chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacy technician refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in 2013, the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date in 2016, the patient was diagnosed the shingles. The outcome of shingles was unknown. The relatedness between vaccination with ZOSTAVAX and the shingles was not reported. Additional information has been requested.
I received my first Pfizer vaccine on 3/9. This past Thursday, 3/18/21,  I woke up with increased tinnitus (I?ve always had some) and hearing reduction in my right ear. It reminded me of a middle ear infection I had in my youth but this one had resulted in no pain, fever, or dizziness. I do not have a cold or any infectious respiratory issues. I found that it did resolve somewhat if I?d move to a higher elevation and as the day progressed. My left ear would have short spells that would eventually resolve. This continued through Sunday evening when my right ear cleared and I noticed a foul taste in my mouth. Today it?s resumed somewhat, not to the level it was at before, with a little congestion in my left ear...it "crackles" a little when I swallow, but often will clear if I yawn or cough.  I did a little research about the Pfizer vaccine and this situation is listed as a possible side effect that is supposed to be reported, so I am doing so.
Numbness/tingling  in upper extremities lasting for short period of time, chills and rigors following
muscle aches mostly legs fever (up to 102 degrees), chills  all lasted about 4-5hrs. fine next am
COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a nurse concerning a 5-year-old female who on 02-AUG-2007 was vaccinated with a dose of Zostavax (Oka/Merck) instead of "the varicella vaccine," Varivax (Oka/Merck).  It is reported that the office was out of the "the varicella one".  It is unspecified if medical attention was sought.  No adverse events were reported.  It is reported that this was a case of product confusion since the packing for both vaccines was similar.  This is one of several reports from the same reporter.  No more information is expected. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Information has been received from a nurse concerning an 8-year-old (previously reported as 5-years-old) female who on 07-AUG-2007 (previously reported as 02-AUG-2007) was vaccinated in the left deltoid at 9 AM with a first dose of ZOSTAVAX (Oka/Merck) (lot# 658082/0744U) instead of "the varicella vaccine", VARIVAX (Oka/Merck). It is reported that the office was out of the "the varicella one". No medical attention was sought. No adverse events were reported. It is reported that this was a case of product confusion since the packaging for both vaccines was similar. The R.N. also reported that the patient's sister was vaccinated with ZOSTAVAX (Oka/Merck) instead of VARIVAX (Oka/Merck) (WAES# 0708USA01361). This is one of several reports from the same reporter. No more information is expected.
received an expired dose of ACT-HIB with no reported adverse event; Initial information received on 31-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3 years old male patient who received an expired dose of hib (prp/t) vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 7v (crm197) (Prevnar) for Immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel) for Immunisation; and hepatitis a vaccine (Hepatitis A) for Immunisation.  On 31-Oct-2022, the patient received a dose 4 of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (strength: standard) 0.5mL (milliliter) total once (lot: UJ600AAB, expiry date: 29-Oct-2022) via intramuscular route in the thigh nos (not otherwise specified) for immunization.  On 31-OCT-2022 the patient received an expired dose of act-hib with no reported adverse event (expired product administered) same day following the administration of vaccine.  No lab data reported.  Action taken was not applicable.  Treatment- will be repeated.   At time of reporting, the outcome was Unknown for the event
THE DAY AFTER BEING VACCINATED THE INJECTION SITE BECAME SORE AND RED (ABOUT 6-8 INCHES IN AREA)
Patient's husband states that patient has experienced shoulder discomfort since receiving vaccine on 10/14/2016.
SHE SAID SHE PHONED ANOTHER PHARMACY THAT WAS OPENED AT 5:00 AM (09/08/19);  SHE COMPLAINED OF CHILLS, BODY ACHE, HEADACHE, NAUSEA, SWELLING, REDNESS
pt seen in office 24SEP98 w/lt upper arm swelling, red, itchy;recv vax 23SEP98;cellulitis vs allerg reaction;
once a day I get flushed and itchy for anywhere; once a day I get flushed and itchy for anywhere; This case was reported by a consumer and described the occurrence of pruritus in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pruritus and flushing. On an unknown date, the outcome of the pruritus and flushing were not recovered/not resolved.   It was unknown if the reporter considered the pruritus and flushing to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The reporter wanted to know was it possible that he/she could still be feeling side effects from a Shingrix shot given in December 2019. About once a day he/she get flushed and itchy for anywhere from 5 to 15 minutes. The reporter was due the second dose but was reluctant to get it.
Received on 12/23/2020 Dose 1 MODERNA 011J20A; Dose 2 on 1/20/2021 042L20A On 2/19/2021, patient underwent asymptomatic pre-travel testing that returned positive PCR for COVID-19 He was asymptomatic.  He has no known prior history of COVID-19
H1N1 vaccine ordered to be given and flu vaccine given. Pt. already rec'd seasonal flu vaccine this season and vaccine expired 6/30/10. No reactions noted.
A few days after the 1st shot, the discharge I have always had in my right ear stopped. The ear felt stuffy. Saw a local ENT doctor on 3/26/21, 4/5/21 and 4/19/21 . Was treated with steroids and had a CAT scan performed. Dr. referred me to hospital. Symptoms worsened from 4/19/21 to 5/10/21, started to slur speech, noticed facial paralysis and slight dizziness. Saw Dr. 5/10/21 and 5/26/21. Treated with steroid ear drops, two MRI scans performed. Abnormal soft tissue thickening detected in right mastoid sinus/ear. Biopsy performed by Dr. 6/3/21. Results are well defined squamous cell carcinoma.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing), notes: other medical history: Arthritis; "Asthma" (unspecified if ongoing), notes: other medical history: Asthma. Concomitant medication(s) included: PRISTIQ; GABAPENTIN; ADVAIR; DUPIXENT. Past drug history included: Aspirin, reaction(s): "known allergies: Aspirin", notes: known allergies: Aspirin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 from 02Sep2022 to 08Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt states his arm has been sore since the shot was given on 9/21/15 but as of 11/05/2015 pt states "It really hurts" and he has a hard time lifting it.
foggy brain; couldn't drive; Vomited once; really tired; headache; weak muscles; fever of 103; chills; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (weak muscles), FEELING ABNORMAL (foggy brain), IMPAIRED DRIVING ABILITY (couldn't drive), PYREXIA (fever of 103) and CHILLS (chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced MUSCULAR WEAKNESS (weak muscles), PYREXIA (fever of 103), CHILLS (chills) and HEADACHE (headache). On an unknown date, the patient experienced FEELING ABNORMAL (foggy brain), IMPAIRED DRIVING ABILITY (couldn't drive), VOMITING (Vomited once) and FATIGUE (really tired). The patient was treated with PARACETAMOL (TYLENOL) on 19-Mar-2021 for Fever, at an unspecified dose and frequency. At the time of the report, MUSCULAR WEAKNESS (weak muscles), FEELING ABNORMAL (foggy brain), IMPAIRED DRIVING ABILITY (couldn't drive), PYREXIA (fever of 103), CHILLS (chills), VOMITING (Vomited once), FATIGUE (really tired) and HEADACHE (headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Body temperature: 103 (High) 103.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient tested negative for COVID and the flu. Concomitant medications were not provided.
Scaled 0-10 Pain at the injection site (6): Can not raise left arm higher than shoulder level Fatigue (8) New or worsened muscle pain (8) New or worsened joint pain (8) Nausea (9): took zofran Vomiting (8) Fever (7): 101F: took tylenol 650 mg Q3 hours since 23:00 on 1/6/2021, 3:00, 6:00, 8:00, 11:00  Chills (8) Other: Burning on urination, eyes burning, left side face tingling,
pt recv vax; 3-4 hr of inconsolable crying; apap given; to er & was advised to cont apap & warm compresses to inject site;pt responded well to it;
Excruciating pain, inability to raise arm, chills, weakness in arm, dizziness. It has been one week since the shot, and I still have radiating pain from my shoulder down my arm and weakness. The shot appeared to be given too high on my arm and was poked harder into my bone. I cannot raise my arm.
significant redness, pain, swelling, pain, fever,  arm weakness, lasting for several days
Information has been received from a physician concerning a child who in approximately January 2002 was vaccinated with a dose of Varivax . In approximately 01/02, the child was prepared to a Pediatrician's office with a rash which was thought to be roseola. It is noted that the child's baby-sitter subsequently developed chicken pox lesions (WAES0202USA00175) after the child had been vaccinated. Additional information has been requested.
Nurse Practitioner notified by the observation nurse that PT had complaints of itching tongue and scratchy throat after receiving the Pfizer vaccine. PT reports having similar symptoms after the first dose, she states that she took Benadryl at home and her symptoms were relieved.  PT reports no difficulty swallowing.  PT was administered 25mg of Benadryl PO with water.  PT reports NKDA, no medical history, and reports no current prescription medications. Vitals are as follows; 0945: 161/113, 100% O2, 95 HR, 18 Resp, 98.4 Temp; 0952: 136/110, 99% O2, 83 HR, 18 Resp; 1005: 127/106, 99% O2, 81 HR, 18 Resp. PT states all symptoms were relieved, total time waited after vaccine administration was 1 hour.
About 6 minutes after the vaccination I begin to experience throbbing pain in the base of the right side of my neck.  I sat back and pushed my head back to see if it would stop but it didnt. 5 minutes after that pain begin radiating up and down my right leg from the thigh to mid calf.  I was checked and monitored for about 15 minutes then my mouth got really dry but even with water it was still very very dry.  After my mouth was still really dry and the pain continued  to radiate I was sent to the urgent care and advised to walk around, so the nurse assisted me in walking around the urgent  care.  I was able to walk but was wobbly and after some time the NP assessed me.  I was given an icepack to put on the base of my neck.  My BP raised and I begin to have a high pitch noise ringing sensation in my ear, sore throat and it felt as if I just needed to keep drinking because my mouth still felt really dry.  I was recline back and my legs were elevated to try to help lower my BP.  And after about 20 minutes my BP lowered and I was continued to be monitored.  I was advised they would not give me any steroids because it would counteract the vaccine but was given a shot of torodol and benedryl to help with the pain.  I had body aches and my arm at the injection site was sore as well. I was monitored for another 30-45 minutes long and was released and was taken off work for the remainder of the day and rested.   The next day the leg pain was gone but the dry mouth, body aches and the fatigue was still there for about another week.
I had Moderna vaccine and a week after vaccine started experiencing dizziness at night after about a week it starting happening during the day.  I went to urgent care and was told it was vertigo given medicine not getting any better and now my husband that had vaccine on same day as me is having same issues.  My dizziness is getting worse
Patient stated that flu shot hurt when administered and was placed high on deltoid muscle. She thinks the vaccination may have inflamed the bursa or maybe entered the bursa of shoulder. She is having pain in shoulder area and limited movement to the side without significant pain. Pain has continued for 12 days with no relief from Ibuprofen. About to see urgent care for possible steroid or treatment.
Patient complained a "metallic" taste soon after receiving he vaccine. Symptoms resolved within 30 minutes. No other symptoms or side effects reported. Patient complained a "metallic" taste soon after receiving he vaccine. Symptoms resolved within 30 minutes. No other symptoms or side effects reported.
patient was given a second dose of Fluzone High-Dose (with no adverse event); Initial information was received on 10-Nov-2020 regarding an unsolicited valid non-serious case from a other healthcare professional.  This case involves a 66 years old male patient who received second 0.7 mL dose of influenza quadrival A-B high dose HV vaccine (Fluzone High-Dose Quadrivalent) (Extra dose administered), (lot UJ535AA/UJ468AB, expiry date: 30-Jun-2020) via an unknown route in unknown administration site for prophylactic vaccination, on an unknown date.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was not reported.  It was a case of an actual medication error due to extra dose administered (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Pt. states that after receiving the 2nd dose of Pfizer 09/20/2021, developed Shingles 09/24/2021. Primary visit with Recommendation use Valtrex for treatment.
I received the Pfizer vaccine on Saturday March 6th. My arm was sore just at the injection site for 2 days and that went away. Tuesday, the 15th, 9 days after receiving the injection, I woke up and my whole arm hurt from my shoulder to my wrist. I thought I?d just slept on it wrong but that usually gets better as the day goes on and is gone the next day. This got worse as the day went on and I have both muscle pain that feels neurological, like a pinched nerve, and joint aches. It?s now Thursday the 18th and my arm still hurts although not as bad as it did Tuesday and yesterday. I don?t know if it?s unrelated but I see many reports of arm paid days later, so I thought it best to report.
Numbing of the entire arm Sore arm at injection site Rash on neck and upper shoulders Itching skin Headache Upset stomach
tested positive; tested positive; This is a spontaneous report from a contactable Nurse. A female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Dec2020 (reported as about 3 days ago, as of 30Dec2020) at single dose for covid-19 immunisation. Medical history, concomitant medications or past drug history were not provided. She received the vaccine about 3 days ago and later tested positive in Dec2020 and asked if the patient needs to restart the 2 doses series. Outcome of the events were unknown.  Lot/Batch and Expiration date has been requested.; Sender's Comments: The reported events drug ineffective and COVID-19 are likely intercurrent conditions and are unrelated to BNT162B2 based on the short temporal relation between vaccination and onset of event.
PATIENT PRESENTED TO PHARMACY AFTER 2 DAYS OF PNEUMOVAX ADMINISTERED AND STATED HIS ARM WAS SWOLLEN AND REDNESS AROUND THE AREA OF INJECTION, HE ALSO STATED THAT HE HAD FEVER.  I ADVISED TO PATIENT TAKE IBUPROFEN AND IF ARM GETS WORSE TO CONTACT HIS PRIMARY CARE PHYSICIAN
Covid arm - huge, egg shaped; Itchy; Swollen arm; General malaise; Very bad chills which lasted for a day; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm - huge, egg shaped), PRURITUS (Itchy), PERIPHERAL SWELLING (Swollen arm), MALAISE (General malaise) and CHILLS (Very bad chills which lasted for a day) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE REACTION (Covid arm - huge, egg shaped), PRURITUS (Itchy) and PERIPHERAL SWELLING (Swollen arm). In 2021, the patient experienced MALAISE (General malaise), CHILLS (Very bad chills which lasted for a day) and HEADACHE (Headache). In 2021, MALAISE (General malaise), CHILLS (Very bad chills which lasted for a day) and HEADACHE (Headache) had resolved. At the time of the report, VACCINATION SITE REACTION (Covid arm - huge, egg shaped), PRURITUS (Itchy) and PERIPHERAL SWELLING (Swollen arm) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medication were provided.  No treatment information were provided.   This case was linked to MOD-2021-358382 (Patient Link).
Inadvertently administered an Engerix adult dose to an 18 year old patient; Inadvertently administered an Engerix adult dose to an 18 year old patient; This case was reported by a pharmacist via call center representative and described the occurrence of accidental overdose in a 18-year-old male patient who received HBV (Engerix B adult) for prophylaxis.   On 2nd June 2022, the patient received Engerix B adult. On 2nd June 2022, unknown after receiving Engerix B adult, the patient experienced accidental overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the accidental overdose and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 05-JUL-2022 Reporter's comments: The reporter stated that they inadvertently administered an Engerix adult dose to an 18 year old patient. The reporter was unable to provide patient details. Additional Supportive Information: The patient received adult dose of the Engerix-B vaccine instead of the pediatric dose of the Engerix-B vaccine which led to accidental overdose andinappropriate age at vaccine administration. VAERS details were not disclosed hence not added.
Severe headache; fever 101.6; nausea; chills; muscle aches; joint pain; This is a spontaneous report from a contactable 57-year-old female Nurse (patient, self-reported). A 57-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL1284 and Expiry date: unknown), dose 2 via an intramuscular route of administration, in the right arm, on 02Feb2021 at 14:45 (age at the time 57-year-old), as single for COVID-19 immunisation in the public health clinic. The patient's medical history included fibromyalgia, migraine, anxiety, and depression. The patient was allergic to depo. Prior to vaccination the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The concomitant medications included vitamin D3, zinc, unspecified multivitamin, duloxetine, which was received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EH9899 and Expiry date: unknown), dose 1 via an intramuscular route of administration, in the left arm, on 05Jan2021 at 01:00 (age at the time 57-year-old), as single for COVID-19 immunisation. On 02Feb2021 at 17:00, two hours and 15 minutes after vaccination, the patient experienced severe headache, fever 101.6, nausea, chills, muscle aches, joint pain. The patient underwent lab tests and procedures which included fever 101.6 on 02Feb2021. Events were considered non serious by the reporter. Therapeutic measures in response to the event were not taken. Outcome of the events were not recovered.  Follow-up attempts are completed. No further information is expected.