chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This medically confirmed literature case (initial receipt 10-Feb-2015) concerns a 62 year old female patient. The patient had medical history of history of autoimmune hepatitis and was on chronic immunosuppressive therapy. The patient's past medication included mycophenolate mofetil which was switched to azathioprine 10 days prior to hospitalisation. His concomitant medication included prednisone. The patient denied any recent travel, localizing symptoms of infection or known exposure to sick contacts. On an unspecified date, the patient received influenza virus vaccine (manufacturer and batch number not reported). On an unspecified date, ten days prior to hospitalisation, the patient also received azathioprine (manufacturer and batch number not reported). On an unspecified date, one week after vaccination, the patient was admitted to the hospital with three-day history of fever, fatigue, diffuse myalgia and a new asymptomatic rash. On arrival at the hospital, her temperature was 39.5 degree Celsius with an increased white blood cell count of 27,000 cells/ul with a left shift and turbid urine. Creatinine was elevated to 2.6 mg/dl. Liver enzymes and bilirubin were unchanged from the baseline levels. Physical examination revealed multiple erythematous, edematous papules with central deep-seated pustules on the right upper eyelid, bilateral cheeks, trunk, and proximal extremities. The mucosal surfaces were uninvolved. A punch biopsy was obtained from the right upper arm. Histologic evaluation revealed a subcorneal pustule with interstitial and perivascular neutrophilic inflammation. There was no significant papillary dermal edema. Gram and periodic acid-Schiff stains were negative. Overall findings were thought to be most consistent with a neutrophilic dermatosis secondary to azathioprine hypersensitivity. Azathioprine was stopped shortly after admission. The patient was continued on prednisone 10 mg/d and started on intravenous cefepime for presumed urosepsis. The antibiotic was discontinued after two days as the patient had no symptoms of dysuria, and both blood and urine cultures remained negative. A wound culture obtained from pustular contents was also negative. The patient's rash and laboratory abnormalities improved significantly over the course of a 4 day hospital stay. The outcome was reported as recovering. Reporter comments: The diagnosis was Azathioprine Hypersensitivity Syndrome (AHS).
lump like a golf ball on her arm; second dose was unrefrigerated; second dose was unrefrigerated; Experienced swelling of the left arm; pain on the injection site; there's blood when she took of the band aid; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: ER2613 and Expiration Date: 13Jul2021), via an unspecified route of administration, on 05Apr2021 at 11:30 (at the age of 74-year-old) as DOSE 2, SINGLE for covid-19 immunization. Medical history included stroke from Sep2020 and Kidney stones from Feb2020.  The patient had no concomitant medications. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204 and Expiration Date: 30 Jun 2021), via an unspecified route of administration, on left arm, on 08Mar2021 at 11:30 (at the age of 74-year-old) as DOSE 1, SINGLE for covid-19 immunization. The patient not had any other recent vaccinations. The patient experienced swelling of the left arm, pain on the injection site and there's blood when patient took of the band aid on 2021. The patient had a lump like golf ball on her arm, on 05Apr2021. The patient further stated that she also thought the vaccine had to be refrigerated, but the person had syringes sitting on the desk, which was different from the first time, when they pulled from fridge to give shot. The Patient noticed that the vaccines being administered in the vaccination site were not in the refrigerator. The patient would like to know if she can have pain relievers like Advil to ease the pain and also Asking if it is ok for the vaccines to stay in the room temperature. The patient would like to know what can she use, Motrin, Aspirin, or Aleve. The patient said, she would like to get the swelling down, she put some heat on the area first which didn't work so she used ice and had more relief from ice. The patient said she doesn't want to have gone thru all this and her vaccine not work because the second dose was four weeks and was unrefrigerated. The patient stated she would also like to know how long the vaccines are allowed to be unrefrigerated if they are allowed to be. Therapeutic measures were taken as a result of event swelling of the left arm included heat and ice. The outcome of the events was unknown at time of report.  No follow-up attempts are needed. No further information is expected.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergies: sulfa/septra" (unspecified if ongoing), notes: Known allergies: sulfa/septra. Concomitant medication(s) included: ROBITUSSIN 12 HOUR COUGH RELIEF, start date: 27Jul2022, stop date: 02Aug2022. Past drug history included: Allergies: sulfa/septra, reaction(s): "Allergy", notes: Known allergies: sulfa/septra.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Reported as On 01Aug2022, I started feeling itchy on my torso/back; no sign of hives or a rash. Breathing normal. By the evening of 02Aug2022, the itchiness extended to extremities; event the palms and bottoms of feet. I could not sleep. treatment provided as Aveeno Oatmeal bath, Benadryl 15mL, moisturizer. Anti-viral detail was provided as Paxlovid for Treatment of COVID-19 from 27Jul2022 to 02Aug2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events.
generalized varicella lesions fever to 102.5 starting approx 12 days post vax;chronic wheeze exacerbated during illness;;
From the vaccine I have had the following symptoms  Intense muscle pain contractions  Acute Shortness of breath  fatigue flu symptoms all getting progressively worse. Feel like there is a heavy weight o.n my chest pressing down all the time.
Early the next morning, roughly 12 hours after the 1st shot, I woke with intense nausea and low-grade fever. I spent the day laying down vomiting only once in the morning. Fever on 9/17 peaked at 100.2 and subsided by 6 pm. Saturday, 9/18 I had woke with a rapid heart rate and a low-grade fever. The rapid heart rate would reach 135 bpm while sitting or laying down and stayed between 112-125 bpm most of the day. By 10 am on 9/18 I spoke with a nurse practitioner on the phone as I was too short of breath and ill to drive to an office. She described tachycardia and advised to seek emergency medical attention or urgent care.  I opted to rest for the day and control my fever which was a high of 99.6 for the day. The following days I still am short of breath at various times of the day and feel weak if walking short distances. My chest has a fullness to it that I can feel my heartbeat rapidly then subside. 9/21 was the first day I wasn't hindered by the symptoms. Still considering a follow-up visit to a primary physician or urgent care if these symptoms continue.
Patient experienced rash on his abdominal trunk area and aches and pains in joints, especially hips, elbows, and wrists. Onset began within 1-2 days after injection. Joint pain has resolved, but rash not completely resolved at this time.
I went out on Monday at the shooting range. On Tuesday my left side, I started experiencing some swelling, I had put ice packs on it. On Wednesday I went to the emergency room, they did a CAT scan that showed extreme swelling. I was given an antibiotic to help with possible infection. I have a follow up visit with my ENT and a needle biopsy.
Hives with itching, after second shot; Hives with itching, after second shot; This is a spontaneous report from a contactable consumer (patient).    A 71-year-old female patient received second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6204; Expiration Date: Jun2021), via an unspecified route of administration in right arm on 09Mar2021 (at 70 years) as single dose for covid-19 immunisation. Medical history included ongoing chronic obstructive pulmonary disease (COPD) form 2021 (reported as approximately 10 weeks before; it was very early stage and it was very mild) . Patient stated that she was allergic to all vaccines and specifically to her allergies with vaccine (all taken for immunization) she reported the Shingles vaccine and her first flu shot, but not the Pneumonia vaccine and she clarified that she broke out in hives and itches. Previously on 16Feb2021 (at 70 years) patient received first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9266; Expiration Date: 31May2021), in Arm Right for covid-19 immunisation.  There were no concomitant medications.  On 09Mar2021 the patient experienced hives with itching, after second shot also described as follows: when she had the second shot, she broke out in hives and itched. She had to have a steroid shot and then was put on 7 days of steroids. She stated that her effects did clear up with the medications 10 days later. Patient recovered from hives with itching on 19Mar2021. Patient was hesitant for getting the booster shot. In Oc2021 she got a Flu vaccine (she can take a flu shot with no additives and that was the one that she took).
Pt presented for HPV #3 on 07-31-07. Approximately 15 seconds after injection pt stated she "did not feel good", complained of dizziness. Pt was assisted to lying position and symptoms resolved after about two minutes. She had not had any problems with first two shots of series.
I had the flu shot and the Pfizer booster shot together.   The next day I woke up nauseous, with a splitting headache and I could not stay awake.  I slept for the full day and night with brief periods of  trying to stay awake. I lost a day of my life.
A RED RASH AT INJECTION SITE THAT WAS CAUSING SOME MINOR ITCH.  RECOMMENDED BENADRYL AT BEDTIME FOR ITCH AND COMPRESS AT INJECTION SITE
hands are now swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 30Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 30Apr2021, outcome "unknown", described as "hands are now swollen".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Maculopapular rash all over area where vaccine was given and has spread across chest, upper back, neck and other shoulder. Not painful, mildly itchy.
The patient first received a fever and then later experienced increased heart rate on the same day. The following day, the patient starting having problem urinating. It started with the patient needing to forced in order to urinate then he later starting having blood in his urine.
Pfizer 12+ COVID BIVBoost given to 11 year old patient.
testing positive; testing positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 10Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 28Nov2021 at 19:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "testing positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results; Negative, notes: tested negative for 3 days strait after Paxlovid on day 4 or 5 of beginning the pills; Positive, notes: I am now testing positive with rebound symptoms. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had no known allergies. The patient had no other medication in 2 weeks. The patient had anti-viral Pfizer product for treatment of Covid-19 from 24May2022 to 29May2022. The patient now tested positive with rebound symptoms of running nose, sneezing and occasional cough. Voice is raspy from congestion. Prior to this rebound, he tested negative for 3 days stright after Paxlovid on day 4 or 5 of beginning the pills.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt has shots on Thursday; on Sun had pain and swelling of lt thigh; Monday came to office, noted to have mild swelling lt thigh, anteriorly. Advised MOTRIN, also went to urgent care.
This is a spontaneous report received from a contactable consumer or other non-HCP. A 76-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EN6200, expiration date: Feb 2022), at the age of 76, in left arm, on Feb 17, 2021, at 14:00, single dose, for COVID-19 immunisation. No medical history or concomitant medications reported. The patient had a headache, onset Feb 2021, with outcome of unknown; and fatigue, with outcome of recovered. Therapeutic measures were taken as a result of headache. Treatment with Excedrin (two tablets once or twice per day as needed) taken Feb 18, 2021 for the headache. No therapeutic measures taken for the fatigue. Additional information: The patient was fatigued after the first dose of the COVID-19 vaccine. Fatigue resolved after a couple of days. Patient also experienced headache. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. Patient had no related tests. No follow-up attempts possible. No further information expected. Sender's comments: Linked report(s): US-PFIZER INC-2021335698 same reporter and drug; similar events; different patient.
had the flu; Initial information was received on 09-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer via Social media.  This case involves patient (unknown demography) who had the flu (influenza), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious had the flu (influenza) (within 2 weeks) following the administration of INFLUENZA VACCINE.  It was reported that, every time after a flu shot within 2 weeks patient had the flu and after that stopped taking it and does not had the flu since.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
very itchy rash on her legs and back, a very diffuse reaction; This spontaneous report as received from a other health professional referring to a female patient of currently 55 years old. The patient's medical history, concomitant medications, drug allergies, or reactions at the time of the reported event were not reported.      On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for prophylaxis (dose, frequency, strength, route of administration, lot number, indication and expiry date were not reported).         On an unknown date, the patient experienced a very itchy rash on her legs and back, a very diffuse reaction. The outcome of rash pruritic was unknown.   The reporter considered rash pruritic to be related to Zoster Vaccine Live (ZOSTAVAX).
barely able to move and walk my knee joints became very difficult to move or bend more then a few degrees. The first day of adverse signs was the worst and each day since is painful mostly in my knees.
4 in x 4 in area of induration and swelling right deltoid, warm to touch, no erythema
Erythema, warmth tenderness up to about 8cm in diameter in RUE @ site of DTP inject; rx'ed w/Tempra; Resolved over 72 hrs; now w/only small residual, non tender; SQ nodule palpable;
Vaccine given 10/22 at 3:30pm 10/23 at 6:00am intense headache, nausea, low grade fever, fatigue/muscle weakness 12:00pm continued fatigue, minimal fever 4:30pm higher fever, chills, increased muscle weakness and fatigue 7:00pm highest fever (102.7), flushed skin, chills, weakness, given 1 dose of acetaminophen and slept through night 10/24 no symptoms
arm pain at injection site; redness from injection site up over shoulder; Tired; chills; body aches; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 17Dec2020 at 12:45 on arm at single dose for COVID-19 immunization. The patient medical history included SVT (Supraventricular tachycardia) with ablation, silicone sensitivity. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no any other medications patient received within 2 weeks of vaccination. The patient experienced tired, chills, body aches, arm pain at injection site, redness from injection site up over shoulder, all on 17Dec2020. All gone within 48 hours of injection. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was recovered in Dec2020 within 48 hours of injection. The report was reported as non-serious.  Information on the lot/batch number has been requested.
sore arm; "move swollen legs bad",; "hurt when touched" arm; felt "tired"; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING ("move swollen legs bad",), PAIN IN EXTREMITY ("hurt when touched" arm) and FATIGUE (felt "tired") in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included Swelling of legs. Concurrent medical conditions included Diabetes (had diabetes and swollen legs). Concomitant products included METFORMIN, GLIMEPIRIDE, ROPINIROLE, CLONAZEPAM (KLONOPIN) and GABAPENTIN for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) 1 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING ("move swollen legs bad",), PAIN IN EXTREMITY ("hurt when touched" arm) and FATIGUE (felt "tired"). At the time of the report, PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING ("move swollen legs bad",), PAIN IN EXTREMITY ("hurt when touched" arm) and FATIGUE (felt "tired") outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) was unknown.       No treatment medication was reported   This case was linked to US-MODERNATX, INC.-MOD-2021-054493, US-MODERNATX, INC.-MOD-2021-054456, US-MODERNATX, INC.-MOD-2021-056977 (E2B Linked Report). This case was linked to MOD-2021-056977 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054456:1st dose patient's case US-MODERNATX, INC.-MOD-2021-054493:2nd dose patient's case US-MODERNATX, INC.-MOD-2021-056977:2nd dose case of patient's husband
SM vaccine site healing no discharge or signs of cellulitis noted. Satellite lesion healing without signs of cellulitis.
Information has been received from a physician concerning a 2 month old female who on 15-MAY-2007 was vaccinated with Rotateq (Lot # 656186/1235F). On 26-JUN-2007, the patient experienced diarrhea. The patient sought unspecified medical attention. The patient's diarrhea persisted. Additional information has been requested.
PT. received 5 immunizations. One of the vaccines was Hepatitis A, which was given in PTs (R) arm (upper) with a 23 G 1" needle, the location may have been given more SQ instead of IM. I called the Health Dept. asking if vaccine needed to be repeated; she said, no. PT waited 20 min. No redness or pain at site.
Pericarditis- Chest pain and pressure, worse with lying down. Happened 24 hours after vaccine.
This case was reported by a consumer via call center representative and described the occurrence of pain in a 60-year-old female patient who received SHINGRIX (batch number YS53Y, expiry date unknown). Concurrent medical conditions included drug allergy (the patient was allergic to FLAGYL and MACRODANTIN). Concomitant products included Levothyroxine. On 16th January 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 16th January 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left arm. The patient experienced some arm soreness which resolved. The patient had denied permission to contact their physician. The first dose was given in a physician's office. For tolerance to next dose, refer case US2018GSK057095.
Severe body aches, fever, chills, headache. Moderate nausea and vomiting.
8 minutes after shot patient became weak, clammy complained of being tired and sleepy, light-headed. . cold compresses were applied and the patient was placed in the floor on back with their feet elevated. . First responders arrived and checked oxygen, hr and blood pressure,,,all .  patient began to feel better and was allowed to sit. first responders repeated oxygen, hr and blood pressure checks. Patient feeling much better, Patient did not want to be transported to a emergency facility. Patient felt much better and left with husband
Rash on trunk, arms, legs, developed 3 days ago. Spots are very itchy. Started out like bug bites, some are developing blisters. Treated with HC cream.