chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid-19) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066K21A, 025A21A, 026A21A and 039D21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Covid-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 22-Apr-2022 to 26-Apr-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2022, SARS-CoV-2 test: positive (Positive) Positive. On 01-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication information provided. It was reported that patient took treatment of COVID-19 from 22-Apr-2022 to 26-Apr-2022 with Paxlovid. Patient experienced Moderate gastric discomfort while taking Paxlovid.  Company comment: This spontaneous case concerns a 78-year-old elderly female patient with no relevant medical history who experienced the unexpected non serious AESI of COVID 19 which occurred approximately 23 days after the administration of fourth dose of mRNA-1273 vaccine. Initial Covid symptoms were mild, like a cold and intense sneezing. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) for 5 days as treatment for COVID 19 from 22-Apr to 26-Apr and the symptoms resolved. 3 days later the symptoms returned, and patient again tested positive for COVID 19 on 01-May. Patient received 3 doses of mRNA-1273 vaccine approximately 4, 12 and 13 months respectively, prior to the last dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 78-year-old elderly female patient with no relevant medical history who experienced the unexpected non serious AESI of COVID 19 which occurred approximately 23 days after the administration of fourth dose of mRNA-1273 vaccine. Initial Covid symptoms were mild, like a cold and intense sneezing. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) for 5 days as treatment for COVID 19 from 22-Apr to 26-Apr and the symptoms resolved. 3 days later the symptoms returned, and patient again tested positive for COVID 19 on 01-May. Patient received 3 doses of mRNA-1273 vaccine approximately 4, 12 and 13 months respectively, prior to the last dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No pertinent medical history was reported. On an unknown dates between 01-SEP-2015 and 09-SEP-2015, the patients were vaccinated with PEDVAXHIB (lot # K026532 and expiration date 07-AUG-2017, lot# L006545 and expiration date 16-NOV-2017, lot# L014427 and expiration date 09-MAR-2018) (dose and route were not reported) that were improperly stored. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
Not being able to hold her head up and complaints of headache; dizziness/lightheadedness; she said she can not get out of bed; when she lays on her back her room spins.; I am very sick, when I first got the shot I was dizzy little bit but now and then it got worse.; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 523587.  A female patient received BNT162B2 (COMIRNATY, solution for injection) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ABDOMINAL PAIN (non-serious), outcome "not recovered", described as "Abdominal pain"; ABDOMINAL PAIN UPPER (non-serious), outcome "not recovered", described as "Abdominal pain upper"; DIARRHOEA (non-serious), outcome "not recovered", described as "Diarrhoea"; NAUSEA (non-serious), outcome "not recovered", described as "Nausea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Took the vaccine and still got nasty shingles/Suspected vaccination failure; Took the vaccine and still got nasty shingles!; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult 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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient took the vaccine and still got nasty shingles. This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratoy test confirming shingles were not provided.
CUSTOMER CAME INTO THE PHARMACY ON SEPTEMBER 15, 2018 FOR A FLU SHOT, SHE RECEIVED THE FLU SHOT. THEN ON OCTOBER 2, 2018 CUSTOMER FILED COMPLAINT ABOUT PAIN AND CONTUSION OF THE ARM FROM THE FLU VACCINATION.
1/29/23 I was exposed to COVID. I started getting a tickle in my throat. I had congestion in my head, allergy type. I went to the clinic on 2/1/23 and tested positive for COVID. I was prescribed PAXLOVID and began taking it that day. On 2/4/23 I tested negative for COVID. My symptoms were mild and pretty much had gone. About 30 days later, I had a dry cough and felt crappy for about 3 weeks. I went to a healthcare provider who told me it was because of the PAXLOVID, I was having a rebound effect and it should go away within a month. There was nothing I needed to do.
Patient reported for immediate care visit with  complaints of body aches, fever and chills on 3/12/21 that began four days prior eyes have become puffy swollen and red. Facial swelling also reported. Tested negative for Covid, Treated with PO benadryl.  Of note patient with history of previouos conjuctivitis in 2019, hx of glaucoma, and cataract
FLU LIKE SYMPTOMS; CHILLS; FEVER; SORENESS IN ARM; This spontaneous report received from a consumer concerned a male 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: Unknown) dose was not reported, administered on 08-APR-2021 14:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-APR-2021, the subject experienced soreness in arm. On 09-APR-2021, the subject experienced flu like symptoms. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced fever. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from soreness in arm, fever, chills, and flu like symptoms. This report was non-serious.
Low fever, mild nausea, a little dizziness for ~12 hours.  Stayed in bed and didn't eat for ~22 hours.  Felt fine the next day.
Information has been received from a physician concerning a 10 yr old male with no medical history who in 1999 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant therapy. The physician reported that in August 2005, the pt developed a typical case of breakthrough characterized by less than 50 lesions. Unspecified medical attention was sought and the pt was noted to be afebrile. At the time of this report, the outcome was unk. Additional information has been requested.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX on or about 23-AUG-2012, as recommended for routine adult health maintenance for the prevention of shingles (lot number, dosage, and route of administration not provided). The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 11-SEP-2013, the patient was treated for a vesicular outbreak that was diagnosed as severe shingles. The patient was prescribed famciclovir (FAMVIR) for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Fever became elevated from 99.0 F at 8:00 AM on day following injection (02/02/2021) to 101.6 F within 4 hours of same day. Slight nausea and total loss of appetite. Minor pain at injection site.
An oval, red, hot, tender, swollen area about 15cm x 11cm on right doesun upper arm.
Pt arrived at pharmacy; questing a large bruise around injection site running down the arm almost to the elbow. Bruise was dark with reddish outer edge. Pt was advised to seek medical attention at local ER.
DTaP and IPV administered in R thigh on 9-9-09 Mom noted redness, swelling and pain around injection site R thigh on 9-11-09. KEFLEX 250/5 2 tsp BID x 7 d prescribed.
Patient was giving  Pfizer Booster vaccination 7 days prior to their "5 month" period.
Patient was administered Janssen Vaccine but thought she was getting Moderna.  She had signed up for the Moderna Vaccine but then got ahead of her intended spot in the vaccine administration sequence.  Similar name mix up between the patient and a vaccine administrator caused the error.  Policies are in place to prevent these errors but due to rare circumstances the error occured.  Error was discovered during the course of the clinic and then reported to patient.
Vaccines administered. Seen 2 days later at 4th BAS with pain, swelling, erythema to right arm from shoulder to elbow. Vitals BP 166/100, P 87, R 16, T 98.6. RX- Cephalexin, Atarax. Patient monitored-then dc'd.  Bedrestx24 hrs. Seen for f/u next day with decreased symptoms.
Developed chills, bad headache, fever 102, generalized itching, hypotensive.
area over right deltoid muscle became red swollen and firm to touch and minimally painful on the evening the vaccine was given. did not resolve so mom returned to clinic.
Janssen vaccine given in LD at 1035. Pt reported itchiness and  urticaria at 1050,then scratchy throat at 1100. Benadryl was  administered by FNP at 1110. Pt reported  symptom resolution at 1130. PT discharged home after 45  minutes, no SOB or unresolved urticaria. Pt was advised to  report to UC/ED if symptoms return or escalate. Pt verbalized  understanding.
Rash on L thigh.  Area warm, itching, 4 inch hard knot. Afebrile.  8/16/05 Per Mom: "Affected Area size of her hand and extended from his knee to hip.  Lasted 2 days. Gave him Benadryl."
A documented mild hearing loss of 12+ years ago left me with hyperacusis, mild intermittent tinnitus (bacon sizzling sounds), and intermittent flares of hearing loss (treated with steroids).  These symptoms have been replaced with more frequent intermittent loss, constant tinnitus and moderate/severe hyperacusis since the third COVID booster in January 2023.  My hearing condition changed within a day of the booster and is listed on my VSAFE account (which I no longer have a chance to access).  I tried a 2-week trial of Widex Hearing Aids to see if the sounds could be adjusted.  The hearing aids rendered no benefit. I cannot access VSAFE information to list specific dates and times. This was my 5th COVID shot (3rd booster)    COVID test positive 12/9/2020 COVID Vaccine - 1/14/2021  Moderna COVID Vaccine - 2/17/2021   Moderna COVID Booster #1 - 11/1/2021   Moderna COVID Booster #2 - 4/20/2022   Moderna COVID test positive - 7/25/2022 COVID Booster #3 - 1/9/2023  Pfizer Bivalent The constant tinnitus is now in a form of white noise/summer insect sounding noise.   The hyperacusis has dramatically increased to the point where I am forced to step back as a pharmacist at the end of July 2023 .  I have suffered increased hyperacusis issues at church listening to certain pitches of voices.  At home, when my family members are talking or eating,  I often leave the room to avoid listening to the crunching issues that are now almost deafening.  Telephone reception sometimes sounds "metallic" in my ears.   I currently have custom-made ear plugs on order from my audiologist.   (I received a telephone call in April 2023 from a CDC representative who encouraged me to file a VAERS report.  I waited to file the report until I could provide updated information on symptoms and treatment.)
initial swelling and pain, then a large red irregular oval shaped area around the injection sight emerged two days later approximately 4 inches by 3 inches.  General tiredness and swelling of lymph nodes under right armpit.
off label use; In Aug2021, patient received booster dose COVID-19 Vaccine; Rheumatoid arthritis flare; Humira not working; This is a solicited report from a Non-Interventional Study (FACILITATED COLLECT) based on information received by Pfizer from regulatory authority (manufacturer control number: 21K-163-4106524-00) from a contactable consumer (patient herself). A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: not reported, expiration date: not reported) intramuscular on 02Feb2021 (age at vaccination: 53 years) as dose 1, single and dose 2 intramuscular on 28Feb2021 (Lot number: not reported) as single, dose 3 intramuscular on an unspecified date in Aug2021 (Lot number: not reported) as dose 3 (booster), single for COVID-19 immunization; adalimumab (HUMIRA, formulation: Solution for injection in pre-filled pen), subcutaneous from an unspecified date (Lot number was not reported) to an unspecified date, at dosage of CF for Moderate to severe rheumatoid arthritis. The patient medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial. On an unknown date in Aug2021, the patient experienced rheumatoid arthritis flare, patient received booster dose covid-19 vaccine, humira not working on an unspecified date in 2021. Rheumatoid arthritis was marked as medically significant. The reporter's causality for the event(s) of Humira not working and Rheumatoid arthritis flare was not provided for Humira and possible for PFIZER-BIONTECH COVID-19 mRNA VACCINE. Clinical outcome of the event drug ineffective was reported as recovering and unknown for rest of the events.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available in narrative the reported  events of rheumatoid arthritis flare , drug ineffective, Immunization and off label use are  assessed as related to suspected vaccine BNT162B2
This case was reported by a pharmacist and described the occurrence of bruise injection site in a 68-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On or about 25 September 2013 the subject received unspecified dose of BOOSTRIX (unknown). On 25 September 2013, immediately after vaccination with BOOSTRIX, the subject experienced injection site bleeding and wrong injection technique. Within days of vaccination the subject experienced bruise injection site. The pharmacist reported the subject was vaccinated with BOOSTRIX approximately four weeks prior to this report on 25 September 2013. "It appears the vaccine was administered approximately two inches below the deltoid" (wrong injection technique). The subject experienced a quarter-size bruise which continues. The subject also noticed blood upon withdrawal of the needle from the arm at the time of injection. At the time of reporting the injection site bleeding was resolved; bruise injection site was unresolved.
Patient received the vaccine on 1/7/21 Developed a 6 inch long in width and diameter rash around the injection site on 1/21/21 that is now hot to touch
The evening after receiving the immunization, her arm was very sore and she could not lift it above her shoulder. The next day there was a large hive looking lump that looked like "a 2nd muscle on my arm". The bump was not at the site of immunization.
12 hours: mild muscle pain, soreness at injection site, and mild HA. 24 hours: Moderate fatigue, increased muscle pain, and fever (101.8) 48 hours: Increased body aches and pains, fever (102.6), increased fatigue 72 hours: Fever (101.2), body aches, fatigue, brain fog, decreased appetite  96 hours: fever (100.2), fatigue, body aches 120 hours: brain fog, fatigue, decreased appetite
expired vaccine used/ Patients received this Moderna vaccine (lot 070H21A) between 8-Apr-2022 and 15-Dec-2022; no adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used/ Patients received this Moderna vaccine (lot 070H21A) between 8-Apr-2022 and 15-Dec-2022) and NO ADVERSE EVENT (no adverse event) in a 69-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used/ Patients received this Moderna vaccine (lot 070H21A) between 8-Apr-2022 and 15-Dec-2022) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine used/ Patients received this Moderna vaccine (lot 070H21A) between 8-Apr-2022 and 15-Dec-2022) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (expired vaccine used/ Patients received this Moderna vaccine (lot 070H21A) between 8-Apr-2022 and 15-Dec-2022).    Patient age was reported as 69 Year 6 Month. It was reported that lot 070H21A, that has an expiration date of 7-Apr-2022. Patients received this Moderna vaccine between 8-Apr-2022 and 15-Dec-2022. No concomitant medication were reported. No treatment medication were reported.
Breakthrough case admission after 4 vaccines Moderna 3/20/21 Lot# 030A21A;  Moderna 4/17/21 Lot# 007B21A;   Janssen 11/24/21 Lot#1855191;   Moderna 7/12/22 Lot# 056M21A
Went to emergency room due to rapid heart rate and palpations increase. Hr in 130s
TINGLING AND NUMBNESS OVER THE LEFT CHEEK AND JAW, ALONG WITH WEAKNESS AT THE LEFT CORNER OF THE MOUTH.  FULLY RESOLVED SYMPTOMS AFTER 2 DAYS.
Vaccine was reconstituted with sterile water with no reported adverse event; Initial information was regarding an unsolicited valid non serious case was received from a other health professional via Agency (Reference number- 00778472) and transmitted to Sanofi on 21-Sep-2021.  This case involves a six-month-old male patient who received HIB (PRP/T) VACCINE [ACT-HIB] vaccine was reconstituted with sterile water (product preparation error).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) for Immunisation, PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  On 14-Sep-2021, the patient received a third dose of 0.5 mL of suspect HIB (PRP/T) VACCINE (Powder and solvent for solution for injection, Powder: lot: UJ585AA expiry date: 22-Oct-2022, Diluent: lot: U7146AB expiry date: 16-Oct-2022) via an unknown route in the right thigh (VASTUS) for prophylactic vaccination.  It was an actual medication error due to product preparation error (latency: same day).  It was reported "ACT-HIB being administered to a patient. Vaccine was reconstituted with sterile water and would like to know if this dose would count as valid? Would also like to know how to proceed if not counted as a valid dose?"  At time of reporting, no adverse event reported.  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 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.
Information has been received from a physician concerning a 66 year old female with a penicillin allergy and no other pertinent medical history who on 30-MAR-2007 was vaccinated SC with a 0.65 ml dose of zoster vaccine (Oka/Merck). Concomitant therapy included alendronate sodium (MSD), sertraline HC1 (ZOLOFT) and "Tri-est". On 31-MAR-2007 the patient experienced pain in lower left arm which extended to her neck, stiffness of the neck and a slight headache. Unspecified medical attention was sought. No laboratory tests were performed. At the time of the report, the patient was recovering. There was no product quality complaint involved. Additional information has been requested.