chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Scalp burning; Scalp burning and total itching.; Tenderness still to touch and burning sensation on right side of skull; Burning sensation on right side of skull; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on an unknown date in Mar2021 (at the age of 46-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 28Apr2021 at 11:15 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 19Mar2021 at 00:00, the patient experienced scalp burning and total itching. Tenderness still to touch and burning sensation on right side of skull. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events burning sensation scalp, itchy scalp, scalp tenderness and burning sensation on right side of skull were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
RAISED AREA LOA, APPROX.70MM X 70MM .  NO OTHER SYMPTOMS.
Extreme fatigue, followed by nausea and headache. These happened after the first dose as well, the difference being that instead of one day, these symptoms lasted three days.  They were no more or less severe than the first time.
Unconscious; Covid 19; This serious case was reported by a other health professional via interactive digital media and described the occurrence of unconscious in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30-NOV-2020, the patient received the 1st dose of Shingrix. On an unknown date, several hours after receiving Shingrix, the patient experienced unconscious (Verbatim: Unconscious) (serious criteria GSK medically significant) and covid-19 (Verbatim: Covid 19). The outcome of the unconscious was not reported and the outcome of the covid-19 was resolved.   It was unknown if the reporter considered the unconscious and covid-19 to be related to Shingrix.     It was unknown if the company considered the unconscious and covid-19 to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-MAY-2023 This case was reported by the patient via interactive digital media. The pharmacy told to the patient if had chickenpox at a risk of getting shingles free vaccination would be offered. The patient received 1st shot and after hours later the patient was unconscious in ambulance, not known. The covid end days later. The follow-up could not be possible as no contact details were available.
Addendum on 31 October 2014. Upon internal review it was identified that the suspect product INFLUENZA INTRADERMAL (476) should have been coded as INFLUENZA INTRADERMAL (390). The correction has been made to this case. Initial report received from a healthcare professional on 24 October 2014. A 59-year-old female patient, whose medical history was unknown, received an intradermal injection of FLUZONE ID (lot number not reported) on 03 October 2014. Approximately 15 minutes post-vaccination, the patient experienced bronchospasm, shortness of breath, nausea, and itchiness. She was seen in the emergency department and treated; treatment information was not reported. Outcome was reported as unknown, however at the time of the report the patient still complained of some ongoing shortness of breath. She had not been evaluated by a physician since 03 October 2014 per the reporter. Documents held by sender: None.
45 seconds generalized seizure. 26 hrs post vaccine, associated with T 102.8.
Burning sensation in hand; Hardness at injection site; Burning sensation and pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning sensation in hand), VACCINATION SITE INDURATION (Hardness at injection site) and VACCINATION SITE PAIN (Burning sensation and pain at the injection site) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced BURNING SENSATION (Burning sensation in hand), VACCINATION SITE INDURATION (Hardness at injection site) and VACCINATION SITE PAIN (Burning sensation and pain at the injection site). The patient was treated with NAPROXEN SODIUM (ALEVE) for Pain, at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (Burning sensation in hand), VACCINATION SITE INDURATION (Hardness at injection site) and VACCINATION SITE PAIN (Burning sensation and pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   Patient is using ice at injection site as corrective.   Reporter did not allow further contact
Tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriatic arthritis, Plaque psoriasis (moderate to severe chronic plaque) and Penicillin allergy. Concomitant products included ADALIMUMAB (HUMIRA) for Plaque psoriasis and Psoriatic arthritis, CLOBETASOL for Psoriasis.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced FATIGUE (Tired). On 08-Feb-2021, FATIGUE (Tired) had resolved.            Treatment medications were not reported.  Action taken with mRNA-1273 in response to the event was Not Applicable    This case was linked to MOD-2021-087480.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: NNI-Added VAER
PATIENT STATED SHE STARTING TO HAVE SEVERE ITCHING DAY AFTER VACCINE AND ALSO NOTICED A LUMP ON HER ARM.  THE EFFECTS WERE GETTER WORSE DAILY .
13cm wide x 10 cm wide.  Reddened area on left upper arm with itchy.  Ice applied.  Advised to call pepifant improved.
Per patients mom, who called 6/6/12, patient had reaction after receiving 3 vaccines (MCV, HPV, TdaP) on 5/29/12. Patient had rash and hives from that evening on through yesterday. Stated on 6/6/12 itching has resolved. Provider advised mother to give patient antihistamine for rash, but mother states patient refuses to take medication.
Severe whole body purpuric rash; fevers to 102 degrees F; fatigue
7:00pm started vomiting, shaking, temp 102 degrees, body aches. Vomiting ended 3:00pm 6/5/13, temp lasted till 5:00am 6/6/13, shaking ended 3:00pm 6/5/13. Still feeling nausea and achy today.
The child received the vaccine then returned to her classroom.  About 15 minutes later she asked to go to the nurse's office with complaints of GI symptoms.  Before she could get out of the classroom, she fainted hitting her head on a hard objection.  She sustained a hematoma.  She recovered quickly from the the fainting spell and was transported to the ER for evaluation of the hematoma.
9:15 a.m. while waiting in 15 minutes observation c/o Tingling to upper and lower extremities VS Hr=59, o2 sat 99-100% x2 151/86 9:20 checked on and states that tingling is resolved. VS Hr=67, o2 sat 99-100%, BP 147/89 9:25 a.m. no new symptoms, states she is feeling fine 9:35 a.m. Patient  stated symptoms resolved and left site, accompanied by co-worker.
Day after 3rd dose of Engerix-B, had onset of generalized joint pain, neck stiffness & pain. Say PMD; temp 101.4. Patient reported jaundice on 7/6/90; to see PMD regarding this.
irregularity as missed periods entirely, they didn't come.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A 42-year-old female patient received BNT162b2 (BNT162B2), on 10Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Manufacturer: Pfizer, LOT: EL1283, EXP: 30Apr2021, Dose and Route: Unknown , Time: in the morning, guessing between 8:00AM-8:30AM), administration date: 26Jan2021, when the patient was 41-year-old, for COVID-19 Immunization, reaction(s): "Menstrual irregularity"; BNT162b2 (DOSE 2, SINGLE, Manufacturer: Pfizer, LOT: EN5318, EXP: 31May2021, Dose and Route: Unknown, Time: 7:45 AM), administration date: 16Feb2021, when the patient was 41-year-old, for COVID-19 immunization, reaction(s): "Menstrual irregularity".  The following information was reported: MENSTRUATION IRREGULAR (non-serious), outcome "not recovered", described as "irregularity as missed periods entirely, they didn't come.". The event "irregularity as missed periods entirely, they didn't come." required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of menstruation irregular.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
My father had a stroke  2 1/2 weeks after his 4th vaccination.  Was in good health prior to it.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 21-Sep-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of refrigeration of vaccine was 19-Aug-2021.  No concomitant medication information was provided. No treatment information was provided.
Pt received flu shot 11/8/04, returned to PCP clinic 11/10/04 with complaints of fever 104 with URI symptoms, diarrhea; given Motrin, Zyrtec, Oratuss and Viravan DM. Instructed to follow up in 2d if temp 101.
Rash all over, loss of eye contact, stopped responding to audible stimuli, stopped babbling and conversing.
This spontaneous report as received from a registered nurse refers a patient of unknown age and gender. The patient medical history and drug reactions or allergies were not provided. On an unknown date, the patient was vaccinated with oral, ROTATEQ (lot # and expiration date were not provided). Concomitant medication information was not provided. On an unknown date, the patient received oral ROTATEQ that was improperly stored. No adverse effects were reported. It was unknown if the patient sought medical attention. At the time of the report, the patient status was unknown. This is one of several reports received from the same source. Additional information has been requested.
per report via email - patient receive COVID vaccine during staff clinic in the AM.  During the evening patient started to feel sick.  symptoms included: nausea/vomiting, uncontrollable jerk like seizures, very disoriented, respirations ragged and rapid.  Family called 911 taken via ambulance to local ER.  per report patient received IV fluids, medicine to treat nausea/vomiting and meds to "get his respirations under control".  patient sent home and is now resting.
I received both the high dose flu shot and the second pneumonia shot at the clinic yesterday.  By the afternoon I had a very sore arm and general tiredness.  As the day transitioned into evening I had joint pain, headache, minor nausea, and a bit of trouble concentrating.  I took aspirin and went to bed.  When I got up in the middle of the night I still had all those symptoms, but they were joined by dizziness.  I was improved this morning, though the headache and a sore back have persisted through this evening.  The aspirin continues to help.  I do not think these symptoms were out of line with expectations, but I have never reacted to a flu shot with more than a mild soreness at the injection site.  I am reporting this just because I feel the high dose flu shot was perhaps inappropriate for me.  I am 66 years old (even though your form can't figure that out).  But I am in wonderful health and do not have any indications of having trouble with my immune system.  The clinic did not ask what kind of flu shot I wanted, the nurse just seemed proud that they had the high dose shot available.  Believe me, this is the last high dose flu shot I'm getting.
Fatigue; tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and FATIGUE (tired) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history not reported). Concomitant products included OCRELIZUMAB.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced FATIGUE (Fatigue) and FATIGUE (tired). At the time of the report, FATIGUE (Fatigue) and FATIGUE (tired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication not provided
Painful headaches that caused my eyes to hurt, seeing yellow flurries, dizziness, nausea, muscle aches, fatigue, bruising at injection site, neck pain radiation to bilateral shoulders and pain shooting down my spine to the middle of my back for 3 days.  I had a fever of 102 degrees for 2 days.  The headaches, neck and shoulder pain continues as of to date.  I took Tylenol 1000mg, Motrin 800 mg and Naproxen 500mg for pain relief.
Mother reports injection site from (R) elbow to (R) shoulder red, swollen and warm to touch. Symptoms reported 24 hours after injection. Does c/o itching. Mother administered BENADRYL.
Pt recvd 3 doses of Engerix-B, 3rd dose given 9NOV90 & it was determined that pt did not convert to a protective surface antibody level;
warm to the touch; Bruised; Swollen; Red; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (warm to the touch), CONTUSION (Bruised), INJECTION SITE SWELLING (Swollen) and INJECTION SITE ERYTHEMA (Red) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, the patient experienced INJECTION SITE SWELLING (Swollen) and INJECTION SITE ERYTHEMA (Red). On an unknown date, the patient experienced INJECTION SITE WARMTH (warm to the touch) and CONTUSION (Bruised). At the time of the report, INJECTION SITE WARMTH (warm to the touch), CONTUSION (Bruised), INJECTION SITE SWELLING (Swollen) and INJECTION SITE ERYTHEMA (Red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Patient received MODERNA COVID-19 vaccine, waited about 15 min afterwards with no reaction and was seen leaving pharmacy area. About 30 minutes afterwards, patient  was found laying on floor in the aisle by a customer who then notified front store employee. When employee approached patient, he was awake and alert, but was described as having white foam coming out of mouth and sweating. He said he was ok but just needed to lay down and rest for a bit. Then he got up and went to restroom and reportedly vomited. 911 was called and response team ended up walking with him out of store.
Systemic: Other- Patient became dizzy causing him to fall. Pt had no injuries from the fall but paramedics/ fire dept came and took him to the hospital for further evaluation. No definitive explanation for fall.
It was a typical respiratory virus with runny nose cough congestion sore throat, the surprising thing is that it was a really bad cough that lasted over weeks and that is when we contacted the doctor. The doctor stated bad viruses are going around that last a long time so we continued with home remedies including cough medicine at night to help her sleep. Due to the bad coughing she threw up a few times.
COVID-19, PF, Pfizer (12+ years) 10/29/2021, 4/27/2021 and 4/6/2021. Hospitalized with asymptomatic COVID-19 1/2/2022.
Information has been received from a 26 year old female Pharmacy student who on 15-MAR-2007 was vaccinated intramuscularly with a 0.5 ml dose of Gardasil. Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO TRI-CYCLEN LO). On 20-SEP-2007 the patient was vaccinated with third dose of Gardasil. On 23-SEP-2007 the patient developed a small bubble under the skin at the injection site. This bubble lasted for a couple of months. On 01-NOV-2007, the bubble got "hug", red, swollen and painful. "It looked like a bite." At the time of the report the patient's outcome was reported as not recovered. Additional information has been requested.
OBSTRUCTIVE SLEEP APNEA ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY
Mild pain, moderate swelling at site, fever 101. Saw Dr twice. Treated for Staph Infection.
Swelling of the throat.  Took 25 mg diphenylhydramine hydrochloride.  This relieved symptoms until 11:00 PM at which time I felt some swelling again and took another dose of the antihistamine.  No symptoms after that.
Patient stated before vaccination that he had no reaction to 1st dose of Moderna.15 minutes after injection, patient started feeling faint. When  speaking to him, he would look at me but didn't seem to understand what I was saying as he wasn't responding to questions. He said in a weak voice that he felt faint and hot and didn't communicate much other than that. He was shakey and sweaty. We gave him an ice pack for the back of his neck, took his blood pressure/pulse, and called an ambulance. BP was 110/64, pulse 101. About 10 minutes later he had to use the restroom and we assisted him to the restroom. Upon returning to the pharmacy, the paramedics were on scene and he was feeling and looking better. They took his BP again and it was 127/72. The paramedics stayed with him for a while, but he was unwilling to go to the ER. They took his BP again which was 139/85 and pulse 66. After paramedics left about a half an hour later, he stayed seated at the pharmacy and was supervised for another 20min. Patient stated he felt fine and went home.
severe side effects; This case was reported by a consumer and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of adverse event (received 1st dose of unknown date, refer case US2020AMR099935).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and experience more severe side effects.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR099935:same reporter
This spontaneous report was received from a physician via company representative refers to a 12 year old male patient. Medical history was not reported. On 02-SEP-2014 the patient was vaccinated with the first dose of GARDASIL and on 03-NOV-2014 the patient was vaccinated with the second GARDASIL injection, intramuscular, lot # K009811, expiration date 19-JUN-2016. Concomitant therapy was not reported. The physician informed that on 04-NOV-2014 the patient had a temperature of 100, sweating and nausea after receiving GARDASIL. The patient sought medical attention by a call. The outcome of the events was unknown. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 63-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Jun2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "recovered" (Nov2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Nov2023) Negative; (17Nov2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 11Nov2023 to 16Nov2023. Clinical Course: Patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / COVID-19 cannot be ruled out,Linked Report(s) : US-PFIZER INC-202300384620 same patient/ reporter, different product/event;