chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash at injection site 4 days later; This case was reported by a consumer via interactive digital media and described the occurrence of injection site rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 4 days after receiving Shingles vaccine, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was unknown.   It was unknown if the reporter considered the injection site rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-AUG-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient had rash at injection site 4 days later. Additional supportive information: The follow-up could not be possible as no contact details were available.
had a headache for approximately 1 day; had a fever and chills for approximately 4 hours; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 20:45 (Lot number: FA7484) at the age of 37 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Keflex, reaction(s): "skin rashes, notes: Known allergies: Keflex caused skin rashes when I was a child. Vaccination history included: Bnt162b2 (Dose number:1, administration date 30Jul2021, administration time: 09:00 PM, Lot number: FA7484, vaccine location: Left arm), administration date: 30Jul2021, when the patient was 37 years old, for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 20Aug2021 23:00, outcome "recovered" (Aug2021), described as "had a headache for approximately 1 day"; PYREXIA (non-serious) with onset 20Aug2021 23:00, outcome "recovered" (Aug2021), described as "had a fever and chills for approximately 4 hours". Therapeutic measures were not taken as a result of headache, pyrexia.  Additional information: Patient did not receive any other vaccines within four weeks. Also, the patient did not receive any other medication within two weeks. Patient did not have covid prior to vaccination neither tested for covid post the vaccination.  Follow-up attempts are completed. No further information is expected.
Patient is a 63 y.o. male admitted  on 10/19/21 with Covid-19 (symptom onset around 10/15) and admitted on 10/24 for worsening symptoms. He was treated with decadron and tocilizumab. Remdesivir was contraindicated due to CKD IV. Due to worsening respiratory status and elevated d-dimer he had V/Q scan on 11/1 which was low probability for a PE. He has been transferred out of the Covid unit as he is off precautions.   Initially he was being weaned from oxygen, awaiting a level low enough for discharge. He had increased oxygen requirements on 11/14. Pulmonary Medicine was consulted. It was opted to started empiric lovenox for VTE. Patient did not want to have CT for PE done, due to concern for contrast injury. needing dialysis. LE venous US was negative for DVT. V/Q scan was done on 11/16 with high probability for PE. TTE with evidence of severe pulmonary HTN, dilated RA but no evidence of RV Strain and normal LVEF. clinically worsening.  Discussed imaging findings which suggest signficant lung damage likely still related to his COVID infection and PE
This spontaneous report as received from a pharmacist refers to a patient of unknown gender and age. Information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. Pharmacist reported that on 21-MAR-2017, the patient was vaccinated with first dose of ZOSTAVAX (lot # m035691, expiry date: 17-NOV-2017) for prophylaxis. The patient received their second vaccine dose on 30-APR-2017 (lot # m038864, expiry date: 12-DEC-2017). Pharmacist mentioned that each ZOSTAVAX dose was reconstituted with a new, separate dose of sterile diluent (Manufacturer unknown) (lot # m020944, expiry date: 24-OCT-2018). No adverse effects were reported. Additional information has been requested.
Started staring, stiffened up and stopped breathing 8 different times. Lasting around 20-30 sec each beginning 05/23/02. The worst 05/26/02 with 3 episodes within 1 hr. Went to ER and hospitalized. A 60-day follow up report received 6/10/2003 adds that pt has recovered.
get sick from the flu vaccine; Initial information received on 29-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer (patient).  This case involves a patient of an unknown age and gender who was sick (illness), while he/she received INFLUENZA VACCINE.  The patient's medical treatments, vaccinations, concomitant medications and family history were not provided.  It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (illness) (Unknown latency, non-serious event) following the administration of INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/ events.  Medication Details and reason for taking the medicine: not provided.  There were no lab data/results available.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for event illness.  There will be no information on the batch number for this case.
Tenderness, Swelling, Welts  started to occur the next day after getting the shot
Information has been received from a physician via company representative referring to a male patient of unknown age. Concurrent conditions, medical history of the patient were not reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route unspecified). Concomitant therapies were not reported. On an unknown date the patient experienced cellulitis, after receiving ZOSTAVAX. At the time of the report, the event outcome was reported as recovering. No product quality complaint (PQC) involved. The relatedness between the vent and therapy with ZOSTAVAX was not reported. Additional information has been requested.
High blood pressure; This case was reported by a consumer via call center representative and described the occurrence of blood pressure high in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On 6th January 2021, unknown after receiving Shingrix, the patient experienced blood pressure high. On an unknown date, the outcome of the blood pressure high was recovering/resolving.   It was unknown if the reporter considered the blood pressure high to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was vaccinated with 2nd dose of Shingrix. On day of reporting patient experienced high blood pressure. This case was reported by patient wife. The reporter believed that the high blood pressure may be related to patient watching news over the last few days. The reporter did not consent to follow up.
pt recvd 4 doses of vax & was found to be a nonresponder; exp a pos titer p/dose 4; exp pain @ inject site following dose 4; addtl exp dizziness & lightheadedness about 1 hr later; felt funny; pt stated felt better p/rest & DPH; soreness
Pt received pnuemococcal 23-valent vaccine at 1800 on 10/1/09 to the right upper posterior arm. Vaccine info includes: Merck & Co, INC., Lot 0507Y, expiration 07/22/10, 0.5 ml sub-q. At 2330 on 10/1/09 pt c/o feeling an "egg" on his arm when he tried to lay on his right side. Palpation to area revealed a cherry tomato sized round lump that caused discomfort but no pain to pt. Area was not erythematous or warm to touch. Spoke with pharmacist regarding reaction as an email had been sent to nursing staff on 9/17/09 regarding potential issues with Pneumovax vaccines. Pharmacist advised to apply ice to area. If no relief or worseneing of symptoms she advised to contact MD regarding findings. Ice applied and pt slept for 3. hours without incident. Pt was awoken at 0330 for bloodwork and upon reassessment of area it was found that the area had grown in size to the size of a large plum. Area was now painful at 6/10; still no redness or erythema noted. Pt given 20 mg roxicodone and MD contacted. Obtained order to administer 25 mg Benadryl now, and another 25 mg if no response in an hour. Benadryl 25-50 mg was also ordered q4-6 prn. Benadryl given at 0500 and pt now resting comfortable. Pt reports a decrease in pain to 4/10 after administration of pain medication. After one hour site is still swollen but less firm. Second dose of 25 mg Benadryl given po at 0630.
A pox developed. The vaccination site was only slightly red for the first few days, then, more red and itchy. The size of a dime. A pox developed - itchy, red, round like a bug bite. The pox never oozed and looked to be scabbed over. Still present 2 weeks after shot. Not painful but very itchy and scab like.
seizures within half an hour of each other; left arm was sore; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of SEIZURE (seizures within half an hour of each other) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: MMR Vaccine (Patient got the vaccine when she was 2 years old). Concomitant products included SERTRALINE for an unknown indication.    On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, the patient experienced PAIN IN EXTREMITY (left arm was sore). On 30-May-2021, the patient experienced SEIZURE (seizures within half an hour of each other) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 30-May-2021 to 30-May-2021 due to SEIZURE. At the time of the report, SEIZURE (seizures within half an hour of each other) had resolved and PAIN IN EXTREMITY (left arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was reported to have no history of seizure episodes.  On 30-MAY-2021, she was reported to have 2 episodes of seizure within half an hour of each other.  Patient was reported to be treated with iv medicine at the hospital, shot of anti-seizure medicine and anti-nausea medicine.  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. Of note, the patient's medical history of sertraline intake may be a confounding factor that may play a possible contributory role to the event of seizure. Further information has been requested.; 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. Of note, the patient's medical history of sertraline intake may be a confounding factor that may play a possible contributory role to the event of seizure. Further information has been requested.
Unable to move shoulder, swelling under armpit. Was diagnosed with Cellulitis in upper left limb. Was prescribed Cephalexin 500mg for 7 days twice a day.
Within minutes of receiving second dose of the vaccine, I had a severe pain in the right side of my neck.  I waited 15 minutes, but felt I could not leave as I was diaphoretic and dizzy when I stood up.  I waiting up to 45 minutes until I could manage to leave after receiving bottled water and orange juice.  About 5 days later, I experienced tinnitus in my left ear (swooshing sound 24/7 that beat to my pulse.)  I went to an ENT appointment several weeks after and was examined. Anatomically there was no findings.  The audiology report showed moderate hearing loss in my left ear.  High dose steroids were prescribed.  I am on day 9 of the Prednisone without any relief of the tinnitus or improvement in my hearing.
No adverse effects reported; was inadvertently administered a dose of PNEUMOVAX 23 instead of PREVNAR 13; Information has been received from a medical assistant reporting on a 1-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On 07-MAY-2019, the patient was inadvertently administered an unspecified dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis, lot# R018731 and expiration date 27-FEB-2020 (route of administration was not reported) instead of pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13). No adverse effects reported.
Pt states 1 day after receiving shot she experienced extreme vomiting. 2 days after she had pain and numbness throughout body. day 3 she has diarrhea
This was not an adverse event, just a patient complaint about the redness associated with intradermal Fluzone shot. He said it was sore and red and he was unhappy about experience. Guest received refund and was reassured after I explained side effects of vaccine and that redness is normal.
All last night barely slept because fever, chills, body aches kept me tossing & turning despite taking Tylenol and Advil. Upper Arm with shot is sore. I slept until 11 am, still aching body and stomach/pelvic pains, then took shower and threw up after noon. Hour later, Walked around block with stabbing stomach and body aches. Got smoothie at 2 pm, still very achy. Took Tylenol at 2:45 pm. Feeling better except for aches. Took Advil at 3:30 pm. Everything better except aches.
Within 48 hours, patient developed blister like rash on left thigh at injection site. Rash continued to spread over the next 2 weeks until it covered every inch of his body. Was painful and itchy.  The full body rash lasted a duration of 2 months. Patient was seen by primary care physician, alternate pediatrician, and pediatric dermatologist within 1 month of vaccine being administered.
2nd vaccine on 1/6/21. on 2/3/21 had a high risk exposure ( husband tested (+) for COVID) and was asymptomatic. on 2/8/21 tested positive for COVID
Extreme Physical fatigue/Chills on second day(Friday)  Saturday apprx 3A,  like the rain stopping,  I felt better. Some "Brain Fog" exists for next 5 days and continues.
Vial was initially stored in refrigerator on 10-MAY-2023 and administered to patient on 12-JUN-2023; No adverse event; 9 adult patients (Not pregnant) received expired Bivalent Blue Cap booster doses of Moderna COVID-19 vaccine on 10JUN2023 through 24JUN2023/Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (9 adult patients (Not pregnant) received expired Bivalent Blue Cap booster doses of Moderna COVID-19 vaccine on 10JUN2023 through 24JUN2023/Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 10-MAY-2023 and administered to patient on 12-JUN-2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (9 adult patients (Not pregnant) received expired Bivalent Blue Cap booster doses of Moderna COVID-19 vaccine on 10JUN2023 through 24JUN2023/Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 10-MAY-2023 and administered to patient on 12-JUN-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (9 adult patients (Not pregnant) received expired Bivalent Blue Cap booster doses of Moderna COVID-19 vaccine on 10JUN2023 through 24JUN2023/Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 10-MAY-2023 and administered to patient on 12-JUN-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (9 adult patients (Not pregnant) received expired Bivalent Blue Cap booster doses of Moderna COVID-19 vaccine on 10JUN2023 through 24JUN2023/Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 10-MAY-2023 and administered to patient on 12-JUN-2023).    Concomitant medication details not reported by the reporter. None of the patients were pregnant. Suspect product dosage text was reported as unknown. The 2.5 ml vial was initially stored in the refrigerator on 10-MAY-2023 and did not underwent any temperature excursions. Treatment details was not reported by the reporter.    This case was linked to US-MODERNATX, INC.-MOD-2023-732805 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732805:Same reporter (Master case)
pt recv vax 1NOV95 & 3NOV95 pt devel redness on rt arm from shoulder through deltoid area;arm was also warm to touch;by 5NOV95, had recovered;
Patient called to schedule her third Hepatitis B vaccine and a Hepatitis B vaccine was pulled and put into a bag for the patient. When the patient arrived the ENGERIX-B vaccine was pulled from the bag and administered to the patient. Later it was found out that the patient was supposed to receive the TWINRIX not the ENGERIX-B because she needed her third shot for the Hepatitis A & B combination product, not just the hepatitis B vaccine.
DONOR REPOTS: GENERALIZED BODY ACHES, CONGESTION, DIZZINESS, RUNNY NOSE. REPORTS S/S INCREASED THROUGHOUT WEEEKEND WITH SORE THROAT ADDED TO C/O TODAY.
This spontaneous report as received from an other health professional refers to a patient of unknown age and gender. On 01-AUG-2016, the patient was vaccinated with improperly stored dose of (wistar ra 27-3) M-M-R II lot # L029266 (dose, route of administration and lot# were not provided). This is one of several reports received from the same source. Additional information has been requested.
very achy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (very achy) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (very achy). At the time of the report, PAIN (very achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported No treatment medications were reported
Pt vaccinated with DTP/OPV/HIB developed unconsolable crying 48 hrs after vaccines. This was intermittent on 9NOV, 10NOV PE was normal Incl Neuro exam.
3 of 10 pain/hardness at the injection site; low grade fever; nausea; vomiting; exhausted; 3 of 10 pain/hardness at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (3 of 10 pain/hardness at the injection site), VACCINATION SITE INDURATION (3 of 10 pain/hardness at the injection site), PYREXIA (low grade fever), NAUSEA (nausea) and VOMITING (vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE PAIN (3 of 10 pain/hardness at the injection site), PYREXIA (low grade fever), NAUSEA (nausea), VOMITING (vomiting) and FATIGUE (exhausted). On an unknown date, the patient experienced VACCINATION SITE INDURATION (3 of 10 pain/hardness at the injection site). At the time of the report, VACCINATION SITE PAIN (3 of 10 pain/hardness at the injection site), VACCINATION SITE INDURATION (3 of 10 pain/hardness at the injection site), PYREXIA (low grade fever), NAUSEA (nausea), VOMITING (vomiting) and FATIGUE (exhausted) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Blood pressure dropped, cold sweats, faint, immediately following injection.   Then 5 days later itchy rash at injection site. Doctor prescribed steroid cream. Lasted for about a week.
VACCINE ADMINISTERED TO PATIENTS AT 4 HOURS 55 MINUTES, 5 HOURS AND 5 HOURS 20 MINUTES RESPECTIVELY , WHICH WAS STORED OUT AT ROOM TEMPERATURE FOR 5 HOURS; VACCINE WAS STORED OUT FOR 5 HOURS AT ROOM TEMPERATURE; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 22-JUN-2021, the subject experienced vaccine administered to subjects at 4 hours 55 minutes, 5 hours and 5 hours 20 minutes respectively, which was stored out at room temperature for 5 hours. On 22-JUN-2021, the subject experienced vaccine was stored out for 5 hours at room temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered to patients at 4 hours 55 minutes, 5 hours and 5 hours 20 minutes respectively , which was stored out at room temperature for 5 hours and vaccine was stored out for 5 hours at room temperature was not reported. This report was non-serious.
Pt. states that after receiving the 3rd Booster of Moderna 11/04/2021, started experiencing symptoms 11/05/2021 of chills, stomach pain, loose stool, hot flashes, and nausea. Transported by Ambulance to Hospital. Admitted for Dehydration and Observation 3 days. Discharged 11/08/2021 with Follow-Up with  Gastrologist 01/13/2021. Symptoms have subsided.
Patient was Ok right after immunization, upon scheduling f.u vaccine patient had a syncopal episode. Patient was nauseous, calmmy, fatigued for about 20 minutes.
complaints: felt faint, reports history of same symptom with venipuncture and injection. History of anxiety Denies chest pain, SOB, headache.  BP: 120/88 HR: 72 Sp02: 98% Patient was monitored 20min  Seen and cleared by NP