chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After about 4-5 hours (around 9 pm), I started with nausea in addition to body aches.  Later, I woke up at 1:30 am. At that point, my bad symptoms started. I was up all night.  1. I had nausea and I threw up. I had body aches and no energy to move. 3. About an hour later, my heart started "racing" really bad. I felt like I was running a marathon, and I couldn't keep up with the pace. I could hardly catch up my breath.  4. Then, my right arm started tingling and feel heavy. I couldn't feel any of my "fingers" on my right hand.  5. My body kept going from extremely hot to extremely cold. I felt like my blood pressure was up and down. I had more nausea. I could barely move. 6. I threw up again and, eventualy, I slept.
Information has been received from a certified medical assistant concerning an adult patient, with unknown medical history and unknown drug reaction/allergies, who on the week of 10-JUL-2006 was vaccinated intramuscularly with a dose of Pneumovax 23 (Lot # 651373/0320F). On an unspecified date, the patient developed pain, swelling, local heat, and redness around the injection site. Subsequently, on an unknown date the patient fully recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
I been having recurring UTI's that would not go away. I was seeing my urologist had done a CAT Scan and we discovered that I had Kidney Stones. I had to have them surgically removed on 2/20/23. Because the treatment of the UTI had not been working we then went to looking for more of what could be happening and that is what led to finding the stones and having them removed. At this point I still have the UTI but the stones have gone away. I have graduated from oral antibiotics to an intramuscular injected antibiotic.
Stated has had (L) arm pain, starting the afternoon after the injection. Has pain in (L) arm while doing any range of motion. Advised to see primary care physician.
covid five times; covid five times; shoulder pain; flu two or three times; illness; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4339039-00.  A 53 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Apr2021 (Batch/Lot number: unknown) at the age of 52 years as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid five times"; ARTHRALGIA (non-serious), outcome "unknown", described as "shoulder pain"; INFLUENZA (non-serious), outcome "unknown", described as "flu two or three times"; ILLNESS (non-serious), outcome "unknown", described as "illness". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: patient experienced covid five times. The action taken for upadacitinib was dosage permanently withdrawn. Clinical information: she had nausea with the second covid vaccine with Rinvoq (Upadacitinib). She felt she had shoulder pain due to being off of her medication a lot due to illness. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Causality for Rinvoq (Upadacitinib) The reporter's causality for the event(s) of covid five times, shoulder pain, flu two or three times, Headache, Nausea with the second covid vaccine unknown onset and Headache, nausea with the second covid vaccine unknown onset was not provided.  The reporter's assessment of the causal relationship of the [covid five times, shoulder pain, flu two or three times and illness] with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Drug Ineffective and COVID-19 which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.
seen by MD 23OCT92; devel fever to 105 R later that night by mom's report; no other sx;
immun given on 12OCT94 mom states pt began to have szs on 16OCT94; no elevated temp @ time seen @ clinic;
"Moderna  COVID -19 Vaccine EUA"   I got the vaccine on 2-11-21. I had no reaction. Eight days later (morning of 2-19-2021)  my upper left arm felt  itchy.  I was rubbing the area. I thought it might be a bug bite. When I looked I couldn't see evidence of bug bite but there was a large  (2" wide by 2 1/2 " long) red, hot, itchy place on my arm in the area I received the vaccine.   I called and left messages on on 2/19 & 2/20. No call back. Called my Dr. Office & spoke with on-call Dr. I would like to know if this delayed reaction is normal?? Please send me information.
Administration of expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 23YL4, expiry date 4th April 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th April 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 7th April 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 7-April-2022 Reporter's Comments: Clinic manager reported that patient was administered a dose of Pediarix which was expired. The reporter did not consent to follow-up.  Additional Supportive Information: The patient received dose of Pediarix that was already got expired which led to expired vaccine used.
My toes and fingers have had multiple bruises and swelling in the muscle tissue.  Fatigue for several weeks after both shots
Patient experienced chest heaviness and warmth from her chest to her arm. Her blood pressure was 220/120s. We monitored her and her blood pressure decreased to 170s/110s over 30 minutes. EMS was called to evaluate her but she refused to go to the hospital.
Had H1N1 2 days ago (nasal vaccine) feels weak and vomited x 3 today. Nausea resolved. No vomiting for 7 hours.
Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.  No Medical History information was reported.  On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (Tiredness). At the time of the report, FATIGUE (Tiredness) outcome was unknown.     No concomitant medication information was reported. No treatment medication information was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Systemic: Vomiting-Medium, Additional Details: Patient faited approximately 5 minutes after receiving flu shot. He hit is head on the counter and fell to the floor. He appeared slightly confused initially. He was taken to the immunization room to wait for paramedics. After about 10 minutes, he vomited. Paramedics took over care shortly after.
18JUN92 fever 102, vomiting, episode of becoming limp & clinched teeth about 3PM; referred to MD by PHN; 19JUN92 seen by MD found to have red ears, t103.5 given PCN & rectal suppositories;
Fever, chills and headache; Fever, chills and headache; Fever, chills and headache; This is a spontaneous report. A contactable consumer (patient) reported that a 52-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EKZ421 or EXZ421) via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunization. Medical history included diabetes, psoriasis. Concomitant medication included metformin for diabetes, secukinumab (COSENTYX) for psoriasis. The patient previously received the first dose of BNT162B2 (lot # EL1284) for COVID-19 immunization. The patient experienced fever, chills and headache in Jan2021. No treatment was received for the events. The outcome of events was not recovered.
Mother called HD to report In evening patient was feeling dizzy and sweaty. No Fever. Went to bed when got up went to school. School called mother to pick child up due to being dizzy and needing help walking. Profuse Sweating but no fever. Instructed mother to call PCP for further instructions.
This spontaneous report was received from registered nurse, concerning a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies were not provided. On 10-MAR-2014, the patient was vaccinated with a dose of PEDVAXHIB, 0.5 ml intramuscularly, (lot number and expiration date were not provided), which was exposed to a temperature of 47F for 10 minutes. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
2 weeks post second vaccine with pericarditis (classic positional chest pain and pericardial effusion); 2 weeks post second vaccine with pericarditis (classic positional chest pain and pericardial effusion); 2 weeks post second vaccine with pericarditis (classic positional chest pain and pericardial effusion); This is a spontaneous report from a contactable Physician (patient). A 47-year-old female patient (pregnant: no) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in right arm on 20Jan2021 (lot number: EL3302) at 19:00 at single dose for COVID-19 immunization. The relevant medical history included CSF leak (Cerebrospinal fluid leakage) from an MVA, depression, asthma, reglan allergy and COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19?: Yes). Concomitant medications included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA), montelukast sodium (SINGULAIR), fexofenadine hydrochloride (ALLEGRA), fluoxetine hydrochloride (PROZAC), lamotrigine (LAMICTAL) and temazepam (TEMAZE). The patient experienced 2 weeks post second vaccine (as reported) with pericarditis (classic positional chest pain and pericardial effusion) on 30Jan2021 at 12:00. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment included prednisone, colchicine, aspirin and anakinra, received for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the event was not recovered.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Pericardial Effusion, pericarditis, Chest Pain and the suspect BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Pt did not convert p/a series of 3 Engerix-B vax on 13MAR90, 13APR90, & 18OCT90, respectively; Each inject recvd was 1 adult dose; Pt was advised of need for further inject & testing;
Had injection at 4:00 PM. Began feeling dizzy about 8. Began feeling itchy and very lightheaded. Daughter called ambulance. BP on ER admission 62/44, O2 saturation upper 80s. CBC and EKG done and kept overnight. Was given albuterol treatment and IV. Daughter reported her mother had diarrhea for several days before flu shot. Follow up: Cardiomegaly is present. No acute infiltrates are identified.
a potential for cellulitis; Tightness in chest; hard to breathe; Has egg size lump in shoulder that is hot, red and swollen; Injeciton site is itchy, hot, irritable, painful and extremely swollen; Has egg size lump in shoulder that is hot, red and swollen; Has egg size lump in shoulder that is hot, red and swollen; Injeciton site is itchy, hot, irritable, painful and extremely swollen; Injeciton site is itchy, hot, irritable, painful and extremely swollen; A spontaneous report was received from an unknown age, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis, chest discomfort, dyspnea, injection site swelling,  injection site pruritus , injection site erythema, injection site pain, and injection site irritation.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26-FEB-2021, before the events onset, the patient received the second of two planned doses of mRNA-1273 (lot/batch: Unknown) for prophylaxis of COVID-19 infection.   On 02-MAR-2021, the patient experienced tightness in chest, hard to breathe. He also manifested injection site swelling; a potential for cellulitis. He reporting having egg size lump in shoulder that is hot, red, swollen. It is not decreasing in size, has been the same size over the last couple of days. The injection site is itchy, hot, irritable, painful, and extremely swollen. No treatment details or laboratory results were provided for the reported events.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of events, cellulitis, chest discomfort, dyspnea, injection site swelling,  injection site pruritus , injection site erythema, injection site pain, and injection site irritation were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
VERY MILD REACTIONS; This spontaneous report received from a patient via a company representative concerned a 74 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,) dose was not reported, administered on MAR-2021 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 MAR-2021, the subject experienced very mild reactions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of very mild reactions was not reported. This report was non-serious.
Increased left hand pain. More pain than typical arthritis pain; This is a spontaneous report from a contactable consumer.  A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration at the left arm on  30Dec2020 17:00 at a single dose for COVID-19 immunization at a hospital.  Medical history included ventricular septal defect (VSD), psoriasis, inflammatory arthritis, and migraines. Concomitant medications included fish oil, magnesium, paracetamol (TYLENOL ARTHRITIS).  The patient previously took naproxen and experienced allergies. The patient experienced increased left hand pain that was more pain than typical arthritis pain on 31Dec2020, 12:00. The patient did not received any treatment for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for it since the vaccination. The patient has not recovered from the events.
Patient reports that the evening immediately following his vaccine administration he began experiencing fever, chills, fatigue, headache, body aches,  These symptoms continued  9 days and counting He tested negative for COVID -19 on 1/18/2021 His physician contacted  a specialist and  suggested that this case should get the 2nd dose  as scheduled
Information has been received from a physician concerning a male who on 22-APR-2009 was vaccinated orally with the first dose of ROTATEQ.  On 12-MAY-2009 the patient was vaccinated orally with the second 2 ml dose of ROTATEQ.  The patient had not experienced any known symptoms.  It was unknown if the patient sought medical attention or not.  Additional information has been requested.
Information has been received from a 66 year old male, healthy professional, emergency medical technician (E.M.T.) with aspirin and yellow food dye allergy, "thyroid", elevated eye pressure and a history of depression who reported that he received a dose of Pneumovax 23 in the year 2000 and he reported that he might have received a dose of Pneumovax 23 2 years ago, with no adverse symptoms noted. In approximately, February 2007, was vaccinated into the right arm with a 0.5 mL dose of Pneumovax 23 (Lot # 655290/0959F). The patient concomitantly was vaccinated with tetanus toxoid into the left arm. Concomitant therapy included LEXAPRO, SYNTHROID and XALATAN. The next day, approximately in February 2007, his right arm was very sore, difficult to raise the arm over his head and the deltoid was sore and swollen. The next day he had pain and tenderness in the bicep. Treated with an unnamed antibiotic and prednisone tapered dose pack. The symptoms continued for about 10 days. There was injection site tenderness and petechial hemorrhage for two weeks. he then had pain in the right finger joints, especially index finger, middle finger and thumb for 5 days. Finger symptoms were diagnosed as osteoarthritis. The patient sought unspecified attention. At the time of the report, the patient had recovered. Additional information has been requested.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 78-year-old, elderly patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degrees Celsius. On 22-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left deltoid, batch number 252230, expiry date: 31-May-2018 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805432 was crossed linked to original cases 201804863 due to same reporter.
Patient had received first Pfizer dose on 04/21/21 at a different facility and thought he had booked an appointment for a Covid test.    He received a second dose on 04/29/2021. He did not experience any adverse effects as of 04/29/21 @  approx. 7:30 pm
Left arm red, tender, and hot to touch. Patient saw MD and was give Abx. MD not sure if infection or reaction to shot
Large local reaction with erythema and edema left upper arm, 10x19 cm induration, erythema, color, L > R 2 cm in circumference.
Mom states child's left arm was swollen from collar bone to mid arm on morning of 7/2/05 was bright red and hot. Arm was so swollen child couldn't put his arm down to his side. Seen at DRH ER was on Benadryl drip and given oral steroid x 5 days. Then Q 4-6 hrs x 5 days.
Patient woke up with red swollen arm hot to the touch with burning sensation in arm and a rash on the arm. She received the ADACEL shot also in the same arm She went to the ER 7/13/2017 and received Keflex and Motrin.
Information has been received from a nurse referring to a 13 year old patient of unknown gender.  The patient's medical history, concurrent medication and drug reactions were not reported. The patient received a dose of GARDASIL (lot # M005714 with expiration date 03-OCT-2017, dose and route not reported) on 05-AUG-2015 and a dose of GARDASIL (lot # K011325 with expiration date 08-APR-2017, dose and route not reported) on 12-AUG-2016 for prophylaxis (inappropriate schedule of vaccine administered). The patient was currently (in approximately August 2017) in the office to receive a dose of GARDASIL 9 (dose, route, lot # and expiration date were not reported) for prophylaxis (interchange of vaccine products). No adverse effects were reported.
Vaccine was expired on March 2, 2022. I misread the label as March 2, 2023.
5/30/02 Had initial seizure; hospitalized for 8 days. Had 2 MRI's, 2 EEG's, blood tests, spinal tap - all negative except EEG's showed slower brain wave movement on left side. Has been treated since and is on 3 medications concurrently. The 60 day follow up received on 9/24/03 states though on medication, seizures continue.
she had no reaction after the 1st dose of Men B vaccine. After the 2nd dose continued now for 2 days later, the injection site is the size of a small pancake, blotchy, feverish and hard. Her arm aches all the way down. Has taken Tylenol, semi-phased it.
The morning after my first vaccine shot I had some blood in phlegm. The amount of blood reduced in the following days and disappeared in a week.
This spontaneous report was received from an administrator referring to unspecified patients of unknown ages and genders. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with a dose of improperly stored M-M-R II lot # M004063, expiration date on 25-JAN-2018 (strength, dose number, route and anatomical location were not provided) for prophylaxis. Nevertheless, no adverse effects were reported. The vaccines experienced the following temperature excursions during 14 hours: 74.5 grades Fahrenheit. Furthermore, no product quality complaint was involved. It was reported that the vaccine M-M-R II was not supported. Also the reporter was not sure if the vaccine was administered or not. This is one of several reports received from the same reporter. Additional information is not expected, since no consent to contact the reporter was provided. Sender's Comments: US-009507513-1612USA008792: US-009507513-1612USA008791.
p/vax pt exp sore lymph nodes on lt jaw bone; had swelling & pain on lt jaw only; low grade fever 99-100; seen in ER; MD stated pt had symptomatic lymph node swelleing caused by mumps vax
7/31 vacc given 7/30 at 830 pm irritations right thigh noticed by father 7/31 mother noticed increased redness, warmth, and tenderness. Mother called nurse who had her mark edge of reaction. Worked into clinic injection site red with 3 x 3 uneven circle patient given BENADRYL cream, ZYRTEC for reaction as well as advised to ice.
p/vax pt appeared weak, limp, pale, no response; used ammonia inhalant w/good response;BP 80/55, P72, R24, T97.8;position on exam table w/feet up,head down;OJ given to drink;called MD into the room;
mo reports pt wouldn't stop crying (painful, high pitched cry); pt given vax approx 11AM; seen in ER approx 3PM where was given 2nd dose of APAP temp no higher than 100; fretful;