chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Has intractable epilepsy, she usually has 5-6 seizures per day that are generally brief myoclonic-astatic type of seizures.  The day after received her second dose of COVID19 vaccine she had an increase in seizure frequency.  By 4/25/2021, she started to develop fevers and new type of seizure with more body twitching and stiffening of her arms.  She was admitted to Hospital in on 4/27/2021 with fever, status epilepticus, found to have an aspiration pneumonia.  She required antiepileptic medication dose adjustment with addition of Valproic acid to her drug regimen, but this caused excessive sedation.  She was discharged from hospital on 5/14/2021.  Status epilepticus did resolve and she was more alert by the end of hospitalization.
Pt developed an area of mild erythema/rash characterized by redness and slight warmth to touch, on left inner  upper arm.
within 40 minutes of the vaccine the patient had an episode of vomiting and a fever, later developed a headache. The following day the headache and fever have resolved.  He has a sore arm.
The pt experienced upper arm edematous with erythema from shoulder to elbow. A 3 cm area of induration under site of immunization. The pt moves extremities well. No treatment was administered and the pt had a full recovery.
Patient is breastfeeding mother, whose infant, 7 months, developed symptoms one week after patient?s second COVID vaccine. Infant experienced rash and mild constitutional symptoms. Patient received second dose 1/7 and felt ill for 36 hours but had no major problems. The afternoon of 1/14, infant developed well-circumscribed flat spots on her face and arms that looked like small bruises. That evening, they developed into larger pink raised lesions and she screamed inconsolably for 1-2 hours. Both rash and fussiness improved with ibuprofen. The rash returned after the ibuprofen wore off.  The spots were up to 1 cm in diameter on her face, head, shoulders, and arms. They blanched and were pink/purple in color. Raised but not vesicular. No mucus membrane involvement. New lesions developed over one week but would improve with ibuprofen.  Infant was somewhat more sleepy but otherwise healthy and recovered completely.  Family had minimal exposure to people outside of household. No one else with similar symptoms. No new foods/detergents/etc.
Covid-19; Strep throat; Slid down the wall and passed out; Hacky cough; Slight headache; Tired; Fever; A spontaneous report was received from a consumer concerning a 73-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced hacky cough, slight headache, tired, slight fever of 100.4, covid-19, strep throat and passed out.  The patient's medical history included artificial hips. Concomitant medications reported included salbutamol, fluticasone propionate, salmeterol xinafoate, salbutamol sulfate, apixaban, mirabegron, metoprolol, cetirizine hydrochloride, colecalciferol, zinc, ascorbic acid and rutoside for unspecified indication.   On 11 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection.   Reporter stated that the patient was not aware of being exposed to COVID on 10 Jan 2021. They found out the following week after receiving the vaccine. The patient had COVID test on 19 Jan 2021 and tested positive.   On 14 Jan 2021, the patient developed hacky cough, slight headache, tired, slight fever of 100.4 degree fahrenheit. The treatment information included fluticasone propionate, salbutamol, steroids, montelukast and azithromycin.  On 17 Jan 2021, the patient got up to go to the bathroom and slid down the wall and passed out. The treatment information included fluticasone propionate, salbutamol, steroids, montelukast and azithromycin.  Action taken with RNA-1273 in response to the event was not provided.  The outcome of the events hacky cough, slight headache, tired, slight fever of 100.4, covid-19, strep throat and passed out was unknown.; Reporter's Comments: This case concerns a 73-year-old male with a serious expected event of loss of consciousness along with a NS unexpected COVID-19, streptococcal pharyngitis, cough and NS expected fever, headache, fatigue.  Event onset 9 days after the first dose of mRNA-1273. Treatment included fluticasone, salbutamol, steroids, azithromycin. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Developed a headache; Chills within a few hours following vaccination; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (Chills within a few hours following vaccination) and HEADACHE (Developed a headache) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced CHILLS (Chills within a few hours following vaccination). On 26-Jan-2021, the patient experienced HEADACHE (Developed a headache). At the time of the report, CHILLS (Chills within a few hours following vaccination) and HEADACHE (Developed a headache) outcome was unknown.            No relevant concomitant medications were reported. The patient wanted to find out if he could take pain medication like Tylenol (acetaminophen). No treatment information was provided.
10x10cm left deltoid swelling, red, tender area. Noted 24 hours after receiving immunizations. On 8/21/02 DTaP given in left deltoid, IPV given in left upper arm.
AFTER ADMINISTRATION, THE STAFF NOTED THE VACCINE WAS EXPIRED BY ~40 DAYS.  EXPIRATION DATE ON THE VACCINE WAS 4/10/2022
the area right below where she got the injection hot to the touch; the area right below where she got the injection itches; hard right below where she got the injection; left arm was sore & hard right below where she got the injection; huge rash on her left arm right below where she got the injection; sore under her left armpit where the lymph nodes are; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (the area right below where she got the injection hot to the touch), VACCINATION SITE PRURITUS (the area right below where she got the injection itches), VACCINATION SITE INDURATION (hard right below where she got the injection), VACCINATION SITE PAIN (left arm was sore & hard right below where she got the injection) and VACCINATION SITE RASH (huge rash on her left arm right below where she got the injection) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Aug-2021, the patient experienced AXILLARY PAIN (sore under her left armpit where the lymph nodes are). On 10-Aug-2021, the patient experienced VACCINATION SITE INDURATION (hard right below where she got the injection), VACCINATION SITE PAIN (left arm was sore & hard right below where she got the injection) and VACCINATION SITE RASH (huge rash on her left arm right below where she got the injection). On an unknown date, the patient experienced VACCINATION SITE WARMTH (the area right below where she got the injection hot to the touch) and VACCINATION SITE PRURITUS (the area right below where she got the injection itches). At the time of the report, VACCINATION SITE WARMTH (the area right below where she got the injection hot to the touch), VACCINATION SITE PRURITUS (the area right below where she got the injection itches), VACCINATION SITE INDURATION (hard right below where she got the injection), VACCINATION SITE PAIN (left arm was sore & hard right below where she got the injection), VACCINATION SITE RASH (huge rash on her left arm right below where she got the injection) and AXILLARY PAIN (sore under her left armpit where the lymph nodes are) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.  The patient had been using cold compresses for the hotness.
Swelling of the arm at the injection site, including soreness, and headache, fatigue, muscle ache, joint pain, slight fever - felt like I had the flu.  Started overnight after the shot and lasted the entire next day. Treated with rest, hydration and Tylenol.  Symptoms were gone by the following morning.
received dose 1 of shingrix on 8/3/2023 and dose 2 on 8/16/2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number YZ9F7, expiry date 08-JUL-2024) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 16-AUG-2023, the patient received the 2nd dose of Shingrix. On 16-AUG-2023, an unknown time after receiving Shingrix and an unknown time after receiving SHINGRIX, the patient experienced drug dose administration interval too short (Verbatim: received dose 1 of shingrix on 8/3/2023 and dose 2 on 8/16/2023).The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date:21-Sep-2023 The patient received 1st dose of Shingrix on 3rd August 2023. No reactions were reported. The reporter consented to follow up via postal. The patient received 2nd dose of Shingrix earlier than the recommended schedule, which led to shortening of vaccination schedule.
patient was administered with expired IPOL, no AE; Initial information received on 05-May-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves a patient who received an expired 0.5 ml fourth dose of vaccine IPV (VERO) [IPOL] (lot: P1A25, expiry date: 02-May-2020) via subcutaneous route in the left thigh for prophylactic vaccination on 04-May-2020.  The patient's medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medications included Varicella Zoster Vaccine (Varicella Vaccine) for Immunisation.  It was an actual medication error due to expired vaccine used.  The patient did not experience any adverse event at the time of report.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Day two after the injection, left arm and hand, right hand, and Lips are numb. This started at 06:30 am on day two (5/27/2021) and is still ongoing 4 hours later.  Called urgent care facility and they told me to file report and to get seen if becomes worse and lose strength.
Some dizziness; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Some dizziness) and PAIN IN EXTREMITY (Arm pain) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Food allergy (Other products) and Drug allergy (cephalosporin antibiotic (Ceclor) Allergy). Concomitant products included ALBUTEROL [SALBUTAMOL] from 28-Dec-2000 to an unknown date and FLUTICASONE PROPIONATE (FLOVENT) from 28-Dec-2000 to an unknown date for Asthma.    On 04-Mar-2021 at 1:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced DIZZINESS (Some dizziness). 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm pain). The patient was treated with BUSPIRONE for Anxiety, at an unspecified dose and frequency; HYDROXYZINE for Anxiety, at an unspecified dose and frequency; MECLIZINE [MECLOZINE] for Anxiety, at an unspecified dose and frequency and MECLIZINE [MECLOZINE] on 20-Apr-2021 for Anxiety, at a dose of 25 mg. On 08-Mar-2021, PAIN IN EXTREMITY (Arm pain) had resolved. At the time of the report, DIZZINESS (Some dizziness) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jul-2021, Electrocardiogram: normal (normal) All results were normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       he didn't take lorazepam and psudoephidrine was prescribed under treatment medication   This case was linked to MOD-2021-296537 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: Patient's demographics (height, weight) ethnic group and race was updated. Patient's allergies and outcome was added.
This spontaneous report as received from a other health professional refers to a 72 year old female patient with type 2 diabetes mellitus and drug hypersensitivity. On 06-NOV-2018 the patient was vaccinated with PNEUMOVAX 23 lot # R017900, intramuscular for prophylaxis. Concomitant therapies included LIPITOR, METFORMIN HYDROCHLORIDE, SYNTHROID and HYDROCHLOROTHIAZIDE plus LOSARTAN POTASSIUM. On 06-NOV-2018, 1 day after onset of therapy the patient experienced peripheral swelling, vomiting, chills, injection site mass, headache, pyrexia, malaise and injection site erythema. The outcome of peripheral swelling, vomiting, chills, injection site mass, headache, pyrexia, malaise and injection site erythema was reported as not recovered/not resolved.
tested positive for COVID; tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 7 year-old male patient received bnt162b2 (BNT162B2), administration date 10Dec2021 (Lot number: FL0007) at the age of 7 years as dose 2, single and administration date 26Nov2021 (Lot number: FK5618) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Jan2022, outcome "unknown" and all described as "tested positive for COVID". He received the 2nd dose 14 days from the 1st dose and due to this the vaccination status is not valid. He also tested positive for COVID on a rapid PCR test on 04Jan2022. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) positive.   No follow-up attempts are possible. No further information is expected.
burning in stomach; nausea; light fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (burning in stomach), NAUSEA (nausea) and FATIGUE (light fatigue) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced NAUSEA (nausea) and FATIGUE (light fatigue). On 20-Jan-2021, the patient experienced DYSPEPSIA (burning in stomach). The patient was treated with OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) at an unspecified dose and frequency and FAMOTIDINE at an unspecified dose and frequency. At the time of the report, DYSPEPSIA (burning in stomach), NAUSEA (nausea) and FATIGUE (light fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided    Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: This follow up contains no new information.
Within 2 hrs. had a headache that didn't go away for a week, By the 3rd day my blood pressure became so elevated that a had to take 2 doses of my blood pressure medicine to get it back to normal, this went on every day for a week my pulse rate elevated to 114,  the second week my blood pressure was extremely low, finally by 3rd week it went back to normal, I've had a headache on a daily basis now, haven't been able to sleep right and I feel I'm in a brain fog all the time.
no additional AE; temperature excursion; This spontaneous report was received from medical assistant and refers to a 42-year-old female patient. Her pertinent medical history, concomitant medications and drug reactions or allergies were unknown.  On 28-DEC-2020, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose and route of administration were not reported) lot # S022598, expiration date 25-FEB-2022, 1 dose for prophylaxis. The medical assistant reported that the temperature excursion occurred on 24-DEC-2020, recorded temperature was 47.77 degrees Fahrenheit (F) for 31 minutes and there was no previous excursion. A digital data logger was used to capture the excursion. No additional adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022598; expirationdate: 25-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Woke up around 5:30am about 47 hours after vaccine with dizziness and nausea and inability to walk straight line.  Called into my clinic to cancel first few hours of patients as I realized I could not drive safely.  Went back to sleep and awoke 2 hours with a left sided frontal/temporal headache with resolution of the other symptoms.  At that time, I realized I had had my first migraine with aura.  I was able to take ibuprofen and drive to work.  Since that vaccine, I co to to have mild short lived headaches in this area a few times/ week.  I had my second covid vaccine on 3/5/21 and did not have recurrence of the migraine with aura symptoms.
The patient experienced redness and itching after administration of PNEUMOVAX 23; The patient experienced redness and itching after administration of PNEUMOVAX 23; This spontaneous report has been received from a pharmacist, concerning a female patient of unknown age.   The patient's concurrent conditions, medical history and concomitant medication were not reported.  On an unknown date,  the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, frequency, anatomical location, lot number and expiration date were not reported) as prophylaxis.   On unknown date (reported as "a couple of years ago"), she experienced redness and itching after the administration of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23). At the reporting time, the outcome for the events was unknown.   The causal relationship between both events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not reported.   This is one of the two cases created from the same reporter (captured in MARRS#2009USA010118).; Sender's Comments:  US-009507513-2009USA010118:
Admitted with acute mixed respiratory failure with hypercapnia and hypoxia.  COVID-19 pneumonia, she is fully vaccinated.  She swabbed negative at outside hospital 2 weeks ago and is now positive on 11/2/21.
Soreness in injection site arm, unable to raise arm over head level, and swollen lymph nodes in left side of neck and shoulder.
"minor congestion"/"little congestion"; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION ("minor congestion"/"little congestion") in a male patient of an unknown age 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 03-Jun-2021, the patient experienced NASAL CONGESTION ("minor congestion"/"little congestion"). At the time of the report, NASAL CONGESTION ("minor congestion"/"little congestion") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants and treatments medications was reported.
This spontaneous report as received from a medical assistant refers to a 12 month old infant patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 13-SEP-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours from 06-SEP-2018. Previous excursion was 50.37°F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868: Original Case: 1809USA002868; US-009507513-1902USA009324: Original Case: 1902USA009323; US-009507513-1902USA009325: Original Case: 1902USA009323; US-009507513-1902USA009326: Original Case: 1902USA009323.
This non-valid spontaneous report was received from a consumer via social media and refers to several female patients of unknown ages. On an unknown dates, the patients were vaccinated with a dose of either quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) injection (dose, route, site of vaccination, lot number and expiration date were not reported) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) injection (dose, route, site of vaccination, lot number and expiration date were not reported) for prophylaxis. The reporter did not specify the type of human papillomavirus (HPV) vaccine used. On an unknown date (reported as hours after this vaccine), the patients expired (reported as "friends lost their daughters. Upon internal review, the events of death was considered medically significant. This is one of the three cases provided by the same reporter. Additional information is not expected, as there was no contact information for the reporter provided. Sender's Comments: US-009507513-1701USA005923: US-009507513-1701USA005922.
Minutes after receiving the vaccine the patient nearly passed out, slid from the chair, was caught by the steward attending the post vaccine patients. Patient was barely responsive and going clonic and the Epi-pen was about to be administered when the patient barely started to respond. After being told to deeply breathe and lie still and flat the patient was able to restore himself and after awhile sit up.
Rash at injection site at 24 hours after administration, then rash on other arm (at corresponding site)