chrisvoncsefalvay/vaers-outcomes huggingface dataset:
temperature excursion, cause unknown, for 18 minutes with a low temperature with no reported adverse event; stability data not provided in temperature excursion  hence non-case
Began experiencing erratic and irregular heart beats accompanied by dizziness, difficulty catching breath for over a week.
Information has been received from an RN concerning a 5 year old female with no pre existing allergies, birth defects, or medical conditions who on  12/30/99 was vaccinated SQ with a 1st dose of varicella virus vaccine live. At the time of vaccination the pt has resolving OM and was being treated with amoxicillin. On 06/23/2004, the pt was brought to the physicians office with a rash that had developed that morning. Upon exam, the physician believed the rash to be caused by varicella. There were 13 lesions located about the groin, back, and trunk and a few more may be developing. No evidence of URI, cough or fever was present. No specific Tx was indicated. No product quality complaint was involved. There were no adverse events following prior vacciantions of the pt or siblings. Follow up information received from a RN indicated that on 06/23/2004. the child was seen in the office with scattered lesions appearing over the course of the morning. There was no evidence of an URI, fever or cough. Tx included symptomatic relief and standard varicella precautions. The outcome was reported as recovered. No additonal information is expected.
Same symptoms as covid !! Cold chills; aching, pain; sick feeling; headache; This is a spontaneous report received from a contactable consumer, the patient. A 56-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Er8727), via an unspecified route of administration in the left arm on 30Mar2021 at 19:00 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. Medical history included prostate cancer, penicillin allergy and COVID-19 (which was diagnosed prior to the vaccination). Concomitant medication was not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021 at 20:00 (one day after vaccination), the patient experienced the same symptoms as COVID which includes cold chills, pain, sick feeling and headache. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events chills, pain, feeling sick and headache was resolving at the time of the report.   No follow-up attempts are possible. No further information is expected.
Vaccine expired at time of administration. It was past the bud of 10 weeks in the fridge.  Expired 3/30/22. Called patient to discuss cdc recommendation of re-vaccination.  Patient did not want re-vaccinated.
On 10Mar2011, this 48 year old male patient received Pneumovax, Combined Tetanus, Diptheria and Pertussis (Tdap) and an unknown influenza vaccine in the ID Clinic. He was offered to receive the vaccines 2 in one arm and 1 in the other arm. The patient requested to receive all three vaccines in the right deltoid. On 11Mar2011 he reported that he was having pain in his right arm, radiating to his armpit and had slight swelling at the injection site. He denied noting any redness. It was recommended that he return to the clinic immediately for treatment but he declined. On 11Mar2011, he will take ibuprofen and use a hot pad to treat his symptoms and go to the emergency room if his symptoms worsen. It is unknown if he continues to experience pain in his right arm and arm pit or swelling at the injection site.
INTENSE SORENESS AT INJECTION SITE (UPPER LEFT ARM), SEVERELY LIMITING RANGE OF MOTION LASTING 4 DAYS.
Left deltoid with red, hot, mild edematous 5 X 6 macule. No tenderness.
This spontaneous report as received from a physician via company representative refers to a 65 year old female patient with allergic to insects and seasonal allergies. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date and dose were not reported). On an unknown date, the patient experienced 8cm swelling with erythema at the injection site. The patient sought medical attention and went to the emergency room for the same. The patient was treated with Clindamycin. On an unknown date, the event of 8cm swelling with erythema at the injection site was recovered/resolved. The physician saw the patient 3 months after the event transpired and was not the prescribing or treating physician associated with the event. This is one of the two reports received from the same reporter (MARRS#1309USA005640). Additional information has been requested.
Several minutes after HPV vaccine was administered, pt's dad reports a syncopal episode with "loss of consciousness and shaking of arms and legs". Patient was awake and alert when this nurse arrived on scene (Patient was in his dad's car). He was oriented but "lightheaded" and diaphoretic. He was placed in Trendelenburg position in the car and transported to the E.R.
Patient had a seizure (first ever) 5-16-04 with a low grade fever (100.6 at highest)He had the fever the day before as well and it lasted a total of 3 days. After the third day, his fever broke and he had a rash all over his body. Small red bumps which were mostly on his belly, back and neck. During the seizure he stopped breathing for about 30 seconds to 1 minute. Was taken into emergency room. Doctor ruled out febrile seizure because fever was too low. Doctor also ruled out being a reaction to vaccines because it was too long after the shots were administerd. (8 days) (which is contrary to the info I reviewed from CDC) I did not have a copy of his vaccinations at the emergency room available for doctor. Doctor did standard tests to check blood and a chest X-ray.
arm sore; body ache; temperature of 102°; chillS; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm sore), MYALGIA (body ache), PYREXIA (temperature of 102°) and CHILLS (chillS) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm sore), MYALGIA (body ache), PYREXIA (temperature of 102°) and CHILLS (chillS). At the time of the report, PAIN IN EXTREMITY (arm sore), MYALGIA (body ache), PYREXIA (temperature of 102°) and CHILLS (chillS) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were provided. No treatment medication details were provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: NNI
02/12/23 presents to ED for "Syncopal episode". PMHx of "down syndrome, dementia, hypothyroidism, subdural hematoma s/p evacuation (12/9/21) , sinus bradycardia, orthostatic hypotension"
No additional adverse effect reported.; M-M-R II, VAQTA and GARDASIL 9 that underwent a temperature excursion (case 01907249) were administered.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported.  On 01-MAR-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #: S022599, expiration date: 25-FEB-2022, dose, strength and route were not reported) for prophylaxis.   The vaccine underwent temperature excursions and was stored at 9 degree Celsius (C) to 25 C (8.7 C) for 30 minutes, 2 C to 8 C (8.2 C) for 30 minutes and 9 C to 25 C (9.43 C) for 45 minutes. There was no previous temperature excursion. The digital data logger was involved. No additional adverse effect reported.   This is one of 20 reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022599; expirationdate: 25-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002970: US-009507513-2104USA002944: US-009507513-2104USA002986: US-009507513-2104USA002980: US-009507513-2104USA002978: US-009507513-2104USA002981: US-009507513-2104USA002976: US-009507513-2104USA002987: US-009507513-2104USA002983: US-009507513-2104USA002974: US-009507513-2104USA002982: US-009507513-2104USA002985: US-009507513-2104USA002973: US-009507513-2104USA002975: US-009507513-2104USA002963: US-009507513-2104USA002971: US-009507513-2104USA002984: US-009507513-2104USA002972: US-009507513-2104USA002989:
recently had an allergic reaction due to what I think was the Pfizer vaccine. Last time my arm had a really bad rash. With the second dose that I received on Saturday, almost exactly 24 hours later my lip started to swell. I spoke to the pharmacist and she said it might be a delayed reaction to the vaccine and it was just showing because I had taken a benadryl when I got the vaccine. It finally went down on Monday. Today at about 8:30 pm my right side of my lip and face have started to swell. I don't have any shortness of breath or any other issues except my injection site is a bit swollen and itchy and I have a slight headache. I haven't eaten anything different or used any new products. I took a benadryl and will go to ER if it gets worse, but I'm wondering if I can get allergy testing done because at this point I don't know if it is still a vaccine reaction or if it's something else.
Patient reported during a phone consultation session with pharmacist that she had received the 2 doses of the Pfizer vaccine in April and got blood work checked "about 9 days later" and had no antibodies present. Patient did not provide location of vaccine or any further details.
62 y/o white male with shingles like skin eruption some 4-5 days after the receipt of ZOSTAVAX.  Rash, focal, pain.
Arm pain Pain in lymph nodes Chills  Headache Eye pain Back if neck pain and sore Muscle soreness entire body  Nauseous  Tired  Pretty much felt like I had covid all over again.   Per vaccine information sheets we are encouraged to report these side effects  Swearing after after about  Tylenol
pt recv vax; screamed inconsolably for 5-6 hr beginning 1-2 hr p/ vax; PAR did not report at time;
15 year old received Adult dose; 15 YO received Adult dose; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 15-year-old female patient who received HAV (Havrix 1440 adult) (batch number 95DB2, expiry date 13th December 2024) for prophylaxis.   On an unknown date, the patient received Havrix 1440 adult. On an unknown date, unknown after receiving Havrix 1440 adult, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt Date: 23-FEB-2023 Reporter's comment: The reporter consented to follow up via mail. Additional supportive information: 15 year old patient was administered an adult dose of Havrix, which led to adult product administered to child and overdose.
Ringing in ears, dizziness, felt throat swelling, hard to swallow, swelling and redness at site, headache, pale, clammy to touch
T 101 (on 09/03/02) for one day, Sore arm, Patient refused to come in to be checked.
Client broke out in generalized hives across torso, back, arms and legs, itching 1 minute after vaccines administered. Client was given 25 mg liquid Diphenhydramine orally, hives subsided and client tired 15 minutes later. No respiratory changes noted. Client examined by physician on site, no further treatment.
STOMACH PAIN; This spontaneous report received from a patient concerned an adult female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On and unspecified date, patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number and expiry: Unknown) dose, start therapy date were not reported administered 1 in total for covid-19 vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. On and unspecified date, the patient received booster dose of non-company suspect vaccine included: tozinameran (Pfizer biontech covid-19 vaccine) (Dose number in series 2) (form of admin unknown, intramuscular, batch number and expiry was not reported), dose, start therapy date were not reported for covid-19 vaccination. No concomitant medications were reported. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number and expiry was not reported) dose, frequency, and therapy dates were not reported for moderate to severe ulcerative colitis. On an unspecified date, the patient experienced stomach pain following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). It was unknown if patient was enrolled in covid-19 vaccine trial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stomach pain was not reported. This report was non-serious.
She got the vaccine, she's healthy.  Within minutes they took her VS and showed no signs of anything happening at that point.   She had a care ride.   At approximately 4:00 PM the EMS was at the facility,  she could not breath or talk and EMS was called and it got worse in the ride to the ER.   She had a severe  headache to the point that somebody grabbed her around the throat and her eyes were popping out of her head.  She had chest pains, and given nitro for that, and had trouble breathing.  She had no voice.  The attempted to give her aspirin in applesauce.  Her temp was taken and it was 97, by the time she was admitted it was elevated.  In the car, EMS was trying to get her veins and 11 attempts were made and she was bruised.   She has waited a year and a half for surgery as she needs right knee replacement, and has spine, joint issues and was not able to move due to extreme weakness.  She was given Epinephrine in her leg and it did not do anything.  She was admitted to the hospital and was there a couple of days until she was able to help her walk.  She had no anxiety and had anger over the nursing staff, attending physician and the way she was treated.  She is a licensed CNA and has worked in 3 hospitals and has a grievance due to the lack of care that she received while in the hospital.  The ER nurses were good, but going to the 6th floor was another issue.     Her Dr. on Saturday ordered a swallow test as they could not determine why she had no voice and could not swallow.  It was done and she was still having difficulty getting food down, but it was slow and did go down.  Since he has been back at ALF she is now better, able to walk, talk and go about her life.   While in the hospital she was having a hard time getting her medications, and was given a breathing treatment in the ER, and was still having problems on the floor and was having problems with them getting her medications so that she could breath.  She finally got their attention and told her that she was not okay with her and the lack of the nursing staff care.   She fought to get her Flonase, and by the time she was ready to leave on Saturday she had been given one treatment of Symbicort.    She did have blood tests done to the point that it was excessive, but she had veins that were blowing and there was no access points.  On Friday she refused them as she had been stuck 11 times.  On Saturday morning they came to get more blood and she refused on Saturday evening when she was being discharged, and she was prescribed a multivitamin to take, which she has never taken one before.    She has no heart issues and no chest pains but was discharged home with nitroglycerin.   She states that she will not be getting the 2nd vaccine.
Patient received a Moderna booster (0.25 mL), when he was supposed to receive a full Moderna second dose (0.5 mL).
neck is tender; neck is slightly swollen; lymph node swelling in the right neck/neck is slightly swollen; chills; aches/pains; tiredness; This spontaneous case was reported by a physician and describes the occurrence of TENDERNESS (neck is tender), SWELLING (neck is slightly swollen), LYMPHADENOPATHY (lymph node swelling in the right neck/neck is slightly swollen), CHILLS (chills) and MYALGIA (aches/pains) in a male 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 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced CHILLS (chills), MYALGIA (aches/pains) and FATIGUE (tiredness). On 06-Dec-2021, the patient experienced TENDERNESS (neck is tender), SWELLING (neck is slightly swollen) and LYMPHADENOPATHY (lymph node swelling in the right neck/neck is slightly swollen). On 01-Nov-2021, CHILLS (chills), MYALGIA (aches/pains) and FATIGUE (tiredness) had resolved. At the time of the report, TENDERNESS (neck is tender), SWELLING (neck is slightly swollen) and LYMPHADENOPATHY (lymph node swelling in the right neck/neck is slightly swollen) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
Rigth arm red rash with warmth measuring 9cmx9cm. Left arm red rash with warmth measuring 8cmx8cm (local vaccine reaction). Red rash with warmth to injection site.
Muscle pain in upper arm; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558-Pfizer sponsored Program Support). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 03Feb2021 (Lot number: EL9265) as dose 2, single and administration date 13Jan2021 (Lot number: EK9231) 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: MYALGIA (non-serious) with onset 2021, outcome "not recovered", described as "Muscle pain in upper arm".  Additional information: Patient stated that she was an average person. Patient had two doses of Covid vaccine (13Jan2021-first dose, 03Feb- second dose). Unfortunately, she was still experiencing muscle pain in her upper arm up until now.  No follow-up attempts are possible. No further information is expected.
No adverse effects were reported.; Patient was administered improperly stored VARIVAX; Information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, previously drug reactions, allergies, concurrent conditions and concomitant medication were not reported.      On 07-JUN-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot number R035222 with expiration date in 04-DEC-2020 (strength, anatomical location, dose and route of administration were not provided) for prophylaxis, that was reconstituted with sterile diluent (DILUENT MRK) (strength, dose, lot number, expiration date and route of administration were not provided) (it was not reported if the sterile diluent (DILUENT MRK) used had an excursion).   The varicella virus vaccine live (oka/merck) (VARIVAX) was stored at a temperature range of -9 degrees Celsius (°C) to 8°C (-3°C), for the time frame of 3 hours and 39 minutes. There was no previous temperature excursion and the call was because of a data logger.   No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA008695: US-009507513-1906USA008644: US-009507513-1906USA008643: US-009507513-1906USA008662: US-009507513-1906USA008721: US-009507513-1906USA008724: US-009507513-1906USA008722: US-009507513-1906USA008723:
Site was red and sore two days post vaccine. On the 7th day is still 3 inches diameter and now extremely itchy.
nausea/vomiting  starting after booster dose for 3 days then cardiac arrest
On 7-9-07 received #2 of Hep. B vaccine.       On 7-9-07 pt. noted 30 minutes after injection with h/a (pounding & heaviness), nausea, eye pressure, right arm soreness/tenderness,(took OTC Tylenol and warm compression).  Nodule noted on          7-10-07. Tender over rib junction after injection on 7-9-07.  Pt. seen via PCP 7-24-07 with ongoing fatique, decrease intake, tenderness @ injection site and rib junction.  Labs obtained LFT and BMP (WNL).  Ordered Ibuprofen 800mg and Nexium.
Diarrhea 6/19, then developing abdominal distension and lethargy 6/20, presented in extremis to emergency room with cardiorespiratory failure, CPR and intubated. Resuscitated in PICU with fluids, dopamine, antibiotics, treated acidosis and hyperkalemia. Found in hospital to have intestinal volvulus and necrotic small bowel at surgery.
as fever in arm; arm hurt; peeled offlike you had a sunburn; felt bad; This case was reported by a consumer via interactive digital media and described the occurrence of skin warm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced skin warm, pain in arm, skin peeling and feeling bad. On an unknown date, the outcome of the skin warm, pain in arm and skin peeling were unknown and the outcome of the feeling bad was recovered/resolved.   It was unknown if the reporter considered the skin warm, pain in arm, skin peeling and feeling bad to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had already Shingles vaccine but his/her physician said need the new one of Shingles vaccine, got it was bad arm hurt, had fever in it later it peeled off like had a sunburn and felt bad for several days. The patient stated that, wish he/she had not taken Shingles vaccine and have to get another one like 5 months later read where it says that the covid-19 vaccine could cause to get shingles so he/she think why physician said that this one was different would not get the second one. The follow-up would not possible as no contact details were available.
pain started when patient got home.  swelling, redness, soreness started the next day.  soreness started to get better two day after imz.