chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tested positive for COVID-19 recently after being exposed to it at baby shower; Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (tested positive for COVID-19 recently after being exposed to it at baby shower) and COVID-19 (Tested positive for COVID-19) in a 71-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced EXPOSURE TO SARS-COV-2 (tested positive for COVID-19 recently after being exposed to it at baby shower) and COVID-19 (Tested positive for COVID-19). At the time of the report, EXPOSURE TO SARS-COV-2 (tested positive for COVID-19 recently after being exposed to it at baby shower) and COVID-19 (Tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment medications were not provided by the reporter.  The patient tested positive for COVID-19 recently after being exposed to it at the baby shower. This spontaneous case concerns 71 years old female patient with no medical history, who experienced the unexpected AESI events of Exposure to SARS-COV-2 and COVID-19 which occurred on unknown date after the unknown dose of mRNA 1273 vaccine .The outcome also was reported unknown. The benefit-risk relationship of mRNA-1273 in not affected by this report   This case was linked to MOD-2021-419540 (Patient Link).; Sender's Comments: This spontaneous case concerns 71 years old female patient with no medical history, who experienced the unexpected AESI events of Exposure to SARS-COV-2 and COVID-19 which occurred on unknown date after the unknown dose of mRNA 1273 vaccine .The outcome also was reported unknown. The benefit-risk relationship of mRNA-1273 in not affected by this report
Information has been received from a nurse concerning her 12 year old daughter who on "summer of 2007" approximately June 2007, was vaccinated with a first dose IM of GARDASIL (Lot#, not reported), the patient did not have side effects. On an unspecified date the nurse's daughter received the second dose of GARDASIL (Lot# not reported), she fainted and 4 months later, after her third dose of GARDASIL (Lot#: not reported), the nurse's daughter fainted, blacked out and hit her head. 24 hours after this happened, she got her period and was nauseous, vomiting, had headaches and got dizzy. The nurse's daughter did not seek medical attention. At time time of the report, the nurse's daughter was recovering. Additional information is not expected.
pt recvd vax;11:45 felt light headed; 3:30 difficulty breathing,tightness in throat;general body aches;5 became n; ha & v for 3 hrs;next day had ha, felt weak but improved;
Hardness and warmth on 1/7/21 Redness noted on 1/8/21 at around 9:30 pm
Within about 30 minutes of the shot I started to get the chills, feel nauseous, hard to focus, and very lethargic. Injection site was hot to the touch and did swell a bit. The following day I went through strong waves of feeling very ill and then feeling ok for about an hour, then back to having chills, nauseous, headache, body ache, and extremely lethargic. Half way through second day I broke out in a rash all over my chest, tummy, and back. Entering into day 3 ( today ) I do feel better, but can't shake the brain fog and feelings of being tired. Rash is still present currently.
A long thing on my shoulder and my neck on the arm where I received the vaccination.; Sore arm; nausea; This is a spontaneous report from a contactable consumer or other non-HCP. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP6955), via an unspecified route of administration on 24Mar2021 as DOSE 1, SINGLE (Age of vaccination: Unknown) for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date of 2021, the patient experienced sore arm and nausea. On 28Mar2021 the patient experienced a long thing on my shoulder and my neck on the arm where she received the vaccination. The outcome of all event was unknown.  No follow-up attempts are possible. No further information is expected.
Only had sore arm with each dose but 3 weeks later lost my hearing overnight in my left ear. Profound deafness on audio gram.
complaints of general itching of arms - resolved in 5 minutes.  HR 80 and regular, No rash.  Treatment of clolse observation for further symptoms x 10 minutes.  No medication treatment required.
No additional AE information was provided; a patient was administered an expired MMR II on vaccine on 3/15/2020 and an expired VARIVAX vaccine on 3/31/2020; a patient was administered an expired MMR II on vaccine on 3/15/2020 and an expired VARIVAX vaccine on 3/31/2020; Information has been received from a licensed practical nurse via a field representative, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications was not provided.      On 15-MAR-2020, the patient was administered with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) (strength, dose, route were unknown; lot # R008031 and expiration date 18-MAR-2020) for prophylaxis. On 31-MAR-2020, the patient was administered with an expired varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route were unknown; lot # R009409 and expiration date 30-MAR-2020) for prophylaxis (expired product administered; inappropriate schedule of product administration). The sterile diluent that was used to reconstitute the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) was not expired. No additional adverse events was reported.
Suspected vaccination failure/Had shingles shots, had shingles on spinal area; Shingles on her spinal area; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 29-Jul-2022 Reporter's comment: The case was received from the patient's children via interactive digital media. The reporter remember that the patient had shingles on her spinal area. The reporter stated guess what, the patient had her shingles shots as recommended by her doctor. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Right arm pain, increasing pain in right arm and wrist for 6 days after vaccination, has been wearing a wrist brace because of the pain
I thought I was getting an ear infection as my ears were hurting on a flight home from a cruise. I had a runny nose  and fatigue also. I had scheduled an appointment with my Primary Care Physician to discuss my ear and possibly get medication for an ear infection. They ran a PCR  COVID-19 test that came back positive. They gave me a prescription for paxlovid and cough medication. I still have fatigue but I have recovered.
lump in her left arm, where she received the injection; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration on 01Feb2021 at a single dose for COVID-19 immunization. Medical history included ongoing arthritis. Concomitant medication included diphenhydramine hydrochloride, paracetamol (TYLENOL PM) for arthritis to help her sleep. The patient reported a "lump in her left arm, where she received the injection" on 01Feb2021. She asked if she could take diphenhydramine hydrochloride, paracetamol after her first and/or her second dose of the vaccine, how long to wait after the injection to take it and she mentioned she sometimes takes it at night to sleep better because she has arthritis. The patient further stated she was holding for drug safety and got disconnected. Stated she took diphenhydramine hydrochloride, paracetamol right after her first shot. She stated she got the Covid vaccine yesterday, stated everyone was telling her that she cannot take diphenhydramine hydrochloride, paracetamol. She clarified that she takes diphenhydramine hydrochloride, paracetamol once and a while for arthritis to help her sleep, wanted to know if this was true or not. The outcome of the event was unknown.  Information about lot/batch number has been requested.
This case was reported by a healthcare professional and described the occurrence of allergic reaction with hives in a 6-month-old subject of unspecified gender who was vaccinated with PEDIARIX (GlaxoSmithKline), Rotavirus vaccine. Approximately three and half years prior to this report, on an unspecified date the subject received 3rd dose of PEDIARIX (unknown), unspecified dose of Rotavirus vaccine (unknown). At an unspecified time after vaccination with Rotavirus vaccine and PEDIARIX, the subject experienced allergic reaction with hives. At 6-months old the subject was vaccinated with PEDIARIX and Rotavirus and had an allergic reaction (hives). The subject received PEDIARIX at 2 months and 4 months of age without any allergic reaction. The subject is currently 4-years old. At the time of the report no additional information was available. At the time of reporting the outcome of the allergic reaction with hives was unspecified.
Information has been received from a specialist and a Doctor of Pharmacy concerning a 71 year old male who on an unspecified date was vaccinated with a dose of Pneumovax 23 (lot 651437/0899F).  Subsequently, the patient experienced a "significant reaction" including "swelling, a large knot" at the injection site, elevated temperature and chills.  The patient was being treated with an unspecified antibiotic.  At the time of this report, the outcome was unknown.  The Pharm D. requested a lot check to be performed on lot 651437/ 0899F.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  The reporter felt that the patient's swelling at the injection site, increased body temperature, and chills were other important medical events.  Additional information has been requested.
blackly rash up from waste to arm of injection; sore throat; ear pain/discomfort; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), EAR PAIN (ear pain/discomfort) and RASH (blackly rash up from waste to arm of injection) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included FINASTERIDE, TAMSULOSIN, MIRTAZAPINE and MEMANTINE HYDROCHLORIDE (NAMENDA) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat) and EAR PAIN (ear pain/discomfort). On 13-Feb-2021, the patient experienced RASH (blackly rash up from waste to arm of injection). At the time of the report, OROPHARYNGEAL PAIN (sore throat), EAR PAIN (ear pain/discomfort) and RASH (blackly rash up from waste to arm of injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    No treatment medications provided by the reporter.
rash that itches and is erythematous and in different size patches, on the trunk and extremities and some on face child has no fever and no problems with swallowing and appetite is not decreased she has been given Benadryl which helped her get a little relief from the itching
Awoke on 12/13 with Sudden Neurosnsory Hearing Loss.  Loss of balance, loss of hearing in one ear.  Treatment was steroid treatment and injections.  Hearing loss in right ear is permanent, requiring hearing aids.
pt recvd vax; approx 5 min p/ vax broke out in a red splotchy itchy rash resembling measles;redness lasted about 10 min;
heart palpitations/heart pounding; cough; wheezing; This is a spontaneous report from a contactable consumer or other non hcp. An elderly non pregnant female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0158), via an unspecified route of administration, administered in Arm Left on 07Apr2021 17:00 as DOSE 1, SINGLE for covid-19 immunisation at Public Health Clinic facility. No covid prior vaccination. Medical history included arthritis, osteoporosis, blood cholesterol increased, Allergies from lipitor, robaxin, fosamax, IV contrast and surgical glue. Concomitant medications included PRAVASTATIN, CLARITIN, CENTRUM SILVER, D3, CALCIUM. The patient did not received any other vaccine in four week. The patient experienced heart palpitations/ heart pounding, cough, wheezingon 15Apr2021. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Covid tested post vaccination by nasal swab test. The patient underwent lab tests and procedures which included chest x-ray: unknown result, echocardiogram: unknown result, electrocardiogram: unknown result on unspecified date, sars-cov-2 test: negative on 22Apr2021. The clinical outcome of the events was not recovered.  Follow-Up (03Sep2021): Follow-up attempts are completed. No further information was expected.
Information has been received on 08-AUG-2016 from a consumer referring to a 77 year old female patient. The patient's medical history and concomitant medications were not reported. The patient reported "over a year ago" she was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous. On an unknown date after she received the vaccination, she developed shingles. The patient sought medical treatment from her doctor. The patient has been provided with multiple unspecified treatments for the shingles, but "one are helping her recover from the pain she is expecting with the shingles." The patient is requesting compensation for the time she has missed from work because of the time she has to spend at her doctor's office trying to get treatment for the pain, and since she has missed work she has not been getting paid for the days that were missed. The outcome of herpes zoster and pain was reported as not recovered/not resolved. Additional information has been requested.
Repeat titers 4-6 weeks after dose still low; physician collected hepatitis b titers in May 2023 and they were negative; Drug dose administration interval too long; This non-serious case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a 10-month-old male patient who received HBV (Engerix B) (batch number C44K4, expiry date 07-DEC-2024) for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis, Hepatitis B vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis.   On 19-MAY-2023, the patient received Engerix B 1 ml. On 11-APR-2006, the patient received the 3rd dose of Hepatitis B vaccine. On 13-JUN-2005, the patient received the 2nd dose of Hepatitis B vaccine. On 13-MAY-2005, the patient received the 1st dose of Hepatitis B vaccine. On 11-APR-2006, an unknown time after receiving Hepatitis B vaccine, the patient experienced drug dose administration interval too long (Verbatim: Drug dose administration interval too long). In MAY-2023, the patient experienced therapy non-responder (Verbatim: physician collected hepatitis b titers in May 2023 and they were negative). On an unknown date, the patient experienced therapeutic response decreased (Verbatim: Repeat titers 4-6 weeks after dose still low ). The outcome of the therapy non-responder, therapeutic response decreased and drug dose administration interval too long were unknown.   Additional Information: GSK receipt date: 22-Jun-2023 The medical assistant reported that the patient completed hepatits B series as a child. The reporter did not had documentation of which brand the patient received as a child.   The patient's physician collected hepatitis b titers in May 2023 and they were negative, so the physician ordered 1 mL dose of Engerix-B, which was administered.   The repeat titers 4 to 6 weeks after dose were still low, so physician has ordered for patient to finish out another 2 doses to repeat the series, but no further doses have yet been administered at the time of reporting. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow-up. The patient received 3rd dose of Hepatitis B later than the recommended interval, which led to lengthening of vaccine schedule.
Severe cramp on my thighs and calves of both legs, passed out and fell on the floor and injured my left shoulder. Severe pain on the sole of my right foot, left arm and shoulder.
Day 6 patient came down with a 102.5 fever which continued for 6 days and then began to gradually decrease. Patient also had a severe migraine during this time. She was extremely lethargic and dillusional at times. Parents have not ever seen this behavior in their child.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Headache-Mild, Systemic: Nausea-Mild, Systemic: Weakness-Mild, Additional Details: patient stated she experience brain fog dizziness headaches neck pain and back of head pain as well as memory issues patient going to md next week
The evening after getting the vaccine developed severe chills and high fever (104), body aches, shortness of breath and couldn't get out of bed.  High temp and fatigue lasted for following week.  Still experiencing occasional low-grade fever, chest pain and shortness of breath.  Went to the dr week of 5/22.
Was fine at first, within 24 hrs headachy, soreness. Within 48 hrs - soreness increased. Looked under left arm at injection site - red as apple, hot to touch, headache like none other and lump fist sized.
severe aching hands/severe arm pain; feet like arthritis bad day after vaccine; Low grade fever 99.5 c; This is a spontaneous report from a contactable Physician .This Physician reported different events for 2 doses. This case is for 2nd dose.   The 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), at left  arm on 08Jan2021 at SINGLE DOSE for COVID-19 immunization. She received the first dose on 17Dec2020 8:00 AM at right arm at single dose Lot number#Ej1685 and she had flare a week after first vaccine with mild foot swelling but severe leg and foot pain.Medical history included Possible asthma and left foot post traumatic arthritis with multiple surgeries including precious allograph, meralgia parasthetica left side. The patient is not pregnant. No COVID prior vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital.The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. None Concomitant medications (received within 2 weeks of vaccination) .No known allergies. . After second vaccine severe aching hands, feet like arthritis bad day after vaccine. Low grade fever 99.5 c. No treatment received for the events. The events were assessed as non-serious. The patient had not been tested for COVID post vaccination. The outcome of the events was recovering on unspecified date.  Information on lot/batch number has been requested.
Patient developed furuncle abscess site of vaccine about 1 wk after shot given. It is probably unlikely this was secondary to shot. Furuncle was in upper left thigh area.
getting sick and really weak; Hasn't been able to go back to work; Her stomach was hurting so bad at night that she went to ER; She's with diarrhea; Hasn't been able to eat anything; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (getting sick and really weak), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Hasn't been able to go back to work), ABDOMINAL PAIN UPPER (Her stomach was hurting so bad at night that she went to ER), DIARRHOEA (She's with diarrhea) and FEEDING DISORDER (Hasn't been able to eat anything) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL for Blood pressure, INSULIN for Diabetes.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced ILLNESS (getting sick and really weak), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Hasn't been able to go back to work), ABDOMINAL PAIN UPPER (Her stomach was hurting so bad at night that she went to ER), DIARRHOEA (She's with diarrhea), FEEDING DISORDER (Hasn't been able to eat anything) and NAUSEA (Nausea). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, ILLNESS (getting sick and really weak), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Hasn't been able to go back to work), ABDOMINAL PAIN UPPER (Her stomach was hurting so bad at night that she went to ER), DIARRHOEA (She's with diarrhea), FEEDING DISORDER (Hasn't been able to eat anything) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jul-2021, Body temperature: 100 (High) Fever of 100 every day.     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.
Herpes Zoster, Alopecia, Inflammatory arthritis, chronic fatigue, migraines.
Student received TD, Hepb-ped, IPV, Var and MMR at 11:15am, began to c\o back of itchy throat, abdominal pain within 10-15 min. Noted reddened skin, swollen bottom lip. received 12.5mg benedryl by mouth then another 12.5mg benedryl by mouth within 10min. Student continue to c/o not feeling better, crying out, thrashing around, called 911 then who observed child for 5 min before transporting her to the nearest hospital. Child left the clinic talking, moaning about stomach hurting.
REDNESS, PALE, SWELLING AND A RASH SURROUNDING INJECTION SITE.
Arm sore, swollen, wheezing, fatigue, fever, chills, shaking, weak, sleepy over 48 hrs (day 1 and 2).  Began feeling better on day 3.  Doctor told Patient not to get the 2nd vaccine.