chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a 20 year old female patient with no pertinent medical history and no drug reactions/allergies. There was no concomitant medication. The patient was administered three doses in the pediatric RECOMBIVAX HB (lot# not reported) series on 28-DEC-1992, 27-JAN-1993 and 27-SEP-1993 intramuscular respectively. The patient had titers for hepatitis B drawn on 15-JUL-2013 and the results came back as indeterminate. The patient was subsequently administered a 5 mcg (0.5 ml) dose of RECOMBIVAX HB on 18-JUL-2013. The patient sought medical attention by seeing in the office and no treatment was given. No lab diagnostics studies were performed. At the time of reporting, the outcome of patient was not recovered. Additional information has been requested.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 03-DEC-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
high fever up to 105-107 by thermometer (otic) several hr p/vax;pt did have pharyngitis but reporter felt fever from vax;
Patient woke up that morning and could barely open his mouth. Later in the afternoon he was able to open it wide enough to eat. No reaction at site of injection. By the next day he was close to fully recovered.
pt recvd vax; next am reported had an allergic rxn, swollen eyes & difficulty breathing; tx by MD w/ DPH & proventil MDI;
Within 101 min of immunizations, was staring and had ear pain, then eyes rolled back and pt "passed out" mom noted neck pulled to side and pt postured-lasted approx 1 min and postical state. Appeared well after incident (+) For Hx vagal syncope (Dad)
FAINTING, REPORTS HISTORY OF SYNCOPE; B/P- 115/78, HR-66, PULSR OX- %
1st Dose: Injections site pain, tenderness and swelling by the afternoon;  slight light-headed/dizziness in the evening into the next day. Took two dose of Tylenol on the second day for the pain in the arm. The light-headed/dizziness was gone by the fourth day.  2nd Dose: Injection site swelling tenderness and body ache by the afternoon; fever, intense head ache, dizziness, light sensitivity eye pain vision impaired, lost of appetite lethargic state of not feeling well lasted for three days after the injection. Symptoms were treated with Tylenol every 4-hours, intake as much water, bush tea and home-made fish and onion soups that I could and slept/rest. On the third day the fever subsided about midday, but the headaches, eye sensitivity, lost of appetite, and lethargy continued, which continued to be treated with Tylenol, bush tea and soup. By the fourth day the head aches subsided, appetite still light, slight light-headed, some diarrhea and tenderness at the injection site continues. Symptoms were treated with bush tea and rest. Body achy feeling, eye sensitivity are not apparent.
Got real hot after 2nd booster dose; Shaking like crazy after 2nd booster dose; Had chills after 2nd booster dose; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Got real hot after 2nd booster dose), TREMOR (Shaking like crazy after 2nd booster dose) and CHILLS (Had chills after 2nd booster dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056A22A, 052F21A, 039B21A and 039B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Allergy to vaccine (Tetanus) and Blood pressure abnormal. Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), LISINOPRIL and AMLODIPINE for Blood pressure abnormal.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Apr-2022 at 8:30 AM, the patient experienced FEELING HOT (Got real hot after 2nd booster dose), TREMOR (Shaking like crazy after 2nd booster dose) and CHILLS (Had chills after 2nd booster dose). At the time of the report, FEELING HOT (Got real hot after 2nd booster dose), TREMOR (Shaking like crazy after 2nd booster dose) and CHILLS (Had chills after 2nd booster dose) outcome was unknown.            It was reported that patient not had Covid test nor diagnosed with Covid.  Patient did not received treatment for the events.   This case was linked to MOD-2022-543463, MOD-2022-543447, MOD-2022-543464, MOD-2022-543463 (Patient Link).
Full body bone/joint pain, extreme fatigue/exhaustion, swollen painful lymph nodes in armpit on injection side
This patient received the vaccine at another clinic, however she experienced redness, swelling and bruising for 3 weeks and was concerned about getting the 2nd dose. I am reporting this in case it was not reported previously.
sleeplessness with chills all night Woke up the next morning  3/19 with a fever of almost 103 and headache Took 2 advil and put a cold cloth on my head Temp went down in about an hour and was normal by evening  Very fatigued but only slept about 2 hours the night of 3/18 Feeling much better now  just alittle headache  and tire easily
vaccine administration error regarding Pfizer lot # GL0087  administered on 02/20/2023 with beyond use date of 02/17/2023 with recommendation to get booster at local pharmacy
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), 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. It was unknown if patient was pregnant at the time of vaccination. The patient's relevant medical history included: "migraines with aura" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "Known allergies : penicillin" (unspecified if ongoing); "Known allergies: Sulfa/Clindamycin/Doxycycline" (unspecified if ongoing). Other medical history included migraines with aura, PCOS. Patient known allergies included allergies to penicillin, clindamycin, sulfa, doxycycline. Concomitant medication(s) included: SPIRONOLACTONE, start date: Jul2022, stop date: 07Jul2022. Other medication in 2 weeks included Spironolactone from Jul2022 to 07Jul2022.   The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received the vaccine. Patient received Paxlovid from 07Jul2022 to 13Jul2022 for the treatment of COVID-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Baby was sick for 1-1/2 weeks, then violently ill for almost a week with severe vomiting, diarrhea, and painful head (would wake up screaming & touching his head).  Recovered immediately upon receiving a religious priesthood blessing, but wealthly parents have a lawyer to handle all future medical care.
At injection site on upper right arm, a swollen, red, hot, and itchy  3-inch circular patch is presented. Very tired and sleepy
Chills, headache, body aches, swollen lymph nodes, redness at injection site
I might have cancer; the nodules that form in my breast/ swollen lymph nodes (lymphadenopathy); shortness of breath; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 63 years as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "I might have cancer"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "the nodules that form in my breast/ swollen lymph nodes (lymphadenopathy)"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath". The events "i might have cancer" and "the nodules that form in my breast/ swollen lymph nodes (lymphadenopathy)" were evaluated at the physician office visit. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PATIENT'S WIFE CALLED TO PHARMACY AND SAID HE WOKE UP FROM NAP AND HAVING EXTREM PAIN IN HIS ARM AND SHOULDER OF SHINGLES INJECTION ARM. HE TOOK IBUPROFEN 600MG ABOUT AN HOUR AGO AND PAIN SEEMS NOT GETTING BETTER. ADIVSED PT TO WAIT MAYBE ANOTHER AN HOUR UNTILL IBUPROFEN WORKS AND IF THE PAIN GETS WORSE OR NOT GETTING BETTER, CALL US BACK OR WALK IN TO URGENT CARE TO HAVE DR TO LOOK AT THE INJECTION AREA. PT HASN'T CALLED US BACK YET.
This case was received from a health professional on 26 March 2009, via another manufacturer (document number 45215838). A patient received Flu vaccine (manufacturer and lot number not reported) "sometime in the past" and subsequently experienced an anaphylactic reaction. No additional information was available.
Janssen COVID-19 Vaccine EUA  Muscle pain from lower back down. Lasted 24 hours. Started 7-8 hours after shot. Hurt to walk and sit.  Chills. Started 7-8 hours after shot. Lasted 3 hours.  Headache. Started 7-8 hours after shot. Headache still going strong 3 days later.  Arm pain. Started right away and is still painful after 3 days.  Tiredness. Started 7-8 hours after shot. Lasted 2 days.
11 days after 2nd vaccine I woke up in middle of the night with Vertigo and vomiting and needed to be seen at the emergency room of the Hospital. Later in day I had a migraine
Pt received vaccine and roughly 2 minutes later began to experience hot flashes, nausea, sweaty palms, and shortness of breath. She alerted pharmacy personnel who assessed patient for anaphylaxis. Pt was A&O x4, able to relay her name, age, where she was, and the year. Slightly altered mental state, slow to understand questions and maintain eye contact but could track when asked and answered all questions correctly. Pt was able to take breaths and shallow breathing lasted less than 60 seconds. RPh opted not to administer epipen, though one was readily available. Pt was assisted by 3 individuals to a shaded spot out of the sun, and ambulated without issue. Emergency response team was called to assess. Pt symptoms began to dissipate within minutes, mostly gone by the time EMS arrived. BG was 109, BP 127/77 sitting and standing, HR 86, EKG was normal. Pt refused transport to hospital and was observed for 30 more minutes until she drove home. Verbalized having a husband and son at home to keep an eye on her and that if symptoms returned she would seek emergent assistance. No history of fainting or allergic reaction in the past to vaccine or medication besides bactrim.
first dose of Shingrix in December of 2018 / second dose of Shingrix in December of 2020; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in December 2018).   In December 2020, the patient received the 2nd dose of Shingrix. In December 2020, 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 reported as follows: The reporter was patient's wife.  The age at vaccination was not reported. The patient received 2nd dose later then the recommended interval, which led to lengthening of vaccination schedule The reporter did not consent to follow-up and did not give permission to contact the healthcare professional.
Fever to 104.7 fever started D7 after vaccine. Lasting at least 3 days.
Stiff legs (not walking well), hands paralyzed below 2nd knuckle, voice raspy, cannot complete sentences, going to physical therapy, occupational therapy, and speech therapy.
Patient received vaccine around 4:15pm on 12/24/20. Around 11pm he was feeling extremely tired, however, patient had been working very hard the week leading up to Christmas.  Patient woke up in the early hours of the morning with chills and very fatigued. Chills and fatigue remained on and off through out the day and the patient realized he was running a temperature of 102.8 at some point during the day. Patient stayed at home and rested and took Ibuprofen and eventually started feeling better towards the evening and night. However, the fatigue still remains on 12/26/20.
Wheel and flare reaction with induration/erythema on anterior aspect of right thigh. Given Benadryl.
Sore throat, sniffles, but mainly i was just exhausted,  same symptoms as when i had the valley fever. i have not have a fever or shortness of breath.
pregnant at the time of her shot; mild soreness of the arm; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant at the time of her shot) and PAIN IN EXTREMITY (mild soreness of the arm) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for an unknown indication.     Concurrent medical conditions included Drug allergy (Neosporin allergy.). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and IRON (IRON COMPLEX [IRON]) for an unknown indication.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 20-May-2021. On 21-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnant at the time of her shot) and PAIN IN EXTREMITY (mild soreness of the arm). On 21-Mar-2021, EXPOSURE DURING PREGNANCY (pregnant at the time of her shot) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (mild soreness of the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details reported.
booster; contracted the Omicron variant of SARS-COV-2; contracted the Omicron variant of SARS-COV-2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION, outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "contracted the Omicron variant of SARS-COV-2".  Clinical courses: Earlier last week, the patient contracted the Omicron variant of SARS-COV-2 and experienced mild symptoms.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200058493 same reporter/drug/event, different patient
injection site started itching; arm has been reddish; sore arm; Swollen; A spontaneous report was received from a (Reporter like HCP) concerning a 81 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events (PT term) list.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11/Jan/2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 039K20A ) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 11/Jan/2021  , The patient experienced the events list (verbatims)  Call was transferred from Moderna Customer Care (case #00032052) Caller received 1st dose of the Moderna COVID-19 vaccine on 11JAN2021. She received the shot on her non-dominant (left) arm. Her arm has been reddish, sore, and swollen since she received the vaccine. 2-3 days ago, around 19JAN2021, the injection site started itching and has been extremely itchy since then. None of the reactions have subsided or gotten better. She has been putting ice packs on it and that seems to help with the itching. Consent given for Safety follow-up with patient. Consent given for Safety follow-up with HCP. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  On  11/Jan/2021 date, the outcome of the event(s) was, not resolved
Has a knot on her hand; Knot on her hand and it was swollen; This case was reported by a other health professional and described the occurrence of induration in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th December 2020, the patient received Shingrix. On 5th December 2020, less than a day after receiving Shingrix, the patient experienced induration and hand swelling. On an unknown date, the outcome of the induration and hand swelling were unknown.   It was unknown if the reporter considered the induration and hand swelling to be related to Shingrix.  Additional details were provided as follows: The reporter gave Shingrix this afternoon on the day of reporting and patient called back 2.5 hours later and had a knot on her hand and it was swollen. No reaction at the injection site but the hand was on the arm of the injection.
Golf ball sized itch rash. Extreme thirst. I?ve had over two gallons of water in 24 hours and am still very thirsty.  Salt. Mildly salty foods are inedible.  I?ve checked this against my husband who had phizer two weeks ago and said foods were normal.?
I began having itchiness on my arms and legs not near the injection site (also back and upper chest). I also began having a hive/welt reaction when I extracted the itches. These will subside after a period of time.
L arm swollen and not able to move well. Pt to elevate arm and apply heat if no better pt to go to ER.
Bad pain in left arm where shot was for hours 1-2 hours later sudden chest pain, on and off Took a nap and woke up crying Severe chills, headache, body pains Then switched to really hot face and body, exhaustion
acute onset Bell's palsy w/in 24hr of vax;otherwise asymptomatic;pt w/down's synd;
Severe body aches; Jaw aches; liver ache "like in the upper part of the abdomen"; Headache; Coughing; Fatigue; large, red induration at the injection site; large, red induration at the injection site; Fever; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (Severe body aches), PAIN IN JAW (Jaw aches), HEPATIC PAIN (liver ache "like in the upper part of the abdomen"), HEADACHE (Headache) and COUGH (Coughing) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 27-Apr-2020.    On 04-Jan-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Severe body aches), PAIN IN JAW (Jaw aches), HEPATIC PAIN (liver ache "like in the upper part of the abdomen"), HEADACHE (Headache), COUGH (Coughing), FATIGUE (Fatigue), VACCINATION SITE INDURATION (large, red induration at the injection site), VACCINATION SITE ERYTHEMA (large, red induration at the injection site) and PYREXIA (Fever). At the time of the report, PAIN (Severe body aches), PAIN IN JAW (Jaw aches), HEPATIC PAIN (liver ache "like in the upper part of the abdomen"), HEADACHE (Headache), COUGH (Coughing), FATIGUE (Fatigue), VACCINATION SITE INDURATION (large, red induration at the injection site), VACCINATION SITE ERYTHEMA (large, red induration at the injection site) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Body temperature: 101.7 °F.     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.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Less than 10 minutes after getting my shot, I started to sweat, I felt slightly neausous and I felt pressure and ringing in both of my ears. I also had a slight amount of constricting in my vision.  This lasted for less than 20 minutes and I was able to walk out of the facility no problem. It's been a few days now and I think my hearing is still slightly degraded but it's hard to say for sure. I can hear fine, there may be some slight ringing though.
intense pressure headache, nausea, diarrhea w/blood, tremendous burning sensation in sinuses; 3wks to recover from sx