chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; Rash on back, armpit and chest; Blister on back, armpit and chest; Fever; Achy; Burning sensation in my armpit and arm; Shingles; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included never had shingles in the past.   On 31-MAY-2023, the patient received the 1st dose of Shingrix (left deltoid). On 07-JUN-2023, 7 days after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles) and burning sensation (Verbatim: Burning sensation in my armpit and arm). On 10-JUN-2023, the patient experienced pain (Verbatim: Achy). On 11-JUN-2023, the patient experienced fever (Verbatim: Fever). On 12-JUN-2023, the patient experienced rash (Verbatim: Rash on back, armpit and chest) and blister (Verbatim: Blister on back, armpit and chest). On an unknown date, the patient experienced pain in arm (Verbatim: Sore arm). The patient was treated with valaciclovir (Valacyclovir). The outcome of the shingles was not resolved and the outcome of the fever, pain, burning sensation, pain in arm, rash and blister were unknown.   It was unknown if the reporter considered the shingles, fever, pain, burning sensation, pain in arm, rash and blister to be related to Shingrix.     It was unknown if the company considered the shingles, fever, pain, burning sensation, pain in arm, rash and blister to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-JUN-2023 The patient self-reported this case. The reporter reported that he received the Shingrix vaccine and just had a sore arm for the first few days. Then had a burning sensation in his armpit and arm of the vaccinated arm. The patient woke up on 11th June 2023 with a fever. The patient started getting blisters and rash on his back, armpit and a chest. The rash on the back, armpit, and chest are located on the left side.   The patient started Valacyclovir medicine from the day of reporting. The reporter asked question that why he got this, he took the vaccine to avoid getting it, could not be the only person that had experiencing this. This agent made an outbound call to gather further information. The vaccine in question was Shingrix. The patient was diagnosed with shingles and was started on Valacyclovir from the day of reporting. The reporter did consent to follow up with health care professional.
2 weeks post perioribital edema for > 24 hours; swollen lips; Hives over entire chest , stomach and legs; This is a spontaneous report from a contactable other hcp (Patient). A 53-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0178,), via an unspecified route of administration, administered in Arm Left (Left deltoid) on 23May2021 16:00 (at the age of 53-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included Hashimoto's thyroiditis from an unknown date and unknown if ongoing Verbatim: Hashimoto's thyroiditis. Concomitant medications included levothyroxine, liothyronine (NP THYROID), topiramate (TOPAMAX) taken for an unspecified indication, start and stop date were not reported. on 23May2021 after 3 hours later on 19:00 patient experienced swollen lips and hives over entire chest, stomach and legs. On an unspecified date 2 weeks post perioribital edema for greater then 24 hours . Therapeutic measures were taken patient received treatment with Topical steroids and antihistamines. The outcome of events was 2 weeks post perioribital edema for > 24 hours was recovered on unspecified date rest of all events recovered in 2021.  Follow-up attempts are completed. No further information is expected.
No adverse events, side effects or symptoms have been reported by parents of patient when they were spoken to following the incident.
Malaise/fatigue/lack of energy, noticed when she received the shot for 1 week.
Excessive hoarseness; dry mouth (woke me up x 2 nites); dry cough. 2nd day after getting vaccine! Throat "tightened". Ears had buzzing sound. 2 days after vaccine: paroxysmal cough, wheezing on expiration; per Dr: bronchitis and laryngitis x 1 wk.
Heavy nosebleed in left nostril. 27 weeks pregnant. No history of nosebleeds.
Patients significant other states that patient had been in the bed since the vaccine on 4/8/21. He was told that he was positive for COVID.  She advised the patient not to come in for vaccine.  She reports that he had dizziness, chills, fever, and nausea along with lethargy.  He was told by a physician that he was dehydrated.  He has been resting since the last vaccine and drinking fluids.  As of today, she states that the patient is out of the bed and improving.
Last time got shot and was sick with flu for 2 weeks; Last time got shot and was sick with flu for 2 weeks; Initial information was received on 18-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer.  This case involves patient with unknown demography who was sick with flu for two weeks (illness and influenza), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatments, vaccinations, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (Produced by unknown manufacturer, lot number and expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious was sickness with flu for two weeks (illness and influenza), unknown latency following the administration of INFLUENZA VACCINE.  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The outcome of the events was unknown.  There will be no information on the batch number for this case.
Patient received Pfizer as her 2nd dose, it should have been Moderna. Moderna was her 1st dose
CDC reports: 17 mo child developed a rash following DTP/OPV/MMR immun; Hospitalized  1 day.
Covid arm:  Bruising, swelling, red patch, rash, thick hard center core, sensations of itching, burning, shooting pains, tenderness, tired arm, sensation of thick subcutaneous mass at rash site.  Involved area approximately 2-1/2"×3-1/2 inches
Rashes on body; 1st dose Jan2021, 2nd not yet; Tingling in legs; Numbness in legs/ numbness in her feet; tingling and numbness in her legs which was painful; Uncomfortable; Kept up at night; This case was reported by a consumer via call center representative and described the occurrence of tingling of extremity in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, ELASOMERAN (COVID 19 VACCINE MODERNA) for prophylaxis, TOZINAMERAN (PFIZER BIONTECH COVID-19 BOOSTER) for prophylaxis, TOZINAMERAN (PFIZER COVID VACCINE) for prophylaxis and TOZINAMERAN (PFIZER COVID VACCINE) for prophylaxis.   In January 2021, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix, COVID 19 VACCINE MODERNA and PFIZER BIONTECH COVID-19 BOOSTER. In March 2021, the patient received the 2nd dose of PFIZER COVID VACCINE. In February 2021, the patient received the 1st dose of PFIZER COVID VACCINE. In March 2021, between 2 and 3 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced tingling of extremity, numbness in leg, leg pain, discomfort and nocturnal awakening. On an unknown date, the patient experienced generalized rash and incomplete course of vaccination. On an unknown date, the outcome of the tingling of extremity, numbness in leg, leg pain, discomfort, nocturnal awakening, generalized rash and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the tingling of extremity, numbness in leg, leg pain, discomfort, nocturnal awakening and generalized rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-Feb-2023 Reporter's Comments: In February 2021, the patient received the first Covid (Pfizer) vaccine, and in March 2021, received the second COVID (Pfizer) vaccine.  The patient reported that about 1 week after receiving the second COVID vaccine, the patient experienced tingling and numbness in legs which was painful, uncomfortable, and kept the patient up a night and this lasted for quite a while.  The patient also received the first (Pfizer) and second (Moderna) COVID boosters and after the first COVID booster, the patient again experienced tingling and numbness but it was not as bad as the first experience.  After the second COVID booster, the patient did not experience numbness and tingling. However, once in a while, the patient gets numbness in feet but not as bad as it used to.  Lately, the patient had been getting rashes on the body.  The reporter gave permission to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive the second dose of Shingrix which led to incomplete course of vaccination. It was unknown if the reporter considered the tingling of extremity, numbness in leg, leg pain, discomfort, nocturnal awakening and generalized rash to be related to 1st and 2nd of Pfizer Covid vaccine, Covid-19 vaccine Moderna and Pfizer Biontech Covid-19 Booster
He has since been exposed to, and tested positive for Covid19 illness/tested positive after 1st dose; Tested positive for Covid19 illness/tested positive after 1st dose; This is a spontaneous report from a contactable consumer (patents wife) and Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 1st via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received his first dose of Pfizer-Biontech Covid19 vaccine and was scheduled for a 4-week return date. He has since been exposed and tested positive for Covid19 illness. Reporter asked about do they have for him for receiving his second dose since he was positive. As by the time he completes quarantine/isolation, it may be outside the 42-day interval before he receives his second dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Upon waking up with extreme migraine the night of the  2nd vaccination I have been experiencing ?brain zaps? or ?brain shakes? that typically happen when changing an SSRI. There has been no recent change in my medication, this effect has been steady as the other vaccination side effects have subsided throughout the day.
Allergic reaction to flu vaccine; pt presented with numbness in throat and tingling and swelling in mouth--lips and tongue; General puffiness in facial area, 10 minutes after receiving vaccination. Treatment:  Benadryl IM.  Fully recovered and released.
The caller did not clarify if the caller was diagnosed with diabetes before or after receiving the vaccine; This is a spontaneous report. A contactable consumer (patient) reported for himself. A 74-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 07Apr2021 as dose number unknown, single for COVID-19 immunization. The patient medical history included diabetes mellitus (The patient mentioned that he also has diabetes). Concomitant medication was not reported. Other Products, patient history and investigation assessment: not provided. The patient did not clarify if the patient was diagnosed with diabetes before or after receiving the vaccine in 2021. Reporter seriousness of the case was unspecified. The outcome of the event was unknown.  The lot number was not provided. Information on lot number has been requested during follow up.
No adverse effects reported; patient were vaccinated with improperly stored ROTATEQ; Information has been received from a nurse referring to a 6 months old patient of unknown gender. The patient's drug reactions/allergies, pertinent medical history and concomitant medication were not provided.  On 20-MAR-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # R021650, expiration date 27-MAY-2019 for prophylaxis (strength, dose, frequency and route were not provided). No adverse effects reported. The outcome of the events was unknown. The storage temperature of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) was reported as -11.9 degrees Celcius for a time frame of 1 hour and 45 minutes. There was no previous temperature excursion. The call was due to a data logger. No product quality compliance provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1903USA010666: US-009507513-1904USA004568: US-009507513-1904USA004569: US-009507513-1904USA004570: US-009507513-1904USA004571:
Chills, fever, night sweats, body aches, nausea, fatigue .  Tylenol , rest. . Symptoms started about 12 hours after the injection and were moderate and higher through the night. I was significantly fatigued throughout the following day. Some fatigue lingered through the next day and with waves of nausea.  My previous COVID vaccines caused similar side affects.
arm was inflamed, red, hot, 2 inch wide red band all the way around my arm and up into my armpit  severe neck pain on right side; could not lift head off the pillow
Erythema, warmth, and swelling around injection site of DTAP measuring 14cm in diameter.
Seizure activity, child afebrile, 1st occurrence. 11/23/09 Medical records received for DOS 11/15/09. Final DX: Questionable seizure activity vs vasovagal episode resulting in vasovagal seizure vs hypoglycemic episode resulting in seizure-like activity. D/C to home. Refer to neuro.  Seizure like activity, foaming at mouth, shaking. Preceded by blurry vision. Unable to walk. Bld sugar 76.    .
Severe local reaction at injection site, right anterior thigh. Noticed by parents the day after vaccination, was the size of a "lime". When seen in pediatric clinic on Monday, 26 September, it was approximately 5-6 inches in diameter.
Initial information received on 25-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 32 years old male patient who received a 5 mL dose of vaccines FLUZONE HIGH DOSE lot UJ00AA, expiry date: 25-MAR-2019 via intramuscular route in the right arm on 19-Sep-2018, when he was supposed to have FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to wrong vaccine administered, overdose and Inappropriate age at vaccine administration. It was unknown whether patient experienced any adverse reaction after the vaccination. 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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. Documents held by sender: none.
a 6 month old accidently received the FLUZONE HDQ with no adverse event; Initial information received on 21-Dec-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 6 months old patient accidently received the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age). On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination.      Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  This was an actual medication error case due to the event product administered to patient of inappropriate age (latency: unknown).  At the time of reporting, no adverse event was reported.  No laboratory data was reported.  Disclaimer: 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 directive 2001/83/ec and module VI of the good Pharmacovigilance practices. 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.  There will be no information about batch number was reported for the case.
I had headache, sore throat, feeling fatigue; I wasn't sure if it was a fibromyalgia flare-up, but I realized my significant other was recovering from COVID-19 so I knew I probably had just contracted it from him. My doctor told me I didn't need to take a test to confirm since my partner had already taken an at-home test and PCR tests, which both came back positive. I'm disabled so I don't work, and having fibromyalgia only worsened the pain of my symptoms. I was in so much physical pain. I took MOTRIN, TYLENOL, and MUCINEX to help subside my symptoms.
Myalgia, Arthralgia, Fever, severe body aches and rigors with fever to 102.4 F - used tylenol- back to work 01/25/21 Narrative:   sever body aches, fever tpo 102.4 F - used tylenol and now improved after 3 days
Night of vaccination, patient had numbness, tingling and pain in her arms and legs. Went to the ER for care. Discharge diagnosis was paresthesia and patient was prescribed Flexeril.
warm; felt dehydrated; dizzy; felt like she had a fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (warm), DEHYDRATION (felt dehydrated), DIZZINESS (dizzy) and PYREXIA (felt like she had a fever) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced FEELING HOT (warm), DEHYDRATION (felt dehydrated), DIZZINESS (dizzy) and PYREXIA (felt like she had a fever). At the time of the report, FEELING HOT (warm), DEHYDRATION (felt dehydrated), DIZZINESS (dizzy) and PYREXIA (felt like she had a fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the events include ibuprofen
pt recvd vax & 13hrs post vax vomited;for 3 days inj site has been very swollen,red & very hot to touch in a large area on upper arm;seen in ER;
Pfizer Dose 1 3/23/21 (EN6208); Pfizer Dose 2 4/14/21 (EW0153); Pfizer Dose 3 10/23/21 (FF2593); COVID Positive 1/7/22; 1/7/22: Is a 61 year old male who presented to ED via EMS with complaints of a syncopal episode.  has felt unwell for the past several days. Decreased appetite and oral intake. He developed a fever and chills last night. He felt unsteady on his feet during ambulation, stating and hold onto walls to make it to his bedroom. He woke up early this morning ambulating to his kitchen to get a drink and had a syncopal episode. EMS was called at that time. He denies shortness of breath or chest pain.  He admits to chills, productive cough and sore throat.  He denies nausea or vomiting.  Denies diarrhea, patient states he feels constipated.  He has been fully vaccinated against Covid-19, as well as booster. Patient has a past medical history of moderate to poorly differentiated adenocarcinoma of the lung status post right upper lobectomy (July 2011) with metastatic disease to the adrenal glands, he underwent a right adrenalectomy in 2012 and left adrenalectomy in 2017, hypertension, obesity former tobacco use.. He is chronically on hydrocortisone and fludrocortisone. He is not currently undergoing treatment.  On arrival to ED the patient was severely hypotensive 69/50.  Laboratory findings were significant for hyponatremia 126. Acute kidney injury BUN 33 and creatinine 3.50.  Transaminitis AST 47.  Lactic acidosis 3.5.  FOBT positive.  Leukocytosis 11.85.  CT head no acute intracranial abnormalities.  V/Q scan low probability of acute thrombolytics disease.  Checks x-ray left basilar atelectasis.  Zosyn was initiated in ED.  Solu-Medrol 125 mg IV given an IV fluid hydration with NS 0.9% 6 L bolus. Patient was ultimately started on Levophed for pressor support.  1/10/22: 61-year-old man who presented with complaints of syncope and was found to be profoundly hypotensive on presentation.  Aggressive intravenous fluid resuscitation, pressor support and stress steroids were initiated in view of his history of adrenal insufficiency.  He was admitted, COVID-19 PCR was subsequently positive.  Clinical response was favorable with improvement in blood pressure and resolution of hypotension, pressor support was weaned off.  Stress dose steroids were weaned down and he was discharged home on home dose of hydrocortisone and fludrocortisone.  He has been discharged in stable medical condition to continue outpatient care.
-Shoulder ache, sometimes into the neck. Started the day after vaccination, lasted 5-7 days and is now intermittent. Take ibuprofen for relief. -Severe headache the day after vaccination. Ibuprofen did not help. -Constant fatigue, feeling drained, especially when attempting anything physical, even after adequate sleep and rest. I just feel tired all the time. Started the day after vaccination and is ongoing, nothing seems to help.
Chills lethargic neck ache occurred around midnight lasted till 730 the next day.
Tiredness, shivering (chills), nausea, headache, swelling and redness around injection spot