chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sever distress, no food, water, sleep four days; Sever distress, no food, water, sleep four days; BP 180/120; fever; sweats; body pain; headache; 24 lbs lost 7 days; chills; smell/taste; smell/taste; still sick; This is a spontaneous report from a contactable consumer reporting for himself.   A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 08Apr2021 at 10:45 (Batch/Lot number was not reported) as a single dose for covid-19 immunisation.  Medical history included chronic pain from an unknown date and unknown if ongoing, and liver issues from an unknown date and unknown if ongoing. Concomitant medication(s) included morphine taken for an unspecified indication, start and stop date were not reported; fluoxetine taken for an unspecified indication, start and stop date were not reported; gabapentin taken for an unspecified indication, start and stop date were not reported; tamsulosin taken for an unspecified indication, start and stop date were not reported; and naproxen (NAPRO) taken for an unspecified indication, start and stop date were not reported. Past vaccination history included the first dose of BNT162B2 on 18Mar2021 as a single dose in the left arm for covid-19 immunization. The patient experienced sever distress, no food, water, sleep four days on 09Apr2021 at 20:00 with outcome of not recovered, blood pressure 180/120 on 09Apr2021 at 20:00 with outcome of not recovered, fever on 09Apr2021 at 20:00 with outcome of not recovered, sweats on 09Apr2021 at 20:00 with outcome of not recovered, body pain on 09Apr2021 at 20:00 with outcome of not recovered, headache on 09Apr2021 at 20:00 with outcome of not recovered, 24 lbs lost 7 days on 09Apr2021 at 20:00 with outcome of not recovered, chills on 09Apr2021 at 20:00 with outcome of not recovered, smell/taste on 09Apr2021 at 20:00 with outcome of not recovered, and still sick on 09Apr2021 at 20:00 with outcome of not recovered.  The patient underwent lab tests and procedures which included blood pressure measurement: 180/120 on 09Apr2021, sars-cov-2 test nasal swab: negative on 11Apr2021. Therapeutic measures were taken as a result of sever distress, no food, water, sleep four days, blood pressure 180/120, fever, sweats, body pain, headache, 24 lbs lost 7 days, chills, smell/taste, and still sick and included migraine medications, pain control, fluids, and supportive care. It was reported that he was hospitalization in ER twice for supportive care and also reported that Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
had covid19 infection 3 months prior to vaccination. 1 day after vaccination, developed confluent raised erythematous non blanching itchy rash on forearms, spreading up to behind neck. not resolved after 2 weeks of Benadryl, along with increased wheezing, and severe joint pain and swelling of knees and ankles. Required outpatient treatment with 10 day oral prednisone taper.
swelling, redness, tenderness in inject site; chilling; 5 cm raised, indurated, erythematous warm area @ inject site; pt given med;
had the shot and had them/ suspected vaccination failure; had them; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter mentioned that, the patient had the shot and had his 3rd bout with shingles after the shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation for shingles were unknown at the time of reporting.
Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extremities)-Mild, Additional Details: Tingling, pin pick, numb feeling in right arm/hand
Narrative:  No documentation found in chart review indicating that death was related to COVID-19 vaccine administration
This is a spontaneous report from a contactable consumer (caregiver/patient's mother). A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 14Jul2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included exposure to covid-19 in 2021. Reporter stated that her 16 year old daughter got her first dose of the Pfizer BioNTech Covid-19 vaccine on 14Jul2021, and is scheduled for her second dose on 04Aug2021. She tested positive for Covid after coming into contact with someone who was suspected of having it on 17Jul2021. Reported asked Can she get that second dose then? Reporter stated that she was not sure if her daughter will be able to get her second dose from the same vaccination site as the first, and is wondering how she should handle that. The patient underwent lab tests and procedures which included sars-cov-2 test positive in 2021. Outcome of the event covid-19 was unknown.  The lot number for the vaccine, (BNT162B2) was not provided and will be requested during follow up.
nauseous, hx of vasovagal syncope. Resloved with rest and cold pack. VS- BP 110/80
Aggravation of G6PD condition causing blood in the urine, hair loss, brittle nails, and a general feeling of weakness.  Referral to Nephrologist and Dermatologist
itchy rash/hives around vaccine site and on face; worsened over two days before improving
urticaria, generalized, syncopal episode approx 12 hours after administration  Benadryl resolved urticaria
I started to have tremors in my right forearm, and in my right leg, and I have also had muscle weakness on the right side. No medications have been prescribed, but my primary care recommended that I started taking a baby aspirin. I am having no other symptoms other than that. I have an appointment to have an MRI done of the brain on Thursday 11/3/22.
Injection site pain; Extreme fatigue; This spontaneous case was reported by a nurse and describes the occurrence of INJECTION SITE PAIN (Injection site pain) and FATIGUE (Extreme fatigue) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (Injection site pain) and FATIGUE (Extreme fatigue). At the time of the report, INJECTION SITE PAIN (Injection site pain) and FATIGUE (Extreme fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant information was provided by the reporter   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up document is received on 25-MAY-2021 and it doesn't have any new information.
tingling in both hands and feet; more significantly after second dose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient in her 50's (unknown if pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization. The following information was reported: PARAESTHESIA (non-serious) with onset 02Apr2021, outcome "unknown", described as "tingling in both hands and feet"; CONDITION AGGRAVATED (non-serious) with onset 02Apr2021, outcome "unknown", described as "more significantly after second dose".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A mother presented to the clinic on 04/27/00 at 1:30 PM with her child, area of LVL swollen and warm to touch. The mother states the child was warm to touch in the early AM, she didn't take the temp. The mother states the child had redness but no swelling in the area of AVL with immunization on 09/05/00 unknown if the same vaccine.
Profuse perspiration, lightheadedness, & dizziness. B/P 86/68 10 min later 144/94 30 mins later 110/70.
achey, upset stomach, diarrhea & bloaty 2 1/2 wks post vax; eyes swollen irritated 3 wks post vax;
Achy/feverish feeling began at 10 pm the day of injection.  At midnight, temperature was 101.5; in morning, temp was 100.  Fever lasted until early afternoon the day after injection.  Suddenly, I felt fine.
PATIENT CAME UP TO THE PHARMACY COUNTER AND SAID HE FELT LIKE THROWING UP. THIS WAS ABOUT 5 MINUTES AFTER THE VACCINE WAS ADMINISTERED. I TOLD THE PATIENT TO SIT DOWN I TURNED AROUND PATIENT LOOKED DIZZY AND SWEATING PROFOUNDLY. HE FELL OVER AND HIT HIS HEAD FELL ON THE FLOOR. HE WAS CONSCIOUS.
Dizziness (severe), cannot sit up or stand up without passing out, convulsing (shaking) and severe nausea.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On unknown dates the patients were vaccinated with improperly stored (at -3.2 centigrade for 69 hours) does of PNEUMOVAX 23 (dose and route unknown, lot # M005286, expiration date 08-OCT-2017). There was no temperature excursion issue previously. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Area of erythema approximately 5cm in diameter, red, warm to touch nontender, no knot.
Fever 101; Headaches; Bodyaches; Fatigue; This is a spontaneous report from a contactable physician. An adult male patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number Ek4231), via an unspecified route of administration from 06Jan2021 09:00 to 06Jan2021 09:00 at a single dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE on 16Dec2020. It was reported that the patient experienced Fever 101, Headaches, Bodyaches and Fatigue on 06Jan2021. The patient took Tylenol as treatment. The outcome of the events was recovered on an unspecified date in Jan2021.
Patient received a Moderna Booster dose (0.25mL) on 1/7/22 at 10:15AM which was punctured and refrigerated on 1/6/22 at 10:00AM. Roughly 12 hours past its time of use.  Patient has been called and voicemail left. Waiting on call-back.
Information has been received from a physician concerning a 15 month old female with no pertinent medical history or drug reactions/allergies who on 23-OCT-2006 was vaccinated with a first dose of Hib conj vaccine (OMPC). On 18-DEC-2006, the patient was vaccinated with a second dose of ACTHIB. On 02-MAR-2007, the patient was vaccinated with a third dose of Hib conj vaccine (OMPC). Following the first three doses, the patient had no adverse side effects. On 13-DEC-2007, the patient was vaccinated with a fourth dose of PedvaxHIB (lot# 657387/0995U). Concomitant therapy included influenza virus vaccine (unspecified) and Prevnar. On 13-DEC-2007 after receiving the three vaccines the patient did not have any problems or adverse side effects. Later that same day, at approximately 6:30 PM, the father saw the child chewing on a glass Christmas ornament. He removed the ornament from the child's mouth. As he did so, he saw glass fragments in the child's mouth and he reported that he believes that he removed all of these fragments. The child then took a nap. When the child woke up, her lips were blue but then the lips turned back to a normal pink. Subsequently, the family took a trip by car. With the child in a car seat, the child began drooling and her eyes began to roll. The child appeared to be having a seizure. The child was taken to the emergency department of a local hospital and subsequently transported to a regional hospital. The child continued to have seizures. The child was incubated on a respirator and medically sedated. Presently, the child is still hospitalized in the ICU in a medically induced coma. Some blood was found in the child's stomach. Many tests have been done. This included a CAT scan of the head, blood tests, lumbar puncture, endoscopy and bronchoscopy. To date the test results have been negative. The reporter felt that lips turned blue, inappropriate schedule, seizure, medically induced coma, blood in the stomach all required hospitalization and were considered to be life threatening, disabling and an other medical event (OME). Additional information has been requested. 4/9/08-records received for DOS 12/13-12/14/07-presented after possibly ingesting a crystal ornament at home. Day of vaccination began with tonic-clonic seizure febrile, eyes deviated, drooling, tremulousness of hand. Intubated.
Itchy, tingley, throat.  Itchy bottom of feet.  Drank water.  Lasted ~20 minutes.  No visible rash.
2-3 hrs post inject reported area of itching, 1 1/2" redness @ site; c/o shakiness (sl) icepack to site; reported to MD DPH given; pt c/o being hivey 30 mins p/med redness, itching dec;
Shingles on going - trunk and dental; Treated with pain control, anti viral, neurotin
Patient received 1st dose of Moderna COVID vaccine 7/21/2021 at Medical Center.  Patient was diagnosed with an acute DVT of left lower extremity on 8/4/21 and was admitted to the hospital for treatment. Patient did have a previous history of DVT however this was an acute finding.
Feeling hot less than 12 hrs post vaccine then chills after, Headache, fatigue, light sensitivity, body aches
Patient had an anaphylactic reaction to the Pfizer Covid19 vaccine. She had chest tightness in the first 10 minutes and received two oral Benadryl capsules. At about 20 minutes post vaccination, she then felt her throat swelling up and we then had to give her three epipens. Her symptoms included chest tightness, shortness of breath, coughing, and eventually throat swelling, which resulted in a brief, repeated loss of consciousness.
Developed s/s of COVID on 4/27/2021, hospitalized, then transferred to another HCF was inpatient ICU 5/8-6/21  expired 6/21/21
Hospital Course:  Patient is a 76 y.o. female patient of DO with a history of CAD s/p PCI, paroxysmal atrial fibrillation, HFpEF, Addison's disease on hydrocortisone, chronic pain on suboxone, IDDM2, and OSA/OHS. Presented to hospital 11/18/22 from her ECF with encephalopathy and hypoxia requiring intubation due to acute on chronic hypoxic and hypercapnic respiratory failure with ARDS. Further workup revealed sepsis secondary to polymicrobial pneumonia - RSV, COVID-19, and ESBL E coli; treated with dexamethasone and ertapenem. Ultimately extubated 12/4/22 to heated high flow and BiPAP. Unfortunately could not be weaned from BiPAP. Goals of care discussion with patient and family led to decision to transition care to comfort measures on 12/5/22. Time of death was 12/5/22 at 0200.    Discharge Diagnoses: Acute on chronic hypoxic and hypercapnic respiratory failure with ARDS Combined pneumonia - RSV, COVID-19, and ESBL E coli  Severe sepsis Acute encephalopathy  Tracheomalacia by CT Addison's disease  Paroxysmal atrial fibrillation
fever; itchy scratchy hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 95-year-old female patient received bnt162b2 (BNT162B2 NOS), in 2022 as dose number unknown, single (Batch/Lot number: unknown), in arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URTICARIA (non-serious) with onset 2022, outcome "recovered" (2022), described as "itchy scratchy hives"; PYREXIA (non-serious), outcome "unknown", described as "fever". Therapeutic measures were taken as a result of urticaria, pyrexia.  Additional information: Caller is a consumer calling about the Covid-19 vaccine for last year. His mother had a reaction to the Flu vaccine and to the Covid-19 vaccine from last year. They treated her with cortisone and pain killers. Reporter said that he thinks they had her on a prednisone taper.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Misses doses from time to time; headache; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 56-year-old male patient received tofacitinib citrate (XELJANZ), since 15Oct2021 (Batch/Lot number: unknown) at 5 mg; bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT DOSE OMISSION ISSUE (non-serious), outcome "unknown", described as "Misses doses from time to time"; HEADACHE (non-serious), outcome "unknown", described as "headache". The action taken for tofacitinib citrate was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial unsolicited report received from pharmacist on 01 December 2015. This case involves a female patient (age not reported) who was vaccinated with a dose of FLUZONE HD (batch number: U5022BA, expiry date: 29 April 2015, dose, dose in series, were not reported) on 29 November 2014. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. Concomitant medications were not reported. On an unknown date, following the vaccination the patient had developed swollen arm, hot to touch at injection site, skin peeled at injection site like a sunburn and broke out in hives all over her body. Laboratory data and corrective treatment was not reported. On an unknown date, the patient was recovered from the events. List of documents held by sender: none.
After the TD was given pt started bleeding, complained verbally of pain at the sit soon as shot was given. The site of shot is warm to the touch and swollen. Have pt move muscle where shot given. Instructed to take Tylenol Q4 x 2 days to come back to office if s/s worsen. Apply warm compress to site. Raise more than 1/4 inch diam size of 1/2 dollar.
PT WAS VACCINATED ON FRIDAY. ON SATURDAY HE HAD A SEIZURE. HE WAS HOSPITALIZED AND LATER PUT ON A VENTILATOR. PT WAS DISCHARGED SUNDAY
This spontaneous report was received from a female patient (who was also a nurse) of unknown age via a company representative, reporting on herself. No information about the patient's medical history and concurrent conditions was provided. On an unknown date, when the patient was in her 50's, the patient was vaccinated with ZOSTAVAX injection (lot#, expiration date, dose and route of administration were not reported). No information about the concomitant therapies was provided. On an unknown date (reported as "later"), the patient experienced shingles. The shingles case "was not so bad". Varicella-Zoster Virus (VZV) packet was not sent as the patient's physician was unknown. The outcome of the event was unknown. The causality between the event and ZOSTAVAX was not reported. Product quality complaint was not involved. Additional information is not expected as no reporter contact details were provided.
It was a bad 24 hours; Chills; Fever that climbed to above 102 degrees Farenheight; Bad body aches; Fatigue; Injection site arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (It was a bad 24 hours), CHILLS (Chills), PYREXIA (Fever that climbed to above 102 degrees Farenheight), MYALGIA (Bad body aches) and FATIGUE (Fatigue) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced FEELING ABNORMAL (It was a bad 24 hours), CHILLS (Chills), PYREXIA (Fever that climbed to above 102 degrees Farenheight), MYALGIA (Bad body aches), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Injection site arm hurt). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (It was a bad 24 hours), CHILLS (Chills), PYREXIA (Fever that climbed to above 102 degrees Farenheight), MYALGIA (Bad body aches), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Injection site arm hurt) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, Body temperature: climbed to above 102 degrees farenheight (High) climbed to above 102 degrees Farenheight.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2022-571008, MOD-2022-571007 (Patient Link).
Slight joint pain in hips at 0700 on 1/9/21 progressing to severe pain in hips, back, and neck by 1200.  Unable to move without pain rated 9/10.  Tylenol and Motrin used PRN.  Also noted fatigue and redness, swelling, pain at injection site. Called in to work 1/9/21 and 1/10/21.  Pain continued rated at 8/10 until 1/12/21 when patient visited Urgent Care at 0930 .  Provider gave 10mg oral Decadron and 30mg Toradol IM. Oral prednisone 50mg prescribed for 3 days starting 1/13/21.  And continue regiment of tylenol, motrin, heat, bath for relief of symptoms.  1/13/21 patients lower back pain resolved.  1/14/21 patients left hip pain resolved.  Right hip pain continues at same intensity, though somewhat more controlled with PRN tylenol, motrin, heating pad.  Unable to work as of the submission of this report.
Tongue swelling with patchy white spots. Onset began ~1 day after vaccination; treatment with stomatitis cocktail, loratadine
I had itching and pain at the injection site early in the day.  At around 3 pm I started to having itching around my jaw line and hives started to pop up on my face.  Over the next 30 mins about 5 hives arrived until I was able to talk with my doctor, read CDC guidance and take 1 benadryl (25 mg) then the itching resolved.