYALGIA (muscle pain) and TREMOR (tremors) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced PYREXIA (fever), HEADACHE (headache), PAIN (body aches), MYALGIA (muscle pain), TREMOR (tremors), ASTHENIA (weak) and BONE PAIN (bone pain). On 06-Mar-2021, PYREXIA (fever), HEADACHE (headache), PAIN (body aches), MYALGIA (muscle pain), TREMOR (tremors), ASTHENIA (weak) and BONE PAIN (bone pain) had resolved. 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 medications taken. No treatment information provided.   This case was linked to MOD-2021-090705 (Patient Link).
Diagnosed with Shingles on 1/20/2021- Unsure if the immune response from the vaccine is what triggered it or not.  My shingles symptoms are rash, pain, itching, burning, fever, headache and chills.
Initial report was received from a health care professional on 29 November 2011. A 31-year-old female patient had received an intramuscular right deltoid injection of FLUZONE, lot number UT499A on 25 October 2011. On an unspecified date, the patient complained of right arm pain for one month after the injection. The patient went to an orthopedic doctor who told her it was bursitis. Medical history and concomitant medications were not reported. No adverse events following prior vaccinations were reported. No further information was available at the time of the report. The patient outcome was not recovered. Documents held by sender: none.
Flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (Flu). At the time of the report, INFLUENZA (Flu) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and Treatment was not specified.
PHARMACIST ADMINISTERED FIRST DOSE OF MODERNA COVID-19 VACCINE AND PATIENT IMMEDIATELY EXPERIENCED SWELLING AT THE INJECTION SITE (ONCE THE NEEDLE WAS REMOVED)
pt recv vax 7AUG98 & approx 1wk p/vax pt exp diarrhea which lasted 203wk;21AUG98 pt recovered from exp;
No adverse event, peds dose given and should have given patient an adult dose. Used VFC stock because patient had insurance (not realizing he was over 18) and did not realize it was also peds dose. Patient is an adult and should have received an adult size dose
p/vax that morning pt exp n/v, h/a, myalgias/body ache, fever & chills;By 330PM pt vomited 15-16 times;pt was taken to ER, tx w/hydration & antiemetics;pt blood chem & CBC were nl, w/exception of a RBC of 5.11;Gastroenteritis;
Swollen and tender neck lymph glands Red raised bump on forehead - approximately 1 1/2 inch wide and raised @ 1/4 inch. Some itching
Pt states that her arm suffers from pain and discomfort since the vaccine and states that the vaccine was not immunized properly.
headaches, body aches, cough, lower energy, poor sleep took ibuprofen and/or tylenol for the first 24 hours to reduce symptoms of aches (alternated every 4 hours).  took two days for symptoms to reduce completely
dizzy headed a/getting home; aching profuse sweating; loss of appetite; has pump device for pain in back; sore throat, headache;
I experienced mild menstrual bleeding on the day of vaccination of the first dose up until the the day of the second dose. Then I am experiencing moderate bleeding with headache and stomachache, today the next day after the second dose.
Heart aortic dissection; This is a spontaneous report received from contactable reporter(s) (Consumer). The reporter is the patient.  A 79-year-old female patient received BNT162b2 (BNT162B2), on 17Feb2022 as dose 4 (booster), single (Lot number: FJ6369, Expiration Date: May2022) at the age of 79 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 24Aug2020, for COVID-19 immunisation, reaction(s): "terrible headache", "severe diarrhea"; BNT162b2 (DOSE 2, SINGLE), administration date: 15Sep2020, for COVID-19 immunisation; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Batch/Lot number: FC3184; Expiration: Oct2021), administration date: 02Sep2021, for COVID-19 immunisation. The following information was reported: AORTIC DISSECTION (hospitalization, medically significant) with onset 07Sep2022, outcome "unknown", described as "Heart aortic dissection". Therapeutic measures were taken as a result of aortic dissection. Clinical course: Valve replacement of her heart aortic dissection and stent was also placed during this serious operation on her heart. She was a participant in a trial of developing the Pfizer covid vaccine. Patient had Other Conditions and no Investigations were performed. She did not know if she received a different dose since she was a senior.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300190182 Same patient/vaccine, different dose/events (dose 5);US-PFIZER INC-202300190194 Same patient/vaccine, different dose/events (dose 1);
Patinet has muscle cramps, vertigo, hyperinsomnia, fatigue, nausea, redness and itching around the injection site
Severe dizziness, nausea, balance issues - at the time I did not think about it being related to flu vaccine - however, it happened every October for several years.
Pt. age at vaccination time was 7 weeks.  Vaccines given @ approx 4:45 pm 9/24/2009.  Mom called County Health Dept at 2:00pm 9/25/2009 and stated infant had been having nonstop crying starting at 9:30pm 9/24/2009 until about 4:30 am 9/25/2009, and has been crying all day. Sleeping now, instructed Mom to take infant to ER.
Fever first night after vaccine.  11/13/2019 began to have pain roof of mouth.  Be among increasingly more severe.  11/16/2019 went to urgent care.  Diagnosed with Herpes Zoster vs herpetic stomatitis.  Prescribed Acylovir 800 msg 5 per day for 7 days. Prescribed Oralone 0.1% paste TID.
Very weak; carotid artery and a pain in right chest started coming and going; Fever; shivering pretty bad; Achy all over; Slight headache throughout the day; Couldn't sleep most all night; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730) via an unspecified route of administration in left arm on 24Mar2021 at 09:15 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. The patient medical history included gallbladder taken out 3 years ago and penicillin allergy from birth. Concomitant medications included crestor (MANUFACTURER UNKNOWN) 20mg/daily started on an unknown date for unknown indication and hydrochlorothiazide (MANUFACTURER UNKNOWN) 25mg started on an unknown date for unknown indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. It was reported that the patient was ok until about 7pm and started getting a fever (100.1), shivering pretty bad, achy all over, slight headache throughout the day (24Mar21). Tried to sleep but could not sleep most all night, shivery, fever, tossed and turned all night. Next day, felt pretty good, slight fever but not as bad but about noon, started feeling all the same symptoms again throughout the rest of the day 25Mar2021. The patient had another thing happen (believed was unrelated but). What she thought was her carotid artery and a pain in right chest started coming and going. Today (26MAR2021) so far, she felt just very weak (9:02am) so should go slow. The patient hope that she done with the bad symptoms. She took ADVIL but it still came and went. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent lab tests and procedures, which included fever with 100.1 (units unspecified). The clinical outcome of Achy all over, carotid artery and a pain in right chest started coming and going, couldn't sleep most all sight, fever, shivering pretty bad, slight headache and weakness throughout the day was resolved on 26Mar2021.  No follow-up attempts are needed. No further information is expected.
103 temp 3 days, dizziness, hard time walking, vomiting, diarrhea, glands swollen, achy. No breathing problems but said felt like someone was sitting on her chest.
On February 21, 2023, I felt extremely tired. I took a nap. I woke up with acid reflux. I also had loose bowels that were mustard yellow. After dinner, I immediately vomited my entire meal. I felt decent for the next few days. I had such severe acid reflux on Saturday, February 25, 2023, I thought I was having a heart attack. I went to the emergency room. They did an EKG and blood work. The confirmed I was not having a heart attack and sent me home. I went back to the doctor on February 28, 2023. They prescribed omeprazole. They also scheduled a stress test to rule out cardio issues. I took that on March 04, 2023. I went back to the doctor on March 3, 2023, as well. She completed a urinalysis and stool sample. Stool sample showed Sapovirus. They took me off omeprazole and put me on pantoprazole instead. I went back to the doctor around March 20, 2023. They suggested I take a probiotic. Most of the reflux subsided after taking it. I still have occasional diarrhea. I had an Upper Endoscopy last Friday, April 14, 2023. I saw a Gastroenterologist yesterday. He ordered additional stool tests, but I have not completed them yet. I'm feeling 80% better, but I have occasional symptoms.
This spontaneous report was received from a physician via company representative and refers to a 79 year old male patient. No medical history or concurrent conditions were reported. On 01-NOV-2012, the patient was vaccinated with ZOSTAVAX for prevention of shingles. No concomitant medications were reported. On 15-FEB-2015, the patient developed shingles on his upper chest area, the patient sought medical attention with the physician on the same day. The patient received TYLENOL, valacyclovir (manufacturer unknown), hydrocodone (manufacturer unknown), VICODIN and LYRICA as treatment for the adverse event (dates unknown). It was unknown if the patient had a history of shingles. The outcome of the event was unknown. The reporter did not assess the causality of the event with ZOSTAVAX. Additional information has been requested.
arm is red, swollen, warm and hurts.  these symptoms then traveled into the arm pit and on down into the side of the left breast
13MAR98 pt found deceased in crib 830AM;parents put to bed 11:30PM on 12MAR98;well check up done 12MAR98;all nl findings;
doses administered after excursion; No adverse event; Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 28-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 19-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    Concomitant medications details were not reported by the reporter.  Reportedly, Pharmacist called to discuss a temperature excursion that occurred several days ago in the freezer. the excursion was found out in an audit and all the vaccines were viable.  Treatment details were not reported by the reporter.
I was COVID positive; COVID positive; I am vaccinated (COVID-19 Vaccine) twice; I was COVID positive; COVID positive; I am vaccinated (COVID-19 Vaccine) twice; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administration date 28Jan2021 (Lot number: EL1283) at the age of 66 years as dose 2, single and administration date 07Jan2021 (Lot number: EK5730) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Emphysema" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; SYNTHROID; VITAMIN D [ERGOCALCIFEROL]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I was COVID positive; COVID positive; I am vaccinated (COVID-19 Vaccine) twice". The patient underwent the following laboratory tests and procedures: laboratory test: (Jan2022) unknown results; metabolic function test: (Jan2022) unknown results; sars-cov-2 test: (unspecified date) positive. Therapeutic measures were taken as a result of covid-19. The patient was in a COVID positive pass held and she went heading calls and she could not locate any of the infusions for the monoclonal antibodies (further clarification unknown). Treatment for adverse event: Consumer stated, "No and steroids, they started steroids in the hospital (daily shot) but that was it." The patient was vaccinated (COVID-19 Vaccine) twice but no booster, so did very well. When clarified if consumer was tested COVID positive after receiving COVID Vaccine, Consumer stated other people might have still be positive including her daughter who worked in a nursing facility. So, they all had it, they were all positive this past weeks including the children (further number of patients and patient details were unknown hence split not made), whatever they did very well. She tested 'blue' positive in the hospital so (further clarification unknown). Confirmed that consumer was tested COVID positive after receiving COVID Vaccine.
About 10 days after receiving second vaccine,  muscle on top of right thigh started hurting/aching. Pain still continues. Unable to get a good night of sleep since this started. Taking Tylenol for pain, and sleep aids for sleeping.
headache; dehydration due to not drinking enough fluids; first Sept 2019 and second dose on July 22, 2020 due to Covid-19; sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on 3rd September 2019, refer case US2020140202).   On 22nd July 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 22nd July 2020, less than a day after receiving Shingrix, the patient experienced pain in arm and social problem. On 23rd July 2020, the patient experienced headache and dehydration. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the headache, dehydration and social problem were unknown.   It was unknown if the reporter considered the pain in arm, headache and dehydration to be related to Shingrix.  Additional information was provided as follows: The patient received 2nd dose later than the receommended interval due to COVID 19. The patient developed sore arm a few hours after dose, and sore arm was getting better. The patient woke up with a headache next morning and believed this was caused from dehydration due to not drinking enough fluids last night to support potential dehydration hypothesis, caller reported usually waking up in middle of night to use bathroom but did not last night. The patietn took Tylenol for headache. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020140202:first dose
Patient given a HIB vaccine on 8/14/23, that expired on 8/11/23.
I had overlooked that the patient had already received a bivalent booster on 9/28/22 and a second bivalent booster was administered today.
pt recv vax 15JUN95 & 16APR96 devel about 10 pox on chest, back & face;to MD & varicella was suspected;19APR96 pt had devel about 250 to 280 pox all over body;returned to MD & pt felt to conclusively have chicken pox;also devel eye infect;
Patient experienced syncope,possibly seizure,Patient fell and bumped her head.Helped patient upright into a chair, applied ice pack to bruise on forehead.Patient was alert,answered all my questions.Observed patient for the next 30-40 minutes.Patient was driven home by her mother.
This spontaneous case was reported by a patient family member or friend and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered a vaccine that is expired) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. No Medical History information was reported. On 08-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered a vaccine that is expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered a vaccine that is expired) outcome was unknown. No relevant concomitant medications were reported. It was reported that vaccine was expired on 05-JUL-2022. Treatment medication was not provided by the reporter.
experiencing fever after second dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (experiencing fever after second dose) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 025AZ8) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PYREXIA (experiencing fever after second dose). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (experiencing fever after second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications are provided by the reporter. It was reported that patient had 100,101 temperature. Patient stated experiencing fever after second dose.   This case was linked to MOD-2021-377249 (Patient Link).
sore arm x 2 months post vaccination, pain with muscular movement doing normal daily activities requiring use of the arm. Patient not currently receiving treatment.  Patient states she will give her symptoms until the end of the month to seek medical advise.
This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced fever, pain and myalgia. On an unknown date, the outcome of the fever, pain and myalgia were unknown. It was unknown if the reporter considered the fever, pain and myalgia to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. After receiving 1st dose of SHINGRIX, the patient had a temperature, soreness and myalgia for a few days.