chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4/24/23  I started getting congestion in my lungs, they started hurting. I had a fever that went up to 100, which my normal is 97.5.  It felt like my body was burning, I got clammy, dizziness, my sinuses were flaring up and hurting.  My fibromyalgia was exacerbated. The muscle aches were pretty intense. I took an at home COVID test on 4/25/23 and it was positive. I sent the results to my PA. I was prescribed Paxlovid and began taking it that day. Throughout that week, I had varying symptoms. I had one incident when I took a hot bath and passed out getting out of the bathtub. My oxygen dropped to 80 and my husband put me on the O2 which brought my level back up. I have been treated for dizziness since a concussion a few years ago.  I was doing better until COVID and now have a lot of dizziness preventing me from driving.
she tested positive for Covid; she tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Batch/Lot number: unknown), on 09Feb2021 as dose 2, single (Batch/Lot number: unknown), on 08Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 21Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CALCIUM; D3 VITAMIN; LIPITOR. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23May2022, outcome "unknown" and all described as "she tested positive for Covid". The patient underwent the following laboratory tests and procedures: Pyrexia: (unspecified date) 99.1°F; SARS-CoV-2 antibody test: (23May2022) Positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Tinnitus and heaviness in ears.  Vibrating sounds intermittent for about 3 weeks.
Arm pain immediately after shot continuing for four days Fever, Chills started 24 hours after shot, continued for 48 hours
This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Aches all over her body), HEADACHE (Mild Headache) and PYREXIA (Fever 101 Farenheit) in a 65-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 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced MYALGIA (Aches all over her body), HEADACHE (Mild Headache) and PYREXIA (Fever 101 Farenheit). The patient was treated with PARACETAMOL (TYLENOL) on 27-Jan-2021 for Fever and Headache, at an unspecified dose and frequency. On 28-Jan-2021, MYALGIA (Aches all over her body) and PYREXIA (Fever 101 Farenheit) had resolved. At the time of the report, HEADACHE (Mild Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, Body temperature: 101 (High) 101 F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported.
expired ipol was accidentally administered to a patient, with no reported adverse event; Initial information received on 05-Aug-2022 regarding an unsolicited valid  non-serious case received from a Nurse.  This case involves an unknown age and unknown gender patient to whom expired IPV (VERO) [IPOL]was accidentally administered to a patient, with no reported adverse event.   The patient's past medical history, medical treatment(s),concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect IPV (VERO) (strength, formulation, lot number and expiry date was unknown) via unknown route in unknown administration site for Immunization. Information for batch and expiry date was requested.  On an unknown date the patient developed a non-serious event of expired ipol was accidentally administered to a patient, with no reported adverse event (expired product administered) (latency: unknown) following the administration of IPV (VERO).Reporter would like some guidance on next steps.  Action taken with POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) was not applicable.  Outcome: Unknown  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 the guidelines. 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.
Information has been received from a registered nurse concerning a 46 year old female nurse with a penicillin allergy, a history of contact dermatitis and no illness at the time of vaccination who on 05/15/2002 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (Lot 639375/0706L) in the right arm. Concomitant therapy included estrogens, esterified (+) methyltestosterone (ESTRATEST) and famotidine (MSD). On 05/26/2002, the pt developed red blotches on her face, a mild fever and a sore throat. On 05/27/2002, the pt had some itching and an increase in the rash and fever. Unspecified medical attention was sought. The pt received no treatment. The pt's rash and fever subside by 05/31/2002. No additional info is expected.
Pt had Tdap & MENACTRA vaccines 6/9/11. Given both at left deltoid. Arm red, swollen & itchy. Measures 15 x 16 cm.
the patient came this morning requested the updated bivalent moderna , I adminstered the regular moderna , I called the patient she will be back after 2 moths for the bivalent
2/28 thought I had food poisoning started with severe diarrhea lasted all day later chills, fever, headache day 2 headache fever later in day burning feet, day 3 fatigue and red hot and itchy toes
Extreme dizziness minutes after admin on day of vaccine. Passed after ten mins.   Regular soreness at injection site first couple of days. Then entire upper arm has became very swollen, red like sunburn with burning and extreme itching to upper arm. Still have 13 days after injection.
rheumatoid arthritis was aggravated after receiving the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (rheumatoid arthritis was aggravated after receiving the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) UNK dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (rheumatoid arthritis was aggravated after receiving the vaccine) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (rheumatoid arthritis was aggravated after receiving the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case pertains to several patients of the rheumatologist who received the Covid-19 vaccine and  were indicating that their rheumatoid arthritis was aggravated after receiving the vaccine.  Concomitant product use was not reported.  No treatment information was provided.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment  Based on the 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.   This case was linked to MOD-2021-143032 (Patient Link).; Sender's Comments: Based on the 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.
Within a few minutes of vaccination patient lost consciousness and had seizure like activity primarily on right side, lasted less than 1 minute.  Pallor, diaphoretic. Vital signs were stable.  Regained consciousness.  Sent to ER via EMS.
Feeling like I had a cold. Sore throat,sinus pressure, low temperature. Slight nausea and occasional dizziness. Injection site has heat,swollen and itching 48 hours later
Patient stated she got up at 1:30 am and states she was hallucinating as the sheets were moving, like a wave, on the bed. She also stated she was having hallucinations again during the day on the 26th. This has not happened with any of her other COVID vaccinations.
Sick; Got real weak; Just did not feel right; Aching; Headache; Fatigue; Drowsiness; This is a spontaneous report from a contactable consumer (patient herself). An 81-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3249), via an unspecified route of administration on 14Jan2021 at single dose for covid-19 immunization.  There were no medical history and concomitant medications. Patient stated she got sick after the shot  on 14Jan2021 and she got her first Covid vaccine on Thursday 14Jan2021, she did not know how to get an appointment, said to make an appointment for her second dose, stated she tried to make an appointment for 04Feb2021 and they told her everything was booked, caller was looking for availability of the vaccine in her area, stated she cannot drive all the way to get the second vaccine. She had some aching, headache, fatigue, drowsiness and got real weak and just did not feel right on 14Jan2021. She stated she really wanted the vaccine because they have lost 5 people in her neighborhood to Covid. Caller wanted to know if she should still feel the side effects if that was normal and if when she got the second dose will she be safe from Covid.  Caller stated she was still having headache today. Her daughter was nurse and she said those were normal side effects of the shot. She did not want to report this. She was better than she was on Thursday. She was not calling to report anything. She was calling because she was supposed to get the second shot. Outcome of fatigue, drowsiness, sick and not feel right was unknown, outcome of other events were not recovered.
No adverse event; 6 doses administered after 30-day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 doses administered after 30-day use by date) and NO ADVERSE EVENT (No adverse event) in a 13-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 doses administered after 30-day use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (6 doses administered after 30-day use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (6 doses administered after 30-day use by date).    No concomitant medication was reported.    Date the vial was initially stored in the refrigerator on 29-Sep-2022. The vial did not undergo any temperature excursions. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-668207, US-MODERNATX, INC.-MOD-2022-668172, US-MODERNATX, INC.-MOD-2022-668208, US-MODERNATX, INC.-MOD-2022-668214, US-MODERNATX, INC.-MOD-2022-668215 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-668207:Same reporter US-MODERNATX, INC.-MOD-2022-668172:Same reporter US-MODERNATX, INC.-MOD-2022-668208:Same reporter US-MODERNATX, INC.-MOD-2022-668214:Same reporter US-MODERNATX, INC.-MOD-2022-668215:Same reporter
according to patient by night time her arm (site) was swollen and red and hot and was painful
TIRED; FLARE OF CONGESTION, SINUS, RED EYES; FEVER; RED EYES; CONGESTION IN HEAD AND EARS/ SINUS ISSUES; CHEST PAIN/TWINGE OF PAIN IN UPPER CHEST; RACING HEART; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included: no thyriod gland, and concurrent conditions included: high cholesterol, non alcoholic, non smoker, trees allergy, grass allergy, ragweed allergy, pollen allergy, and latex allergy, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: 23-AUG-2021) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. Concomitant medications included levocetirizine dihydrochloride for allergy, montelukast sodium for allergy, rosuvastatin calcium for high cholesterol, and levothyroxine sodium for thyroidectomy. On MAR-2021, the patient experienced red eyes. On MAR-2021, the patient experienced congestion in head and ears/ sinus issues. On MAR-2021, the patient experienced chest pain/twinge of pain in upper chest. On MAR-2021, the patient experienced racing heart. Laboratory data included: Blood test (NR: not provided) no significant findings, and Laboratory test (NR: not provided) no significant findings. On 05-MAR-2021, the patient experienced fever. On AUG-2021, the patient experienced flare of congestion, sinus, red eyes. On an unspecified date, the patient experienced tired. Treatment medications (dates unspecified) included: paracetamol, methylprednisolone, and azithromycin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from red eyes, and congestion in head and ears/ sinus issues on JUN-2021, chest pain/twinge of pain in upper chest, flare of congestion, sinus, red eyes on OCT-2021, and fever on 09-MAR-2021, and the outcome of tired and racing heart was not reported. This report was non-serious.
Nausea on the first day, but on the second day much stronger and now on the third day still feel nauseated. Wondering how long this nausea will go on
Started swelling 6 hours post chicken pox vaccine. 48 hours after vax wheal & induration 60 mm x 70 mm. Erythema 140 mm x 140 mm.
Pt received 2nd dose of Pfizer on 09/08/21, with development of severe L-sided CP and SOB x3 days ago.  Pt tachycardic and hypoxic on arrival to ED. Pt desatted to 89% on RA, placed on 2L NC to improve sats to 94%. Pt tx with IV narcotics/antiemtics, EKG and CTPE done. As pt has new oxygen dependence, pt requiring transport to higher level of care. Pt still in ED, pending transfer to outside facility.
receiving doses from a vial that was taken out the day before; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving doses from a vial that was taken out the day before) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving doses from a vial that was taken out the day before). On 14-Jan-2022, EXPIRED PRODUCT ADMINISTERED (receiving doses from a vial that was taken out the day before) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
Fever Runny nose Dry cough Diarrhea Chills Night Sweats No appetite
2nd dose of Moderna I woke up a little lethargic. Work for a few hours. Started getting a headache, a fever, and chills around 2pm in the afternoon. I took Tylenol and rested. The fever broke around 11pm.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. Concomitant therapies included sterile diluent. On 06-FEB-2019, the patient who was only supposed to receive a dose of PROQUAD (per subcutaneous route, lot# R002676; expiration date 15-JAN-2020 for prophylaxis) was also inadvertently administered a dose of VARIVAX (lot# R007695, expiration date 14-MAR-2020 for prophylaxis). The reporting medical assistant mentioned the error occurred because the provider who was administering the doses knew that the patient was due to be vaccinated for measles/mumps/rubella and varicella, but she did not notice that PROQUAD contains both, and essentially thinking that the dose of PROQUAD was a dose of M-M-R II), and therefore thought she needed to administer a dose of VARIVAX as well. No adverse effect reported. Lot Number R002676 is NOT valid for PROQUAD.
This spontaneous report was received from medical assistant and refers to unspecified number of patients' of unknown demographics. On unknown date(s), the patients' were vaccinated with improperly stored doses of VARIVAX (lot # M047662, expiry date: 02-DEC-2018) for prophylaxis (incorrect product storage). Temperature Excursion details were as follows: Temperature and Time frame: Between 32 degree Fahrenheit (°F) to 35°F for 8 hours and between 47 °F to 77 °F for 9 hours. Previous temperature excursion included 32°F to 35°F for 9 hours. The call was because of a data logger. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient experienced a Cellulitis infection post injection. Patient was prescribed Cephalexin to treat infection on 9/2/2016 to be taken 3 times a day for 7 days.
SM noted that he could feel a "bump" on this inside of his L eyelid. The next day it was more swollen and he reported to sick call at his PC clinic. They were uncertain of what it was. On 7/18 he returned to the research nurse for his follow up visit for the SPV study and her concern was that this was autoinoculation to the eye. Symptoms: Swelling, Red eyes.
Patient with racing/irregular heart rate, severe body aches, headache, and fatigue for 24-48 hours after immunization.
Dilated cardiomyopathy. Began having symptoms approx 2 months after smallpox vaccine. Following up with cardiologist records requested. 60 day follow up 4/5/04: Diagnosed with dilated cardiomopathy. Patient reports cardiac output still less than normal. Patient continues to follow up with cardiologist. Per annual follow up report, Still taking med for A fibrillation, Cardiac output returned to normal, still a few episodes of PSVT.
Narrative: Other Relevant Hx: Symptoms: Dizziness & Chills Treatment:
Fever 101.5; Muscle and joint pain; Headache Symptoms lasted about 24 hours
Patient signed up for Pfizer booster Covid appt. Parent and patient checked in for appt and completed paperwork. Moderna was incorrectly noted as the vaccine to be administered. Pt was then administered moderna. Error was discovered upon billing when received error message that booster can't be administered for pt under 18.  Message left with parent, but no response at this time
Report fever, chills, HA, dizziness and fatigue. Treatment: Tylenol Outcome: Mild improvement does not interfere with ADLs.
INTUSSUSEPTION 8 DAYS AFTER 2ND DOSES OF PEDIARIX, PREVNAR, HIB, ROTATEQ.  11/12/07 Received vax record from pcp which confirms RO dose & lot # as reported. 12/4/07 Reviewed hospital medical records which reveal patient experienced irritability, fever, vomiting, pallor, cold extremities & bloody stools x 1 day.  Admitted 11/6-11/14/2007.  Taken to OR for exp lap & ileocolic resection when unable to reduce in radiology. Placed on TPN postoperatively in PICU.  Progressed well & d/c to home. FINAL DX: Intussusception, surgically reduced.  Records faxed to CDC.
Shooting pain in right arm. About 6 times day, It started on 01/30/2021 and still happening
Fever to 103,  Severe headache  Muscle pain Difficulty walking due to pain in my feet Skin hypersensitive  Light headed on 2nd and 3rd day after shot Low blood pressure (94 systolic) on day 3 after shot         Resolved with increased fluid intake in 2-3 hrs All symptoms resolved on 4th day after shot
This spontaneous report was received from a registered nurse refers to multiple, different unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medication were not reported. On an unknown dates, the patients were vaccinated with improperly stored (-14 degrees Celsius (C), for 2 hours and 48 minutes) (Merck) VARIVAX injection, lot # L029466, expiry date 06-AUG-2017, (dose and frequency not reported.) Vaccine had previous temperature excursion (-14 C) for 32.5 hours, with call because of "data logger". No adverse effects were reported. No product quality complaint (PQC) was involved. Follow up information has been received from the nurse on 11-MAR-2016. She provided the patients identifiers. On 15-FEB-2016, a patient of unknown age and gender received one dose of improperly stored (Merck) VARIVAX (stored in -14 degrees C, for 56 hours). This same vaccine was previously exposed to a high temperature of -14 C for a cumulative total of 91 hours, 18 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Approx 20 min after injections pt c/o itchy rash to hands and throat "feeling funny". Palms of hands blotchy in appearance and reddened. Pt given 50mg BENADRYL IM. By time pt left approx one hr later pt voiced she was feeling much better; itchiness gone; redness gone; throat better. Hands blotchy but unsure of appearance prior to vaccines.
Patient received Moderna COVID vaccine on 1/16/21, 2/11/21, and 8/26/21. On 2/1/22, patient admitted to our med/surg unit with acute metabolic encephalopathy likely due to COVID and delirium, sepsis, and hyponatremia. As of today (2/4/22), patient is still admitted in the med/surg unit.
pt recv vax 23OCT95 & pt devel a severe inj site rxn characterized by pain & inflammation;pt had recovered;this is one of six patients from this site who exp the above rxn
patient has a history of passing out during blood draws, he did warn us of this.  Once given the covid vaccine he passed out about 2 minutes after.  He came in and out of consciousness a few times.  During this time his blood pressure dropped, he turned pale and was sweating.  The paramedics were called as he continued having issues staying conscious.  His blood pressure started to go back up, his blood sugar was checked by the paramedics and he was taken to Hospital for evaluation.  He had later informed us that he had not eaten breakfast in the morning.
4-30-2012 0930 resident disoriented, tachycardic, diaphoretic, experienced shortness of breath. Transported to hospital at 1000, 4/30/12.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, fatigue, injection site pain Narrative:  Other Relevant: