chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10/01/2021 @ 03:00 AM, I woke up with a throbbing headache.  I had the headache till 01:00 PM.  On 10/01/2021, at night, I started with redness in my left arm in the injection site. It started the size of a nickel and started getting bigger. On 10/02/2021-I ran a fever of 99. I run a low body temp. I had a little bit of a flush face with it . Took Tylenol within 2 hours I had a normal body temperature. On 10/03/ 2021 -the injection site arm was getting bigger. It looked like a goose egg size where the injection went in along with the redness, and sore to the touch. I went to work on 10/04/2021- I work in healthcare and they looked at it and suggested I see my doctor. I went to my doctor at 2:30 pm that day , he thought it was a normal reaction, but because it was pretty red, and swollen , he gave me a prescription. I ran a fever that evening on 10/04/2021- 99.1, took Tylenol again, within 2 hours it came down. On 10/05/2021 I had marked it to make sure it wasn't going outside the line. It was going a little outside the line by lunchtime. I went ahead and filled the prescription Tuesday night, 10/05/2021. Clarithromycin 500 mg 1 tablet bd. for 10 days. I took the 1st dose on 10/05/2021, I did 6 doses. I only took it for 3 days. I took the last dose on 10/08/2021. It started to resolve on 10/06/2021, whether the antibiotic helped it or not, I am not sure.
Received Td in clinic - was ok, walked to lab station, fingerstick blood test done. Patient few minutes later felt dizzy and fainted. No loss of consuousiness. Blood presure normal. Patient rested and symptoms resolved after a few minutes. (Reaction felt probably secondary to blood draw not vaccine but form completed)
Information has been received from a registered pharmacist concerning an 80 year old female patient with penicillin allergy and a history of cancer in 1980 who on 10-SEP-2010, was vaccinated SQ with 0.65 ml dose of ZOSTAVAX (Merck) (lot# not reported). It was reported that on 16-SEP-2010, the patient went into the pharmacy to have evaluate her arm because where she had the ZOSTAVAX (Merck) injection on her arm, the area (3 inches by 2 inches in size) was dark red, inflamed, swollen and warm. The pharmacist stated that she recommended the patient put ice on the area and apply a hydrocortisone cream to the area. The pharmacist stated that the patient reported that it helped. On 01-OCT-2010, the patient returned to the pharmacy and the pharmacist stated that she looked at the patient's arm and the area was better, the site was smaller, was not as red, not as inflamed, not as swollen and not warm but was still present. Lab diagnostics studies were not performed. At the time of the report, the patient was recovering. The patient sought unspecified medical attention. Follow-up information was received from a registered pharmacist who stated that the female patient with no illness at time of vaccination was vaccinated on 10-SEP-2010 with a dose of ZOSTAVAX (Merck) (Lot# not reported). Concomitant therapy included atenolol, alendronate sodium (manufacturer unknown) and SMZ-TMP. It was reported that on 16-SEP-2010 (also reported as approximately on 14-SEP-2010), the patient experienced red, raised, hard and warm to touch. The patient was treated with ice in the arm and with hydrocortisone cream OTC. On 17-SEP-2010, the cream seemed to be helping. On 01-OCT-2010, the patient's arm was not as severe, half size and the patient was bandaged with hydrocortisone by the physician's suggestion. On 22-OCT-2010, the patient's arm was still pink, had and warm to touch. The patient did not seek medical attention by doctor because she could not afford. On 04-DEC-2010, still there light red, still a lump "but it did not bother her", the area was about "3 times wide". The patient did not want to see a doctor. There was not relevant diagnostics test. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Improvement in tendinitis in knee and shoulder; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Improvement in tendinitis in knee and shoulder) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Tendinitis (In shoulder and knee).   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Improvement in tendinitis in knee and shoulder). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Improvement in tendinitis in knee and shoulder) outcome was unknown.            It was stated that after receiving the vaccine the tendinitis in both the knee and shoulder subsided for several month with no side effects. Just recently the tendinitis has begun to present itself but is not as the levels prior to vaccination.   Concomitant medications included unspecified allergy pill No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow-up information included no new information.
Feeling of weakness in L upper/lower extremity; numbness/blunted sensation in L whole upper lower extremity, L face, L tongue; numbness/blunted sensation in L whole upper lower extremity, L face, L tongue; This is a spontaneous report from a contactable physician (patient herself). A 29-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), intramuscularly on the left deltoid, on 11Jan2021 09:55, at a single dose, for covid-19 immunization. The patient's medical history was not reported. The patient's father got thyroid storm from influenza vaccination. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), intramuscularly on the left deltoid on 20Dec2020 18:00 for covid-19 immunization at the age of 29-years-old and experienced L face; tongue, L upper; lower, extremity numbness. The vaccine was received at the hospital. The patient experienced numbness/blunted sensation in L whole upper lower extremity, L face, L tongue on 11Jan2021. As treatment, the patient received acetaminophen 650mg po on 11Jan2021. The patient then experienced feeling of weakness in L upper/lower extremity on 22Jan2021. All the adverse events resulted in a visit to an emergency room. The patient was admitted to the hospital due to all adverse events for 2 days, from 02Mar2021 to 04Mar2021. The patient underwent lab tests and procedures on 24Jan2021 which included the following: MRI brain w/wo con with results of negative, MRI spine w/wo con with results of negative, CT head wo con with results of negative, and CXR with results of negative. The patient underwent lab tests and procedures on 02Mar2021 which included the following: MRI head with results of negative, CBC with results of negative, MRI neck with results of negative, MRI brain w/wo con. with results of negative, CMP with results of negative, UDS with results of negative, U/A with results of negative, and B12 with results of negative. The patient underwent lab tests and procedures on 03Mar2021 which included the following: CSF with results of negative, TSH with results of negative, and PT/INR with results of negative. The patient underwent MRI spine w/wo con on 04Mar2021 with results of negative. The outcome of the events was unknown.; Sender's Comments: Causality cannot be excluded for the reported serious events and suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).The impact of this report on the benefit/risk profile of the Pfizer product 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.
site injection soreness; tightness extended into her neck on the same side as the injection; This spontaneous case was reported by an other and describes the occurrence of VACCINATION SITE PAIN (site injection soreness) and MUSCLE TIGHTNESS (tightness extended into her neck on the same side as the injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (site injection soreness) and MUSCLE TIGHTNESS (tightness extended into her neck on the same side as the injection). At the time of the report, VACCINATION SITE PAIN (site injection soreness) and MUSCLE TIGHTNESS (tightness extended into her neck on the same side as the injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment and concomitant information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Followup received on 12-APR-2021 and contains NNI.
This spontaneous report was received from a pharmacist refers to a three patients of unknown age and gender. Medical history was not reported. On an unknown date the patients were vaccinated with PNEUMOVAX 23 injection, lot # J013345, expiration date: 11-JAN-2015, intramuscular (dosage was not reported). Concomitant therapy was not reported. The pharmacist informed that on an unknown date two of the patients came back to the facility and complained of soreness, redness and pain at the injection site. Because of this the facility called another patient who received the PNEUMOVAX 23 as well, and that patient also complained of soreness, redness and pain at the injection site. The pharmacist stated that these reactions were not treated in anyway. The patients sought medical attention by a facility's visit. Additional information has been requested.
Information has been received from a physician concerning a female who on January 24, 2003, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). It was noted that in 2003, prior to vaccination, a titer showed that the patient was "varicella negative". On February 05, 2005, the patient was diagnosed with vaccine related varicella. She is "now" pregnant and lab studies were ordered which showed "she is IgG negative and IgM positive". The physician who ordered the studies felt these results indicated that she "has active chickenpox". There was no product quality complaint involved. At the time of the report the patient's outcome was not recovered. Additional information has been requested.
1100 patient sitting in recovery. states she feels "funky". Declined w/c and stated she really needed to use the restroom. Patient ambulated without difficulty, gait steady and nurse accompanied to restroom. Patient describes a strange tingling type of sensation in left arm and face that has progressed all over head. Pt. voided and ambulated accompanied to private observation area.  1105 BP 149/93; HR 97; O2 sat 99% on room air. EMT in attendance.  1108 Patient moved to outside and mask removed due to feelings of anxiety over the "strange sensations" Encouraged to deep breath. Offered patient ambulance transport. Patient declined.  1116 Patient BP 128/81; HR 94; O2 97%. Husband with patient, patient signed declination of ambulance transport, left with husband to personal vehicle. gait steady.
Patient has not received the second dose of the vaccine and it has been more than 36 days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient has not received the second dose of the vaccine and it has been more than 36 days) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient has not received the second dose of the vaccine and it has been more than 36 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient has not received the second dose of the vaccine and it has been more than 36 days) had resolved.            Concomitant drug was not reported.  Treatment medication was not reported.
Grabbed the MMRV rather than the MMR alone. Gave the MMRV and Varicella. Age of patient at time of event: 12 months. Type of Event: Wrong vaccine. Contributing Factors: Similar brand names; Similar generic names; Similar vaccine abbreviations; Similar vaccine container labels/packaging; Products stored near one another; Not familiar with products.
Client complained of pain on the left side of her head. She stated began having a headache five mins after receiving vaccine. Assessment revealed no hives, no rashes, and no difficulty breathing, no chest pain or other signs of anaphylaxis. Client reported a 7/10 pain on the left temporal region. She denied pain or swelling upon palpation. She denied any allergies and has a history of hypertension with prescribed meds.  Client declined any other pain throughout her body. She was given water, and vitals were taken at 5mins intervals. She was observed for an additional 30mins,  After 20 mins she reported that she "much better" and her headache was gone. She decided to leave 10mins before her 30mins of observation were completed. She was in no apparent distress when leaving. She was given ER precautions. Pfizer fact sheet was provided.
She came today (9/3/18) to inform she had a cellulitis in the left arm (deltoid muscle).
positive for SARS-CoV-2 infection; lack of drug effect; This literature-study case was reported in a literature article and describes the occurrence of COVID-19 (positive for SARS-CoV-2 infection) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypertension and Kidney transplant. Concomitant products included TRIAMCINOLONE, MYCOPHENOLATE MOFETIL (MMF) and PREDNISONE for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (positive for SARS-CoV-2 infection) (seriousness criteria hospitalization and medically significant) and DRUG INEFFECTIVE (lack of drug effect). The patient was hospitalized from sometime in 2021 to sometime in 2021 due to COVID-19. The patient was treated with DEXAMETHASONE for Adverse event, at a dose of 1 dosage form and REMDESIVIR for Adverse event, at a dose of 1 dosage form. At the time of the report, COVID-19 (positive for SARS-CoV-2 infection) was resolving and DRUG INEFFECTIVE (lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Metabolic function test: 20.85 (normal) 20.85. In 2021, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered COVID-19 (positive for SARS-CoV-2 infection) to be possibly related. No further causality assessment was provided for DRUG INEFFECTIVE (lack of drug effect).    Part of a retrospective, observational study of SOTR patients who received SARS-CoV-2 vaccine  that was conducted at a Hospital by chart review. Severity of COVID-19 classified by authors as "severe."  Company comment: This is a case of lack of efficacy of the product in an immunosuppressed transplant patient.  Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Report contains no significant information.; Sender's Comments: This is a case of lack of efficacy of the product in an immunosuppressed transplant patient.  Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.
myopericarditis; This is a spontaneous report from a contactable Physician. An 18-year-old male patient received his second dose of bnt162b2 (Pfizer-BioNTech Covid-19 vaccine) as an intramuscular single dose in left arm on 10May2021 14:30 (lot number unknown) for COVID-19 immunisation. The patient received his first injection as an intramuscular single dose in left arm on 16Apr2021 02:45 pm (lot number unknown) at age of 18-year-old for Covid-19 immunization. The patient's medical history included asthma and morbid obesity (BMI 47). Patient had no known allergies. Concomitant medications included salbutamol (ALBUTEROL HFA). The patient did not receive other vaccine in four weeks. Patient developed chest pain and was admitted to the hospital with myopericarditis. The event started at 03:00 am on 13May2021. He had elevated troponin and an abnormal EKG. He improved with NSAIDS and Colchicine. The patient was hospitalized for 3 days and recovered from the event on an unspecified date. The patient had no Covid prior vaccination and had real time PCR via nasal swab on 13May2021 with negative result.   Information about the Lot/batch number has been requested.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported event myopericarditis along with its symptoms and the use of BNT162B2 cannot be fully excluded. However, the  patients state of morbid obesity and asthma maybe considered risk factors. The limited information available precludes further assessment.  The impact of this report on the benefit/risk profile of the Pfizer product 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 Authorities, Committees and Investigators, as appropriate.
Localized reaction, approximately  5cm X 5cm raised reddened area.   Lasted approximately 8 days,
Headache Fatigue, chills, injection site pain and swelling, joint pain Narrative:
Redness around arm near injection site, with feeling of warmth. Dr treated pt with antibiotics and redness has subsided as of 10/06/2005.
Redness & swelling left arm. Tx-Aleve & ice for swelling.
Rash on entire body, similar to poison ivy, originally diagnosed as poison ivy, treatment 2 rounds of prednisone 3 per day for 5 days , symptoms return as soon as medication stops
Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program. This nurse reported same event for 20 patients (15 residents and 5 staff members). This is the seventeenth of 20 reports.  A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient have tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if patient should receive the second dose. Outcome of the events was unknown.    Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be completely excluded for reported events.,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient
suspected vaccination failure; worsening of his shingrix outbreaks; worsening of his shingrix outbreaks; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (before the vaccine, the patient would break out in a small spot in the same place).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml and the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria medically significant), shingles and condition aggravated. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and condition aggravated were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and condition aggravated to be related to Shingrix and Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient received both Shingrix vaccines about a year ago from the date of reporting, exact dates were unknown. The patient received 2nd dose in an unknown deltoid. The patient stated that, ever since getting the vaccines, he had worsening of his shingles outbreaks. The patient would break out in a small spot in the same place before the vaccine.  Since the vaccine, the shingles had spread throughout the body. No lot number or expiration date was known for vaccines. The reporter consented to follow up. This case was considered as suspected vaccination failure since the details regarding, laboratory confirmation of shingles was not provided.
ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/12/2023 HTN (HYPERTENSION) ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/12/2023 ASTHMA, UNSPECIFIED
It was reported that a pt (2 of 3) rec'd a Tripedia vaccination, date not specified. Reportedly sometime after the vaccination the pt developed a local reaction. Further information is requested. Per telephone conversation with DA, LPN on 3/27/01 it was reported that patient 2 of 3 received Tripedia from the same vial as pt 1 0of 1 (U2001-00540). The lot # of Tripedia in report U2001-00540 was reported as U0039CA. LPN DA reported that (2or 3) other children had rec'd vaccine from this vial without reactions. Apparently, pt 2 of 3 had a little erythema "physician chose not to complete VAERS form for patient 2 of 3. requested further information. On 3/28/01. From additional correspondence rec'd 4/16/01, no new information was provided. From additional correspondence rec'd on 5/14/01, it was reported from phone call and conversation with the pt's father several days after the onset of the reaction the father stated. Fully recovered. No erythema, no fever, no pain, acting fine. This case is closed.
Pt diagnosed with Neuritis. Pt complains of burning sensation on trunk of body. Symptoms started approx. 4 days after having flu immunization.
at 12:15 i woke up completely wet and with a temperature of 103.4 i am normally 96/97  i also had a pounding headache....and my legs kept feeling like they were buckling beneath me..... i couldn't walk. also i was having chills. pj's ,sweater,bathrobe and 4 blankets and i was still shaking and freezing.   my fever is 100 now ...i still have the headache i feel very tired but so far my legs are not buckling anymore