chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client complained of itching at injection site initially and then to whole body.  Noted to have hives . MD onsite ordered Benadryl 50mg IM. Client observed and symptoms resolved.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 26-AUG-2020, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength and frequency were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml as prophylaxis (lot # S036821 with expiration date 21-APR-2022) (strength, frequency, route of administration and anatomical location were not reported).  The improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
pt recvd vax & began shaking; running fever & was sleepy; pt taken to Hosp treated w/Epi; pt had fever that noc;
Patient got a flu vacc, immediately developed flushing, sweating. Said he has never  gottena flu vaccine in the past. No egg allergy. No shortness of breath, no  rashes. VSS. Given 25 mg benadryl 'po' from ward stock. Symptoms began to  subside after a few minutes. Patient given bed rest. Advised to see nursing staff if  he develops any more reaction. Patient agreed.
abd pain, nausea & h/a;19SEP94 bitten by stray cat that ran off but was hit by a car;because of injury the cat was taken to vet;cat died & vet sent head for exam;results pos rabies
pt recv 2 doses of vax 1OCT95 & 1JAN96 & on 23MAY96 pt exp failure to seroconvert;
Every few weeks since the vaccine I experience a sharp stabbing pain at the vaccine site.  Another symptom that that began slowly (every week or so) until now when it is several times daily-feeling a prick and then a  burning sensation on one of my toes or fingers like a fire ant is biting me. The pain lasts for hours-no red marks. I have also experienced the same sensation on my arms, over ribs, abdomen and legs. I have not spoken to my Dr. about this, but will if the frequency keeps up.
Patient states she is 22 weeks pregnant.  She received 2nd dose and waited 15 minutes under observation.  Patient was preparing to leave in her car and began to experience severe abdominal pains in the parking lot accompanied by dry heaving.  Patient was taken to hospital via ambulance.
redness; swelling; This case was reported by a nurse via sales rep and described the occurrence of erythema in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema and swelling. On an unknown date, the outcome of the erythema and swelling were unknown.   It was unknown if the reporter considered the erythema and swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The nurse mentioned there were a few patients that experienced redness, swelling following 1st dose of Shingrix. The reporter consented to follow up.
10 days after the 3rd jab (booster shot), intensive itching on the neck, head and face. Been to the emergency and given antihistamine pills.  12 days after the 3rd jab, emergency again with heavy hives all over the body and shortness in breath, difficulties in swallowing. Been to an emergency and received cortisone infusion. The infusion worked only for 15 mins and hives appeared again. Given different antihistamines 5mg x 3 a day.  14 days later, again to the emergency with increased hives and shortnesss in breath and difficulties to swallow. Antihistamines are changed to Zyrtec 10mg.   Today, hives are still present, shortness in the breath for around 2-3h every evening. Zyrtec keeps the hives more under control.   The vaccine ruined my life.
A few days after receiving injection, patient starting feeling pain in the muscle which began to radiate to shoulder & elbow & eventually to wrist. She could not raise her arm above her head & went to her physician who started her on an antibiotic to treat the infection. The pain went away but has reoccurred multiple times & most recently she had a small bump that itched but was treated with topical antibiotics. Patient is still in pain today.
quantitative IgG level was very low; This is a spontaneous report from a contactable physician, the patient. A 67-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EH9899) via intramuscular route of administration in the left arm on 12Jan2021 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriasis. The patient had no allergies to medications, food, or other products. Concomitant medications included ustekinumab (STELARA) taken from unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 21Dec2020 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. 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 an unknown date in Feb2021, one month after the second dose, the patient experienced that his quantitative Immunoglobulin G (IgG) level was very low. He feared whether Stelara had blunted the dose and if he had been fully vaccinated. The patient was still practicing medicine and at a risk for COVID, so he wondered if he can hold his Stelara and get a booster and he was willing to do it as research if needed. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event low quantitative IgG level was resolved on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
This case was reported by a healthcare professional and described the occurrence of allergic reaction in a 32 year old female subject who was vaccinated with Fluarix for prophylaxis. The reporter is the subject. The subject's medical history included allergy to gentamycin, allergy to phenergan, penicillin allergy, rocephin allergy, sulfa allergy and vancomycin allergy. The subject reported that she is "not allergic to latex." There were no concurrent medications. The subject had received influenza virus vaccine in previous years and had experienced "the flu." On 13 November 2006 the subject received unspecified dose of Fluarix in the left arm. On 13 November 2006, 2 hours after vaccination with Fluarix, the subject experienced an allergic reaction described as rash, itching and erythema on the lower body extremities and hives. "That evening," on 13 November 2006, the subject experienced flu like symptoms, aches, and head and spine pain. The subject was seen by a physician. The subject was treated with Benadryl. At the time of initial reporting, 22 November 2006, the events were improved. The vaccination course with Fluarix was discontinued. Follow-up received on 03 January 2007 from the healthcare professional (who is also the subject) noted that she considered the events to be related to the use of Fluarix because "it contains gentamicin."
soreness @ injection site initiated 2 hours later & persisted for days:  fatigue & sleepiness initiated after 2 hours & persisted for days after 16 hours of sleep; dull headache at base of skull initiated after 4 hours & dissipated after 48 hours.
Within about 2-4 hours after injection, I developed cold and flu symptoms with fever. Went to clinic on Thursday when I could not shake this.
This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 09-JUL-2015, the patient was vaccinated with a dose of improperly stored VAQTA (10Pk 50U/1 mL) lot number K008984, expiration date of 21-OCT-2015 (route of administration was not reported), which was stored 3 times with the following lowest recorded temperatures: 34F (1.111 celsius degrees) for 88 hours, 32 F (0 celsius degrees) for 40 hours and 33 F (0.555 celsius degrees) for 40 hours. No highest reported temperatures were reported. The type of storage was refrigerator. No concomitant therapies were reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
Flu-like symptoms 2 days following Hep B vaccination.  Fever, body aches & headache, slight shortness of breath.  No rash.  Went to emergency room 3 days after where chest x-ray was normal.  Treated with Ibuprofen, Tylenol, Benadryl and vicodin (which helped).
the rash started about 2 - 7 days after the vaccination; probably related to a viral infection. Said it looks like pityriasis rosea; probably related to a viral infection. Said it looks like pityriasis rosea; This is a spontaneous report from a non-contactable consumer (parent) reported for a 13-year-old (same age during vaccination) male patient (son) that patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) on 15May2021 as single dose for COVID-19 immunisation. Patient s medical history and concomitant medications were not reported. Caller's son received the first dose of the Pfizer vaccine on 15May2021. Rash occurred a week later. Caller stated the rash started about 2 - 7 days after the vaccination. Caller stated, they went to the pediatrician, they think this may not be caused by the vaccine, probably related to a viral infection. Said it looked like pityriasis rosea. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Vertigo Dizziness  Meclizine- did not reduce symptoms Valium Currently have a follow up appointment with my primary doctor.
Disoriented; Ringing in my ears; Numbing of my lips; Numbing of my left cheek/Numbing of my left hand; Chest pains; High blood pressure; Lightheadedness worse; Fatigue; Migraine on the left side of my head; shortness of Breath after running; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN, HYPERTENSION, MIGRAINE, DISORIENTATION, and TINNITUS in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced DYSPNOEA EXERTIONAL (shortness of Breath after running). On 26-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MIGRAINE (Migraine on the left side of my head). On 27-Mar-2021, the patient experienced CHEST PAIN, HYPERTENSION, DISORIENTATION, TINNITUS, HYPOAESTHESIA ORAL, HYPOAESTHESIA, DIZZINESS, and FATIGUE. On 27-Mar-2021, MIGRAINE had resolved. On 09-Apr-2021, CHEST PAIN had resolved. At the time of the report, HYPERTENSION, DISORIENTATION, TINNITUS, HYPOAESTHESIA ORAL, HYPOAESTHESIA (Numbing of my left cheek/Numbing of my left hand), DYSPNOEA EXERTIONAL, and FATIGUE outcome was unknown and DIZZINESS (Lightheadedness worse) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not reported.  Treatment information was not provided.     This case was linked to US-MODERNATX, INC-MOD-2021-100429.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: New lab test EKG and heart test were reported. Sender's Comments: Based on current available information and the temporal association between product use and the start date of events a causal relationship cannot be excluded.
Patient received Moderna as a 1st dose on 04/07/2021. Patient received Pfizer as a 2nd dose on 05/03/2021.
Patient is currently in her 3rd trimester. She received a Fluzone vaccine on her right arm and her Boostrix on the right arm. She was complaining of intense pain in her shoulder area radiating down the arm. She has been taking tylenol around the clock to help ease the pain. It went away for a couple of days but on 9/5/20 when she came into the pharmacy she stated that the pain came back.  I counseled her to continue taking the tylenol and also try putting ice on the area. I advised her to follow up with her OB if the pain doesn't go away.
Patient received the vaccine at an outside healthcare facility on 2/11/21. At approximately 1 pm she screamed out and fell out of her chair. EMS was called and patient was found to be in Vfib. ACLS was performed for approximately 42 minutes prior to arrival at ED. At that time the patient had been pulseless for 25 minutes. Patient received 450 mg of amiodarone, epinephrine x7, sodium bicarbonate x2, and 7 AED shocks. In the ED 3 more doses of epinephrine were given, one more dose of sodium bicarbonate, and 5 additional shocks. ROSC was not achieved and time of death was called at 1416.
exposed to COVID; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (exposed to COVID) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20Q) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (exposed to COVID). At the time of the report, EXPOSURE TO SARS-COV-2 (exposed to COVID) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2021-370402, MOD-2021-370489 (Patient Link).
Information has been received from a female who on 31-MAR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (therapy route and lot # not provided) in the arm for prevention of shingles. After getting the vaccine, the injection site was red and hot for two to three weeks. But the patient had not experienced any other side effects. No treatment was given to the adverse events. Patient did not seek medical attention. At the time of reporting, the patient's status was not provided. Additional information has been requested.
Severe swelling in lymph nodes under left arm.  Patient was advised to go to the ER by her physician.
Information has been received from a physician concerning an 88 year old male with a history of aortic stenosis who on 30-APR-2007 was vaccinated with a dose of Zostavax. Concomitant therapy included "a lot of medications" (therapy unspecified). On 15-MAY-2007 the patient experienced exacerbated bronchitis and was admitted to the hospital. The patient's exacerbated bronchitis persisted. The reporter felt that exacerbated bronchitis was not related to therapy with Zostavax. No product quality complaint. Additional information has been requested.
Client was feeling "cold." Client was a 14-year-old female sitting upright in her observation chair, alert and tracking with her eyes. Client had a chief complaint of dizziness and feeling cold.  Client stated that she began to feel cold and dizzy a few minutes after her observation had begun. This was the client's first dose of the Pfizer vaccine. Client denied any medical history or known allergies. Assessment revealed no swelling, hives, discoloration, shortness of breath or other signs and symptoms of anaphylaxis. Client stated that she felt "cold" and "dizzy." Client stated that her only meal was the snacks provided at the vaccination site. Airway, breathing and circulation were intact. Client's initial set of vitals at 1006 was 116/78 blood pressure, 80 heart rate, respirations 16, alert and oriented to person, place, date and event. Temperature 97.8*f. EMTs present were unable to obtain an O2 sat due to client's nail but client was negative for signs of shortness of breath. Client was asked to lie down until her complaint was resolved. Client was provided with food and was able to eat without difficulty. Client was reassessed every 15 minutes due to her stability. Vitals were as follows: 1011 - 108/78, 84, resp. 14 1021 108/78, 88, resp 14 1029 - 108/78, 80, resp 16. After approximately 10 minutes, the client denied any symptoms and was asked to sit up in an observation chair for the remainder of her observation. Client and her mother were instructed to seek emergency care if signs or symptoms of an allergic reaction occur later this evening.
injection given into left deltoid, within 5 minutes, patient complained of syncope, then became flaccid.  He never lost consciousness and kept talking to immunizer.  we applied a cold compress to neck and gave water and accompanied patient until he departed the store
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On an unknown date, the patient was inadvertently administered an incomplete dose of M-M-R II, (lot number N027782, expiry date: 16-AUG-2019) subcutaneously for prophylaxis due to patient moving arm (underdose). No adverse effects reported. No product quality complaint involved.
This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with the improperly stored doses of PROQUAD (strength, dose number, route, anatomical location, lot number and expiration date were not provided.) This is one of several reports received from the same source. Additional information has been requested.
This is a spontaneous report from a noncontactable nurse. A 61-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# FC3184), at the age of 61, intramuscularly, in the left arm, on Aug 26, 2021, at 11:30, single dose, for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, patient was diagnosed with COVID-19. Concomitant medications not reported. On Aug 27, 2021, patient had left arm pain that travelled up her shoulder and over to the left-side of her chest. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of left arm pain that travelled up her shoulder and over to the left-side of her chest: unknown (at the time of the report). No follow-up attempts possible. No further information expected.
I awoke in the middle of the night 2 days post vaccination, with swelling to my upper lip.  After going back to sleep I awoke the next morning and my lip was more swollen than it was previously. The swelling went down by the end of the day, but was followed by rashes all over my body.  The rashes now occur anytime the skin is agitated and have been consistent since that day.  While home on leave (1 week later), I went to an urgent care facility, I was prescribed Famotidine Benadryl and Prednisone. This did work but was temporary.  I have not experienced any skin issues prior to these occurrences.
Generalized tonic clonic seizure as per parents which lasted 45 to 50 sec. Temperature was 99.3 deg F. Outpatient was seen by neurology and exam was normal.  10/13/09 Hospital records, DC summary received service dates 7/22/09 to 7/23/09. Assessment: Seizure disorder. Baby started shaking all 4 limbs with jerky movements, rolling eyes upward, frothing from mouth, blood in saliva. Crying before incident. Lethargic afterwards. Loose stools, dark green moist stool. Temperature elevated. Baby presents sleepy but later is active, alert, and moving 4 extremities. Admitted for onservation. Strawberry birthmark on post R thigh. To follow up with neurologist.
itchies; pricklies; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (itchies) and RASH (pricklies) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PRURITUS (itchies) and RASH (pricklies). At the time of the report, PRURITUS (itchies) and RASH (pricklies) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported. Treatment information was not provided.
Swollen tongue/Tongue swelling did not go away; Anaphylactic reaction/rushed to the hospital; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Swollen tongue/Tongue swelling did not go away) and ANAPHYLACTIC REACTION (Anaphylactic reaction/rushed to the hospital) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced SWOLLEN TONGUE (Swollen tongue/Tongue swelling did not go away) (seriousness criteria hospitalization and life threatening) and ANAPHYLACTIC REACTION (Anaphylactic reaction/rushed to the hospital) (seriousness criteria hospitalization, medically significant and life threatening). The patient was hospitalized on 07-Apr-2021 due to ANAPHYLACTIC REACTION. At the time of the report, SWOLLEN TONGUE (Swollen tongue/Tongue swelling did not go away) had not resolved and ANAPHYLACTIC REACTION (Anaphylactic reaction/rushed to the hospital) outcome was unknown.            No concomitant medications were reported.  No treatment information was reported.  Company Comment  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.   Reporter did not allow further contact; Sender'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.