chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient experienced right-sided arm pain which progressed to bilateral arm pain the following day headache and nausea as well as muscle aches. He did not have fever. Immediately after the immunization he developed lightheadedness and a near syncopal episode occurred. He lied down and once feeling better was sent home.
Nurse Triage Note of 3/29/2021:  3/29/2021  8:40 AM EDT ----- Symptoms or Concerns: 2nd vaccine fever and delirious breathing issues/ Patient is on a Antibiotic. Symptoms:  Caller with patient. Patient's pulmonologist recently put him on 1 tablet of azithromycin three times a week, started 3/24, to see if it improves his lung function. He saw Dr. on 3/24 to discuss this. He received his 2nd Moderna vaccine on 3/26 at 10:30am and two hours later he developed a fever. The fever has since broke. Per wife his SOB started yesterday but he's been using 2L of O2 since he got the vaccine. He normally uses the oxygen with his CPAP at night only. His SpO2 has been as low at 80%. Now at 8:44am it was 88% (on 2L O2) with a pulse of 96. Patient can be heard breathing laboriously over the phone. He's felt a little lightheaded and dizzy. See care advice given.  Advised to  go to ED. 3/29/2021  ED/Hospital admission.  Patient admitted for respiratory failure. He reports prior to admission he was mod I using 4WW for ambulation. He lives with his spouse in a 2 level home with main level living. The patient is a white male, came by ambulance today. His main complaint is shortness of breath. He has an extensive medical history as listed below. This is both COPD, CHF. He tells me he has had increasing oxygen needs over the last several days. He denies exposure to coronavirus to his knowledge. He is not been coughing up any blood but he has been bringing up some phlegm. He does not think he had fevers. He is on Eliquis. Patient has oxygen at home, he states sometimes he does not need to wear it at all but he has been wearing it constantly the last few days because of how tired he feels. Clinical Impression 1. Dyspnea, unspecified type; 2. Pneumonia of left lower lobe due to infectious organism; 3. Acute cystitis without hematuria.
slight itch in area of Zostavax vaccine, reddness, tender to touch, slight swelling
No adverse event; 2, 4 year old twin female patients who had their 2 primary series, inadvertently got a 3rd primary dose instead of the Moderna Bivalent booster today, 17May2023; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (2, 4 year old twin female patients who had their 2 primary series, inadvertently got a 3rd primary dose instead of the Moderna Bivalent booster today, 17May2023) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Mar-2023, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (2, 4 year old twin female patients who had their 2 primary series, inadvertently got a 3rd primary dose instead of the Moderna Bivalent booster today, 17May2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (2, 4 year old twin female patients who had their 2 primary series, inadvertently got a 3rd primary dose instead of the Moderna Bivalent booster today, 17May2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (2, 4 year old twin female patients who had their 2 primary series, inadvertently got a 3rd primary dose instead of the Moderna Bivalent booster today, 17May2023).    No concomitant medications were reported. Patient had received 2 primary series dose. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-716158 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716158:2nd Child Female Twin Patient
Shingles vaccine given 6/27/12. 6/28/12 chest wall pain - ER visit. 6/29/12 worsening radiating pain incapacitating. Admitted to hospital for dx & treatment.
Patient developed a fever that lasted about 4 days. She then developed a cough that lasted for over a month. The cough came and went for the next 2 months. Patient was then noted to cough whenever she ate peanuts. She developed a peanut allergy.
Starting day after vaccine, patient started showing neurological side effects: tic and circling of head and body, swaying back and forth, unable to sit straight upright, and increased fatigue - unable to stay up all day.  1/16/2020: saw MD, did urine culture. 1/19 took patient to the ER, diagnosis of UTI. Started antibiotics 1/20 according to culture and sensitivity. After 1 dose of Augmentin, starting to see improvements of neurological symptoms.   Neurological symptoms likely due to UTI.
Patient came into pharmacy about 3 days after getting PREVNAR 13 vaccine said he's been feeling dizzy/lightheaded since he got vaccine.
Patient has shingles on the left lower extremity from the mid post sacral area to the bottom of his feet.
Information has been received from a pharmacist refers to a 21 year old female patient with cold sores and no drug allergies or reactions. On 12-APR-2013, the patient was vaccinated with a first dose of GARDASIL (lot # 1073AA, exp date 11-OCT-2015). 0.5 ml, intramuscular; on 31-MAY-2013 was vaccinated with a second dose of GARDASIL (lot # H018755, exp date 21-MAR-2015), 0.5 ml, intramuscular and on 18-OCT-2013 was vaccinated with a third dose of GARDASIL, 0.5 ml, intramuscular lot # reported as J007850 exp date 07-APR-2016. Concomitant therapies included VALTREX. The pharmacist stated that patient tested positive for HPV on a "pap smear" on a recent, unspecified date in 2013. The outcome of patient tested positive for HPV on a "pap smear" was reported as not recovered/not resolved. No other adverse effects had been observed or reported. The pharmacist stated that the physician is going to repeat the "pap smear" in 6 months on an unspecified date, and the physician would be agreeable to follow-up. The patient sought unspecified medical attention. Additional information has been requested.
Pediatric Patient received 50mcg or 0.25ml of Moderna Covid-19 vaccine from an Adult vaccine with a Red Cap; child received a 50mcg dose instead of the 25 mcg dose for his second dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Pediatric Patient received 50mcg or 0.25ml of Moderna Covid-19 vaccine from an Adult vaccine with a Red Cap) and INCORRECT DOSE ADMINISTERED (child received a 50mcg dose instead of the 25 mcg dose for his second dose of the Moderna Covid-19 vaccine) in a 5-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 21-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Pediatric Patient received 50mcg or 0.25ml of Moderna Covid-19 vaccine from an Adult vaccine with a Red Cap) and INCORRECT DOSE ADMINISTERED (child received a 50mcg dose instead of the 25 mcg dose for his second dose of the Moderna Covid-19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Pediatric Patient received 50mcg or 0.25ml of Moderna Covid-19 vaccine from an Adult vaccine with a Red Cap) and INCORRECT DOSE ADMINISTERED (child received a 50mcg dose instead of the 25 mcg dose for his second dose of the Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.  The Medical Assistant had a situation where for a pediatric patient received 50mcg or 0.25ml of Moderna Covid-19 vaccine from an Adult vaccine with a Red Cap the child was 5 years of age. The child received a 50mcg dose instead of the 25 mcg dose for the second dose of the Moderna Covid-19 vaccine.   Reporter did not allow further contact
He experienced heart issues as a reaction to the second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 20 year-old male patient received bnt162b2 (BNT162B2), administration date 28Apr2021 (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), administration date: 07Apr2021, when the patient was 19 years old, for COVID-19 Immunization. The following information was reported: CARDIAC DISORDER (non-serious), outcome "recovered", described as "He experienced heart issues as a reaction to the second dose". The event "he experienced heart issues as a reaction to the second dose" was evaluated at the physician office visit.  Additional details: Patient received Pfizer COVID-19 vaccines at the age of 19 years on 07Apr2021 and 28Apr2021. Patient is now 20 years old and experienced heart issues as a reaction to the second dose. Patient did not go to the hospital as a result of the adverse event. It was reported that by the time patient visited his cardiologist, he was back to normal. Reporter enquired if there was any data on patients who experienced side effects of myocarditis with the primary series, getting a booster dose.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Immediately had a sore arm.  Woke up in the middle of the night with chills, severe pain in left arm (hurt to move it or lay on it).  Legs were like jello.  Lasted all of the next day.  Woke up on Friday (2 days after shot) and felt fine.
inappropriate shedule of vaccine administered; no adverse event; This spontaneous report has been received from a lawyer, from a case in litigation for zoster vaccine live (ZOSTAVAX) (regulatory authority # 1907USA003436), concerning a 66-year-old female patient.  On 30-APR-2013 (at 65 years old), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23 (reported as PNEUMOVAX)); then on 12-MAR-2015, she was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (reported as pneumococcal) (manufacturer unknown) (strengths, doses, routes, anatomical locations, lot numbers and expiration dates for both administrations were not reported) as prophylaxis (inappropriate schedule of product administration). It was stated that no adverse reaction or side effect was experienced due to the patient's vaccination.; Sender's Comments:  US-009507513-1907USA003436:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 1, single (Batch/Lot number: unknown) and (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pericarditis" (unspecified if ongoing), notes: Other medical history: Pericarditis. Concomitant medication(s) included (in 2weeks ): DAYQUIL/NYQUIL, start date: 03Jan2023, stop date: 04Jan2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid as treatment for Covid 19 from 04Jan2023 to 09Jan2023 and patient did not have any known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Guillain Barre/GBS symptoms; This serious case was reported by a other health professional via call center representative and described the occurrence of guillain barre syndrome in a 45-year-old male patient who received HBV (Engerix B) (batch number 7MH25, expiry date 07-DEC-2025) for prophylaxis.   Co-suspect products included Mmr ii for prophylaxis and Aesculus hippocastanum (Varivax) for prophylaxis.   On 18-OCT-2023, the patient received Engerix B (intramuscular, left deltoid), Mmr ii (subcutaneous, left arm) and Varivax (right arm). On 11-NOV-2023, 24 days after receiving Engerix B, the patient experienced guillain barre syndrome (Verbatim: Guillain Barre/GBS symptoms) (serious criteria hospitalization and GSK medically significant). The outcome of the guillain barre syndrome was not resolved.   It was unknown if the reporter considered the guillain barre syndrome to be related to Engerix B and Engerix B Pre-Filled Syringe Device.     It was unknown if the company considered the guillain barre syndrome to be related to Engerix B and Engerix B Pre-Filled Syringe Device.   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: 15-NOV-2023 The reporter called to report that a patient received Engerix B along with MMR and Varivax on same day, and developed GBS symptoms. The patient was admitted to the hospital and currently was in the ICU. Reporter was uncertain what dose in the 3 dose series of Engerix B the patient received. On 11th November 2023, 24 days after receiving Varivax and MMR2, the patient experienced guillain barre syndrome. The MMR2 was administered subcutaneously in the back of the left arm (not deltoid) and the Varivax was administered in the right arm. MA was uncertain what dose in the 3 dose series of Engerix-B the patient received. It was unknown if the reporter considered the guillain barre syndrome to be related to Varivax and MMR2 vaccine. The reporter consented to follow up.
Patient said injection site is warm to touch, painful, swollen and red..seemed to be spreading down arm toward elbow.  Also had night sweats for 2 nights so far that required 4x pajama change and a fever of 101.3 Thursday night 11/20/08.  Reported slight shortness of breath when climbing stairs. She said she was ignoring symptoms and hoping that it wasn't really happening...that is why she didn't call until Friday at 3:45pm 11/21/08.
Metallic taste in mouth almost immediately after administration of the vaccine.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196) via an unspecified route of administration in the right arm on 15Jul2021 at 18:15 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included migraine and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included naproxen sodium (ALEVE) from an unknown date and unknown if ongoing for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took clindamycin (MANUFACTURER UNKNOWN) and experienced allergy. On 15Jul2021 at 18:15, immediately after the vaccination, the patient experienced a metallic taste in the mouth. The events did not result in doctor or other healthcare professional office/clinic visits, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event metallic taste in the mouth was not recovered at the time of the report.
Information has been received from an approximately 63 year old female patient with penicillin allergy and shingles about six years who in approximately March 2010 ( about two or three months ago"), was vaccinated with a dose of ZOSTAVAX (Merck) (lot number not provided). There was no concomitant medication. In approximately March 2010 ("about two or three months ago"), the patient experienced shingles for about three days, and the rash was in the same spot the original rash had been. The patient also experienced intense breast pain. After a few days of these symptoms, the patient had been about 90 percent pain free. Shingles had made her very tired and now she had her energy back. No lab diagnostics studies were performed. In approximately April 2010 ("about two months ago"), the patient recovered. The patient did not seek medical attention. No further information is available.
Before given vaccination baby breastfeed with no difficulites. Immediately after vaccinations childs O2 stats would drop when feeding and would no longer accept the breast. Also for the next 2 years had aspiration pneumonia.
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: Patient fainted once, then almost again. Called 911 to have evaluated before leaving. Was feeling ok upon departure
Narrative:  Per Telecare note from 7/6/21, patient stated that he has rashes on his right hip and right buttock area that looks like a blister, stated he had his shingles vaccine [on 6/29/2021] and noticed the rashes on Sunday (7/4/21). After examination of rash, PCP prescribed valacyclovir and lidocaine ointment. Per Telecare note on 7/12/21, patient reports the rash is still present and burning/itching. Note states it is therefore "unclear if rash was due to zoster" and it was recommended to seek emergency care. Patient called back same day and said he would be going to a local non agency ER.
Day 1-5, had high fever treated with Tylenol and Motrin. Day 6, raised rash behind ears, fever and cough; day 7, raised rash on face and fever; day 8, raised rash on neck and fever; day 9, raised rash all over face, neck, body and fever and day 10 to day 25, "measles rash" and fever.
Burning; Itching; Really red and really big blotchy reaction at the site of injection; Glands in her armpit are sore; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Burning), INJECTION SITE PRURITUS (Itching), RASH MACULAR (Really red and really big blotchy reaction at the site of injection), AXILLARY PAIN (Glands in her armpit are sore) and PYREXIA (Low grade fever) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K 20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced INJECTION SITE PAIN (Burning), INJECTION SITE PRURITUS (Itching), RASH MACULAR (Really red and really big blotchy reaction at the site of injection), AXILLARY PAIN (Glands in her armpit are sore) and PYREXIA (Low grade fever). At the time of the report, INJECTION SITE PAIN (Burning), INJECTION SITE PRURITUS (Itching), RASH MACULAR (Really red and really big blotchy reaction at the site of injection), AXILLARY PAIN (Glands in her armpit are sore) and PYREXIA (Low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment include ice and hydrocortisone cream. No concomitant medications were reported.
Severe joint pain, difficulty walking ,sleeping, holding items. Exacerbation of arthritis . Elevated ANA blood test.  The pain is worsening day by day since day 2 after receiving the vaccine
Information has been received from an unspecified reporter via social media referring to thousands of unspecified female patients. On unknown dates the patients were vaccinated with GARDASIL (dose, lot # and route were unknown). On unknown dates. the patients were killed and disabled by therapy with GARDASIL. Outcome of disability was unknown. It was unknown if autopsies were performed. Additional information has been requested.
9/5/08 - Mom states child had redness and swelling 1 hour after receiving immunizations. Mom states child had a fever and was given Motrin. Area on lateral part of LT. arm was slightly red, swollen - about the size of fifty cents piece and was warm to touch. Instructed mom to take child to family MD or ER. Mom will call us back and let us known what MD found.
only received one dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (only received one dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (only received one dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (only received one dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported.  No treatment medication were reported.  Patient received his first dose of the Moderna vaccine back in late Apr 2021 or early May2021.
This spontaneous report was received from a registered nurse via company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot#, expiration date and route not reported). No concomitant medications were reported. On an unknown date the patient experienced vomiting and nausea post vaccination of GARDASIL. No lab diagnostic studies were performed. No treatment was given for the events. Medical attention was not sought for the events. Outcome of the reported events were unknown. Additional information is not expected.
Pt came to pharmacy at 250pm on 10/29/17. The lower half of his upper arm was red and warmer than the rest of his arm. About six hours after the vaccines were administered, he stated that the redness began at the injection sites and became "extremely sore." The soreness has mostly gone away, but the redness still exists on the lower half of his upper arm. Pt did not seek treatment. He will monitor himself for worsening of the pain, redness, inflammation and breathing difficulty.