chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Migraine Headache; Sore Arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Arm at injection site) and MIGRAINE (Migraine Headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore Arm at injection site). On 16-Apr-2021, the patient experienced MIGRAINE (Migraine Headache). At the time of the report, VACCINATION SITE PAIN (Sore Arm at injection site) and MIGRAINE (Migraine Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
pt recvd vax; pt devel a raised, scaley rash on body  including scalp, chest, knees, elbows & rectum;
Information has been received from a male consumer of unknown age referring to himself. There was no concurrent condition or medical history reported. On 02-DEC-2015 the patient was vaccinated with ZOSTAVAX (dosage and lot # unknown) subcutaneously for prevention of herpes zoster. There was no concomitant medication reported. The patient reported, on 25-JAN-2016 he starting having light pain in upper right thigh making him unable to sleep. He also reported, on 28-JAN-2016 he experienced rash broke out on back of right leg thigh and on buttocks. The patient visited the physician's office. He was treated with prednisone, acyclovir and NEURONTIN. The patient reported that he was fully recovered but with scars remaining from rash on an unknown date in 2016. Additional information is not expected as no contacted detail was provided.
pt recv vax 26MAR96 & 10APR96 pt devel a boil @ inj site, which devel into a vesicle, followed by 4 more vesicles around the chest area;no further details were provided;
Right arm deltoid area red and swollen, started 10-20-10, about 10:00am started to get larger. 5cm x 5cm area of redness noted on right deltoid.
3 cm x 2 cm red, raised rash at site of MMR injection right arm.  Hot to touch, no pain or discomfort.  Denies itching.  No other adverse effects.  Observed x 25-30 min.
Swollen lymph node near the collar bone on the left side.  Tender to the touch
Red, itchy rash 14x11 cm and felt warm around injection site on left thigh x 5 days.  Was evaluated at day 7 post vaccination with swollen lymph nodes in the groin.
Large hive formed around & below injection site (about 4 inches in diameter).  Hive is still there 48 hrs later, but not as bright red. Gave Benadryl orally and applied cortisone cream to hive.  Itches A LOT.
Sore, Red Rash and swelling.  Received topical Hydroortisone 1%, and Cetirizine Hydrochloride 10 mg
Blood clot in blood vessel in the left hand at the base of the middle finger causing darkening in the lower part of the finger and numbness in the whole finger.
Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 13-APR-2015, the patient was vaccinated with a dose of PEDVAXHIB (lot # K008878) 0.5 ml (expiration date, route and site of administration were not reported) that underwent 72 hours temperature excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
There was no adverse reaction, vaccine expired on 08/31/2021 and vaccine was administered on; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (There was no adverse reaction, vaccine expired on 08/31/2021 and vaccine was administered on) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2021 at 4:07 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (There was no adverse reaction, vaccine expired on 08/31/2021 and vaccine was administered on). On 17-Sep-2021, EXPIRED PRODUCT ADMINISTERED (There was no adverse reaction, vaccine expired on 08/31/2021 and vaccine was administered on) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (There was no adverse reaction, vaccine expired on 08/31/2021 and vaccine was administered on) to be not related.    No concomitant medication and treatment information provided.
not able to find an appointment for second shot and he has missed the window; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (not able to find an appointment for second shot and he has missed the window) 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 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (not able to find an appointment for second shot and he has missed the window). At the time of the report, PRODUCT DOSE OMISSION ISSUE (not able to find an appointment for second shot and he has missed the window) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided. Action taken with mRNA-1273 in response to the event was unknown
Starting Wednesday, July 26th patient reported redness and swelling/pain at injection site for immunization given 7/20/17. She also reported nausea, fatigue and fluctuating blood sugars.
Upon injection, most of the vaccine squirted out of the syringe and did not enter the subcutaneous tissue. It was difficult to determine if this was due to leaking at the cutaneous tissue or if there was a defect in the syringe. The dose was repeated. The pt reported no unusal SE.
Fever, Chills, Headache, Stomach ache, and body ache.
Increased Heart Rate and Tingling in the Arm and Dizzyness right after the vaccine. Dizzyness continuted through out the day Increased Heart Rate had continued off and on, went to ER and have seen Cardiologist
Patient stated their arm became hot and swollen about 11 hours after administration of the vaccine. Over the course of the weekend their arm became red and the swelling as progressed down their arm. They came into to see us 4 days after the vaccine administered and it was still swollen.
a dose that expired was administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 36-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA591A, expiry date 31st August 2022) for prophylaxis.   On 1st September 2022, the patient received Menveo. On 1st September 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK Receipt Date: 01-SEP-2022 Reporter's Comments: The reporter reported that patient received expired dose of Menveo which was expired one day before reporting. The reporter consent to follow up via email. Additional Supportive Information: The patient received an expired dose of Menveo, which led to expired vaccine used.
Administration of improperly stored PROQUAD; No additional AE/PQCs reported; Information has been received from a patient of unknown age and gender who was reporting on theirself. There was no information about patient's concurrent conditions, medical history, concomitant medications or drug reactions/allergies.  On an unknown date, the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # T021639 and expiration date of 21-DEC-2021, (route of administration and anatomical location were not reported) for prophylaxis, which was stored in an unknown temperature range for 1 hours and 32 minutes. No previous temperature excursion was reported. No adverse effects were reported.   Digital data logger was involved.
Injection site pain, headache, chills, nausea, feeling unwell. Injection site pain and chills went away after two days. Headache, nausea, and feeling unwell is still going on but intermittent as of 8 days after the first injection.
she had a temperature of 103.8; splitting headache; muscle ache; cough; diarrhea; her throat, ears, and nose hurt; her throat, ears, and nose hurt; her throat, ears, and nose hurt; tested for Covid, but it came back negative; This is a spontaneous report from a contactable consumer or other non healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had a temperature of 103.8, splitting headache, muscle ache, cough, diarrhoea, her throat, ears, and nose hurt leading to oropharyngeal pain and tested for covid, but it came back negative, sars-cov-2 test negative on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included body temperature 103.8 and sars-cov-2 test: negative.  No follow-up attempts are possible. No further information is expected.
17 y/o, believed to be and self described as 18 y/o, given Moderna Vaccine
Extremely sore arm, unable to sleep, very weak, fever, migraine, chills, nauseous, sore throat
ill; severe headache; checked my blood pressure and it was162/96 it was 196/122; dizziness; blurry vision; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VISION BLURRED (non-serious) with onset 03Oct2023, outcome "unknown", described as "blurry vision"; DIZZINESS (non-serious) with onset 03Oct2023, outcome "unknown"; BLOOD PRESSURE INCREASED(medically significant) with onset 06Oct2023, outcome "unknown", described as "checked my blood pressure and it was162/96 it was 196/122"; HEADACHE (non-serious) with onset 06Oct2023, outcome "unknown", described as "severe headache"; ILLNESS (non-serious), outcome "unknown", described as "ill". The events "checked my blood pressure and it was162/96 it was 196/122" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (06Oct2023) 162/96 mmHg; (07Oct2023) 196/122 mmHg. The clinical course was reported as follows: "on 03Oct2023, I awoke with dizziness and blurry vision. I worked for 4 hours and left to go home and slept for approximately 8 hours. The following 2 days I was still ill and on Friday I checked my blood pressure and it was 162/96 and I had a severe headache. The following day I checked my BP  again and it was 196/122 and I went to the emergency room. I have no history of hypertension". The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
5 days after (jan4th) the first shot (dec 29th) I developed mastitis and 3 days (jan 29th) after the second one (Jan 26) I developed mastitis again. Something I never had before these shots in my 14 months of nursing. Development of mastitis was very sudden within a few hours of having breast pain -breast was red/hot, had chills, mild fever and body aches. Mastitis was in the same breasts each time but I did get the shot in different arms each time. Urgent care 1/4/2021 and Telehealth visit 1/30/2021, prescribed antibiotics
Redness, Swelling, Pain led to Cellulitis and Abscess of Upper Arm.
starting on 22MAR93 pt had fever of 103 to 104 & hyperactivity w/occasional screaming for 5 days; fever was treated w/APAP; pt was taken to ER 23MAR93 dx as react to MMR immun & staph infect in throat; mom states had racing of heart;
Went home from work and 4 hours after vaccine began with throat tightening, shortness of breath. Wheezing, eyes swelling. Use inhaler for history of asthma, Ibuprofen went to bed, restless all night and at 2 pm felt nausea and chest tightness remained, at 9:30 AM evaluated Temp 99.2 BP 136/85 general flushing, slight diaphoresis. Seen by occupational health physician.
Dose reconstituted with diluent from MMR vaccine; Dose reconstituted with diluent from MMR vaccine; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 10-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA761A, expiry date 30th November 2023) for prophylaxis.   On 2nd February 2023, the patient received Menveo. On 2nd February 2023, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 09-FEB-2023 Reporter's Comments: The clinic supervisor reported that the patient was administered a dose of Menveo. The dose was reconstituted with the diluent from MMR vaccine and not with the supplied Menveo CYW-135 diluent. At the time of reporting, the dose has not been repeated. The vaccine administration facility was the same as primary reporter. Reporter consented to follow up. Additional supportive information: As dose was reconstituted with the diluent from MMR vaccine and not with the supplied Menveo CYW-135 diluent which led to inappropriate dose of vaccine administered and wrong solution used in drug reconstitution. This case is linked with US2023021184, reported by same reporter different patient.; Sender's Comments:  US-GSK-US2023021184:Same reporter
Low Back Pain - Assessed by, PA on 1/19/2021 and treated for UTI with Doxycycline 100mg, po, bid X 10 days.
The pt received a booster dose of Hep B vaccine since her Hep B titer was "0" after 3 initial doses. Within one hour she had a rash over her body, itching, which increased at 2 hours post vax. She reported to an ER feeling weak, itchy and with large rash. She was given Benadryl and Medrol.
On October 15th, I developed sustained dizziness, vertigo, nausea and vomiting that did not respond to Zofran and Meclazine.  ED assessment by CT, CTA and MRI diagnosed PICA Stroke.  Hospitalized for 24 hours.  Started on Lipitor 80mg and ASA 81mg.
(L) arm I had an immediate migraine headache and redness over the area of the site and then, soreness, swelling, itching, blistering and feeling of skin from 10-9 to 10-19 2015. It kept me from doing normal activities, as usual.
2 hrs after vax my right jaw swelled up when eating. Swelling subsided upon return to doctor office. Swelling continued to happen every time I eat but would go down afterward leaving a knot under jawbone of right ear. Doctor thought it was only a coincidence and believed it to be a blocked saliva duct and scheduled me for a CT scan at local hospital on 08/12/2021. Upon arrival X-ray Tech advised wrong test ordered and contacted Dr office. Dr in turn contacted Insurance for approval. Insurance placed it in 'Medical Review' and did not approve test. All symptoms were gone by 08/15/2021.
Felt like a really nasty head cold for about 3 days: plugged up, couldn't breath, stuffy; Felt like a really nasty head cold for about 3 days: plugged up, couldn't breath, stuffy; Felt like a really nasty head cold for about 3 days: plugged up, couldn't breath, stuffy; had a headache; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Felt like a really nasty head cold for about 3 days: plugged up, couldn't breath, stuffy), DYSPNOEA (Felt like a really nasty head cold for about 3 days: plugged up, couldn't breath, stuffy), NASAL CONGESTION (Felt like a really nasty head cold for about 3 days: plugged up, couldn't breath, stuffy) and HEADACHE (had a headache) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included LISINOPRIL, CARVEDILOL, FENOFIBRATE (ADIPEX [FENOFIBRATE]), SIMVASTATIN, TADALAFIL (CIALIS), FUROSEMIDE, SPIRONOLACTONE, ACETYLSALICYLIC ACID (BABY ASPIRIN), ASCORBIC ACID (VIT C) and MULTIVITAMIN [ASCORBIC ACID;COLECALCIFEROL;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE] for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced NASOPHARYNGITIS (Felt like a really nasty head cold for about 3 days: plugged up, couldn't breath, stuffy), DYSPNOEA (Felt like a really nasty head cold for about 3 days: plugged up, couldn't breath, stuffy), NASAL CONGESTION (Felt like a really nasty head cold for about 3 days: plugged up, couldn't breath, stuffy) and HEADACHE (had a headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 26-Mar-2021, NASOPHARYNGITIS (Felt like a really nasty head cold for about 3 days: plugged up, couldn't breath, stuffy), DYSPNOEA (Felt like a really nasty head cold for about 3 days: plugged up, couldn't breath, stuffy), NASAL CONGESTION (Felt like a really nasty head cold for about 3 days: plugged up, couldn't breath, stuffy) and HEADACHE (had a headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-086187, US-MODERNATX, INC.-MOD-2021-085661, US-MODERNATX, INC.-MOD-2021-085677 (E2B Linked Report). This case was linked to MOD-2021-086668 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Contact information updated. On 17-May-2021: non-significant follow up On 25-May-2021: Non-significant follow-up appended; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-086187:father case for dose 2 US-MODERNATX, INC.-MOD-2021-085661:wife case for dose 1 US-MODERNATX, INC.-MOD-2021-085677:wife case for dose 2
I received the Pfizer covid booster in one arm, and the flu shot in the other arm on 1-13-22. I slept for 17 hours straight that weekend, only waking up to use the restroom once. The following Monday (1-17-22), I felt slight disorientation and slight vertigo, with hot/cold flashes, sweating, and general body/brain fatigue.  Starting 1-26-22, the vertigo became severe and the home epley maneuver did not resolve symptoms. General fatigue continued as well. Shortly thereafter, I started to develop post concussion syndrome-like symptoms, including, but not limited to, vestibular issues, heart rate issues, dysautonomia, overall brain fog/fatigue, focus issues, debilitating noise sensitivity, debilitating vertigo/loss of spatial awareness and proprioception, vision issues, and severe headaches.
Itchiness at injection site immediately post injection, ongoing. This morning I had a large red mark on my upper shoulder and by mid-day a large knot under the red mark with swelling. (Photo was taken to monitor for possible progression.) There is considerable heat over the red mark, but that is expected with the swelling.
tiredness; body aches; chills; fever; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th May 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 19th May 2020, 1 days after receiving Shingrix, the patient experienced tiredness, general body pain, chills and fever. On 20th May 2020, the outcome of the tiredness, general body pain, chills and fever were recovered/resolved.   It was unknown if the reporter considered the tiredness, general body pain, chills and fever to be related to Shingrix.  Additional case details were reported as follows: The patient reported that he experienced fever, chills, body aches, and tiredness after the 2nd dose of  Shingrix. The reporter follow up was consented by the wife of the patient. This case was linked with case US2020091005 reported by the same reporter
5 days after the vaccine,  I began experiencing symptoms of chest pain, difficultly breathing, and light headiness. Symptoms worsen over the next 5 days. I nearly passed out from bending over and raising up. I followed up with a emergency room visit for chest pains and dizzy spells.
BRADYCARDIA; DIAPHORETIC; PALE; HYPOTENSIVE; This spontaneous report received from a health care professional concerned multiple patients. The patient's weight, height, and medical history were not reported. Patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered 1 total on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  Health care professional reported that, on 07-APR-2021, after vaccination, while being observed the patients were diaphoretic, pale, hypotensive and bradycardia. EMS (Emergency medical service) was called and patients were evaluated. Patients decided against transport and were discharged home. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the diaphoretic, pale, hypotensive and bradycardia was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210418457, 20210417209, 20210417256, 20210417456, 20210417469, 20210417550 and 20210417620; Sender's Comments: V0: 20210417122-covid-19 vaccine ad26.cov2.s -Bradycardia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Fever, febrile seizure, abdominal pains, change in behavior; tested negative for mono, no treatment.
Pt. 14 year old male. Came to receive his shots.  Mother was aware child would be receiving 6 shots plus TB.  Pt. was laughing and complaining why he was receiving so many shots.  I explained to him and his mother the reason to all the shots.  I began placing MCV4, HPV, and Polio, TB on rt arm.   09:18am Pt. stated "My B/P dropped".  I stopped and held pt. by his shoulders.  He's stated he wanted to throw up.  I told pt. to deep breath thru nose and out thru mouth. Pt. began to look pale.  I called PHN for help.  We transferred pt. onto the ottomon.  Laid him down and raised his feet.  O2 NC started @ 6L.  Began initial B/P 118/64 HR56.  Began to ask pt. his name, age and where he was at  AOx3.  Pt. stated he was feeling better.   09:23am reassessed patient.  O2 Sats @100%, tapered O2 to 4L. B/P 118/74 HR 80.  Pt. stated he wanted to sit up.   09:27am Sat pt. up on ottomon.  Reassessed patient B/P 110/78 HR 76 O2 Sats @ 98%.  Tapered O2 to 2L.  I asked pt. and mother if they wanted to continue with remaining shots.  HAV, Tdap, VZV on left arm.  Mother and pt. agreed.   09:33am  Asked patient if he's like to stand up.  Reassessed patient.  B/P 100/72 HR76 AOx3 , O2 Sats@ 100% discontinued O2.   09:45am  Pt. stated he could walk out with no assistance.  Mother walked along side him.