chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pfizer-BioNTech COVID-19 Vaccine EUA Patient had eaten before the vaccination, but had walked to the location of the vaccine administration, administration facility heat was on/very high, approximately 8 minutes after receiving the vaccine the patient stated that she felt hot, prickly, lightheaded and weak. She laid on the floor, remained conscious but used an ice pack on her forehead. She was able to walk to another chair located away from the heater and was observed for 30 additional minutes at which time she had a snack, drank water and was cleared to leave. Patient states that she feels okay today.
Vaccine was administered at approximately 12:20 PM on 11/10/13. Patient complained of itching at 12:22 PM. An approximately 2"x2" red, irritated area was at the injection site. Patient was observed for 30 minutes, area of redness lessened to a 1"x1" area. Per patient itching went away. Patient was referred to a doctor immediately.
This spontaneous report as received from a pharmacist refers to a 65 year old female patient. Non drug reactions or allergies reported. On 23-NOV-2013, the patient was vaccinated with ZOSTAVAX (concentration, dose and route were not reported), lot # J006829, expiration date: 14-SEP-2014. Concomitant medication was not reported. On 28-NOV-2013, the patient noticed a red mark on her arm around the injection site, about 2 inches long and 1 inch wide that itched a little. Treatment was not given for the adverse events. Lab studies were not performed. The patient called the pharmacy to seek medical attention. The pharmacist noted that as of 02-DEC-2013, the patient had still the reactions. The patient's present status was reported as not recovered. Causality was not reported. Additional information has been requested.
This medically confirmed report (initial receipt 25-Mar-2015) concerns a 60 year old female patient who had a medical history of asthma. Concomitant medications included fexofenadine. The patient did not receive other recent immunisations within the last 3 months. In Oct-2014, the patient received an unspecified influenza virus vaccine injection (manufacturer and batch number not specified). On an unspecified date, following the flu vaccine administration, the patient developed an injection site adverse event. The patient developed redness and swelling from her elbow up to her shoulder in the arm which she received the flu vaccine (not both arms) and it lasted for about one week. It looked almost like a cellulitis. The patient also had a fever for four days and described feeling hot. On an unspecified date, the patient visited the clinic and she did not have a measured elevated temperature. No treatment was given for redness, swelling or fever symptoms. Outcome was recovered in Mar-2015. Follow-up (01-Apr-2015): Reporter details, AE #3 and AE #4 as-reported terms, clinical course, new AE, outcome.
Client saw PMD 9-17-09 c/o L arm swollen red from shoulder to elbow - c/o itching- relates no Rx - felt better by 9-19 09.
Sore Arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "post op asexual", start date: 2014 (unspecified if ongoing), notes: had a surgery but a female now (7 years ago); "dystonia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore Arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
tender lymph gland (near collarbone, on same side as vaccinated arm); swollen lymph gland (near collarbone, on same side as vaccinated arm); Nausea; Headache; diarrhea; General tiredness; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 27Mar2021 at 10:45 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications included statin (MANAFACTURER UNKNOWN) 40 mg, multi vitamin (MANAFACTURER UNKNOWN) all from an unknown date for an unspecified indication. 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 28Mar2021 the patient experienced tiredness, and on 01Apr2021 experienced nausea, headache, diarrhea, swollen lymph nodes, lymph node tenderness. It was reported that swollen and tender lymph gland near collarbone, on same side as vaccinated arm. Lymph gland was still swollen - 8 days later. The patient did not receive treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Clinical outcome of tiredness, nausea, headache, diarrhea, swollen lymph nodes, lymph node tenderness was not recovered at the time of reporting.  No follow-up attempts are needed. No further information is expected.
The patient had a fever of 103, within 12 hours after DTap / Hib/ IPV / Prevnar. The patient also had irritability, and cried for 3-5 hours non-stop.
The evening of the vaccination the patient had a sore left upper arm.  The patient experienced shaking and chills that lasted all night long.
Productive cough with white sputum along with increasing SOB, fevers of 103 F, worsening weakness, patient can no longer walk.
Intern, administered to patient the final dose of Varivax and second dose of Twinrix under supervision of pharmacist. Shortly after administration, patient exhibited symptoms of lightheadedness and loss of consciousness. Husband was present. Pharmacist intervened to keep patient alert and directed intern to call EMS as a precaution. Patient was in and out of consciousness but later became alert and instructed intern to dismiss the EMS call because she was feeling much better and did not want to go to the hospital. Pharmacist asked patient if she was diabetic or if she felt that her blood sugar or pressure was low. After sitting for some time, blood pressure was taken by pharmacist with patient consent and it was assessed to be 88/59. Pharmacist recommended that patient take a Gatorade with electrolytes and sit for some time. Patient drank Gatorade and felt better. Pharmacist instructed patient to sit for 10 more minutes under pharmacist observation. Patient agreed and waited with husband. After the suggested time, patient said she was feeling much better (interpreted) and both patient and husband thanked the pharmacy for their assistance as they left.
17-year-old patient received the 1st dose of the vaccine; A spontaneous report was received from a health care professional, concerning a 17-year-old, patient who received the first dose of Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, it was reported that one of the pharmacies administered a 17-year-old patient the first dose of the vaccine. No treatment information was reported.   The outcome of the event, 17-year-old patient received the 1st dose of the vaccine, was resolved.; Reporter's Comments: This case concerns a 17 year old patient of unknown gender who received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly for prophylaxis of COVID-19 infection.  There were no reported adverse events in this case of product administered to patient of inappropriate age.
This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age and gender. The patients' medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with a doses of GARDASIL 9 lot # L007560, expiration date 15-JUN-2017, which were exposed to temperatures outside of the recommended range. No adverse experience has been reported. This is one of several reports received from the same reporter. Additional information has been requested.
severe muscle and joint pain, chills, massive headache, cough developing, extreme tiredness.
Pt seen in the ED with eye swelling, difficulty talking, non-radiating chest pressure treated with BENADRYL 25mg po. 10/15/08.
Redness, soreness, turned in purple color - ONG blister at site of injection - on 10-15-07 - the purple color faded away - and still red and warm to touch - (LF arm site - cold sweats, dizziness after the shot.
Doctor called to station #11 for vaccine inquiry.  Patient report having developed a rash to her abdomen 3 days post vaccination with 1st dose. PSHx of lap hernia repair ~3 weeks prior to vaccine with skin irritation from tape used to the area. Pt. described rash as "small red dots" after "diaper rash ointment" prescribed for the irritation was applied. Doctor consulted with patient and reports that rash appears as a contact dermatitis by description and explanation. Vaccine dose 2 given to left deltoid.  Pt. observed x 30 minutes without reaction prior to sending home.
period & cramps eight days early 7 hours after receiving the vaccine. my period is very punctual & over a week early is extremely unusual/does not happen
Patient was given vaccine at approximately 10:20am and completed 15 minute monitoring in office. Patient returned to clinic at approximately 10:45 with complaints of left arm numbness, tongue tingling, tongue swelling, and speech difficulty. 0.3mg Epipen and 50mg benadryl was administered and patient immediately reported resolution of tongue swelling and speech difficulty. Patient was transported via EMS per clinic  protocol.
Pt states about ten minutes after receiving vaccine, they began to feel dizzy, labored breathing, and a tight throat. Pt transferred to Med. Obs. via wheelchair and was transferred to bed in semi-fowler position. Pt given water and crackers. Pt was instructed to rest. Pt stated they began to feel better after resting. Pt was advised to take 25-50mg of Benadryl at home as a precaution and to call 911 if the symptoms reoccurred.
Patient had redness, tenderness at the injection site. However, on 2/2/12, patient developed hives, wheals, and itching. By 2/3/12 AM, the hives were alleviated (patient taking diphenhydramine), but still displayed some red spots and systemic itching.
Soreness in arm at site of injection with swelling and redness...bad chills, stood in hot shower for 1/2 hour to get warm...then  too hot , throwing off covers  bad with joint pain and nausea just not feeling well at all on Tuesday night, the day after injection ..woke on Wednesday with a terrible headache, took 2-500 mg of  Extra Strength Tylenol which helped but started to feel better  late Wednesday  afternoon...could not eat Tuesday, to nauseated  but kept a bowl of cereal down on Wednesday night... by Thursday I was feeling 100% better...still have swelling and redness at injection site but all other symptoms are gone..
About 16 hours after the shot, I got nausea and vomiting.  I had dizziness, diarrhea, and body ache.  My arm site was very sore.  The next day, I was tired and fatigue.   But my other symptoms was gone.  Within six week after, I have 3 UTI.  Where I had to take antibiotics for.
Patient complained of numbness around and mouth area. Symptoms persisted longer than 30 minutes. And  eventually resolved after 35-40 minutes.  VS taken by EMS increased included B/P 112/70, HR 73, 98RA. Cleared By EMS and NP
No additional adverse event reported; Nurse reported an expired MMR II vaccine was administered to a patient. The MMR II expired on 30 AUG 2020 and was administered on 21 SEP 2020; This spontaneous report was received from a licensed practical nurse concerning a patient. The patient's concurrent conditions, medical history, drug reactions/allergies, historical drug and concomitant therapies were not provided.  On 21-SEP-2020, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) recombinant human albumin (rHA) 0.5 milliliter, lot number R024906 and expiration date 30-AUG-2020 (expired vaccine administered), for prophylaxis. (route of administration was not provided)
Info regarding Prevnar injection was received from a healthcare professional regarding a pt, now 2 years old, who received four doses of Prevnar and experienced "low or no titer levels for Prevnar". Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. Event Details: The pt received four doses of Prevnar and subsequently experienced "low or no titer levels for Prevnar (antibody test abnormal). No additional info was available at the time of this report.
Insomnia - unable to sleep the entire night of 3/30/2018 - 3/31/2018.
Covid positive resulted on 2/19/2021, collected on 2/18/2021
Vial was first punctured on 30-Jun-2022 10:00am and administered on 01-Jul-2022 08:20am; HCP reports that patient received dose from a Moderna vial that had been punctured for more than 12 hours and 24 hours at ambient room temperature; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP reports that patient received dose from a Moderna vial that had been punctured for more than 12 hours and 24 hours at ambient room temperature) and PRODUCT STORAGE ERROR (Vial was first punctured on 30-Jun-2022 10:00am and administered on 01-Jul-2022 08:20am) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Jul-2022 at 8:20 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jul-2022 at 8:20 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP reports that patient received dose from a Moderna vial that had been punctured for more than 12 hours and 24 hours at ambient room temperature). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 30-Jun-2022 10:00am and administered on 01-Jul-2022 08:20am). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP reports that patient received dose from a Moderna vial that had been punctured for more than 12 hours and 24 hours at ambient room temperature) and PRODUCT STORAGE ERROR (Vial was first punctured on 30-Jun-2022 10:00am and administered on 01-Jul-2022 08:20am) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. It was reported that number of doses/vials were 3 doses. On 30-JUN-2022 10:00am vial was first punctured. Vial stored post puncture in room temperature in the machine. Vial did not undergone any temperature excursions. For roughly 24 hours vial was exposed to room temperature range. Treatment medication was not provided by the reporter.
Total amount of time the vial was exposed to room temperature range was over about 24 hours and 30 minutes; No adverse event; Patients received the vaccine after 24 hours at room temperature; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine after 24 hours at room temperature), PRODUCT STORAGE ERROR (Total amount of time the vial was exposed to room temperature range was over about 24 hours and 30 minutes) and NO ADVERSE EVENT (No adverse event) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044C22A) for COVID-19 prophylaxis.     No medical history was reported.  Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), VIBEGRON (GEMTESA), OMEPRAZOLE, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HYDROCHLOROTHIAZIDE) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 02-Aug-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine after 24 hours at room temperature). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Total amount of time the vial was exposed to room temperature range was over about 24 hours and 30 minutes) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine after 24 hours at room temperature), PRODUCT STORAGE ERROR (Total amount of time the vial was exposed to room temperature range was over about 24 hours and 30 minutes) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine after 24 hours at room temperature) and PRODUCT STORAGE ERROR (Total amount of time the vial was exposed to room temperature range was over about 24 hours and 30 minutes).    Patient did not report being immunocompromised.  Patient received the 2nd booster of the Moderna vaccine.  Date the vial 09:30  am. Date of administration of vaccine was on 1st 02Aug2022 at 10 am and administered every 15 minutes after 10 am until 11 am. The vial stored in room temperature post puncture. The vial did not undergone any temperature excursions.  Patient did not report having side effects.  No treatment medications were reported.
Information has been received from a 56 year old female licensed practical nurse with sarcoidosis in remission who between approximately 26 Oct 2006 and 05 Nov 2006 administered 12 doses of varicella zoster virus vaccine live. It was noted that during the same time period she also administered three doses of varicella virus vaccine live. On 05 Nov 2006, the nurse contracted herpes zoster starting with pain and developing into a painful rash on the face as of 09 Nov 2006. Unspecified medical attention was sought and since 08 Nov 2006, the nurse has not been allowed to work. The nurse reported that there were no needle sticks or skin contact with the vaccine. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information has been requested.
Disseminated varicella zoster virus infection; Vaccination failure; Literature Report: This literature report has been received from authors of a published article, titled as above, regarding a 70 years old female patient.  The patient with a history of giant cell arteritis and resolved SARS-CoV-2 infection 10 months ago presented with a diffuse erythematous vesicular rash. Eighteen days ago, she completed a 20-week low-dose methylprednisolone taper for giant cell arteritis, initiated at 10 mg daily. Eight days prior to presentation, she received the first dose of the mRNA-1273 (Moderna) COVID-19 vaccine; 5 days later, a pruritic skin eruption with associated daily fevers developed in her. The examination demonstrated thin erythematous papules and vesicles over the forehead, trunk, and extremities. No antecedent dermatomal eruption was noted; of note, the patient had received zoster vaccine live (ZOSTAVAX) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis 10 years ago. Dermatopathology demonstrated papillary and mid-dermal lymphocytic infiltrate with admixed neutrophils and foci of lymphocytic vasculitis; findings of varicella zoster virus (VZV) immunohistochemistry were negative; however, findings of polymerase chain reaction from a sampled vesicle were positive for VZV DNA. The patient was initiated on oral valacyclovir 1000 mg 3 times daily; the following day, she was admitted to the hospital for intravenous acyclovir (10 mg/kg, every 8 hours for 5 days). One week after hospital discharge, she had a nearcomplete resolution of her infection with diffuse postinflammatory hyperpigmentation. One week after completing valacyclovir and 4 weeks after her first dose, she received the second vaccine dose without complications. The patient received adulthood VZV vaccination, yet presented with nondermatomal, acutely disseminated VZV (disseminated varicella zoster virus infection; vaccination failure). In the case, valacyclovir between vaccine doses may have been protective against a similar reaction following the second dose. Thus, it is our opinion that disseminated VZV reactivation should not be a contradiction to completing the mRNA-based SARS-CoV-2 vaccine regimens. The outcome of event disseminated varicella zoster virus infection was recovering. The outcome of vaccination failure was unknown.  The causality between both events and zoster vaccine live (ZOSTAVAX) was related.  A copy of the published article is attached as further documentation of the patient's experience.
lost taste; lost smell; no appetite; lost so much weight; had no energy; lethargic; had to push himself every day to go to work; felt like he had COVID 19; wasn't feeling well; woke up at night in cold sweat; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (wasn't feeling well), COLD SWEAT (woke up at night in cold sweat), AGEUSIA (lost taste), ANOSMIA (lost smell) and DECREASED APPETITE (no appetite) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced MALAISE (wasn't feeling well) and COLD SWEAT (woke up at night in cold sweat). On 18-Aug-2021, the patient experienced AGEUSIA (lost taste), ANOSMIA (lost smell), DECREASED APPETITE (no appetite), WEIGHT DECREASED (lost so much weight), ASTHENIA (had no energy), LETHARGY (lethargic), IMPAIRED WORK ABILITY (had to push himself every day to go to work) and FEELING ABNORMAL (felt like he had COVID 19). On 17-Aug-2021, MALAISE (wasn't feeling well) had resolved. On 18-Aug-2021, COLD SWEAT (woke up at night in cold sweat) had resolved. On 25-Aug-2021, AGEUSIA (lost taste), ANOSMIA (lost smell), DECREASED APPETITE (no appetite), WEIGHT DECREASED (lost so much weight), ASTHENIA (had no energy), LETHARGY (lethargic), IMPAIRED WORK ABILITY (had to push himself every day to go to work) and FEELING ABNORMAL (felt like he had COVID 19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Aug-2021, SARS-CoV-2 antibody test: negative (Negative) test showed no Antibodies.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided  No treatment medications were provided.
Hives in patches all over body: legs, back, stomach, arms, neck. Taking Benadryl to no avail.  Also received my menstrual cycle 2 days after shot. This is out of my normal cycle.
sore throat, injection site pain 73 yo male with PMH nicotine dependence, solitary nodule of lung, BPH, and COPD reported on 3/4/2021 (at his second covid19 vaccine appt) that he had injection site pain and sore throat after his first dose of covid19 vaccine on 2/11/2021, symptoms self-resolved.
Shivers, fever, incontinent to urine and bowels, nausea, pain on urination, urinary tract  infection.  This went for several weeks.  Have never had a UTI prior to this incident.