chrisvoncsefalvay/vaers-outcomes huggingface dataset:
8 days after 2nd dose, besides a sore arm, I developed a lump under my arm and across my breastbone to the middle of my chest with pain radiating from the injection site all the way across. The lump stayed and I started going to the CDC website to see what to do and it said it was normal on the website, but it wasn't under it was crossing over. It was a big lump too, in inches. I iced it, and as it went down it started to itch. On May 31 I had a heart attack, and the lump went down. They told me they couldn't verify if it was the vaccine or not. My heart threw a clot, and I had to have open heart surgery and they put in a stent. I left on the 3rd day from the hospital. I live enclosed now because I'm scared to catch COVID, and I am scared to die. I didn't have any heart disease before this.
Injection site of arm is warm, hot; Dry heaving; Nauseous and dry heaving; Fever; Chills; Injection site of arm is warm, hot and red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site of arm is warm, hot), RETCHING (Dry heaving), NAUSEA (Nauseous and dry heaving), PYREXIA (Fever) and CHILLS (Chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939906 and 042C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported  by the reporter.  Concomitant products included VITAMINS NOS (DAILY VITAMINS) for an unknown indication.   On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Injection site of arm is warm, hot), RETCHING (Dry heaving), NAUSEA (Nauseous and dry heaving), PYREXIA (Fever), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Injection site of arm is warm, hot and red). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Injection site of arm is warm, hot) and VACCINATION SITE ERYTHEMA (Injection site of arm is warm, hot and red) had not resolved and RETCHING (Dry heaving), NAUSEA (Nauseous and dry heaving), PYREXIA (Fever) and CHILLS (Chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.     The patient continued using ice and Tylenol for ongoing symptoms after taking guidance from HCP and pharmacist.
1310c/o nausea 1312 vitals taken BP 156/85 P111 O2 sat100% 1317 still c/o nausea. Vitals BP 14./84 P101 MD stat called. 1318 c/o itching in head  1321 c/o hard to breathe. 1322 MD arrived. 1323 stated nausea subsiding. 1324 BP 121/81 P77 PO2 99  1327 Pt stated felt "normal" MD stated was ok to leave.
Pt reports rash to left upper arm since 2 days ago started with itchiness and pt notices redness, warmth, and soreness.  pt states Moderna shot to same arm on 19 MAY.
Dizzy; Headache; Bodyaches; Temperature of 100; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 23Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FL9893) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3, Manufacturer unknown), for COVID-19 immunization.  The following information was reported: PAIN (non-serious) with onset 23Apr2022 at 18:00, outcome "unknown", described as "Bodyaches"; DIZZINESS (non-serious) with onset 23Apr2022 at 18:00, outcome "unknown", described as "Dizzy"; HEADACHE (non-serious) with onset 23Apr2022 at 18:00, outcome "unknown"; BODY TEMPERATURE ABNORMAL (non-serious) with onset 23Apr2022 at 18:00, outcome "unknown", described as "Temperature of 100". The patient underwent the following laboratory tests and procedures: Body temperature: (23Apr2022) 100. Therapeutic measures were not taken as a result of dizziness, headache, pain, body temperature abnormal.  Additional Information:  the patient received no other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination,  the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Mom states that pt was due for next dose of APAP; noted that pt felt "like was burning up; mom went to get the APAP; mom came back, pt was having sz; t103 p/sz; pt vomitted x 1; ER dx ear infect;
temperature excursion; This spontaneous report was received from a nurse concerning a patient of unknown age. The patient's current condition, medical history and concomitant therapy were not reported.   On 20-AUG-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (lot # T002843, expiry date: 23-JAN-2022; at the dose of 0.5 ml, frequency and route were not reported) as prophylaxis.         The nurse was calling to report temperature excursion (product storage error) that was intermittent beginning since 20-AUG-2020 (also reported as 28-JUL-2020), but not previously reported, involving administered dose of varicella virus vaccine live (oka/merck) (VARIVAX). The call was because of data logger. The temperature was from -14 degrees Celsius to -10 degrees Celsius (max -9.5 degrees Celsius). The time frame was reported as total 38 hours and 30 minutes.
Had a lot of body ache; This keeps coming and going; My whole back and shoulders and arms were hurting; My whole back and shoulders and arms were hurting; My whole back and shoulders and arms were hurting; This is a spontaneous report from a contactable consumer (patient). A 80-years-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) , on unspecified date at SINGLE DOSE for Covid-19 immunization. The patient medical history was not reported.  The patient's concomitant medications were not reported. Consumer stated, "I got the Pfizer vaccine last Friday, the 8 (not clarified) and I had the reaction right away that night and the side effects the whole day, I had a lot of body ache. With the week, it got somewhat better but this keeps coming and going. Like this morning, I was, also the same thing, my whole back and shoulders and arms were hurting and when I took a hot shower, it seems to help like for a half an hour or so. Now, I have the same pain again. So, I had called the center, I went back because I am in a community, and we got the vaccine there. So, I went back and I asked them, can I take Advil, because Tylenol did not do nothing for me. So, the Advil did helped me somewhat and by Saturday night, it went away. However, the whole week again comes and goes and this morning, I do not know I took Advil at night like at 01:00 and it just made me sweat but the pain in the morning, I still get the same reaction. So, what can I do for it? I am just calling to know."Outcome of the events was unknown.  Information on the Lot/batch number has been requested.
Right eye developed a green line like a fat magic marker from inside of eye up towards middle of outside of eye.  Changes color to Orange and red.  Never had this before.  Had symptoms for one hour on the night of injection then went away,  returned mid day the next day.  As I am writing this.
Alopecia Areata within a few weeks of first dose; to include loss of facial hair.
Pt felt dizzy, lips turned blue and BP was low after administering shot. Called 911 and sent her to hosp. Followed up after 2 days and pt felt fine. Had low BG too.
Tested positive for Covid. Symptoms experienced include spiking fevers, headaches, muscle aches, no energy, and excessive coughing. I was limited to bed rest for 13 days, spending about 23 hours a day in bed each of those days. Coughing was still extreme for a full month, even when taking Robitussion. Coughing still occurring to day when exposed to cold air, at night, and random times throughout the day, but not as bad or severe.
first injection in Aug 2020/Didn't get 2nd injection till June 2021.; This case was reported by a consumer via Shingrix GSK and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in August 2020).   In June 2021, the patient received the 2nd dose of Shingrix. In June 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient was due for 2nd dose of Shingrix in October 2020 but didn't get it until June 2021, eight months after it was due, which led to lengthening of vaccine schedule. The patient want to know if the patient would be safe from Shingles, or if the patient should get 3rd injection. The follow up would not be possible as no contact details were available.
Apparent sudden infant death syndrome, fed normally at 1am, found unresponsive at 5:30am.
BODY ACHES, SLIGHT FEVER, HIGHER BLOOD PRESSURE, NAUCIOUS, SLEEPING AND STAYING IN BED FOR 3 DAYS
22FEB93 shortly p/vax apneic episode-CT brain-nl;septic work-up-blood, spinal fluid; Ampicillin/Claforan IV started;23FEB93 just p/MN sz activity-status epilepticus-phenobarb coma-intubation on 24FEB93;lt sided weakness;sepsis w/u
noisy ear; started feeling dizzy; had a five-hour vertigo attack/Since that date she has had seven more vertigo attacks; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included meniere's disease (had been inactive for 18 months).   On 12th May 2021 15:14, the patient received the 1st dose of Shingrix (intramuscular). In May 2021, 17 hrs 46 min after receiving Shingrix, the patient experienced dizziness and vertigo. On an unknown date, the patient experienced ear noises. On 13th May 2021, the outcome of the vertigo was recovered/resolved. On an unknown date, the outcome of the dizziness and ear noises were not recovered/not resolved.   It was unknown if the reporter considered the dizziness, vertigo and ear noises to be related to Shingrix.  Additional details were provided as follows:  The case was reported by the patient herself. The patient received the 1st dose of Shingrix at 03:14 PM into the right deltoid.  The next morning on 13th May 2021 at 09:00 AM, the patient started feeling dizzy.  On 13th May 2021 at 06:00 PM, 1 day 2 hours 46 minutes after receiving Shingrix, the patient had a five-hour vertigo attack.  Since then the patient had seven more vertigo attacks and experienced noisy ear and still felt dizzy at the time of reporting. The reporter consented to follow up.
Administer expired vaccine to 450 patients after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. Total of 102 doses/vials were given for LOT  026C21A. The vial did not undergone to any temperature excursions. No treatment medication information provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live Follow-up received contains non significant information
Vaccine Administered at Inappropriate Site; Erythema about 1.5 inches in diameter at the injection site; Injection site indurated; Injection site swollen; Injection site warm; This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 41-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number J75AH, expiry date 30th June 2020) for prophylaxis.   On 7th October 2019, the patient received Fluarix Quadrivalent 2019-2020 season (intramuscular). On 7th October 2019, unknown after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced vaccine administered at inappropriate site. In October 2019, the patient experienced injection site erythema, injection site induration, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site induration, injection site swelling, injection site warmth and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site erythema, injection site induration, injection site swelling and injection site warmth to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were received as follows: The patient received Fluarix not in the deltoid muscle but about 4 inches below the deltoid muscle on the lateral side of the left arm, which led to vaccine administered at inappropriate site. In addition, the patient also had erythema about 1.5 inches in diameter at the injection site which is warm to touch with induration and it was swollen. The reporter consented to follow up.
This spontaneous prospective pregnancy report as received from a nurse midwife refers to a 17 year old female patient. No information regarding the patient's medical history or concurrent conditions was provided. The patient became pregnant with the date of last menstrual period (LMP) of approximately 31-JUL-2015 (it was reported that the patient was between 10 and 11 weeks pregnant at the time of this report) and estimated delivery date (EDD) of 06-MAY-2016 (calculated from LMP). On approximately 25-SEP-2015, reported as about 2 weeks ago, the patient was vaccinated with a dose of GARDASIL injection (lot# K023432, expiry date 18-JUN-2016; dose and route of administration were not reported). It was reported that the patient was about 8 weeks pregnant at the time of vaccination. There were no concomitant therapies reported. No adverse effect was reported. The patient did not seek medical attention and no treatment was given to her. At the time of this report, the pregnancy outcome was pending and the fetal outcome was unknown. There was no product quality complaint involved. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 57 year old female patient with drug hypersensitivity. The patient's medical history included herpes zoster. On an unknown date the patient was vaccinated with ZOSTAVAX for prophylaxis. Concomitant therapies included duloxetine hydrochloride(CYMBALTA), fluoxetine hydrochloride(PROZAC), metoprolol succinate(TOPROL XL TABLETS), losartan(LOSARTAN), aspirin(ASPIRIN), prasugrel hydrochloride(EFFIENT), trazodone hydrochloride(TRAZODONE HYDROCHLORIDE), atorvastatin calcium(LIPITOR) and lansoprazole(PREVACID). On JUN-2018 the patient experienced rash. On an unknown date the patient experienced occupational exposure to product. The outcome of rash was reported as not recovered/not resolved. The outcome of occupational exposure to product was unknown.
Several hours after the injection I experienced the onset of Flu-like symptoms. Body ache all over, lasting 3 days. Second day I also experienced sneezing, coughing and stuffed nose, but not like a regular head/chest cold but rather like a severe allergic reaction. Symptoms lasted about 6-7 days.
Pain in the left shoulder with restricted range of motion. Injection site was noted to be high on the deltoid and injection might have been given into the left shoulder joint.
Vaccine given to a 16 year old; A spontaneous report was received from a parent concerning a 16-year-old, male, patient, who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 22 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 22 Jan 2021, the patient received his first dose of the Moderna vaccine and he is only 16 years old. The patient was fine and has had no side effects. Consent given for Safety to follow up.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, vaccine was administered to a 16 year-old, was considered resolved on 22 Jan2021.; Reporter's Comments: This case concerns a 16-year-old, male, patient who received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. There were no reported adverse events per reporter for this case of product administered to patient of inappropriate age
Pneumonia; This is a spontaneous report from a contactable consumer (patient).  A 66-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 24Feb2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient stated she received the first dose of Pfizer COVID-19 vaccine on 24Feb2021 and then got Pneumonia and was unable to get second dose until 06May2021. She had three doctors telling her she needed to repeat the series. She would like to know if this was true. She also asked if there was any information on the efficacy of getting the second dose outside of the 6week mark and if there was any information about receiving a third dose. She stated looking forward to receiving the booster when it was available. The outcome of the event was unknown.  Information about batch/lot number has been requested.
Hearing loss; Dizziness; This is a literature report.  A 67 year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "autoimmune inner ear disease" (unspecified if ongoing), notes: 3+ years - stable; "Meniere's" (unspecified if ongoing), notes: 3+ years - stable. The patient's concomitant medications were not reported. The following information was reported: DEAFNESS (medically significant), outcome "unknown", described as "Hearing loss"; DIZZINESS (non-serious), outcome "unknown", described as "Dizziness". The events "hearing loss" and "dizziness" were evaluated at the physician office visit.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between reported events and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Extensive swelling of left thigh, started next day (mother noticed), size of an orange and redness from upper thigh to approx 3-4 cm above left knee and laterally.  Patient went to ER and admitted with diagnosis of Cellulitis (suspicion). Admitted 3/4/07-D/C 3/6/07.  03/15/2007 MR received for an ER visit for c/o an erythematous area on the right thigh at the site of the DTaP 2 days prior.    PE: WNL except a 10cm area of moderate swelling on the right thigh.  There is evidence of infection as manifested by moderate erythema, induration, warmth, and mild to moderate tenderness.  Diagnosis:  Leg cellulitis.   Confirmed with vaccine administrator (who verified with mother)  that vaccine was given in the LEFT thigh.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information on patients' medical history or concurrent conditions was provided. On an unknown dates, the patients were vaccinated with improperly stored doses of (Oka-Merck) PROQUAD injection, lot # L021599 with expiration date 10-DEC-2016, L009210 with expiration date 17-SEP-2016 (dose and route of administration were not reported). No information on patients' concomitant medication was provided. The reporter could not determine which of the reported lot numbers were administered to the patients and which were not. No adverse effects were reported. This is one of the two reports from the same reporter. Additional information has been requested.
Pt anxious and states lightheaded and numbness in mouth area.  Pt was in ADA drive thru observation; laid seat chair back, removed mask and encouraged sips of water.  Noticed pt had portable oxygen in passenger seat, states he was COVID positive in Jan and was discharged with the O2 to be used prn.  Medics evaluated pt; VSS, O2 sats 98%.  Pt left but was not  in distress.
Pt has autoimmune disorder (Graves), hives, swollen and hurt arms to elbows (knots 4 days), palpitations, confusion, headache, nausea (lasts 4 days), sore throat, runny eyes and nose which increased hyperthymia, raspy cough. Pt on sedatives and antihistamines,