chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a male consumer of unknown age, referring to himself. Current conditions and relevant medical history were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (subcutaneous injection, strength, dose number, route, anatomical location, lot # and expiration date not reported). Concomitant medications were not reported. The consumer stated that on an unknown date developed a rash on various parts of his body after receiving ZOSTAVAX. The outcome of the event was unknown. Causality assessment was not provided by the reporter. Additional information is not expected. because no contact details were provided.
Diarrhoea; Mini version of Covid; Stomach ache; Rash at the injection site; red bumps on stomach; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhoea), COVID-19 (Mini version of Covid), ABDOMINAL PAIN UPPER (Stomach ache), VACCINATION SITE RASH (Rash at the injection site) and ERYTHEMA (red bumps on stomach) in a female patient of an unknown age 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.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced DIARRHOEA (Diarrhoea), COVID-19 (Mini version of Covid), ABDOMINAL PAIN UPPER (Stomach ache), VACCINATION SITE RASH (Rash at the injection site), ERYTHEMA (red bumps on stomach) and HEADACHE (Headache). At the time of the report, DIARRHOEA (Diarrhoea), COVID-19 (Mini version of Covid), ABDOMINAL PAIN UPPER (Stomach ache), VACCINATION SITE RASH (Rash at the injection site), ERYTHEMA (red bumps on stomach) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sudden unattended death.  Autopsy results pending (inconclusive 2/25/08).  2/26/08 Reviewed pcp medical records & vax records which reveal patient received HPV#1 0469U 7/16/07 & HPV#2 09300 9/17/07.  In 11/20/07, noted to have left sided head pain intermittently along with lightheadedness; dx w/tension HA.  HPV#3 was scheduled for 1/16/2008 but postponed due to no parental signature.  Returned to office 1/24/08 for left wrist pain from cheerleading injury s/p ER vs for same on 1/19/08.  Patient last seen in office by nurse only on 2/20 for HPV #3, no notes for visit. PMH: kicked in face by horse in past (undated) & had contusion on cheek; acne vulgaris, started Yasmin & topicals 4/07 w/improvement after multiple other drug failures; 1/19/08 wrist contusion from cheerleading.   5/2/08 Autopsy report states COD as undetermined.  Autopsy states patient had intermittent HAs x 2 mo & had been on BCP x 1 year for acne.  Found w/small facial laceration from striking flower pot when fell.  The autopsy was neg for all findings.  Scene indicated sudden death from collapse & fall.  Suspected long QT interval syndrome w/fatal arrhythmia rather than new onset seizure in patient w/no history of either. Suggested testing family members.
Information has been received from a registered pharmacist concerning of a 66 years old white female who on 10-Nov-2008 was vaccinated with VARIVAX (Oka/Merck) (lot# 654409/1148X) instead of ZOSTAVAX (Oka/Merck), due to human error at the physician's office. No adverse effects were noted. The patient sought medical attention through an office visit. Follow up information has been received from a registered nurse who indicated that on 10-Nov-2008, the patient received the second dose of VARIVAX (Oka/Merck), SQ (lot #663198/1419X). Further information is not expected.
my back hurts/thing hurts; injection site hard and hot; very tired/exhausted/just tired/hard to get off the couch; pukey feeling; injection site all red/and rounded 3 inches across; injection site hard and hot; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (my back hurts/thing hurts), VACCINATION SITE WARMTH (injection site hard and hot), FATIGUE (very tired/exhausted/just tired/hard to get off the couch), NAUSEA (pukey feeling) and VACCINATION SITE ERYTHEMA (injection site all red/and rounded 3 inches across) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04A021A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OMEPRAZOLE, LITHIUM, QUETIAPINE FUMARATE (SEROQUEL), PRIMIDONE and LEVOTHYROXINE for an unknown indication.   On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BACK PAIN (my back hurts/thing hurts), VACCINATION SITE WARMTH (injection site hard and hot), FATIGUE (very tired/exhausted/just tired/hard to get off the couch), NAUSEA (pukey feeling), VACCINATION SITE ERYTHEMA (injection site all red/and rounded 3 inches across) and VACCINATION SITE INDURATION (injection site hard and hot). On 30-Jan-2022, VACCINATION SITE ERYTHEMA (injection site all red/and rounded 3 inches across) was resolving. At the time of the report, BACK PAIN (my back hurts/thing hurts), FATIGUE (very tired/exhausted/just tired/hard to get off the couch) and NAUSEA (pukey feeling) outcome was unknown and VACCINATION SITE WARMTH (injection site hard and hot) and VACCINATION SITE INDURATION (injection site hard and hot) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2022, Thyroid function test: low (Low) low.         No treatment medication was provided.  No patient medical history was provided.  Patient has given higher medication for low thyroid value   Most recent FOLLOW-UP information incorporated above includes: On 30-Jan-2022: Significant follow up was received which included patient occupation, Date of Birth, lab data, first, second, third dose information, concomitant medication and new events.
Narrative:  The patient reports she received the Moderna mRNA COVID-19 vaccination at Pharmacy. Following vaccination the patient states she immediately noted a metallic taste in her mouth similar to pennies. The patient states she left the pharmacy after - 15 minutes without acute symptoms. At her allergy appointment the patient stated she developed 3 oral sores, and her lips felt smoother and puffier than usual. The patient also noted some substernal chest pressure without dyspnea, throat clearing, cough or wheezing. Patient also reported extreme nausea that resolved with ondansetron. The patient then visited  the ED for evaluation and was treated with an EpiPen. The patient also reports she had tachycardia. Per allergist review, the patients symptoms did not particularly suggest anaphylaxis per WAO criteria and incidence is rare (2.5/million for Moderna vaccine)
On July 7, 2022, I tested positive for COVID-19. I contacted the doctors and I was prescribe the Paxlovid. I took the Paxlovid for five days straight. I feel about 85 percent better.
This infant was immunized on 03/15/01. The mother reports the child developed "tic" in which the child twitched head to one side. On the night of 03/17/01, the child had 2-3 generalized shaking episodes which lasted 3 seconds each, followed by a glazed / lethargic look. This was not typical seizure activity. However unsure. Patient to see a neurologist.
Dysautonomia -   1 week later she lost her appetite became fatigued, developed severe sweats and freezing cold 24 hours a day 7 days a week.  The cold waves would come multiple times an hour.  She would have waves of nausea but no fever.  She was weak and bedridden.  By the time of her booster shot 4 weeks later she was starting to feel better.  She was on Enbrel and prednisone as usual.  She got her second shot and 5 days later she felt miserable.  She was finally starting to be able to walk again and then after a few weeks of doing this she got up to 36 minutes of walking and hit a wall.  She became fatigued and nauseated again.  She felt terribly weak.  She would stand up and her heart would pound.  She go to the kitchen to try to prep something and she could not do it.  She felt brain fog and had difficulty getting words out.
patient described soreness in arm and limited ability to lift it; patient described soreness in arm and limited ability to lift it; fever of 100.0 F; fatigue; body ache; no appetite; This is a spontaneous report from a contactable consumer.  A 37-year-old female (not pregnant) patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6201), via an unspecified route of administration on 10Mar2021 14:30 as single dose for covid-19 immunisation . The patient medical history and concomitant medications were not reported. Prior to vaccination and since the vaccination, the patient was not diagnosed with COVID-19.Previously on 17Feb2021 patient took the first dose of the vaccine (lot EL9269) at the age of 37 years for covid-19 immunisation. On  10Mar2021 the patient experienced soreness in arm and limited ability to lift it, fever of 100.0 F,fatigue, body ache and no appetite. It was unknown if treatment was given. Outcome of the events was recovering.No follow-up attempts are needed. No further information is expected.
Raised blood pressure 170/90; Nausea; Headache; Fever; Dizziness; Fatigue; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: 30130BT, Expiration date: Not reported), via an unspecified route of administration in right arm on 23Sep2021 (at the age of 40-years-old) as unknown dose, single for COVID-19 immunization in a pharmacy or drug store. The patient's medical history and concomitant medications were not reported. No relevant past drug history was reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient experienced raised blood pressure of 170/90, nausea, headache, dizziness, fatigue and fever on 23Sep2021. These events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient received treatment for these events and reported as no prolonged hospitalization. The case was reported as non-serious and the outcome of events was not recovered at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a consumer and described the occurrence of pneumonia in a 84-year-old male subject who was vaccinated with Flulaval GlaxoSmithKline for prophylaxis. A physician or other health care professional has not verified this report. The reporter was the subject's wife. Concurrent medical conditions included arthritis and heart condition. Concurrent medications included Cardiovascular medication. On 2 January 2007 the subject received primary course of Flulaval (0.5 ml, unknown, unknown arm). Seven to ten days after vaccination with Flulaval, the subject experienced pneumonia. This case was assessed as medically serious by GSK. The reporter considered that the events were disabling and life-threatening. At the time of reporting the event was resolved.
Feeling drunk, but not drinking.  Trouble driving.  Perception of surroundings abnormal.  Blocked right ear.  Physical exam by clinic revealed vertigo.  After diagnosis of BPPV underwent
Headaches, nausea, vomiting, dizziness, lightheadedness, inability to PO with 5lb weightloss over 7 days, tinnitus, fever, chills
Rash on chest/arms/back w/HA x 3 days with itchiness; denies any SOB/N/V/Photophobia/vision changes; reports taking Tylenol 1000mg at 0530 with some relief; J&J rec'd 5May21
Headache, sore arm and chills (all expected) set in around midnight (about 12 hours after the booster shot). Restless sleep. Throughout the night I noticed a lot of chest tightness, soreness and aching just to the left of center of my chest, as well as, it being harder for me to breathe deeply. The whole next day was very much the same. Now (two days later), I have shed most all of the original symptoms. The chest pain has subsided, but is still there a tiny bit. I'd say about 10% of what it was yesterday.
I had allergic reaction to where my whole left side was swollen and numb to where I couldn?t feel anything plus when I was eating too.
Cerebrovascular accident; This case was initially received via another Manufacturer (Reference number: PVIUS2021001059) on 14-Jun-2021. The most recent information was received on 06-Jul-2021 and was forwarded to Moderna on 06-Jul-2021. The license partner had received the report from FDA VAERS (Reference number: 1422940).    This regulatory authority case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Cerebrovascular accident) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Cerebrovascular accident) (seriousness criteria hospitalization and medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Cerebrovascular accident) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was provided.  No treatment medication details was provided.  Very limited information regarding the event has been provided at this time. Patient's history of diabetes may be a confounding factor. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Event verbatim Updated. Sender's Comments added. Report type of this case updated from spontaneous to Regulatory Authority.; Sender's Comments: Very limited information regarding this event has been provided at this time. Patient's history of diabetes may be a confounding factor.
Patient did not report the reaction till today's appointment 7/26/22. She reports that the day after receiving 1st dose of Twinrix she had bilateral hand swelling. She did not take anything & reports that it resolved on it's own that day.
This spontaneous report as received from a physician refers to an unspecified patient of unknown demographics. The patient's current conditions or medical history were not reported. On 14-JUL-2014, the physician reported that the patient was in her office to receive their third dose of GARDASIL (dose, route, lot number and expiration date not reported). The patient should had received that dose two months ago on an unspecified date (approximately in May 2014). No adverse effects reported. Additional information has been requested.
Coughing with tickles in the throat; Coughing with tickles in the throat; They think allergic, now this is the third week.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 12 year-old female patient received bnt162b2 (BNT162B2), administration date 27Aug2021 (Lot number: FC3181) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single, Lot: FA7484), administration date: 06Aug2021, for COVID-19 immunization.  The following information was reported: COUGH (non-serious) with onset 29Aug2021, outcome "not recovered", THROAT IRRITATION (non-serious) with onset 29Aug2021, outcome "unknown" and all described as "Coughing with tickles in the throat"; HYPERSENSITIVITY (non-serious) with onset 2021, outcome "unknown", described as "They think allergic, now this is the third week.". The events "coughing with tickles in the throat", "coughing with tickles in the throat" and "they think allergic, now this is the third week." were evaluated at the physician office visit. Therapeutic measures were taken as a result of cough, throat irritation, hypersensitivity.  Additional information: The reporter called behalf of his daughter Second dose 27Aug2021, next Sunday she started coughing, with tickles in the throat. Wanted to know if this is because of the vaccine or something else. Still has the cough currently. She's better but she's still coughing. She already has medicines. Trying to recall which ones, reporter can't recall which ones. Has already seen HCP. They think allergic, now this is the third week. Just wanted to see if this is an adverse event of the vaccine. She claimed tickle in throat made her cough. Two days after vaccine started coughing, third week. Now I will wait. I just want to be sure it's not the vaccine.   No follow-up attempts are possible. No further information is expected.
Menstrual cycle disrupted. It's been 4 weeks since second shot and over 5 weeks since previous cycle. No possibly of pregnancy.
prescription written for Menveo for a 84 year old; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted product prescribing error in a 84-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced intercepted product prescribing error. On an unknown date, the outcome of the intercepted product prescribing error was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that theyreceived a prescription written for Menveo for a 84 year old patient and the vaccine not administered, which led to intercepted product prescribing error. The reporter did not consent to follow-up.
Swelling and erythema left deltoid 12hrs - Myalgia 24hrs. Severe headache 36hrs. To E.R. All lab - UA normal. Treated with I.V. saline & Toradol 30 mg.
This spontaneous report was received from an office manager referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unspecified dates in January and February 2017, the patients received improperly stored doses of M-M-R II lot # M007277, expiration date: 09-FEB-2018; lot #M034857, expiration date: 27-JUL-2018 (dose and route of administration were not reported) for prophylaxis. The reporter had not been informed of an adverse experience. Administered doses of M-M-R II were exposed to temperature excursions as follows: In January 2017, between 5°F and 14°F for 4640 minutes (806 minutes highest 32°F); in February 2017, between 5°F and 14°F for 5164 minutes (560 minutes highest 36°F). Data logger was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA008835: US-009507513-1703USA009922: US-009507513-1703USA009923: US-009507513-1703USA009924: US-009507513-1703USA009925: US-009507513-1703USA009926: US-009507513-1704USA001629: US-009507513-1704USA001630: US-009507513-1704USA001631:
7/14-7/17: Had dull ache in muscle, which went away. Approximately 1 week later, the entire upper arm had a burning pain that got worse when the muscle was used. Took Alee and used both cold/warm compresses to decrease pain. Early sym until now: can still pinpoint exact area where vaccine was given: which was about 6" below the shoulder, below the of the deltoid muscle, burning pain continues and radiates out from the center. Raising arm above shoulder to left makes pain worse. Has called MD but has not see a doctor yet. Was advised to see a doctor for further assessment and treatmetn.
Throat and tongue felt thick/swollen. Severe arm tremors, headaches, shortness of breath, heart palpitations, severe pain at injection site, weakness, extreme fatigue, memory loss, fingers twitching on their own. To this date, I have extreme fatigue, severe pain at injection site, involuntary hand/finger movements, weakness and continuous/non stop all over twitches and tremors throughout my body, especially in both arms and nerve pain through out body.
A 71 y.o. female with history of type 2 diabetes, GERD, hypertension and hyperlipidemia who presents today with generalized weakness, fatigue and hypoxia.  Patient stated she had onset of symptoms fatigue, weakness, body aches, nausea, vomiting, diarrhea, cough and decreased appetite.  Patient stated sick contact was her grandson who had COVID.  Patient noted the worst of her symptoms is extreme fatigue and weakness.  She run an adult foster home and the last 2 nights she used a pulse oximeter which showed she would drop to the high 80s on room air overnight.  She denied any shortness of breath, chest pain, calf pain, fever or chills.  She did receive her COVID-19 vaccinations.  She stated that she is so weak and fatigued that she could not take it anymore prompting her to be seen at Emergency Department for evaluation.   Patient's laboratory studies relatively unremarkable.  She was given Zofran and able to tolerate Vernors.  COVID-19 positive.  Chest x-ray demonstrated mild/moderate coarse strandy and hazy/patchy bilateral airspace disease, most extensive in the lower lungs. No effusion or pneumothorax is seen.  Patient's vitals were stable on room air until she got up and became tachycardic with heart rate into the 130s-140s.  She was admitted for symptom management of COVID-19.   Patient was admitted under observation.  She received monoclonal antibody infusion, tolerated well.  She was also treated with dexamethasone 6 mg a day.  She did not qualify for remdesivir.  She continued to have extreme fatigue, weakness body aches and nausea.  Her nausea improved with Zofran and was able to have adequate oral intake.  She remained on room air and her vitals were stable.  She was discharged home in stable condition with a prescription for Protonix, Zofran ODT, and dexamethasone for 8 days.  She was instructed to self quarantine and call to make an appointment for with her PCP.  All questions and concerns were addressed prior to discharge.