chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable nurse. An 18-year-old female patient received TRUMENBA via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history included cytosis. The and concomitant medications were not reported. On an unspecified date the patient experienced elevated WBC 15.7 thousand (white blood cell count increased), low hemoglobin of 8 on, fever of 102.2, generalized body aches and fatigue. The outcome of the events was unknown. The patient underwent lab tests and procedures which included body temperature: 102.2, haemoglobin: lowof 8, white blood cell count: 15.7 thousand.
No additional AE reported; Nurse reporting a temperature excursion for GARDASIL9 RECOMBIVAX ROTATEQ VAQTA that occurred on 12/16/2022 states it is unknown at time of call if any products have been administered.; This spontaneous report has been received from a nurse and refers to an unspecified number of patients of unknown ages and genders. There was no information regarding the patients' medical history, concurrent conditions, concomitant therapies, previous drug reactions or allergies provided.  On unspecified date, the patients were vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) syringe injection, at a dose of 0.5 milliliter (ml) (strength, route of administration, vaccination scheme were not provided; lot number 1775808 that was verified to be valid, expiration date reported and established as 20-AUG-2023); hepatitis b vaccine (recombinant) (thimerosal free) (RECOMBIVAX HB) intramuscular injection (lot number W023937 that was verified to be valid, expiration date reported and established as 06-DEC-2023);hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (lot number W023937 that was verified to be valid, expiration date reported and established as 06-DEC-2023) (strengths, doses, routes of administration and vaccination schemes were not provided); and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, with a default oral route of administration, at a dose of 2 ml (lot number 1837117 that was verified to be valid,  expiration date reported and established as 3/24/2023) (strength and vaccination scheme were not provided)(product storage error). All of the vaccines were administered as prophylaxis.  The administered doses of the vaccine were stored at a temperature of 27.03 degrees Fahrenheit (F) during a time frame of  6 minutes, and it was mentioned that the temperature excursion occured on 16-DEC-2022. There was no previous temperature excursion. No additional adverse events were reported.    Follow-up information has been received on 24-FEB-2023.  Case previously reported as non-valid due to a lack of patient identifiers, has now patient's demographics . Referring a 11-year-old female patient. Suspect vaccine was updated to only hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), vaccination anatomical location left deltoid.  This is one of several reports received from the same reporter.
A few hours after receiving the first dose, I was extremely tired and felt overall body fatigue but promptly recovered and felt fine.  One week and a day later, I got a 2 inch round red spot at the injection site that itched very much.  I still have it a day later, but the itching has subsided a bit.
since i received my booster for moderna, which was my 2nd booster, i've had pain that isn't subsiding as well as having isues with mobility on my right arm
pt recvd vax 10AUG93 & 13SEP93 noted to stumble & drool; clonus & hyperreflexia noted 1OCT93; opthalmoplegia noted 8OCT93 w/tongue deviation; no MRI of brain x 2, spine, spinal tap; no encephalitis;
Called our facility and notified us that we needed to add a VAERS report. This vaccine was a monovalent vaccine instead of a bivalent vaccine.
12:28 approx 7 min after moderna booster administration. Patient experienced the following-shivering/ shaky/cold sweats, slow response to questions, c/o dry mouth, increase thirst-drank 5 20ounce bottles of water, vitals 115/78, 75, 98.3, 18, O2 at 98%, no signs of dyspnea.  12:45 urinary incontinence. Blood sugar of 83, fine rash noted to left shoulder and back. 1:11pm -epi pen administered to left thigh 1:20pm 120/74 1:28 Physician obtain B/P of 128/80, assessed patient and administered 2 liter  of oxygen-nasal canula  1:30pm EMS transported staff to local hospital, per wife ER MD stated it was a panic attack , patient has no history of panic attacks or anxiety disorder.
FluLaval was in a cooler with the temp log reading  minus 1.6 Celsius; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number E5MN5, expiry date 30-JUN-2024) for prophylaxis.   On 14-OCT-2023, the patient received FluLaval Quadrivalent. On an unknown date, an unknown time after receiving FluLaval Quadrivalent, the patient experienced incorrect storage of drug (Verbatim: FluLaval was in a cooler with the temp log reading  minus 1.6 Celsius). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-OCT-2023 The pharmacist reported that he had some FluLaval that was in a cooler with the temp log reading minus 1.6 Celsius. The vaccine was injected and the reporter wonder if need to revaccinate those individuals. 64 patients received the vaccine from the cooler reading minus 1.6 Celsius which led to incorrect storage of drug. The pharmacists reported that he had 185 doses, that had not been injected. The reporter consented to follow up via postal.    The vaccine administration facility is the same as primary reporter. The Healthcare professional stated she would rather provide patient demographics at follow up. This case is linked with US2023AMR148062, same reporter.; Sender's Comments:  US-GSK-US2023AMR148062:Original Case : US2023144281
Within minutes of the vaccine (in my right deltoid), the heavy/warm/numb sensation radiating from the vaccine site moved up my right shoulder to the right side of my neck. There was no itching.  One hour after my vaccine, the heavy/warm/numb sensation moved into the entire right side of my face, though my facial movement was unaffected. I kept looking to make sure I had symmetrical movement on both sides of my face, and I did, but it took several hours for that sensation to subside.   Note: My daughter and sister have had intermittent Bell's Palsy (unrelated to vaccination) in the past, but I never have. I was concerned that might be what was about to happen, but it subsided. I've not heard of any of my relatives having this reaction to the vaccine, so I wanted to report it for data keeping purposes.
Patient claimed to be unvaccinated prior to being vaccinated. We later received a call from his university informing us that the patient had in fact received a first dose of Moderna one day before, Jan 31, and had sought a Janssen vaccine in order to meet a need to be "fully vaccinated" sooner. No adverse effects reported as of yet.
Patient found vomiting (1619) NP evaluated patient.  Patient still complaining of nausea. Patient complains of stiff neck and headache. 1619:  VS: 179/119- 88-Sat 99% on RA. R-16
a flare in their immune system; severe symptoms happening 12 hours after receiving the Moderna vaccine; A spontaneous report was received from a consumer concerning 20 people (age and gender unknown) who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a flare in their immune system (Sjogren's syndrome) and severe symptoms (vaccine adverse reaction).  The patients medical history included Sjogren's disease. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patients received their dose of mRNA-1273 (lot/batch: UNKNOWN) intramuscularly for prophylaxis of COVID-19 infection.  Consumer reported that she is in a social group and 20 people with a medical history of autoimmune disease Sjogren's experienced a flare in their immune system and severe symptoms happening 12 hours after receiving the Moderna vaccine.    On an unknown date, the patients experienced the events: a flare in their immune system (Sjogren's syndrome) and severe symptoms (vaccine adverse reaction).   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), a flare in their immune system, severe symptoms was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Patient received Fluad and PPSV-23 in the left arm and was diagnosed with cellulitis of the left arm soon after.
Sore arm, following day fatigue , swollen lymph node right neck and sore axilla on right side. Third day, swollen lymph node to left neck lasting several days . Did not prevent me from doing anything.
Constipation; Back pain: second dose; Vomiting: second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Apr2021 10:30 (Lot number: EW0170) at the age of 50 years as dose 2, 0.3 ml single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ALEVE taken for headache. Vaccination history included: Bnt162b2 (First dose, Batch/lot number:ER8733, Dosage text:injection, 0.3ML, right upper arm, Caller states she received the vaccine, around 11.00 or 11.30), administration date: 28Mar2021, when the patient was 49 years old, for Covid-19 immunization, reaction(s): "sore arm". The following information was reported: CONSTIPATION (non-serious) with onset 28Apr2021, outcome "recovering", described as "Constipation"; BACK PAIN (non-serious) with onset 28Apr2021, outcome "recovered" (02May2021), described as "Back pain: second dose"; VOMITING (non-serious) with onset 28Apr2021, outcome "recovered" (28Apr2021), described as "Vomiting: second dose". Therapeutic measures were taken as a result of constipation.  Additional information: Caller states she has no primary care provider. Caller states her constipation has improved, but not naturally, she has had to take stuff. She said she (50 years old female) her boyfriend (52 years old male) and sister (60 years old) are experiencing bad constipation after the Pfizer covid vaccine. Her doctor has prescribed laxatives and they are taking 8-9 prunes a day. Caller states she might have taken a pain killer like Aleve for headache or something maybe one or two pills. Caller declines having a headache after her Pfizer Covid Vaccine. Constipation; Vomiting: Caller states the constipation started last week on Wednesday, it was really bad, she even started vomiting with back pain. Caller states the vomiting and back pain started on the same day as her constipation. Caller states when she got home, she thought she was having her period or food poisoning. Caller states she vomited 3 times and then she was constipated. Back Pain: Caller states that she had back pain that began 28Apr2021 and it would come and go. Caller states it is gone as of now. Caller states the last time she had back pain was two days ago, 02May2021. Caller states she has received completely.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021510559 Same Vaccine/event, different  patient
Temperature of 102; Arm  really sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm  really sore) and PYREXIA (Temperature of 102) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm  really sore). On 11-Mar-2021, the patient experienced PYREXIA (Temperature of 102). At the time of the report, PAIN IN EXTREMITY (Arm  really sore) and PYREXIA (Temperature of 102) had not resolved. Not Provided          Treatment information was not provided.
Pt was diagnosed with shingles on his eye (a mild/moderate case) pt was treated & treated with ZOVIRAX 400 (2 tabs five x day for 7 days).
Passed away; Slight soreness in arm; A regulatory report was received from a pharmacist concerning a 72-year-old male patient who received Moderna covid-19 vaccine and death occurred 4 days after the vaccine and also experienced soreness in his arm after the vaccine administration.  The patient's medical history includes diabetes mellitus, Hypertension, Hypercholesterolemia, CVD, previous stroke and Depression. No relevant concomitant medications were reported. No information on allergies.   On 4-FEB-2021 at 10:43 am, prior to the onset of events, the patient received his first of two planned doses of covid-19 vaccine for the prophylaxis of covid-19 infection.   He had soreness in his arm the day following the shot, but he had no other symptoms.   He passed away on 08-FEB-2021 at 10 am. As per his wife, they never made it to the hospital, and he had poor health prior to vaccination.  Action taken with 2nd dose of Moderna Covid-19 vaccine was not applicable.  The outcome of the event death is fatal.; Reporter's Comments: This is a 72 year old male with hx of diabetes mellitus, hypertension, hypercholesterolemia, and CVD who died 4 days after the vaccine was administered. No autopsy report provided. No further information is expected in this regulatory report case.; Reported Cause(s) of Death: Unknown cause of death
Shingle like rash by injection site; Shingle like rash by injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site rash and vesicular rash. On an unknown date, the outcome of the injection site rash and vesicular rash were unknown.   It was unknown if the reporter considered the injection site rash and vesicular rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The reporter stated that, provided the following statement and was wondering if shingrix is known to cause shingle like rash by injection site. The reporter did not consent to follow up. No further details was provided.
Developed shortness of breath, wheezing, cold extremities, and hives within 5-15 minutes after receiving four immunizations and PPD.  5/14/09 hospital records received DOS 4/23/09 to 4/24/09. FINAL DIAGNOSIS: Anaphylactic Reaction Post vaccination: difficulty breathing, wheezing, coughing, retracting.
Patient presented to the drive through vaccine tent for Boost vaccine of Pfizer, patient too soon for booster vaccine. Supervisor notified. Patient notified.
2 inch by 3 inch erythema and 2 to 3 areas of 1/4 inch erythema.  Location 1/2 inch below injection site.  Warm to touch initially for less than a day.  Only small areas were raised, little pain to the touch.  No itching.  Went away after two days with one use of hydrocortisone cream.  No systemic symptoms.
Case number PHEH2016US028856, is an initial spontaneous report received from a nurse on 02 Nov 2016. This report refers to a 64 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 1619221) at a dose of 0.5 ml intramuscularly in left deltoid on 12 Sep 2016. The patient was vaccinated with FLUVIRIN that had experienced several temperature excursions prior to administration (minus 2.7C for 6 hours and 4 minutes minus 3.6C for 21 hours and 48 minutes minus 3.4C for 21 hours and 2 minutes minus 3.3C for 21 hours and 3 minutes minus 3.3C for 8 hours and 4 minutes 1.2C for 1 hour and 1 minute 1.7C for 1 hour and 5 minutes was not frozen). The nurse also stated that, the patient has been revaccinated on an unknown date. No adverse event was reported following this administration error. The case was assessed as non serious by the nurse.
received only the adjuvant; received only the adjuvant; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number F5TT2, expiry date 4th February 2023) for prophylaxis.   On 2nd November 2021, the patient received Shingrix. On 2nd November 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient received only the adjuvant ASO1B of Shingrix without lyophilized component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was linked with case US2021237467, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021237467:same reporter
My right arm became red at the injection site. It also itches a lot but I can't seem to reach the spot when I rubbed my arm. It also is a raised hard bump.
emphysema; COPD; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 ( booster),single for covid-19 immunisation. Relevant medical history included: "immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1), for Covid-19 immunisation; Covid-19 vaccine (Dose 2), for Covid-19 immunisation.  The following information was reported: EMPHYSEMA (non-serious), outcome "unknown", described as "emphysema"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "COPD".  Additional information: patient read in the paper that country is doing trials for a fourth vaccine of Covid for immunocompromised for people older than 65. She was immunocompromised and had the booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
About 45 minutes after receiving vaccination, my arm became weak. After that, my face and left side of my tongue became numb. We had to call 911. EMT came and assessed me. I felt pins and needles in my arm. They gave and administered Benadryl for me. I was taken to the ER. I had dysarthria, slow speech where I could speak but couldn't form full sentences. I noticed a temperature difference between my left & right sides of my body. I woke up at 2am and felt shot in my right deltoid and couldn't move my arm. I had MRI, MRA, CAT scans conducted in the ER. Thursday morning I was discharged and the pain reoccurred Thursday evening and the shooting arm pain happened again Friday. I noticed the temperature difference of both sides of my body. I couldn't recollect/remember things that occurred that day and kept losing time while trying to complete my daily routine. I didn't feel like myself and had high impulsivity. I had sharp shooting headaches and nausea episodes that developed. I saw my PCP and asked for a referral to a neurologist and allergist. That Saturday, I had a high sense of urgency. I had new axleria and my left arm felt weak, I was given 2 ibuprofen to help reduce the pain. The physical symptoms had me weak and I couldn't do anything. I had bad arm pain on Monday and called/connected with Moderna, got a case # with rep. I saw Dr., a neurologist who conducted neuropathic tests on me and informed me to  stay out of work until the 22nd. By Wednesday,  both arms calmed down, not so much pain. lighter sensation. I had an EEG done at Hospital. On Thursday, I could walk outside, could do more normal routine and steadily increased daily routine into the weekend with breaks in between; I had some left side chest pain that woke me up at night but reduced by morning.
Patient reported concern because "I can feel my face". Denies pain, lip/tongue swelling, blurry vision, headache, dizziness, chest pain, SOB. Otherwise, feeling baseline. Vitals 147/98, SpO2 99%, 94 bpm. Pt reports he has a history of high blood pressure readings. Offered patient to stay longer for observation, pt declined stating he is feeling well. Advised patient to seek emergent medical attention with onset of symptoms of distress such as SOB, difficulty breathing, chest pain, dizziness. Patient verbalized understanding and had no further questions or concerns at this time
Patient received first dose of the Pfizer Biontech COVID19 Vaccine. Within 15 minutes of the post-administration monitoring process, the patient reported dizziness. Then the patient reported not being able to breath, they were given Epi-pen 0.3mg. The patient was then taken to the emergency department where they received 8 mg Dexamethasone tablet and 25 gm Diphenhydramine capsule. According the emergency department provider, the patient is stable (01/28/21 @ 1345).