chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recvd vax & exp dose 3 pt exp a rash on arms; had a flushed face & was warm, weak, dizzy, & SOB; tx DPH; resolved in 24 hrs;
Within 48h of receiving vaccine, diarrhea and vomiting occured. No fever. No treatment, observe only.
same evening had onset of h/a not relieved by APAP & only partially relieved by Ibuprofen; h/a cont & next day also devel sharp shooting pain lasting a few seconds;
Breakthrough Case of COVID-19: I started to feel ill, I did an at home test, it was positive. I had a mild fever, headache, sinus pressure, and residual coughing. I am still quarantining.
This spontaneous report was received from a healthcare worker refers to six different unspecified patients of an unknown age and gender. The relevant medical history, concurrent condition and concomitant medication of the patients were not reported. On an unknown dates, six different unspecified patients were vaccinated with six doses of improperly stored VARIVAX (Merck) lot # L048465 (expiry date: 02-DEC-2017) (dosage not reported). The temperature excursions were 3C for 1 hour 54 minutes and 3.8C for 2 hours 11 minutes. No previous temperature excursion involved. No adverse effects were reported. Additional information has been requested.
According to pt's descriptions, she developed high fever and injected arm swollen and severe painful a few hours post vaccination given; then progressed into N/V/D then developed acute mental status changes, electrolyte imbalance, and arrthymia dehydrated on 12/26/02, Hep A and B IgM (+).
Swelling mid lower arm to shoulder. Redness at site Rt arm, fever 102.
Irritability & screaming;tx w/Ibuprofen & DPH per MD order;
nausea; severe vertigo; This is a spontaneous report from a contactable consumer, the patient via a Pfizer sales representative. A patient of unspecified age and gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date 11 days post vaccination first dose, the patient experienced severe vertigo for 3 days with nausea. The outcome of events, severe vertigo and nausea was unknown.   The lot number for vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021211715 second dose
PRESENCE IN LEFT LEG; BACK TENSION; FATIGUE; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: 23-JUN-2021) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, the subject experienced fatigue. On 12-MAY-2021, the subject experienced back tension. On 18-MAY-2021, the subject experienced presence in left leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from back tension, and fatigue, and had not recovered from presence in left leg. This report was non-serious.
Headache, nausea, and fever of 100.8 starting 1 hr after vaccine administration. Taking ibuprofen with relief. Symptoms still present on evaluation 9/8/2016.
Patient felt anxious prior to coming for vaccine due to last minute sign up.  Right after getting the vaccine she experienced her throat tightening - stated she felt off- was shaky, lightheaded and heart racing. She came to the observation station- while sitting for observation she felt she wanted to get away from everyone else and came to the check in desk. Her symptoms started to subside when I escorted her to the recliner.  I gave her some Gatorade   bP 90/60 pulse 80.  She was feeling less anxious   O2 sat done at 11:51 99 % she stated she was feeling fine .  repeat BP 104/60 p 60 at noon.  I checked with lead at the clinic who agreed she should stay till 12:10 She felt fine when she left this nurse discussed the plan if she needed help would be to go to urgent care or call police if it was urgent.
Refrigerator went in and out of range while there was flu vaccine in it. Doses were administered - no adverse effect This spontaneous case initially received on 02-Nov-2016, was reported by a health professional and concerns an 83 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 09-Sep-2016, the patient received AFLURIA for indication not reported. Dose regimen: Not reported. Route of administration: Not reported. Batch number: WT53706. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 09-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. The patients will be contacted for revaccination.
he felt like his skin was burning; he felt like his his hands were peeling; Patient broke in a rash all over the body, except face and hands; Injection was more painful after booster dose; Redness around the injection area; Sore arm; A little bit of swelling on his left arm; This spontaneous case was reported by a consumer and describes the occurrence of SKIN BURNING SENSATION (he felt like his skin was burning), SKIN EXFOLIATION (he felt like his his hands were peeling), PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (A little bit of swelling on his left arm) and RASH (Patient broke in a rash all over the body, except face and hands) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059H21A, 040B21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Kidney stones. Concurrent medical conditions included Chronic lymphocytic leukemia (15 years ago) and Blood pressure high (20 years ago). Concomitant products included LEVOTHYROXINE, AMLODIPINE, SIMVASTATIN, TAMSULOSIN and ALPRAZOLAM for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (A little bit of swelling on his left arm), VACCINATION SITE PAIN (Injection was more painful after booster dose) and VACCINATION SITE ERYTHEMA (Redness around the injection area). On 29-Dec-2021, the patient experienced RASH (Patient broke in a rash all over the body, except face and hands). On an unknown date, the patient experienced SKIN BURNING SENSATION (he felt like his skin was burning) and SKIN EXFOLIATION (he felt like his his hands were peeling). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Pain in arm, at an unspecified dose and frequency. On 31-Dec-2021, PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (A little bit of swelling on his left arm), VACCINATION SITE PAIN (Injection was more painful after booster dose) and VACCINATION SITE ERYTHEMA (Redness around the injection area) had resolved. At the time of the report, SKIN BURNING SENSATION (he felt like his skin was burning), SKIN EXFOLIATION (he felt like his his hands were peeling) and RASH (Patient broke in a rash all over the body, except face and hands) had not resolved.            Alprazolam medication dosage includes as necessary.  The caller broke on a rash all over the body, except his face and hands. A medication was prescribed for rash, but patient did not remember the name, and stopped treatment a week ago, because felt like his skin was burning and his hands were peeling.   This case was linked to MOD-2022-496528, MOD-2022-496478 (Patient Link).
Moderna COVID-19 Vaccine EUA.  Erythematous, raised, warm and tender 5 cm macule at the site of injection estimated to be a delayed T cell reaction to the vaccine.
High fever; He was having a fever and he ended up sweating it out on the bed, he was not even making the signs; Actually woke up in a furrow of water that came out of his body with a 102 degree fever; Sore throat; Teeth hurt; Teeth ache; Teeth all hurting; Pain on my teeth; Body ache; High fever; He was having a fever and he ended up sweating it out on the bed, he was not even making the signs; Actually woke up in a furrow of water that came out of his body with a 102 degree fever; Fatigue all over body; Sweaty sweat all over body, dripping sweat; I broke out with sweat and sweaty palms and forehead; Really sweaty; Woke up super-hot like the whole bed was wet; Got sick; Feeling tired all over, Very tired; We were really hot at night, it is like burning inside; Extremely very hot, very thirsty, and dizzy, kind of tired, fatigue; Extremely very hot, very thirsty, and dizzy, kind of tired, fatigue; Extremely very hot, very thirsty, and dizzy, kind of tired, fatigue; This is a spontaneous report from a contactable consumer. There were 2 reporters on the call reporting for themselves. This is the second case out of the two cases where reporter handed over the phone to her Fiancée (Consumer) and he is reporting for himself.   This consumer (patient) reported for himself that a 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0191), via an unspecified route of administration on 19Jun2021 at 16:15 (at the age of 46-year-old), as dose 1, single in deltoid left, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had no family medical history. On an unspecified date, the patient experienced high fever; he was having a fever and he ended up sweating it out on the bed, he was not even making the signs; actually woke up in a furrow of water that came out of his body with a 102 degree fever; sore throat; teeth hurt; teeth ache; teeth all hurting; pain on my teeth; body ache; fatigue all over body; sweaty sweat all over body, dripping sweat; I broke out with sweat and sweaty palms and forehead; really sweaty; woke up super-hot like the whole bed was wet; got sick; feeling tired all over, very tired. Patient was really hot at night, it was like burning inside; and extremely very hot, very thirsty, and dizzy, kind of tired, fatigue. Patient received treatment for the events. Treatment medications included Tylenol 500mg and Advil 200mg and Naproxen 500mg, once every 12 hours, twice a day. Patient had to take Nyquil and half a Benadryl to help fall asleep because of the pain on his teeth, and sore throat. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The clinical outcome of all events was reported as unknown.  Follow-up attempts are completed. No further information is expected.
I experienced COVID-19 after my vaccine. I had terrible headache and do not recall I had a cough. The first day it was very bad, came on very fast and did take Paxlovid for 2-3 days and I quit taking the whole dosage because of the weird taste in my mouth. On day 3, I started to feel better.  I have recovered from my symptoms.  I never had any adverse effects to any vaccines.
Shot 11:30 am. At 3 pm painful extension of arm. Swell area injection. Later area turned pink and continued to spread down and around arm. Second day large red area 2" above bend of arm, inside. Continued to swell & spread. Emergency in afternoon. IV treatment then 5 days of KEFLEX & hot compresses 5 days.
Low grade fever, sore hot arm, redness injection site ~ 9hrs post injection.  Vomiting 16hrs post injection continuing 24 hrs post injection.  A little tired and vomits when she feels too hot. Still monitoring, giving fluids and tylenol as needed for fever.  Otherwise in great spirits
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 35-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. 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.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300182900 same reporter/patient, different drug/AE.;
Patient passed out, was briefly unconscious in chair. She woke up and felt disorientated. She felt tingling sensation throughout body and a burning pain in stomach.
I started feeling bad on Monday night. I rested on Tuesday. By Tuesday night, I tried to get up, felt hot and faint, and nearly passed out in my bedroom. I did fall down and hyperextended my knee and scraoed my feet, so now I can hardly walk. Thankfully, my boyfriend ran in the room and grabbed me. I got up again to go to the bathroom and felt hot and faint, so I put a cold washcloth on my head and laid in the bathroom. I stopped taking Tylenol, but I am still feeling weak, faint, and dizzy nearly 72 hours later. I've tried to walk around a little bit, but I'm still feeling like I could faint - weak, off, dizzy. I've tried to rest and drink lots of fluids. Frankly, I'm scared of how I feel.
approximately 25 minutes past receiving the COVID vaccine I felt numbness in my neck and clavicle area.  This resolved on its own after about 2 hours of receiving  the vaccine
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Shakiness-Mild, Systemic: Vomiting-Medium, Additional Details: patient fell in the ground  a few min after  he received vaccine and he  started sweating. pt felt better after he vomited and refused to go to the hospital
very bad rash at the injection site/very big round rash; red; Hot; itchy; little hurt arm; tired; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (little hurt arm), FATIGUE (tired), INJECTION SITE RASH (very bad rash at the injection site/very big round rash), INJECTION SITE ERYTHEMA (red) and INJECTION SITE WARMTH (Hot) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included blood pressure medicines, water pills, VITAMINS NOS, stomach probiotic and ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced ARTHRALGIA (little hurt arm) and FATIGUE (tired). On an unknown date, the patient experienced INJECTION SITE RASH (very bad rash at the injection site/very big round rash), INJECTION SITE ERYTHEMA (red), INJECTION SITE WARMTH (Hot) and INJECTION SITE PRURITUS (itchy). At the time of the report, ARTHRALGIA (little hurt arm), FATIGUE (tired), INJECTION SITE RASH (very bad rash at the injection site/very big round rash), INJECTION SITE ERYTHEMA (red), INJECTION SITE WARMTH (Hot) and INJECTION SITE PRURITUS (itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications included Cortisone 10 cream she buy in a store and then the doctor prescribed Betamethasone.
MULTIPLE BLOOD CLOTS; This spontaneous report received from a consumer concerned a 6 decade old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: not feeling well when the patient went in for his vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose and start therapy date were not reported, 1 total, for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date (11 days after vaccination), the patient experienced multiple blood clots and was hospitalized (dates and duration unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of multiple blood clots was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210902779-COVID-19 VACCINE AD26.COV2.S - Multiple blood clots. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
My daugther had a fever of 105-106 she started having seizures. Then she had Rashes. She was running high fevers for over 2 days 105+. She was not focusing on her toys. she couldnt stay awake for over 30 minutes.
hurt; This case was reported by a consumer and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient took the shingles on thursday and stated was not suffered much but it did hurt a lot.
2-3 days p/vax pt devel redness & rash @ immun site, pruritis, no  inc temp, no inc crying;no cough, no resp sx;today 21JAN97 scabbed areas seen @ site from pruritis;referred to MD;
Pt stated, on 11/26 - 11/27, starting noticed rash on the lower center back. They were itching. Pt presented today to let us know. The rash looks red, small bump and scabbed. Pt was instructed to call Md to report the adverse effects
Patient is 16 years old and was given Moderna.  There was no adverse reaction.  Patient's parent was given EUA and consented to vaccine.
Patient was given 0.2 mL of undiluted vaccine.  No Diluent added.  Patient observed in clinic for 30 minutes without any adverse reactions noted.
Received varivax and fluzone in right arm, small amount of swelling and redness noticed for a few days after, started to go away and then returned and worsened on 10 /4/19 with induration of 0.5x2cm and 1x3cm erythema nontender. Warm to touch. Started on a course of Keflex X 10 days
PUI tested positive on 9/16 after experiencing diarrhea and dehydration. PUI was admitted to Hospital from 9/17-9/19 for an IV as she was dehydrated. PUI has no other symptoms. PUI is fully vaccinated with Pfizer vaccine that she got on 2/25 and 3/15. PUI has an autoimmune condition, kidney disease and diabetes that she is not experiencing any difficulties with during this time.
Gave a patient a full dose of 0.5 mL instead of a 0.25 mL booster dose.; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Gave a patient a full dose of 0.5 mL instead of a 0.25 mL booster dose.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Gave a patient a full dose of 0.5 mL instead of a 0.25 mL booster dose.). At the time of the report, ACCIDENTAL OVERDOSE (Gave a patient a full dose of 0.5 mL instead of a 0.25 mL booster dose.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information was provided.
Perioral and hand numbness shortly after vax. No actual OP or chest sx. No rash.   Pulse 83 Ox 97%   Likely vaccine reaction.   Felt better with lying down and pushing PO fluids.
pt recvd vax; area around immun on rt arm red,size of quarter,tender to touch; no fever;15nov94 soreness, lasted 2 days;
Pt recved Hep B vax in OCT90 & in JAN & FEB 1991 pt exp flu-like sx; Im MAY or JUN 1991 pt was rejected for blood donation; pt was informed that post for Hep B core antibody;
Patient explained that she experienced a metallic taste immediately upon receiving the vaccine. The taste lasted a few minutes before going away.
Fever 101.2  Nausea with vomit Tiredness  Hot flashes and chills Light headed Confusion
pt recvd vax; MD wonders whether arhtritis related to vax; severe rheumatoid arthritis; had other vax in june 94 & had rash  & arthritis; vax on jun10, had rash & arhtarlgia; arthritis worsened & pt dx adult stills'disease;
Case number PHEH2014US025048, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 66 year old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 1455701) intramuscularly at a dose of 0.5 ml on 03 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion.
Minor discomfort following Shot at first  Following with pain at injection point.   I took it more it was cause by person giving shot as it was central to the injection site.  Was given by a Pharmacist   On May 24th 2021  went for quarterly Dr visit and was put on Jardiance 10mg Tab  my weight was 388.   I started to get a loss of apatite and abdominal pain.  On June 8th it became severe  Contacted PCP.  PCP  ordered a ultra sound  ended up going to Went to ER on   June 19th.    had a cat scan run to look at intestinal and found swelling
Hep B given on 9-30-14 LD; pt came to clinic 10.2.14 when symptoms appeared that morning. Arm reddened, warm, and hard, pt stated it was itching. Ice pack applied via instructions by provider.