chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bilateral rash on upper arms, bilateral rash on upper thighs; fever up to 101.4.
Myalgia, Arthralgia, Fever, fatigue, chills Narrative:
The monitoring nurse observed client with elevated hand, reported feeling "tingling to hands, lip, feet".  No signs of acute distress.  Patient denied any respitory difficulty, and there were no signs of anaphylactic reactions.  Skin clammy to touch.  Patient felt nausea, so was assisted to clinic restroom and had 2 vomiting episodes.  Vital signs b/p 123/86, pulse 84, resp. rate 22, O2 sats 99%  After continued observation, dizziness and nausea subsided.  Felt comfortable enough to leave clinic  Vital signs b/p 119/87, pulse 76, resp. rate 22, O2 sats 97%
For 24 hours following vaccine, infant was lethargic, difficult to awaken, only fed 2 times in 29 hours, then 24 hours of irritability and crying.  NO fever.  Exam was normal.  After 48 hours, back to normal.
Fever of 101 for 36 hours that started about 12 hours after getting the shot. Severe body aches and sharp pains in joints for 48 hours. Photosensitivity, extreme fatigue for 48 hours and nausea for 48 hours.
indication=Treatment of COVID-19; indication=Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Lot number: EL3302), in left arm, on 10Mar2021 as dose 2, single (Lot number: EN6206), in left arm and on 02Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild asthma" (unspecified if ongoing), notes: Mild asthma treated by inhaler PRN; "hayfever" (unspecified if ongoing); "Known Allergies: Tetracycline related medications (developed PIE)" (unspecified if ongoing); "Known Allergies: Soy (Anaphylaxis S2)" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Macrodantin, reaction(s): "Known allergies: macrodantin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19May2022, outcome "unknown" and all described as "indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-1 test: (unspecified date) Negative, notes: when I tested on June 6 or 7, I was again negative; (19May2022) positive; (24May2022) Negative; (30May2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had a sore throat and tested positive for COVID-19 on 19May2022. She was prescribed Paxlovid and was able to start the 5 day routine for the medication that same day (19May2022) and stopped on 23Jun2022. She was really never sick or fatigued. Her test result was light pink, not a bright pink as other positive tests she have seen. She tested negative on 24May2022. On 29May2022, she woke up with a mild sore throat. It was still sore on 30May so she tested again and was positive. She did not test for a week and when she tested on 6 or 7Jun2022, she was again negative. No S/S since then.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events.
vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (vaccination adverse reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (vaccination adverse reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
had shot, trigger herpes outbreak / suspected vaccination failure; herpes outbreak / cold sores; sick; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), oral herpes and sickness. On an unknown date, the outcome of the vaccination failure, oral herpes and sickness were unknown.   It was unknown if the reporter considered the vaccination failure, oral herpes and sickness to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient's friend. The age at vaccination was not reported. The patient had shot and felt sick a few days. The reporter enquired did this normal and did the shot trigger herpes outbreak such as cold sores. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Redness, Swollen (L) arm 3.8 x 2.8, Pain, Dry skin/irritated, Hot to the touch. Took BENADRYL, Ice pack.
Patient passed out a few minutes after vaccines were given. Patient then began to have a seizure. Medical provider classified as vasovagal event.
Ran a persitant fever for 10 days. 9-14-07 given amoxicillin,did blood work up. Everything was normal except for the neut which was elevated. fever ended within 3 days after medication.9-20-07 2 lymph nodes in groin swelled, one nickel size other pea size. took her back to the doctor, they did nothing. 9-25-07 a third lymph node swelled to nickel size next to the other two.Took her back again,they changed her meds and took more blood, and did a tb test. Tb was neg. blood came back normal. Her reactive lymph was a 5.She had not been acting herself through all of this.Was extremly cranky. Screamed for no reason for an hour or 2 at a time. And nothing would sooth her.She would refuse to eat.
Overall body pain is really bad; severe pain in joints; Severe pain in lymph nody; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Overall body pain is really bad), ARTHRALGIA (severe pain in joints) and LYMPH NODE PAIN (Severe pain in lymph nody) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Overall body pain is really bad), ARTHRALGIA (severe pain in joints) and LYMPH NODE PAIN (Severe pain in lymph nody). At the time of the report, PAIN (Overall body pain is really bad), ARTHRALGIA (severe pain in joints) and LYMPH NODE PAIN (Severe pain in lymph nody) outcome was unknown.            No concomitant medication were provided by the reporter  No treatment medication were provided by the reporter   Reporter did not allow further contact
pt recv vax; 2 approx 30 mins of staring episodes; truncal rigidity w/o distractability; fixed gaze to light to tonic straightening thru back w/ neck extension not assoc w/ significant fever; T 100 in er; Leukocytosis w/o shift;
Shingles; This is a spontaneous report from a contactable consumer or other non-HCP (patient himself). A 69-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09May2021 10:30 (at the age of 69-years-old) as dose 2, single for COVID-19 immunization. Vaccination facility type was reported as Pharmacy or Drug Store. Patient medical history included high cholesterol and known allergies to chestnuts. The patient previously received simvastatin for high cholesterol from unknown date. The patient previously received varicella zoster vaccine (shingles vaccine) on an unspecified date in 2018. Historical vaccine received the BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- EW171) via an unspecified route of administration in left arm on 18r2021 10:30 as dose 1, single for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11May2021 at 22:00, 2 days after the second vaccine, the patient experienced a series of red dots appeared in a triangular pattern on 2 parts of upper right thigh. The patient dermatologist diagnosed it as Shingles. The patient had the shingles vaccine in 2018, hence was surprised by this side effect. The patient underwent lab tests and procedures which included Sars-Cov-2 (nasal swab) test for COVID-19 on 17May2021 and tested negative. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of shingles and included treatment with valacyclovir. The clinical outcome of the event shingles was not recovered at the time of this report.   The lot number for the vaccine, [BNT162b2], was not provided and will be requested during follow up.
Injection site pain (immediately following) Entire arm pain within 1 hour following  Fever 101.5 Headache/migraine  Chills Body aches  ALL began within 2 hours
82-year-old female with history of hypertension, chronic kidney disease, hyperlipidemia, chronic congestive heart failure.  For the past week has had increased weakness fatigue and near syncope.  Patient came to the ER with O2 sat in the 80s.  Patient was also complaining of nausea with dry heaves and vomiting.Patient has been overly lethargic per family.  Patient's work-up 3.6, H&H 15 and 46, platelets 91, sodium 135, potassium 3.8, BUN 22, creatinine 1.05, troponin VI 28, lactic acid 0.8, pro-Cal 0.15. + covid 19
expired MENACTRA was given to a patient with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional and non-health care professional/consumer via Medical Information (Reference number- 00752479) and transmitted to Sanofi on 02-Sep-2021.  This case involved 16-year-old male patient was given expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered)  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.  On 30-Aug-2021, the patient received second 0.5ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot: U6691AB and expiry date: 21-Aug-2021) (Frequency = once) (Strength = standard) via intramuscular route in the left deltoid for prophylactic vaccination (expired product administered).  It was reported,"caller states that for some reason the vaccine was put back into rotation, caller also inquiring when a repeated Menactra vaccine can be administered. Management of Adverse Events and Product Technical Complaints Pasteur AE (adverse event) Reporting Refunds/Credits will not be issued due to adverse events".  This case was an actual medication error due to expired vaccine used (latency: same day)  At the time of reporting, no adverse event  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
6/23/21 @ 0830 14 y/0 F came to clinic for TDAP, IPV, MMRV, Hep A, and Hep B vaccinations. Pt has NKDA and no PSH/PMH. 6/18/21 pt had her 2nd Pfizer vaccine, no side effects verbalized.  Approximately 2 minutes after administration pt was standing against padded pediatric exam table and fell back onto table, her legs buckled and she gently slid down onto floor in sitting position with head slumped down causing her eye glasses to fall off. Pt did not hit head. Syncopal episode lasted 5 seconds. When pt regained consciousness she was alert and oriented, pale and c/o of dizziness and blurred vision. The patients mother and I assisted her to a chair. After 1-2 minutes pt?s eyes rolled back, her left arm contracted up, her entire body stiffened and she was having seizure like activity lasting 5-10 seconds. Pt was flushed and did not breathe during this episode. 911 was called at this time. When patient regained consciousness she c/o of fatigue, feeling cold, dizziness and blurred vision. She was AAOx3 and very pale. After applying her eye glasses her vision improved some, still c/o dizziness and stated she just wanted to go to sleep. Pt was provided a cool rag and was kept awake and talking until EMS arrived. Report given to EMS. F/U call made to pt?s mother whom reported pt was discharged from ER. No lab work or radiology was performed. MD stated that ?this was a normal anxiety related reaction for a patient her age.? Since discharge from hospital pt has been asymptomatic and back to her baseline.
I received the 2nd Pfizer COVID Booster shot on 8/23 from my local pharmacy. I experienced expected side effect, but also enlarged painful lymph nodes. Today I noticed I have a cold sore on my mouth - I rarely get these, nearly never so I suspect it is a side effect and I just want to report it incase other people have the same experience and it is something that can be fixed.
STILL HAVE SORE ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On APR-2021, the subject experienced still have sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from still have sore arm. This report was non-serious.
Initial unsolicited report received from a Physician via Partner Company (Pfizer) on 03 February 2016. This case involves a patient (age and gender not reported) who was vaccinated with a dose of Flu shot (batch number, route and site of administration not reported) last year on an unspecified date. The patient's medical history concomitant medications concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had experienced Guillain-Barre Syndrome. Laboratory data and corrective treatment were not reported. The outcome of event was not reported. Upon internal review the case was considered as serious because of important medical event Guillain-Barre Syndrome. List of documents held by sender: none. Sender's Comments: The manufacturer of the INFLUENZA VACCINE involved in this report is not known. Guillain-Barre Syndrome is reported following administration of INFLUENZA VACCINE. This case is very poorly documented consumer case to assess the role of the vaccine. However, investigation results ruling out a concurrent condition and other etiologies would be helpful to further assess this case.
fever up to 103 F starting eight days after vaccines with 2 minute generalized seizure 9 days after vaccines
Patient received 0.2 ml of undiluted pfizer covid 19 tris-sucrose 10 mcg (5-11yr) vaccine
SEVERE headache, chills throughout night of inoculation and into 1/2 next day, with moderate temperature and muscle aches.
Progressive weakness, dysphagia, and hypoxia, eventually progressing to flaccid paralysis.  Diagnosed as Guillain-Barre syndrome.  Treatment included 2 day course of intravenous immunoglobulin.  Patient eventually intubated and transferred to outside facility due to complexity of care.
PATIENT REPORTED "PINS AND NEEDLES FEELING THROUGHOUT ARMS AND LEGS FOLLOWED BY ICE COLD FEELING FLOWING THROUGH HER VEINS" ABOUT 15 TO 30 MINUTES AFTER SHE RECEIVED THE VACCINE
26 days between doses; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 29th March 2021, the patient received the 2nd dose of Shingrix. On 29th March 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix, earlier than the recommended schedule, which led to shortening of vaccination schedule. No further events were reported.  The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter.
p/ pt recv vax in 3/98 w/1 dose of varicella virus live pt approx 2 mo later devel rash on his chest, pt not seen by m.d. addl info recv indicated pt exp ``mild case of chickenpox uncomplicated''
Patient received only the AS01BAportion; Patient received only the AS01BAportion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 82-year-old female patient who received Herpes zoster (Shingrix) (batch number 2F9M5, expiry date 19th May 2023) for prophylaxis.   On 2nd March 2022, the patient received the 1st dose of Shingrix. On 2nd March 2022, 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 nurse reported that patient received only the AS01BA portion of the Shingrix vaccine which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. The case has been linked with the case US2022039279 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022039279:Same reporter.
lt arm w/redness, swelling & warm to touch;denies fever;arm is stiff & sore;has been applying warm compresses, alcohol & taking aleve for the soreness;
Dizziness, HYPERtension, elevated blood pressure Narrative: dizziness 10 min after injection and by was 139/75.
Came in to have Tdap since new Baby in family given RUA and later in the evening her arm was sore, swollen and she had diarrhea, vomiting and temp. with bad headache. This went on for the whole next day and then the arm started with the above symptoms. Today still red and warm to touch, and painful.
This spontaneous report as received from a pharmacy technician refers to a 1-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 26-FEB-2018 the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558.
There was an opened unlabeled vial of Moderna in the fridge. There had not been any mentions of an open Moderna vial . I grabbed the open vial along with an unopened vial of Moderna and proceeded to the Covid clinic. There were 7 doses of this vaccine given to patients. As of 9/27 we were off on our counts and now realize that the vial that was used on 9/24 to those 7 patients was an expired vial. The vial had originally been opened on 9/23 by RN. These 7 patients have been located and will be contacted once recommendations from CDC are reviewed.
My eyes started getting slightly puffy 15-30 min after vaccine. I didn't notice it before I left the vaccine clinic but I noticed it later in a selfie I took then. Later that day they started itching and where more puffy & when I woke up they were swollen (R eye the most). I made an apt, slept a few hours and by the time I got there my lips were also swelling and I was diagnosed with angioedema and given Methelprednisone. I also had mild arm pain and extreme exhaustion, Vitals at clinic HR 105, BP 140/90, Temp 99.2,  O2 95
Vaccine was expired on 09-Nov-2021 and administered on 11-Nov-2021/Expired vaccine was administered after the 30-day Use by Date or after manufacturer date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 09-Nov-2021 and administered on 11-Nov-2021/Expired vaccine was administered after the 30-day Use by Date or after manufacturer date of expiration) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 09-Nov-2021 and administered on 11-Nov-2021/Expired vaccine was administered after the 30-day Use by Date or after manufacturer date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 09-Nov-2021 and administered on 11-Nov-2021/Expired vaccine was administered after the 30-day Use by Date or after manufacturer date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Vials did not undergone any temperature excursion.  No treatment medication was reported.   This case was linked to MOD-2022-581986 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live follow up was received with non-significant information of secondary reporter was added.