chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2013US021243 is an initial spontaneous report received from a health care professional on 09 Oct 2013 with a follow-up received on 11 Nov 2013: This report refers to a 45-year-old female patient. Her medical history was unknown. Her concomitant medication included Estradiol at 1mg orally QD. She was vaccinated with FLUVIRIN (batch number: 1308901 and expiry date: Apr 2014) intramuscularly at 0.5 ml in to the left deltoid on 07 Oct 2013. Immediately after vaccination, she complained of 4 to 5 inches itching, redness, soreness, swelling and induration at the injection site. The events resolved on 09 Oct 2013. No further information about seriousness and causality were reported. Follow-up received from the health care professional on 11 Nov 2013: Updated patient demographics, concomitant medication, site and date of application of FLUVIRIN, onset and end dates of events and outcome of the events.
PATIENT RECEIVED MODERNA VACCINE ON 1-29-21. PATIENT REPORTED THAT ON 2-8-21 THERE WAS AN ITCHY, RED, SWOLLEN , BUMPY RASH FROM DELTOID OF INJECTION SITE TO ELBOW. SHE CALLED THE PHARMACY TODAY TO LET US KNOW. TODAY THE RASH IS RED BUT NOT SWOLLEN. PHARMACIST ADVISED PATIENT TO CONTACT MD FOR FURTHER CONSULTATION AND TO INFORM PHARMACY OF ANY UPDATES.
2nd day post vaccine I started to feel really anxious, irritable, flushed skin, migraine and started to have tachycardia that would not go away. Felt like my skin was crawling increased SOB with how fast my heart rate was. + dizziness and lightheaded also. My resting heart rate was 180-200. when SX did not get better I was seen at the MD office and sent directly to the ER. I was admitted for OBS & treatment for the tachycardia. Advised to never receive the vaccine again. I was discharged home with new medications and a cardiac halter monitor to wear nonstop x 2 weeks. serial Troponin's, EKG's and cardiac ECHO/TEE also completed.
presented to ED with SOB (increasing over last 3 days), diarrhea x 5 days, fever, chills, and fatigue; COVID test positive; PMH:  sickle cell disease; diagnosed with pneumonia due to COVID, sepsis, hypoxia; started on oxygen, steroids and antibiotics; pt's condition worsened and he passed away in the hospital
Vaccine was really quite awful; 5 days in bed; This case was reported by a consumer via interactive digital media and described the occurrence of feels awful in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feels awful and bedridden. Shingles vaccine was discontinued. On an unknown date, the outcome of the feels awful was unknown and the outcome of the bedridden was recovered/resolved.   It was unknown if the reporter considered the feels awful and bedridden to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-OCT-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient reported that this vaccine was really quite awful for him/her. 5 days in bed.  The patient said second dose was supposed to be worse.  So, he/she did not take it.  The patient said fully vaxed otherwise, very pro vaccine, but just saying to prepare yourself if you do this vaccine. Additional Supportive Information: The follow-up would not possible, as no contact, details were available
1 hour post injection, patient returned to the vaccine clinic c/o burning and tingling (L) side of face near cheek bone & eye. While talking, she developed a "cold sensation, like when you get IV fluids" on her left side.
Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) had resolved and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms).    No concomitant medications were reported. No treatment medications were provided.  Patient 39 out of 42   This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:
Case number PHEH2014US018206 is an initial spontaneous report received from a consumer on 09 Sep 2014. This report refers to an adult female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 145402) intramuscularly at a dose of 0.5 ml on an unspecified date. It was reported that FLUVIRIN was stored at temperature of 32 degree F (0 degree C) for 10 hours. No adverse events reported after the maladministration.
The morning following administration, I discovered localized swelling at the injection site, approximately 2cm protrusion from nominal skin level, approximately 15cm diameter circular area. Area was abnormally firm to the touch, and abnormally warm to the touch. The symptoms began to subside after 48 hours, and were completely subsided after 7 days. This is the first instance of this type of reaction in my military vaccine history. Telephone consult was completed with attending medical technician on first day after vaccine administration, and symptoms were described as "normal."
Patient given expired medication, manufacturer contacted, vaccine maintained the activity necessary to protect against Covid-19 at time of administration.
Hearing loss starting in the evening two days after vaccination.  Both ears.  Greatly reduced overall hearing. Next morning upon awakening more loss.  Called Doctor a friend and also my ENT doctor.  It was a Saturday, she was not available.  She recommended Prednisone.  Problem with pharmacy so I could not get prednisone.  I took Turmeric  instead.  Hearing returned within an hour or so.   Definite hearing loss.  Rapid recovery.
10/4/2021 2:51 pm called patient, the number is to a care facility. Left a message. She will ask his caregiver to call return call.  10/18/2021 11 am Left message for his caregiver to return call.  10/18/2021 2:Text message sent via portal.  10/23/21 Called care facility and left message for caregiver to return call. Viewed portal client received a booster dose on 12/8/2021.
This spontaneous case was reported by a nurse and describes the occurrence of LETHARGY (Lethargic), FATIGUE (tired), PYREXIA (a little of fever) and MYALGIA (body aches) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The patient's past medical history included Heart disease, unspecified. Concurrent medical conditions included Hypertension and Diabetes. Concomitant products included Hydrochlorothiazide; Plavix; Premarin; Flecainide; Diltiazem for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced LETHARGY (Lethargic), FATIGUE (tired), PYREXIA (a little of fever) and MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. On 13-Feb-2021, LETHARGY (Lethargic), FATIGUE (tired), PYREXIA (a little of fever) and MYALGIA (body aches) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient height was reported as 5'3. Patient was allergic to contrast dyes. This case was linked to MOD-2022-547408, MOD-2022-547429, MOD-2022-547432 (Patient Link).
pt recv vax 14MAR96 & 5APR97 pt exp full blown chickenpox;f/u from pt MD indicated that pt rash was similar to varicella;pt recovered;
no adverse event; When vaccine was being administered, right at the end they felt a droplet of liquid go down his shoulder about 3 to 4 inches; This spontaneous case was reported by a patient and describes the occurrence of UNDERDOSE (When vaccine was being administered, right at the end they felt a droplet of liquid go down his shoulder about 3 to 4 inches) and NO ADVERSE EVENT (no adverse event) in a 77-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-Mar-2023, the patient experienced UNDERDOSE (When vaccine was being administered, right at the end they felt a droplet of liquid go down his shoulder about 3 to 4 inches). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, UNDERDOSE (When vaccine was being administered, right at the end they felt a droplet of liquid go down his shoulder about 3 to 4 inches) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (When vaccine was being administered, right at the end they felt a droplet of liquid go down his shoulder about 3 to 4 inches).    No concomitant medications were reported. It was reported that patient asked the vaccinator what was the liquid and they said it was the vaccine but it was not very much. No treatment information was provided.   Reporter did not allow further contact
A non serious spontaneous report of administration of expired FLUMIST has been received from a health professional concerning a seven-year-old female patient. The patient's medical history and concomitant medication details were not provided. The product expired on 12-Dec-2010. The patient received the expired FLUMIST on 13-Dec-2010. There was no adverse event associated with this vaccination error: therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Expired Twinrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 32-year-old female patient who received HAB (Twinrix) (batch number P9LT9, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th January 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 11th January 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 11-JAN-2023 Reporter comment: Medical assistant reported that a patient received a twinrix expired dose. The reporter consented to follow up. Additional Supportive Information: The patient received an expired dose of twinrix vaccine which led to expired vaccine used.
No additional AE's; VARlVAX had been administered to 3 patients after undergoing multiple temperature excursions; This spontaneous report was received from a nurse prescriber and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 22-OCT-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # S033952, expiration date: 24-OCT-2021, frequency reported as 3 (exact dose, injection site and route of administration were not provided) for prophylaxis.  The administered vaccine experienced multiple temperature excursions (exact temperature and time frame were unknown). No additional adverse events were reported.   This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2103USA007465: US-009507513-2103USA007466:
This spontaneous report as received from an office worker refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical histories and concomitant therapies were not reported. On unknown dates, the patients received three doses of improperly stored RECOMBIVAX HB (lot # M010671, expiration date: 02-JUN-2017) (dose and route of administration were not provided). No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
22APR93 pt c/o swelling side of face-warm to touch per pt; pt referred to MD; side effects from MMR should not be evident sooner than 1 wk p/administration;
On 06-06-2021- I developed shingles in my body and also have excessive sweats.  To this day I continue to experience these symptoms.
fatigue; slight headache; hives came; allergy meds; This is a spontaneous report from a contactable consumer (patient). A 66-year-old patient of an unspecified gender received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number- EL6200) via an Intramuscular route of administration, administered in arm right on 21Feb2021 at 10:30 (at the age of 66-year-old) as single dose for COVID-19 immunization at School/Student Health Clinic. Medical history included ongoing osteoporosis (all medications stopped due to reaction or ineffective), high blood pressure from 1985 and ongoing, hives, allergy and hormone therapy. Concomitant medications included felodipine taken for hypertension from an unspecified start date and ongoing, estradiol (IMVEXXY) taken for hormone therapy from an unspecified start date and ongoing, fexofenadine hydrochloride (ALLEGRA) taken for hives, allergy from an unspecified start date and ongoing; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for hives, allergy from an unspecified start date and ongoing. The patient previously took zyrtec and experienced allergy, allegra and experienced allergy. The patient's historical vaccine included first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number- EL9261) via an Intramuscular route of administration, administered in arm left on 31Jan2021 at 10:30 (at the age of 66-year-old) as single dose for COVID-19 immunization allergy meds. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Feb2021 at 17:30, patient experienced fatigue, slight headache, hives came and allergy meds. Adverse events fatigue and headache resulted in physician office. Seriousness was reported as non-serious. Relevant tests were reported as unknown. Therapeutic measures were taken as a result of the adverse events which included allegra and zyrtec . The outcome of events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a 75 year old female who on approximately 04-APR-2007 was vaccinated SC with a dose of Zostavax. On approximately 03-MAY-2007 the patient developed musculoskeletal pain in the left arm. Unspecified medical attention was sought. Subsequently on 08-MAY-2007, the patient recovered. There was no product quality complaint involved. Additional information has been requested.
Day of Vaccine Tuesday - just tired and right are ached Day after Wednesday started in a.m.  nausea and then vomiting repeatedly throughout the day, body aches and terrible headache, no fever but chilled where teeth were actually chattering, running nose all day, acid reflux, no appetite but even water made me vomit, I became very weak.  Slept a lot on and off all afternoon. Next day  thursdayI had no symptoms but was weak from all the trauma of the day before.  Friday I felt fine
Severe exacerbation of fibromyalgia for 3 days and itching at the injection site
Strong metallic taste in mouth; weakness and low energy; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Strong metallic taste in mouth) and ASTHENIA (weakness and low energy) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B218) for COVID-19 vaccination.     The patient's past medical history included Nerve compression (HERNIATED  PINCH NERVE ON NECK), Intervertebral disc bulging and Patellofemoral pain syndrome. Concomitant products included VITAMIN D3, BIOTIN, VITAMIN C [ASCORBIC ACID] and CHONDROITIN SULFATE, COLLAGEN, GLUCOSAMINE (UC II) for an unknown indication.    On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced DYSGEUSIA (Strong metallic taste in mouth) and ASTHENIA (weakness and low energy). The patient was treated with VITAMIN B NOS (B-COMPLEX [VITAMIN B NOS]) at a dose of 1 dosage form. At the time of the report, DYSGEUSIA (Strong metallic taste in mouth) and ASTHENIA (weakness and low energy) had not resolved. Not Provided          Patient lab data SARS-COV-2 AB test and the results came back at >2500.0   This case was linked to MOD-2021-214839 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow-up received does not contain any new information
Headache, Fever, injection site pain, body aches, chills, sensation of cold, fatigue Narrative:
One week after vaccine was received - redness, swelling and itching approximately one inch below inoculation site.  Swelling was approximately 1 inch in diameter. Through Sunday 2/21 the swelling started getting darker and spreading.  Due to itching, otc Cortizone was applied to affected area.  Yesterday, my doctor suggested warm compresses.  The swelling is almost gone and the redness is not spreading.
He developed transient aphasia on 3/10/21 (2 days after receiving the 2nd vaccination), then had back/stomach pains and on 3/14/21 developed more protracted aphasia, which resolved but was found to have severe thrombocytopenia (plt= 23k), markedly elevated LDH (1115), MAHA and was diagnosed with TTP (ADAMTS level <5% with a positive inhibitor). Was treated with plasma exchange and prednisone (100mg daily) x 6 days with complete resolution and dischared to home.
On the second day after I received the flu vaccine, my body began to break out in red, itchy hives all over my body.  They appeared in patches,  some hives small, some very large.  They would itch for approx. 4-6 hours before beginning to fade.  When they faded the skin in the middle of the each hive would turn normal color, but there would be a bright red line outlining the hive.  While patches were fading, new patches of hives in different body areas would begin to appear.  This lasted approx. four weeks.  After the first week and 1/2 I went to the P.A. associated with my Dr.'s office, and she prescribed a shot. and six  20 mg. pills of prednisone, the pills to be taken once per day.  She also prescribed hydroxyzone to be taken no more than 4 times/day.  This treatment alleviated the itching for the most part, however the hives continued to break out the same as originally described.  After the treatment, I put up with the hives.  At the end of the third week, the number of outbreaks began to lessen.  Only three days ago (Oct. 15th) did the hives finally fail to break out.
COVID symptoms started within 8-9 days of vaccination. No fever, general not feeling, chills. Turned into very difficult breathing, low oxygen levels and pneumonia. Tested positive for COVID at Hospital ER on Wednesday, January 27. Died in the hospital Saturday morning, January 30, 2021.
got a sh gles shot and by chance got the shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female 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 received as follows: The age at vaccination was not reported. The patient got the shingles vaccine and experienced shingles. The reporter wanted to look at the ingredients first, aluminum, mercury and formaldehyde. This case was considered as suspected vaccination failure as time to onset, number of doses and laboratoty confirmatory test were unknown at the time of reporting.
Patient vaccinated at 5:30pm that she began to feel a tingling sensation on her tongue. The patient was assisted to the bed where she lied down and three sets of vitals were obtained. Contacted Dr. and was instructed to administer 25mg of Benydryl orally. Obtained 3 sets of vital signs. The patient relayed she would like to walk around and was assisted walking around the gym. The patient relayed that she no longer had any symptoms and was assisted to the door.
RECEIVED VACCINES LATE AFTERNOON 8/22, REDNESS, SWELLING AND WARM TO TOUCH WITH DISCOMFORT REPORTED 8/23 6 PM.  RECEIVED MOTRIN ONE DOSE PM 8/23 AND 2ND DOSE 8/24 AM.  REFERRED TO MD FOR EVALUATION
- urinated 6 times every hour throughout the night - at 3am she got cold - went to sleep early at 8pm
patient returned to provider's office after the patient developed itching and redness over the upper body 60-90 minutes after vaccination.
2 hours within taken the 2nd vaccine started feeling extreme uncontrollable jerking and shakiness as I did with the first vaccine.  My mom called they told her to tell me to stay as calm as possible and if we felt the need to go to EMR.  I didn't go to EMR this time due to the high bill I occurred the last time.  My mom have me children benadryl in med dropper and muscle relaxer to try to control the jerk. It lasted 3 hours. But continued off and on through out the night and into the next day 6/23/21. Each episode lasting anywhere between 2 to 4hours.
Patient fell and hit back of head (remained conscious). Silver dollar-sized swelling. No bleeding. BPs 233/85, final BP 202/90. O2 sat 97%. Sent to ED.
Injection site pain, arm pain - started the evening of the vaccination and for the next 4 days Muscle aches, fatigue, general malaise - started the day following the vaccination and for the next 4 days