chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vaccination was administered on Saturday evening, December 19th, 2020. The next morning around 10 am I began to feel nauseous and light-headed. That feeling waxed and waned all day and improved in the evening. The next morning on Monday, December 21st I was 10/10 nauseous and near vomiting. I went to work but had to leave because of nausea. Ultimately I vomited upon returning home and was nauseous with abdominal pain and achy all day. The next morning on Tuesday, December 22 nausea continued but with a rating of around 6/10. Then came the intense headache, body aches, and fatigue. This continued into the next day  (Wednesday, December 23) prompting me to get COVID tested and take off of work on Thursday, December 24th. Nausea improved (5/10)  on December 24th but fatigue, abdominal pain,  and body aches did not. December 25-27 were slow improvements with nausea, abdominal pain, and fatigue but were limiting activities of daily living. By Monday, December 28th most symptoms had cleared.
Breakthrough Covid-19 First Dose 01/27/2021 79-year-old male who presents to the ER for shortness of breath, cough and fever. He was a bit hypoxic on arrival.
Narrative:  COVID infection following COVID vaccine series 05/26, Pfizer, dose #1 06/21, Pfizer, dose #2 08/05 pt cc: chills, fatigue, fever, headache, myalgias, rhinorrhea exposure: COVID+ son 08/05-08/14 pt symptoms continue 08/06 COVID swab, result: detected 08/06 CXR impression: Stable radiographic appearance of the chest. 08/14 clinically resolved 08/26 crp result: 7.031 08/26 CXR impression: No acute cardiopulmonary disease. 08/30 COVID swab, result: detected 08/30 COVID-19 ANTIGEN result: not detected
Blood sugars running high, fever, dehydration, nausea, vomiting, poor appetite, electrolyte imbalance, ?WBC, lethargic about 1 week after.
2 SEVERE VOMITING; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced 2 severe vomiting, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the 2 severe vomiting and headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20211043449.
An expired vaccine was administered to a patient after expiration, was given 24 hours after being drawn up; Jynneos vaccine was given intradermally.; Case reference number US-BN-2022-004899 is a spontaneous case report initially received from an other-health care professional via Communication (reference number: USBAV22-2148) on 16-Dec-2022 and concerns a patient of unspecified age.  The patient's relevant medical history and concomitant medication details were not provided.  On 16-Dec-2022, the patient was vaccinated with the first dose of expired Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: FDP00042), 24 hours after the vaccine was drawn up, at an unknown dose, intradermally, on an unspecified anatomical site location, for unknown indication (explicitly coded as 'expired vaccine used' and 'intradermal injection').  At the time of this report, it was unknown if the patient experienced any adverse events due to Jynneos vaccination.  Additional information received from Bavarian Nordic on 16-Dec-2022 included local BN case ID.; Reporter's Comments: A patient of unspecified age was vaccinated with the first dose with an expired Jynneos vaccine, 24 hours after the vaccine was drawn up, at an unknown dose, intradermally, on an unspecified anatomical site location, for unknown indication. No associated adverse events were reported. Expired product administered and intradermal injection are listed per company convention. The patient's relevant medical history and concomitant medication details were not provided. Expired product administered and intradermal injection are not related to Jynneos, but to a human factor. The case is non-serious.; Sender's Comments: A patient of unspecified age was vaccinated with the first dose with an expired Jynneos vaccine, 24 hours after the vaccine was drawn up, at an unknown dose, intradermally, on an unspecified anatomical site location, for unknown indication. No associated adverse events were reported. Expired product administered and intradermal injection are listed per company convention. The patient's relevant medical history and concomitant medication details were not provided. Expired product administered and intradermal injection are not related to Jynneos, but to a human factor. The case is non-serious.
Patient felt dizzy, hot, headache after receiving vaccine. EMS notified. Patient left clinic with EMS, vitals stable, no apparent distress.
Patient received vaccines on 6/5/08 (IPV #4, DTaP #5, MMR #2, Varivax #2). Mother noted significant redness, swelling and heat to left inferior thigh the next morning. Patient was seen on 6/7/08 and prescribed antihistamines (oral) as symptomatic treatment.
rash hurt; rash was itchy; rash felt warm; 3 x 4 inch triangle rash on my arm around the injection site; sore raised bump; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (rash hurt), PRURITUS (rash was itchy), VACCINATION SITE WARMTH (rash felt warm), VACCINATION SITE RASH (3 x 4 inch triangle rash on my arm around the injection site) and VACCINATION SITE SWELLING (sore raised bump) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CEFALEXIN (CEPHALEXIN AMEL), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), CICLOSPORIN (RESTASIS), ATORVASTATIN, OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), FAMOTIDINE, CALCIUM, VITAMIN C [ASCORBIC ACID], FISH OIL (OMEGA 3 FISH OILS), BIFIDOBACTERIUM INFANTIS (ALIGN) and PLANTAGO OVATA (METAMUCIL CITRON) for an unknown indication.    On 20-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE SWELLING (sore raised bump). On 29-Jan-2021, the patient experienced PAIN (rash hurt), PRURITUS (rash was itchy), VACCINATION SITE WARMTH (rash felt warm) and VACCINATION SITE RASH (3 x 4 inch triangle rash on my arm around the injection site). At the time of the report, PAIN (rash hurt), PRURITUS (rash was itchy), VACCINATION SITE WARMTH (rash felt warm), VACCINATION SITE RASH (3 x 4 inch triangle rash on my arm around the injection site) and VACCINATION SITE SWELLING (sore raised bump) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       o No treatment medications provided by the reporter.
pt recvd vax & devel weakness chills, & numbness of the tongue, face & arm;  Pt left the clinic, but returned c/o of additional sx of fever (to 102), flushed face, transient breathing difficulties, & swelling of the tongue; leukocytosis;
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 02-DEC-2015 at time- 12:50, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L025738 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 3.5 and 2.4 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
I developed ?COVID arm?. I have some pain and swelling of about 3 inches in diameter at the injection site. This started 12 days after the injection
This spontaneous report as received from a registered nurse (R.N.) refers to an unknown number of patients of unknown age. It was reported that the patients might have received improperly stored liquid PEDVAXHIB (lot # not reported) which were exposed to 54 F for 96 hours on 04-SEP-2012. No adverse effect was reported. It was unspecified whether the patients sought for medical attention. The outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
pt recvd vax & approx 8 wks p/dose 2 exp Bell's palsy; dose 1 administered 13APR93;
PATIENT'S WIFE CALLED PHARMACY TODAY (04/15/2021)  AND REPORTED THAT SHE FELT PAIN IN HER SHOULDER THE NIGHT SHE GOT HER 2ND DOSE OF COVID VACCINE (MODERNA). SHE ALSO STATED THAT SHE WAS DIAGNOSED HAVING SIRVA
Evening of flu shot tongue throat swelling - sore throat - didn't go to urgent care or take any meds. Could breathe laying on side. Swelling decreasing in AM so didn't get checked - had sore throat and mouth up until yesterday 10/14/15 - resolved today 10/15/15.
Patient was administered Pfizer adult dose (30 mcg/0.3 mL) instead of pediatric formulation. Patient is 10 years old and should have received the pediatric dose/formulation (10 mcg/0.2 mL).
Employee received Flu vaccine on 9/26/17. Employee reported 9/28/17 raised hives from waist down.
As per admission H&P, the patient "is a 82 y.o. female  with past medical history per below presented to the emergency room transferred from the Medical Center where the patient presented with complaints of midsternal chest pain. She reports that the pain has been waxing and waning for the past 3 days. Today the pain worsened and started radiating to the left neck. Reports associated shortness of breath with nausea but denies any vomiting. Reports palpitations and diaphoresis. Patient rates her pain up to 7 on 1-10 pain scale. No fever, chills, cough or sputum production reported. She is known to have history of coronary artery disease status post CABG. She was found to have elevated troponin at the transferring facility and was sent to our hospital for higher level of care. Chest x-ray done showing pulmonary vascular congestion with increased conspicuity of chronic interstitial pulmonary markings which may reflect mild interstitial pulmonary edema. EKG showed sinus tachycardia with nonspecific intraventricular conduction delay. CBC and BMP are at baseline with a potassium of 3.5 and troponin elevated at 0.76. The patient is maintained on chronic oral anticoagulation. No heparin was started. COVID-19 test is positive, patient is vaccinated and boosted. "
This spontaneous report was received from a licensed practical nurse, concerning a patient of unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On an unspecified date, the patient was vaccinated with an improperly stored dose (first) of VARIVAX (dose, frequency and route were not reported) lot # M025864 with expiration date of 24-MAY-2018, for prophylaxis. The sterile diluent (manufacturer unknown) used to reconstitute the VARIVAX (lot # 020945 with expiration date of 05-DEC-2018) was properly stored. The temperature of the VARIVAX was between - 14 °C and - 10 °C for a time frame of 29 minutes. The vaccine did not have any previous temperature excursions. No adverse effects were reported and data logger was involved. Follow up information was received on 22-AUG-2017 from the licensed practical nurse. The patient was a 12 months female patient.; Sender's Comments:  US-009507513-1707USA004248:
receiving  Flublok instead of Fluzone Quadrivalent / no AE; 15 year old patient receiving  Flublok instead of Fluzone Quadrivalent / no AE; Initial information received on 07-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2020SA006329 (same reporter).  This case involves a 15 years old female patient who received 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot QFAA1935 (Expiry date 30-Jun-2020) via intramuscular route in the left deltoid, on 07-Jan-2020.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to wrong vaccine administered, Inappropriate age at vaccine administration.  It was reported that 15yr old receiving Flublok instead of Fluzone Quadrivalent.  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 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
02/06/21 -- About five minutes after receiving the injection, I began feeling intense itching on my palms and the bottoms of my feet.  In addition, post-nasal drip started.  I waited at the facility for about 50 minutes.  By then, the itching and the post-nasal drip seemed to have subsided, so I left.  Later that night and the next day, the itching on the soles of my feet (particularly the right one) returned.  By the third day or so, I had no more incidents of itching on my palms or the soles of my feet.  I didn't require treatment. 02/07/21 -- I started experiencing soreness around the injection site.  My arm is still sore to the touch, but I wouldn't otherwise notice the soreness. 02/14/21 -- In the evening, I began feeling an intense itching around the injection site.  I looked and saw a red rash that extended across the width of my arm and about 3.5 inches long.  To me, it looked similar to the arm rash that others have experienced from the COVID vaccine.
chronic pain w/cont n/thoracic neuralgia;no lesions noted;neurologist can find no other explanation or reason
9/28/10 Hives to UC given steroid injection. 9/29/10 Hives entire body to UC, given SOLU-MEDROL inject & Prednisone syrup. 9/30/10 To allergy MD. Rx'd Loratadine, SINGULAIR & continue Prednisone syrup.
Immediate reaction to vaccine starting 2 minutes after shot. Electrical shocks/nerve pain and widespread internal itching throughout body. Nerve pain has continued since then. It is intermittent, often sharp, in various random places on the body. Cardiac symptoms persisted for a month including resting heart rate of up to 165, often in 130-150 range; this resolved. Muscle weakness/dysfunction began soon after vaccine and continues to persist; initially strength was at 50% of normal; has improved slightly. Autonomic nervous system impacts include blurred vision and swallowing dysfunction, both persisting at 8 months. Fatigue onset for several weeks after vaccine but is resolved. Mild twitch in right eye is intermittent/persisting. Severe pelvic pain one month after vaccine, resolved. Numb right leg a few times in July 2021. Unusual severe muscle pains off and on persisting.
This spontaneous report was received from a medical assistant, referring to a currently 28 years old female patient. The patient's medical history, concurrent conditions or concomitant medication were not informed. On an unknown date in approximately 2014 (reported as "when she was 25 years old"), the patient was vaccinated with the fist dose of GARDASIL 9 for prophylaxis (route and lot number not provided).  The patient was now 28 years old and she was in the office to receive the remaining doses of the GARDASIL 9 series. No adverse symptoms reported.
Patient received Pediatric Pfizer Vaccine and stood up, leaned against pole and fell to the ground hitting head on the pole.  No lost of consciousness noted.  Small, round, red lump noted on left side of forehead.  Pt c/o feeling dizzy.  Pt placed in supine position with legs elevated.  Ice to forehead.  After a few minutes, patient stated he felt better and wanted to sit up.  Pt placed in a wheelchair given juice and crackers.  Pt stated dizziness gone and no headache or blurred vision. Lump size slightly decreased in size.  Patient remained in Observation for up to 30 minutes was able to ambulate on own to exit.
Patient received Moderna vaccine, approximately 5 minutes later she stated her throat was closing up and could not breathe. An epi-pen dose was given and gave her relief, about 5 min later she was having trouble breathing again a second dose of epi pen  was given. Ambulance was called immediately when she stated she was having trouble breathing,  she was ok before she left but taken to hospital by ambulance.
After the first does I felt like I had Covid. I had a really high fever and I felt sick. Following the second dose I had the same symptom's but I started to developed hives on my chest and arm area.
Per pt's mother pt developed a rash and fever that lasted for 2 days,  3 days after receiving vaccines on 05/20/2019. Mom notified office of reaction  on 08/13/2019.
Patient administered flu vaccine in left upper arm. Post vaccine administration patient c/o pain radiating down left arm which she described as "tingling".  Pain worse with certain movements of left arm.  Treatment is with abupropin and rest.
still has "red arm" and it is still "painful"; still has "red arm" and it is still "painful"; 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 71-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Nov2023 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: ERYTHEMA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset Nov2023, outcome "not recovered" and all described as "still has "red arm" and it is still "painful"".  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sore, swollen arm from shoulder to elbow. Pt elevated arm, applied heat and took ibuprofen.
pt recv vax 16SEP97 & arm became sore w/an approx 2" red hot areas on upper rt deltoid approx 7PM 16SEP97;small knot appeared on the shot area;next morning pt arm was even sorer;felt sick to stomach & was running a little fever;
I believe the vaccine greatly impacted my menstrual cycle. I got my period twice over the course of one month; that has never happened to me. The time span between the first day of my period in August (8/29) and first day of my subsequent period in September (9/10) was approximately two weeks. This was especially upsetting as I had been trying to conceive and may have been pregnant.
Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case was linked to 2018SA299806, 2018SA299807, 2018SA299808, 2018SA299815, 2018SA299810, 2018SA299811, 2018SA299812, 2018SA299813, 2018SA299814, 2018SA299805 and 2018SA299809 (same reporter). This case involves 83 years old male patient who was vaccinated with a dose of FLUZONE HIGH DOSE (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage as flu vaccines were in shipment for too long. It was reported that, the patient had no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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. List of documents held by sender: none.
Tinnitus started the night of receiving the 2nd Covid vaccine vaccine. Initially it was associated with fever and headache but tinnitus has not resolved
4 weeks after second COVID vaccine a large rash on my torso began forming and turned rubbery and red.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Redness and swelling going down arm of injection to hands-Medium
p/vax pt devel inj site rxn of large lumps; redness; tenderness & warmth; resolved w/compresses
Info has been received from a physician concerning a 12 month old white male who on 4/14/05 was vaccinated in the left leg with a 1st dose of varicella virus vaccine live. On 4/26/05, the pt had 4 to 5 vesicles in different stages that were noted to be 1 to 3mm in size on his abdomen, back, and arms. On an unspecified date, the pt recovered. No further info is expected.
body aches/ soar arm; nausea; fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches/ soar arm), NAUSEA (nausea) and PYREXIA (fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 030M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concurrent medical conditions included Allergy to antibiotic, Drug allergy and Allergy to antibiotic. Concomitant products included MULTIVITAMINS [VITAMINS NOS], COLECALCIFEROL (D3), LUTEIN [XANTOFYL], ALOE VERA (ALOEVERA EXTRA), CALCIUM and MAGNESIUM for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced MYALGIA (body aches/ soar arm), NAUSEA (nausea) and PYREXIA (fever). On 12-Mar-2021, MYALGIA (body aches/ soar arm), NAUSEA (nausea) and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive. On 11-Mar-2021, Body temperature: 99.2 (High) at 2:30 am body temperature increased and 100.8 (High) at 07:50 am  body temperature increased.         This case was linked to MOD-2021-033197 (Patient Link).
Fever; Chills; Muscle aches; Headache; This is a spontaneous report received from a contactable consumer. This consumer reported for a patient of unspecified age and gender who received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient reported of fever, chills, muscle aches and headache. It was reported that events took place after use of the product. Outcome was unknown for all the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.