chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; This is a spontaneous report from a contactable consumer, the parent. A 20-year-old non-pregnant female patient received unspecified dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the arm left on 31Mar2021(at the age of 20-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient received concomitant medication included unspecified birth control within two weeks of vaccination. 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 vaccination. On 01Apr2021, the patient experienced headache. The events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event headache was recovered on 01Apr2021 at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Nausea; Headache; Red area at site of injection; Raised area at site of injection ~3 inches long; Bruising at the site of injection; Arm pain at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm pain at the site of injection), NAUSEA (Nausea), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (Red area at site of injection) and VACCINATION SITE SWELLING (Raised area at site of injection ~3 inches long) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]), VITAMIN D NOS, PROBIOTICS NOS, BECLOMETASONE DIPROPIONATE (QVAR) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE PAIN (Arm pain at the site of injection). On 28-Feb-2021, the patient experienced NAUSEA (Nausea), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (Red area at site of injection), VACCINATION SITE SWELLING (Raised area at site of injection ~3 inches long) and VACCINATION SITE BRUISING (Bruising at the site of injection). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Arm pain at the site of injection), NAUSEA (Nausea), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (Red area at site of injection), VACCINATION SITE SWELLING (Raised area at site of injection ~3 inches long) and VACCINATION SITE BRUISING (Bruising at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Full body hives, wheezing. Had to get a steroid shot from medical doctors office.
Positive Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive Covid-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Historical conditions 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 COVID-19 (Positive Covid-19). At the time of the report, COVID-19 (Positive Covid-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: positive (Positive) POSITIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-023205 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-023205:
I experienced extreme vertigo. With standing felt as though I might faint. Felt unsafe being alone
This spontaneous report as received from a nurse refers to unspecified patients of unknown age. On an unknown date, unspecified numbers of patients were vaccinated with GARDASIL INJ, (dose, frequency, route of administration and indication were not provided). GARDASIL was exposed to 8.8C for 10 days, and then administered to unspecified numbers of patients on unspecified dates. No concomitants were reported. No adverse effects reported. No product quality complaint (PQC) was involved. The outcome of events was unknown. No further information provided. This report is linked to 1405USA013915 and 1405USA013916 by the same reporter link. Additional information has been requested.
About 9 days after my first vaccination, I had a red skin reaction that was warm and burned at the injection site.  It resolved on its own within a couple of days.
Marked redness, swelling and pain at site of PPV 23, Headache, nausea, dizziness, neck pain.
Throat tightening and respiratory distress in a patient with anaphylaxis to allergy shots in the past (that requiring multiple doses of epinephrine to treat). This occurred about 30mins after administration of the Moderna vaccine. Patient complained of worsening symptoms and asked that epinephrine be administered as she felt this was similar to her previous anaphylaxis episode. Though she did not have stridor I felt early administration of epi in this high risk patient was appropriate. Her symptoms improved after administration.
Nausea, pain in injection site, loss of appetite. Sleepiness, numbness in  mouth.
So my PMDD came back with a vengeance after the second dose of the vaccine. After the first dose, I had the most painful period t the most painful 12 hours of my entire life, so I was worried about THAT. Turns out I was physically fine, but mentally very unwell. It felt different/ similar to when I was 19 and tried an antidepressant that made me feel actively suicidal, so. I don't know how to describe the difference in feeling, but it came out of nowhere, was very strong, I wanted to kill myself for half of April, and it wasn't for any *reason* whatsoever, it was just hormonal. So my best guess is that the second dose interfered with the balance my birth control gives me now, and the shock to my system made it even worse than it had been in the past.  This lasted from the 4th, through my period, and after, until the 19th.  I was barely able to take care of myself at all during this time, and it was very difficult/ debilitating. Also scary!
Pt recv vax & exp convulsions. 2 other pt exp same sx. (WAES97050306 & WAES98032329).
numbness in toes/ 3 digits on one foot were numb; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 79 year-old female patient 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 (First dose), for COVID-19 immunization. The following information was reported: HYPOAESTHESIA (non-serious), outcome "recovered", described as "numbness in toes/ 3 digits on one foot were numb".  Additional information: Extended family member reported experiencing numbness in toes following 2 dose of COVID 19 vaccination 3 digits on one foot were numb. Numbness subsided after several weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
patient received an expired dose of vaccine/no AE; Initial information was received on 24-Jun-2021 regarding an unsolicited valid non-serious case received from a nurse via Regulatory Authority (Reference number- 00655131).  This case is linked to case 2021SA212366 (same reporter).  This case involves a patient of unknown age and gender who was vaccinated with 0.5 mL [once; standard] expired dose of TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (batch number R2A301M and expiry date 31-May-2021) via an intramuscular route at the right deltoid on 23-Jun-2021 for prophylactic vaccination (expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy was given.  It was a case of an actual medication error due to expired vaccine used (latency was on same day).  It was reported that "Wanted to know what to do and what recommendations were".  At the time of report, no adverse event reported.  Result of assessment was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information was received on 04JAN2017, 09JAN2017, 10JAN2017 and 13JAN2017 from GlaxoSmithKline (GSK) in the form of blinded CIOMS report. GSK physician indicated the study drug was unblinded and subject received ava (lot FAV634) only and did not receive raxibacumab. Suicidal Ideation. This female subject was enrolled in a blinded GSK study. The subject received ava vs ava+raxibacumab+diphenhydramine from an unknown date as a study participant. The subject's past medical history included impacted wisdom tooth, removal of wisdom teeth and lumbar spine compression fracture. Concurrent medical conditions included back pain. On 17th December 2016, an unknown time after the first dose of ava vs ava+raxibacumab+diphenhydramine, the subject developed moderate - grade 2 suicidal ideation. Serious criteria included hospitalization and GSK medically significant. The outcome of suicidal ideation was not recovered/not resolved. The GSK investigator considered that there was no reasonable possibility that the suicidal ideation may have been caused by ava vs ava+raxibacumab+diphenhydramine. Additional information: GSK study subject was upset over breaking up with her boyfriend and jumped out of 2-story window (about 15 feet from the ground). She was sent to the emergency room for evaluation. She had no physical injuries but was positive for ethanol. She reported back pain, but the subject has a current medical history of back pain and it is unclear at this time if this was a worsening of the back pain. The study subject was involuntarily committed to a mental health facility. She is expected to be released by the end of 2016 and will contact the GSK study site at that time so that they can update this information.
Patient developed cellulitis of the right leg where Dtap was given. Patient was taken to Healthcare at 9:58 pm by mother and patient treated by Dr and given an antibiotic.
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients of unknown age and gender. The patients' medical history was not reported. In April 2016 (reported as between 05-APR-2016 and 14-APR-2016), the patients were vaccinated with improperly stored ROTATEQ (lot # L029617, expiration date reported as 19-MAY-2017, oral (dose was not reported). No adverse effects were reported. Administered doses of vaccines, experienced the temperature excursion of 53.2 degrees Fahrenheit for 4 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports from the same reporter. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Aug2022 as dose 4 (booster), single (Lot number: FP7138) at the age of 65 years, in left 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: other medical history: asthma; "known allergies: yes" (unspecified if ongoing), notes: known allergies: yes. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Flu-like.  Extreme fatigue, headache, no appetite, intestinal distress, brain fog
Initial information received on 05-Mar-2019 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves a six months old female who received a 0.5 ml dose of suspect ACT-HIB (lot UI987AAA and Exp. Date 01-Apr-2020) via subcutaneous route in the left thigh on 04-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error case due to inappropriate route of vaccination. It was unknown whether the patient had any adverse reactions. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Patient received HPV vaccination 9/01/17 at 2:33 p.m. Patient reports at 4 p.m. on 09/01/17 she noticed an itchy red rash throughout (denied SOB) her body, worsening at 11 p.m. She went to E.D. at 2 a.m., was given rx for prednisone x 4 days and diphenhydramine x 4 days. Both completed yest, 9/05/17 w/complete recovery from rash.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program. A patient (no qualifiers provided) received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient had pain/body pain (big problem; 7 months), with outcome of unknown. The batch/lot number for BNT162B2 not provided and will be requested during follow-up.
fever for 1 day after second vaccine; fever and chills after second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever for 1 day after second vaccine) and CHILLS (fever and chills after second vaccine) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 002B21A) for COVID-19 vaccination. No Medical History information was reported.On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced PYREXIA (fever for 1 day after second vaccine) and CHILLS (fever and chills after second vaccine). On 09-Apr-2021, PYREXIA (fever for 1 day after second vaccine) and CHILLS (fever and chills after second vaccine) had resolved. No concomitant medications were reported. Treatment information was not provided. Patient reported no adverse reactions after first dose.
Headache, Mildly elevated, fever 100.4 at home afebrile in office, fatigue, left deltoid soreness experienced the day after vaccine which was received at 11:30 on 3/31/21.
pt recv vax 14MAR97 & that same day pt exp severe h/a w/vomiting & was hosp;vax & pt exp were temporally assoc but a relationship between the two was unk;
Induration, heat, and redness approximately one inch below  and to the left of the injection site.. The reddened, indurated, warm area measures approximately three inches in width and 4  and 3/4 inches in length.   It is painful and tender to touch.
Tinnitus  Had very mild case in right ear from sound damage for 10 years prior...after receiving vaccine the tinnitus suddenly increased more 50%
Fever; chills; runny nose; ear ache; body aches; swollen glands; This is a spontaneous report from a contactable Other HCP (patient). This 27-Year-old female Other HCP patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number El3248/expiration date: unknown), via unknown route of administration, on 22Jan2021 01:45 PM (at the age of 27 years old) as a single dose on left arm for COVID-19 immunisation at a hospital. Relevant medical history included Depression, insomnia. The patient had no known allergies. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number Ek9231/expiration date: unknown), via unknown route of administration, on 04Jan2021 01:00 PM (at the age of 27 years old) as a single dose on left arm for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Relevant concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that on 23Jan2021 01:00 AM, the patient experienced fever, chills, runny nose, ear ache, body aches, swollen glands. The outcome of the events fever, chills, runny nose, ear ache, body aches, swollen glands was not recovered. No treatment was received for the events. Since the vaccination, the patient has not been tested for COVID-19.
Fever first 12 hours.  Extreme fatigue one month later. Low White Blood Count. After vaccine 3.2 one week later 3.0 Extreme malaise and faint.  Palpitations, dizzy spells, complete inflammation. Head aches.
Security notified this writer SM was feeling "light headed" post 1st dose of Pfizer covid vaccine.  SM seated in auditorium seating. Writer approached SM. SM stated she was light headed.  Assessed SM, noted sweating, pale skin and dilated pupils. Patient then went unconscious for approximately 30-60 seconds with seizure like activity. Increased diaphoresis noted.  Upon regaining consciousness patient declined any medical history including DM or seizures.  Rapid was called, arrived within minutes.  VSS were noted to be HR of 43, BP of 68/42.   Legs were elevated in seating.  When attempted to move SM to gurney SM went unconscious again.  Fireman lifted to cart, elevated legs.  No seizure activity noted with second unconscious event. SM placed on left side with legs elevated. Return of consciousness noted.  Moved to alcove with Rapid team.  IV placed, fluids started. Monitored vitals prior to transport to ED. SM's manager made aware and vocera returned to unit.
SORE THROAT, RUNNY NOSE, NAUSEA AND VOMITING,
Coronavirus 04/30/2021 1 of 2 COVID-19, mRNA,LNP-S,PF, 100 mcg/0.5mL [Moderna COVID-19 Vaccine ®]   06/02/2021 2 of 2 COVID-19, mRNA,LNP-S,PF, 30 mcg/0.3mL [Pfizer COVID-19 Vaccine ®]  Client presented card and vaccinator didn't noticed that the first dose was a moderna and client was given pfizer for 2nd dose. Vaccinator educated to ensure that correct vaccine is given and that patient could have been rescheduled to received the correct vaccine. Vaccinator verbalized understanding. Client informed of error.
I had a sore throat, sinus stuffiness, headache, cough which I still have, diarrhea, nausea, extreme fatigue, pain in my chest. I have no sense of smell or taste. General malaise, I just couldn't hardly move and had no energy. All of the symptoms I had were extreme. I had no appetite.  All of these symptoms were happening by the night of 06/24/2022 . On 06/26/2022 I went to Urgent Care. On 07/03/2022 I went back because my lungs were hurting so bad. On 07/03/2022 I was sent to Emergency Care by the doctors. They prescribed two medications based on ER visit. Albuterol Sulfate Inhalation and Benzonatate.
14AUG2019: Receive & shot 11:30AM. 1600PM without warming severe direah began for 3 hours. 1700 without warning, 2-3 stomach contractions causing vomiting. I was very weak. Could not arise from floor. Direah ceased. recovery slow but complete.
SAME DAY OF VACCINE, PT REPORTS ARM SORENESS. 1 MONTH LATER PT RETURNS FOR SECOND DOSE AND REPORTS ARM IS STILL SORE IN DELTOID REGION, PAIN SCORE 2/10
27yo F patient with no PMH, here for Pfizer COVID vaccine 1st dose. Immediately after receiving the vaccine she was feeling "tingling/numbness" in both the left arm (where the vaccine was inoculated) as well as in her left leg, episode lasted < 1min. Patient is afraid of needles and was also experiencing "Rapid heartbeat" before the vaccine was given. Denies any other symptom. Patient was evaluated by on-site EMS and MD. On PE noted to be AAO x 3; Initial VS: HR 84, RR 20, SpO2 100%, BP 120/70. Heart with RRR, lungs clear bilaterally. After 20min observation patient felt better, repeated set of VS within normal limits. Patient was discharged home with complete resolution of symptoms.
Moderna COVID-19 Vaccine EUA.  pain, swollen and redness of entire upper arm
Bleeding stroke; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGIC STROKE (Bleeding stroke) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history provided). Concomitant products included ROPINIROLE HYDROCHLORIDE (REQUIP) for an unknown indication.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced HAEMORRHAGIC STROKE (Bleeding stroke) (seriousness criteria hospitalization, disability and medically significant). The patient was hospitalized from 11-Apr-2021 to 14-Apr-2021 due to HAEMORRHAGIC STROKE. At the time of the report, HAEMORRHAGIC STROKE (Bleeding stroke) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Apr-2021, Computerised tomogram head: brain bleed Brain Bleed.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient states an Anti seizure medicine was used for treatment. After discharge from hospital, patient states she now has to take therapy.   Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, Very limited information regarding this event has been provided at this time.  Further information has been requested.