chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; headache; felt feverish; Child (2-11 Years); Child (2-11 Years); This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP).  A child female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 28Sep2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st, Route: Intramuscular, No Events reported.), administration date: Sep2021, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 28Sep2021, outcome "recovering", described as "sore arm"; HEADACHE (non-serious) with onset 28Sep2021, outcome "recovering", described as "headache"; PYREXIA (non-serious) with onset 28Sep2021, outcome "recovering", described as "felt feverish"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 28Sep2021, outcome "unknown" and all described as "Child (2-11 Years)". Therapeutic measures were taken as a result of pain in extremity, headache, pyrexia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was neither diagnosed with COVID-19 Prior to vaccination, nor been tested for COVID-19 Since the vaccination. The patient received treatment with Advil, and Tylenol for reported events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a pharmacist refers to a 48 year old patient with unknown gender. On 13-OCT-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # J009827, expiration date 10-AUG-2014, 0.5 ml, intramuscular). No adverse effects were reported. The outcome of the event was not reported. No product quality complaint (PQC) involved This is one of several reports received from the same source. Additional information has been requested.
Narrative:  03/31 COVID vaccine dose #1 04/19 Pt contacted telephone health care to report "having more frequent headache and arthritic pain" 04/21 Pt called, "reported that he had the covid vaccine last 03/31/2021 and he had been having headaches, that will not go away, new type of headache and wants to be evaluated by pcp" 06/21 PCP visit, reports "chronic daily headaches usually on right side of head posteriorly." Medication changed from sumatriptan to eletriptan Patient refuses second dose of vaccine
Nose bleed starting today x1, constant for 15 min., controlled now. No history of nose bleeds. Denies fever or any other symptoms. Advised to f/u with PCP.
Information has been received from a provider via a field representative referring to a female patient of unknown age. There was no pertinent medical history, drug reaction or concomitant medication reported. On an unspecified date, in MAY 2016 (reported as "a month ago"), the patient came into the reporter's office for a routine visit and was vaccinated with one dose of ZOSTAVAX injection, (dose, and Lot # not provided) subcutaneously. On an unspecified date, in MAY2016, the patient was vaccinated another dose of ZOSTAVAX at a local pharmacy. After receiving the patient's records, it was realized that the patient had received 2 doses of ZOSTAVAX injection within that month (Accidental Overdose). The patient did not have any complaints or symptoms. Additional information has been requested.
Dizziness; Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and MYALGIA (Body Aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness) and MYALGIA (Body Aches). At the time of the report, DIZZINESS (Dizziness) and MYALGIA (Body Aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication was reported. No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.    This case was linked to MOD-2021-039244 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: NNI; Sender's Comments:  MOD-2021-039244:mother case
Woke up following day with high pitch tinnitus in both ears. The condition is constant. Planning to make appointment with my primary care physician.
Pt vaccinated with DTP/OPV slept after immunizations 3 hrs later, woke w/high pitched scream, was lethargic, very pale, vomitted once. Returned to Dr oc. VS monitored for 1 hr. within hr, color improved to nl, was more alert. Will recheck.
p/vax pt very fussy, not sleeping as well, belly described as bubbling, increase spitting up from days w/in receiving vax until clinic eval 7/20/99;n assoc fever, blood in stool;
Patient came in many months later stating that he had Burning mouth syndrome. He wakes up every morning with his mouth burning as if he has eaten spicy foods.
Admitted to hospital on 2/8 with COVID-19 pneumonia.  Patient is a 83 y.o. never smoker with a history of ESRD, hypertension, BPH who presents to a local ER chief complaint of fatigue and admitted for acute pulmonary edema.   Patient severely hard of hearing; however, answering questions appropriately including orientation reports recent diarrhea for approximately 3 weeks and reportedly noted improvement prior to hospital evaluation.  Developed fatigue and shortness of breath beginning 2/8/2022 with reported elevated temperature 99; therefore, sought ER for evaluation.
Client presented as a member of Ski Patrol to vaccination clinic on 2/5/2021 accompanied by his father. Client presented to vaccination clinic on 3/17/2021 for his second dose of vaccination, the RN caught the age discrepency at this time. Client's father, reported that Client experienced no adverse reactions. This RN called vaccination coordinator. Coordinator found literature from the agency to support administration of the second dose of vaccine in a 16 year old who had received an initial dose. Lengthy discussion with Client's father, he is supportive of Client receiving the second dose. Second dose administered. No side effects have been reported.
Anaphylaxis, allergic reaction: Throat swelling, facial and ear numbness on left side. Ear redness and swelling. Went to ER, treated with IV Benadryl, Epinephrine, Famotidine, Solumedrol, Klorcon M.
This spontaneous report was received from a medical assistant and refers to multiple, unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. The medical assistant reported that multiple doses of improperly stored vaccines of ROTATEQ (Lot # M032636, expiration date 06-APR-2018), GARDASIL 9 (Lot # M036059, Expiration date 03-JUN-2019), and PEDVAXHIB (Lot # M034188, expiration date 20-MAY-2019) were administered (dose, site and route of administration were not reported) to multiple unspecified patients on multiple unspecified dates. The temperature excursion was reported as 47 degrees Fahrenheit  -  77 degrees Fahrenheit for 1 hour. There was no previous temperature excursion. Digital data logger was used. No adverse effects were reported. No further information was provided. Additional information has been requested.
Systemic: Joint Pain-Mild, Additional Details: Patient was being observed, at the 15 minute mark the pharmacist asked how the patient was doing and to see if she had any issues or comments or concerns after the injection, she complained of pain and soreness in her leg but this was from previously diagnosed arthritis and it happens when she sits for long. She had no further questions and felt healthy to go.
Information has been received from a consumer concerning her 73-year-old husband who had no medical history or allergies who on 06-NOV-2007 was vaccinated with Zostavax (Oka/Merck). Concomitant therapy included LIPITOR. On 23-NOV-2007, the patient developed blisters in his mouth, a low-grade fever, was lethargic and developed some lesions on his gums. On 24-NOV-2007, the lesions had spread to the back of his tongue and the inside of his cheek. All of the lesions were noted to be on one side of his mouth except for on the upper part of his tongue which had lesions on both sides. The patient was experienced severe pain, burning, soreness and hoarseness. On 26-NOV-2007, the patient was examined by a physician who was not sure what was causing the patient's symptoms. He was prescribed VALTREX. On 27-NOV-2007, the patient was examined by a Periodonist who diagnosed him with shingles. On 28-NOV-2007, the patient was examined by an ENT physician who diagnosed him with stomatitis. No laboratory/diagnostic tests were performed. As of 28-NOV-2007, the patient was still taking VALTREX and for the first time since onset had some improvement. The patient was noted to be recovering. Additional information has been requested.
Became confused; Had transient global amnesia which lasted about 10 hours; Severe headaches; Eye pain; Feeling very tired; Dizziness; Right hand weakness; Facial numbness; Difficulty speak; Brain fog; Body aches; This is a spontaneous report from a contactable nurse, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0169) via intramuscular route of administration in the right arm on 04Aug2021 at 09:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and COVID-19 on an unknown date (prior to the vaccination, the patient was diagnosed with COVID-19). Concomitant medications included losartan (MANUFACTURER UNKNOWN) and Hydrochlorothiazide (HCTZ) (MANUFACTURER UNKNOWN), both taken for unspecified indications from unknown dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously took ibuprofen (MANUFACTURER UNKNOWN) and experienced drug allergy. On 04Aug2021 at 10:00, half hour after receiving the first dose of vaccine, the patient became confused, then had transient global amnesia which had lasted about 10 hours, severe headaches with eyes pain, felt very tired, dizziness, right hand weakness, some facial numbness and difficulty to speak, brain fog and body ache. On 17Aug2021, the patient underwent COVID-19 antibody test and the result was positive. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in 2021, the patient underwent Magnetic Resonance Imaging (MRI) of brain and inflammatory markers were checked and the results were unknown. Therapeutic measures were taken as a result of the events and included treatment with aspirin 81 mg daily for 1 week. The clinical outcome of the events confused and transient global amnesia were resolved on 04Aug2021, while the clinical outcome of the events, severe headaches, eye pain, felt very tired, dizziness, right hand weakness, facial numbness, difficulty to speak, brain fog and body ache were resolving at the time of this report.
COVID Arm- Severe Arm Swelling, Heat, Pain , Redness, Began within 12 hours of shot and has continued to swell and been painful to touch.  Producing heat, growing redness and discomfort. Trying online recommendations of Antihistamines & Acetaminophen before going to doctors office.
BODY ACHE; WENT FROM HOT TO COLD; BRAIN COULD NOT FOCUS; CHILLS; HEADACHE; FEVER; This spontaneous report received from a consumer concerned an 18 year old female. The patient's height, and weight were not reported. The patient's past medical history included seizure, and concurrent conditions included seasonal allergy, no alcohol, and non smoker.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced body ache, feeling cold, brain could not focus, chills, headache, and fever. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, body ache, headache, feeling cold, fever and brain could not focus was not reported. This report was non-serious.
Left arm (site of injection) pain when in movement.; This is a spontaneous report from a non-contactable physician, the patient. A 42-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the left arm on 11Feb2021 at 13:00 (at the age of 42-year-old), as a single dose for COVID-19 immunisation. Medical history included hypertension, hyperlipidemia, history of cancer and inverse psoriasis (on topicals). The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included enalapril (MANUFACTURER UNKNOWN) and rosuvastatin (MANUFACTURER UNKNOWN); both for unspecified indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 11Feb2021 at 18:00, the patient experienced left arm (site of injection) pain when in movement. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event left arm (site of injection) pain when in movement was recovered on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
he contracted covid in September.; Med Info Agent:  He had both Moderna COVID-19 vaccine shots then he contracted covid in September. After that he had a Moderna COVID-19 booster shot and then on 22Nov2021 he had another positive test. So he had covid twice now? How common is this? Patient denied any other information about his case.; Sender's Comments: This is a spontaneous case concerning a male patient of unknown age with no reported medical history, who experienced the non-serious unexpected AESI event of COVID-19. The event occurred unknown date after the second dose of mRNA-1273 vaccine administration. Causality for the event of COVID-19 was not applicable to the product administration. The rechallenge was not applicable since the event occurred after the second dose and no further dosing is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
That evening, at bedtime, I started seeing the red spots appearing on my arm again - like they did with 1st COVID vaccine. I developed a fever and chills; body aches that night. I had a temperature 101.4 (the highest it got). With red spots on arm  I also had arm pain - similar to the pain in the first - moderate pain. It lasted five days with the red spots on my arm. The arm pain  itself lasted a week. The temperature was gone by day three. February 4th was first day without the temperature. I continued the Benadryl and Claritin for another 7 or ten days after the injection. Along with the Tylenol for the temperature and the arm pain.
Pain and swelling in right armpit (Axillary lymph nodes).  Treatment: tyenol as directed for pain.  Outcome: resolving on day 3 after day of injection.
Nausea/vomiting/weakness/high fevers. Swelling/redness at inj site. 7x3 cm area on (R) deltoid.
injection site is red slightly swollen; injection site is red slightly swollen; injection site very itchy; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th October 2021, the patient received Shingrix. In October 2021, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and injection site itching. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site itching to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received a dose of Shingrix vaccination on Tuesday and the injection site was red slightly swollen and very itchy. The patient asked that there was anything that he/she use to reduce the itch. The follow-up could not be possible as no contact details were available.
VACCINE WAS POSSIBLY PAST THE BUD AT VACCINATION ACCORDING TO THE VACCINE RECORD.  NURSE REPORTED ON VACCINE RECORD THAT VACCINE WAS GIVEN ON 10/31/22 BUT VIAL WAS OPENED ON 10/27/22.  UNABLE TO CONFIRM IF INDIVIDUAL WAS VACCINATED ON 10/27 OR 10/31.
This spontaneous report was received from a registered nurse via a company representative refers to an unspecified child patient of an unknown age and gender. The patients medical history, concurrent conditions and concomitant medications were not reported. On 26-JUN-2017 the patient was vaccinated with a dose of VARIVAX, subcutaneous (dose, frequency unknown) (lot number N014366, expiry date May 2019) to prevent chicken pox. On an unknown date in 2017 the patient received a dose of VARIVAX, subcutaneous (dose, frequency unknown) to prevent chicken pox. It was reported that both the vaccines were given out of temperature range inadvertently. The action taken and outcome of the event was unknown. No further information provided.  This case is linked to case number 1707USA003667 via same reporter link. Additional information has been requested.; Sender's Comments: US-009507513-1707USA003667:
Very ill for about a month. Was taken to emergency room and given an IV with no explanation as to why he was sick. No appetite, no energy, dehydrated, vomiting, diarrhea. His temperature was about 103 and after that is when he seemed to regress. He is now completely non-verbal. He recovered from this illness after about 1 month.
Cough similar to bronchitis. Body & joint aches similar to arthritis. Sudden exhaustion.
No Adverse event; Extra dose administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Extra dose administered) and NO ADVERSE EVENT (No Adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 16-Dec-2022, the patient experienced EXTRA DOSE ADMINISTERED (Extra dose administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Extra dose administered) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (Extra dose administered).    No concomitant medications were reported.  Pharmacist called to report that the patient received a 2nd Bivalent booster on 16-Dec-2022, 2 months after the first Bivalent booster. All vials thawed on 16-Dec-2022.   No treatment drugs were reported.  This case contains the information of 12th out of 13 elderly patient who received the vaccine as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-688372 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-688372
itching-painful-swelling @ site & in lymph x 1 1/2wk;tx ice, DPH;
patient received a Flulval today and was supposed to have received the Fluzone HD, no AE; Initial information received on 16-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves female patient (approximately over 65 years) who was vaccinated with FLULAVAL while she was supposed to receive the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number and expiration date were not reported for bot the vaccine) via unknown route in unknown administration site as prophylactic vaccination on an unspecified date (PT: wrong product administered)  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to wrong vaccine administered.  No adverse event reported at the time of reporting.  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 on the batch number for this case.
Approximately a week after getting Janssen vaccine patient states he developed slowly progressive numbness/tingling in toes of left foot. This progressed up lower leg mainly on lateral aspect up to just below knee.  He also noticed that he was tripping more often with that extremity. He notes that this took many weeks to months.  He then was diagnosed with COVID in JAN2022 and he associates this occurrence to when the symptoms started to improve. They have continued to improve to the time he presented at my office on 02FEB2022 when he stated that just some slight tingling was present in toes now, but sensation is back to normal. A thorough neurologic exam confirms normal function at this time.
4hrs post vax screaming, pale, & seemed to pass out w/limpness. P/30-60 secs woke up & couldn't be comforted & this whole sx complex repeated itself over next 45 min. Slept till 6PM & woke up eyes rolled back, pale & muscle tight.
No Adverse event. Tenivac was ordered by the provider and  Adacel was administered.  Patient and provider notified.  This is being recorded as per my facilities policy.  Patient tolerated vaccine well with NO ADVERSE REACTION.