chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer, the patient. A 78-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the right arm on 23Jan2021 at 09:30 (at the age of 78-years-old) and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266) via an unspecified route of administration in the right arm on 13Feb2021 at 09:30 (at the age of 78-years-old); as a single dose for COVID-19 immunisation. Medical history included laryngopharyngeal reflux disease (LPRD), irritable bowel syndrome (IBS), Raynaud's disease and fibromyalgia. The patient had unspecified allergies to medications, food, or other products. The patient received unspecified medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Feb2021 at 07:00, 10 days after first vaccine, the patient developed tinnitus, which she never had before. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported event. The clinical outcome of the event tinnitus was not recovered at the time of report. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021384484 Same reporter/ drug/ event for different patients
bodyaches, chills, headache, congestion, chest pain, shortness of breath, productive cough, ear pain
Discharge Provider: "Private" DO Primary Care Provider: "Private" DNP, A-GNP Admission Date: 6/9/2022 Discharge Date: Jun 13, 2022  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Nonspecific chest pain [R07.9] Acute hypoxemic respiratory failure due to COVID-19 (HCC) [U07.1, J96.01] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 75y.o. female with a HX of COPD, as well as loss of sense of taste and smell d/t sinus surgery, and NSCLC on left with resection of middle lobe, who presented to the local ER on 6/9/2022 with worsening shortness of breath and left sided chest discomfort. Work-up in the ER r/o cardiac etiology for her chest discomfort but she was found to be COVID-19 positive. In addition she was found to be hypoxic with mild exertion and hypertensive w/o prior HX of HTN. Chest imaging was not consistent with presence of pneumonia. She was admitted for TX of COVID-19 associated acute on chronic bronchitis. She required 4 liters of O2 supplement via NC. She was started on Dexamethasone 6 g q day per protocol. A repeat X-ray revealed what appeared to be worsening air space opacity and pleural fluid on the left. As a result CT angio chest was performed revealing a mucus plug in the left main bronchus. There was no evidence of pneumothorax or PE. Given the proximity of the mucus plug, we contacted the vICU team for input re: the possibility for transfer to higher echelon of care to undergo bronchoscopy. The recommendation was to encourage use of flutter valve device as well as huff coughing and increasing ambulation as tolerated. By 6/12 in the AM the patient's O2 requirement had improved to 2 and subsequently in the evening was weaned off O2 supplement except at bedtime. For reference, her home O2 requirements are 2L via NC at bedtime. Serum potassium and Phos was noted to be low thus PO supplement was initiated. On 6/13 with labs and vitals in stable condition and the patient feeling back to baseline she was discharged to home.
This case was reported by a pharmacist and described the occurrence of nodule injection site in an adult female subject who was vaccinated with BOOSTRIX, (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of BOOSTRIX (unknown). Within days of vaccination with BOOSTRIX, the subject experienced nodule injection site. It was reported that a nodule formed after a female subject was vaccinated with BOOSTRIX. The subject returned to the pharmacy six days after vaccination, the pharmacist reported that the nodule was not red or painful. At the time of reporting the outcome of the nodule injection site was unspecified.
woke up w/rash 11 days p/vax intermittent fever 48hr prior to rash onset, diarrhea;
The night after her second shingle injection she had generalized aching and chills. Within 24 hours she developed tight burning tingling paresthesias in her lower extremities, over the next 2 weeks spreading to the upper extremities as well. No weakness, but she became areflexic. Had difficulty working because of pain. Widespread painful numb tingling burning paresthesias. Didn't respond much to our best symptomatic medications, and only modest response to prednisone. Gamma globulin infusions were started in November 2018 and an almost immediate robust resolution of her paresthesias, and return of deep tendon reflexes. Gamma globulin infusions were continued until March. At this point asymptomatic, and the treatment discontinued. My impression that of an acute post immunization inflammatory neuropathy, a variant of Guillain-Barré syndrome affecting primarily sensory nerves, especially sensory nerve terminals. Triggered by the second dose of SHINGRIX. My office notes provide more detail.
Shot 1 - Pain at injection site within hours of injection. Fatigue, aches and joint pain, and chills began 24 hours after injection and lasted approximately 24 hours.  Shot 2 - Pain at injection site, tiredness, headache, muscle pain, chills, joint pain, low appetite, and nausea began within 6 hours of injection and persisted for 2 days. Now on 3rd day, fatigue, brain fog, and mild muscle pain persist.
Information has been received from a physician's assistant concerning a 16 year old female with pertinent medical history and drug reaction/allergies reported as none who on 21-SEP-2007 was vaccinated with the first dose of Gardasil (lot#658222/0927U), 0.5 ml, IM in the left deltoid. Concomitant medication was not reported. On 08-OCT-2007, the patient told the physician's assistant that she was 7 1/2 months pregnant. In approximately October 2007 (date unspecified), the patient was hospitalized and delivered the baby. The patient reported that the delivery was preterm, but no problems were reported. The physician's assistant reported that there were no known problems with the baby or mother. On 04-DEC-2007 (about 6 to 8 weeks) after the patient delivered the baby, the patient received the second dose of Gardasil (lot#657868/0523U) and a dose of MENACTRA. The physician's assistant was not following the pregnancy, only providing the vaccinations. Subsequently on an unspecified date, the patient recovered from the events. No product quality complaint was involved. Additional information has been requested.
Numbness, tingling, weakness in upper extremities. (Brother of pt reported on 5/15/03 that she had above symptoms in 3/01, 3 weeks following meningococcal vaccine - hemo eval negative and was attributed to meningococcal vaccine. However, review of chart indicated YF vaccine about one week prior to onset of symptoms).
Inappropriate dose of vaccine administered; syringe connection issue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Inappropriate dose of vaccine administered) and DEVICE CONNECTION ISSUE (syringe connection issue) 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 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Inappropriate dose of vaccine administered) and DEVICE CONNECTION ISSUE (syringe connection issue). At the time of the report, INCORRECT DOSE ADMINISTERED (Inappropriate dose of vaccine administered) and DEVICE CONNECTION ISSUE (syringe connection issue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Chills, headache, 102° fever, tiredness, sore arms at injection site
I had the shot at 8:00 am at work. By 12:00 pm I started feeling a pain in my back. By the following morning I was unable to walk upright. Had severe pain on my right side front to back. Went to Dr. office who ordered blood work and a CAT Scan thinking appendicitis or kidney stone. Both came up negative. The pain became more centric to the lower back to hip. The pain persisted and Dr. had me admitted to the hospital where I stayed for 4 days. The pain slightly improved but was still unable to walk upright. Three weeks later I have improved to the point where I can stand upright and walk short distances. It is important to note that I am a very healthy 66 year old who went to the gym 3-4 times a week with virtually no symptoms prior to the shot.
excrutiating pain in right arm, entire forearm red and swollen, temperature over 104 for 3 days, vomiting. Arm continues to be red and painful and swollen 4 days after vaccine was administered. Called dr. several times, she called in vicodan w/ibuprofen for extreme pain.  Took Benedryl and Motrin around the clock for four days so far.  Iced area for 20 min. many times per day. She determined it was a reaction to the pneumovax. Two lymph nodes extremely swollen and sore to the touch--under right arm and above right collar bone.
severe flu like symptoms.. body ache, sweats chills, and headache to lint of nausea.   Neck to wrist pain in injection arm   4/14 only headache  persists other symptoms gone
pt recvd vax & exp pain @ inj site which had persisted for 6 wks as of the date of their report;
Narrative: COVID infection following COVID vaccine series 03/05 Janssen, dose #1 09/12 pt cc: cough, diarrhea, myalgias exposure: unknown 09/17 SARS-COV-2 Variant Sequencing result: pending 09/17 COVID swab, result: detected
Narrative: Headache, Diarrhea, NauseaVomiting, Tachycardia, Shoulder pain, malaise
Patient stated that they woke up sweating with a fever, had to go into the doctors office and was described as 'septic'.
Initial report received from a health care professional via a company representative on 12 August 2010. A 16-year-old girl received at age 12-years an injection (site and route not provided) of ADACEL, lot number C2341AA, and now has confirmed pertussis. The outcome was not reported. Documents held by sender: None.
Information has been received from a registered nurse concerning a patient who on 5/31/96 was vaccinated with a dose of varicella virus vaccine live (lot # 616977/1656B). Subsequently, on 1/20/03, the patient developed chicken pox. The patient was seen in the office. The reporter also indicated that 30 other patient were vaccinated with varicella virus vaccine live and developed chicken pox (WAES0409USA00600, 0409USA01045, 0409USA01046, 0409USA01047, 0409USA01048, 0409USA01049, 0409USA01050, 0409USA01051, 0409USA01052, 0409USA01053, 0409USA01054, 0409USA01055, 0409USA01056, 0409USA01057, 0409USA01058, 0409USA01059, 0409USA01060, 0409USA01061, 0409USA01062, 0409USA01063, 0409USA01064, 0409USA01065, 0409USA01066, 0409USA01067, 0409USA01068, 0409USA01069, 0409USA01070, 0409USA01071, 0409USA01073, and 0409USA01074). No further information is expected.
Lymphadenopathy; 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 LYMPHADENOPATHY (Lymphadenopathy) 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) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Lymphadenopathy). At the time of the report, LYMPHADENOPATHY (Lymphadenopathy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported
not feeling very well, mild condition; woke up at 3am feeling like catching his breath, having some shortness of breath but not that bad; having a weird dream; dry mouth; body aches; feeling feverish; feeling like starting to get a headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (not feeling very well, mild condition), DYSPNOEA (woke up at 3am feeling like catching his breath, having some shortness of breath but not that bad), ABNORMAL DREAMS (having a weird dream), DRY MOUTH (dry mouth) and PAIN (body aches) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 045B21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (not feeling very well, mild condition), DYSPNOEA (woke up at 3am feeling like catching his breath, having some shortness of breath but not that bad), ABNORMAL DREAMS (having a weird dream), DRY MOUTH (dry mouth), PAIN (body aches), PYREXIA (feeling feverish) and HEADACHE (feeling like starting to get a headache). At the time of the report, VACCINATION COMPLICATION (not feeling very well, mild condition), DYSPNOEA (woke up at 3am feeling like catching his breath, having some shortness of breath but not that bad), ABNORMAL DREAMS (having a weird dream), DRY MOUTH (dry mouth), PAIN (body aches), PYREXIA (feeling feverish) and HEADACHE (feeling like starting to get a headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-399973.
Itching; pimple-like hives; rash on her RIGHT ARM; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included biopsy (had biopsies done which had not revealed any information).   In March 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced pruritus, hives and pimple-like rash. On an unknown date, the outcome of the pruritus, hives and pimple-like rash were not recovered/not resolved.   It was unknown if the reporter considered the pruritus, hives and pimple-like rash to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR022529  Additional details were provided as follows: The patient self-reported this case. The patient received dose of Shingrix vaccine in her right arm and within one day she started itching and within four days she started breaking out with pimple-like hives and rash on her right arm in which it subsequently ran down to her elbow. Spoke per package insert (PI). Gave Medical Information phone number for her to provide to HCP to call on her behalf.  The patient was given medical advice disclaimer and was referred to HCP.  The reporter consented to follow-up with HCP (Pharmacy). For tolerance to the 2nd dose refer case US2022AMR022529.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR022529:Same patient, different dose
BODY ACHES; SHAKING; SWEATS; CHILLS; FEVER; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. 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, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, shaking, sweats, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body aches, chills, shaking, fever, and sweats. This report was non-serious.
55 y/o female Behavioral Health Registration Clerk ref by OCC HEALTH to Healthcare Center for determination of how to proceed with required employee 2012-13 Seasonal (IM) Influenza Vaccination, given ER Dx of Bell's Palsy (28OCT2011), two weeks s/p receipt of 2011-12 IM Split Virus Influenza Vaccine. Patient endorses preceding viral illness with fever blister on lip and non-productive cough x 7-10 days prior to onset of Bell's Palsy. She received her 2011 Seasonal (IM) Influenza vaccine, on 04OCT11 at the Flu Drive.
Approximately 2 - 3 hours after receiving immunization for deployment, pt experienced onset of abdominal pain, nausea, chills and headache and was transported to local hospital.
right is the worst rash with blisters; I have a rash on both arms; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE); Lot/batch no: En6200) via unspecified route in the left arm as a single dose on 03Mar2021 at 02:00 for COVID-19 immunization. The patient's past drug history included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/Batch Number: el3302) via an unspecified route of administration in the left arm, as a single dose on 04Feb2021 at 02:00 for COVID-19 immunization. The most recent COVID-19 vaccine was administered in the public health clinic administration facility. The patient was allergic to sulphur. The patient's relevant medical history included asthma. Concomitant medications were not provided. The patient had received other vaccines (unspecified) within 4 weeks prior to the COVID-19 vaccine. It was unknown, if the patient was diagnosed with COVID-19 prior to the vaccination. It was unknown, if the patient had been tested for COVID-19 since the vaccination. On 10Mar2021, the patient had a rash on both arms and the right was the worst rash with blisters. The patient received Benadryl and cortizone 10 cream as treatment for the adverse events. The clinical outcome of the events was reported as not recovered/not resolved/ongoing.   No follow-up attempts are needed. No further information is expected.
About a week after I got the 2nd shot. I started menstruating I haven't had a cycle in 10 years due to my previous PCOS diagnosis. I also had cramps and the menstruations remained afterwards. Ever since I have had my cycle like clock work every month. I am now  having ovulation periods and the cycles are heavy.
Itchy red  swollen and hard at injection site like a giant mosquito bite size of a baseball.  It went away after a couple days.
Fatigue; Injection site soreness; I had my 1st shot in Jan and 2nd today.; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 14Oct2021 18:00 (Lot number: FF8839) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1, time: 3:00pm, route of administration: intramuscular, Batch/ lot number: EN5318; the 5 might be an S, unsure, anatomical site of injection: L deltoid), administration date: 26Jan2021, for Covid-19 Immunization, reaction(s): "fatigue", "Inj. site soreness". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 14Oct2021, outcome "unknown", described as "I had my 1st shot in Jan and 2nd today."; FATIGUE (non-serious) with onset 15Oct2021, outcome "recovered" (2021), described as "Fatigue"; VACCINATION SITE PAIN (non-serious) with onset 15Oct2021, outcome "recovered" (2021), described as "Injection site soreness". Therapeutic measures were not taken as a result of fatigue, vaccination site pain.  Additional Information: Patient did not have any Prior Vaccination (within 4 weeks). No specific relevant test for thromboemobolic events with thrombocytopenia. There was no error, only that he received 2nd dose approx. 10 months after his first shot, thats all.  No follow-up attempts are possible. No further information is expected.
Came with swelling and redness to left upper arm on the vaccine site, stated started around 11 am on 5/8/19 , seen by Dr in the clinic and diagnosed as cellulitis. Prescribed keflex  liquid 200 mg, PO, Q6hr x 10 days , circled the area to monitor and advised to return if worsening or not improving.
Perfectly healthy male with blood work and physical every year.  After vaccination series, developed abnormal thyroid condition.  TSH levels are suddenly high after several labs.
A blister on the temple of the face burst, leaking a lot of yellow fluid on 4/29/21. Over the next couple of days, the blister expanded and  a few more blisters formed on the forehead and neck . Yellow fluid would seep out and crust on the skin.  Over the subsequent 2 weeks, almost entire face went red, excretes out yellow fluid that forms crust over the face. Upon receiving oral broad spectrum antibiotic, face started to swell. At the same time, very itchy pimple-like rash started spreading on arms and torso.  Some parts of the rash eventually form blisters that looked similar to the original on the temple, and leaked some yellow fluid, though much less intense in color and volume.
Information has been received from a licensed practitioner nurse concerning a patient who on an unspecified date was vaccinated IM with 0.5 ml of PNEUMOVAX 23 (lot# 667913/1021z). It was reported that the patient experienced extensive redness, pain and feeling of heat at injection site. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
Started having back pain after an hour realized it was chest pain on the left side of my chest. Went to the emergency room the next day, given an EKG, blood test and an X-ray with no findings. Went to my Cardiologist the next day and was given a Stress Test, EKG and a CT scan of heart, no findings. After a couple of days the pain went away.
No additional Adverse Event.; Caller explained a 12 month old was administered GARDASIL 9.; This spontaneous report has been received from a nurse referring to a 12-month-old patient of unknown gender. The patient's pertinent medical history, previous historical drugs, allergies or reactions, and concomitant therapies were not provided.  On 14-SEP-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  lot number W006229 had been verified to be a valid number; expiration date 15-SEP-2024, for prophylaxis (strength, dose, route of administration, vaccination schedule, and anatomical site were not provided) (product administered to patient of inappropriate age). No additional adverse events.