chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tinnitus, mostly white noise but sometimes ringing; flu feeling for one day; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus, mostly white noise but sometimes ringing) and INFLUENZA (flu feeling for one day) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Tinnitus, mostly white noise but sometimes ringing) and INFLUENZA (flu feeling for one day). At the time of the report, TINNITUS (Tinnitus, mostly white noise but sometimes ringing) and INFLUENZA (flu feeling for one day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication were provided.
DIARRHEA; HEADACHES; TIREDNESS; This spontaneous report received from a patient concerned a 69 year old female. The patient's weight was 93 pounds, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered in Left Arm on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced headaches. On 05-APR-2021, the subject experienced tiredness. On 05-APR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headaches, diarrhea, and tiredness. This report was non-serious.
The next morning I felt chills, really cold, my arm never hurt at all. I was freezing. I had no energy. Very lethargic, with a blanket around me. Never had a fever. All of a sudden, around 2:30PM all dissipated, it was all gone and I was fine. A week later I called my PCP because the symptoms came back - the lethargy. He suggested me to go to the ER. I went and could barely write my name on the sign in sheet at the hospital. They did 5 COVID tests and 4 of them were negative. I was at the ER for 3 days and finally was admitted and stayed for 11 days.  I was sent home with oxygen and my levels are finally getting back to 92/93.  I can't walk at this time. I lost 17 lbs and if I try to walk my lungs shut down. ( I went to the ER n 01/07 and was discharged on the 17th - I was also at the ER the week before when they tested me and it kept coming back negative) My pulmonary MD
pt recvd vax in 1983 & 2 wks later pt devel dec platelets; pt was hospitalized for 1 wk, & treated w/Pred for 6 wks; No further details were provided;
administered improperly stored VARlVAX; This spontaneous report was received from a medical assistant and refers to a 12-month-old female patient. On 25-AUG-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # S038701 has been verified to be a valid lot number, expiration date: 01-DEC-2021, subcutaneously (formulation, strength, exact dose and frequency were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. Administered dose of vaccine experienced the temperature excursion of (-9 to 8 Celsius degree) (-6.1 Celsius degree) (multiple excursions). Time frame was unknown by reporter. Data logger was involved. There were no previous excursions reported. No additional information provided.  Multiple temperature excursion: Improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # S032355 has been verified to be a valid lot number, expiration date: 14-OCT-2021 (formulation, strength, exact dose, route of administration and frequency were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. Administered dose of vaccine experienced the temperature excursion of (-14 to -10 Celsius degree) (-6.1 Celsius degree) for 13 hours. Time frame for 129 hours. Data logger was involved. There were no previous excursions reported.
@5yr-got DT (MFR unk), had sz-> learning disabled & hyperactive;tx w/ Dextrostat & special education; mom says MD attributes learning disabled & hyperactivity to sz @ ages 5 & 2 (see box 21)
Pt recvd 1st dose of Hep B approx JAN91; 1 wk later, pt devel arthralgia of the ankles;
10-22-07 Pt called c/o headache with "backs of eyes hurting" that began 3 days after Tdap vaccine was administered and continues daily.  Referred for medical evaluation.  Pt evaluated at clinic.  Clinic notes have presumptive etiology: migraine headache.  Rx: Relpax 40 mg 1 tab QD prn.  Pt reported on 11-2-07 that the medication relieved the headache.  No headache x1 week, no other symptoms.
Approximately 3-4 hours after injection: 1. all knuckles on both hands and fingernails turned blue (discoloration would come and go) and as of this date it is still occurring but rarely 2.  Fever from 99.9 to 100.9 would come and go, fevers stopped on 12/13/2021. 3.  Severe head/chest congestion, as of today's date still have slight head/chest congestion. 4. Severe exhaustion through 12/13/2021, still more tired than normal as of today's date For all of the above, I went to Urgent Care on 12/8/2021 and doctor advised that it was an allergic reaction to the vaccine.  I was prescribed Prednisone and symptoms began to get better after 2nd day. On 12/12/2021, I began having discomfort in the middle of my chest, between and slightly under my breasts - uncomfortable pressure.  If persists, I will seek medical attention
has gotten Covid; has gotten Covid; This is a spontaneous report from a Pfizer sponsored program. A contactable nurse (patient's wife) reported for a male patient (reporters husband) that male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL9263; Expiration Date: 31May2021), via an unspecified route of administration on 16Feb2021 as dose 1, single, via an unspecified route of administration on 16Mar2021 (Batch/Lot Number: EL9266; Expiration Date: 30Mar2021) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 09Aug2021, the patient experienced has gotten covid. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 09Aug2021. Reporter stated her husband had the Covid vaccines. Patient had the Pfizer Covid vaccines and was diagnosed with Covid on this past Monday. Patient got both doses of the Pfizer Covid vaccine and since then has gotten Covid. Diagnosed with Covid on 09Aug2021. got the first Covid dose 16Feb2021 with Lot number of EL9263. Received the second dose on 16Mar2021 with Lot number of EL9266 and what she believes is an expiry of 30Mar2021. Investigation Assessment: Yes. The clinical outcome of event was unknown. There was product complaint. Description of Product Quality Complaint: Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL9266 and lot EL9263 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL9266, fill lot EL9257, and the formulated drug product lot EL9248. A complaint sample was not returned, and photographs were not received. No related quality issues were not identified during the investigation. There was no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the known drug safety profile, a causal association between the reported events of vaccination failure and covid-19 cannot be excluded.
Patient was administered  a dose of the monovalent COVID-19 vaccines after they were no longer authorized. Patient was notified and did not report any symptoms.
Client took Moderna Booster shot on 12/7/21 afternoon. On 12/9/21 morning Client was found dead in a bathtub while taking a bath. Wife noticed she was in a bathtub from about 8am but he is taking too long so she checked on him about 10:45 and found him unresponsive. 911 was called and ambulance was summoned but he was pronounced dead. The body was released by 11:30.
This case was reported by a healthcare professional and described the occurrence of passed out or vomiting in approximately 7 to 8 subjects of unspecified age and gender who were vaccinated with BOOSTRIX (GlaxoSmithKline). On unspecified dates the subjects received unspecified dose of BOOSTRIX (details unknown). At an unspecified time after vaccination with BOOSTRIX, the subjects experienced passed out or vomiting. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified. The healthcare professional did not have specific details regarding these approximately 7 to 8 cases. The healthcare professional also reported a female subject (see case ID A0798941A) and a male subject (see case ID A0798931A) who passed out after receiving BOOSTRIX.
Itching all over body; Nausea; Warm flush over my head; Throat was tightening; Abdominal cramping; Super dried mouth; Pains and needles in hands and feet; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itching all over body), NAUSEA (Nausea), FLUSHING (Warm flush over my head), THROAT TIGHTNESS (Throat was tightening) and ABDOMINAL PAIN (Abdominal cramping) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol. Concomitant products included PANTOPRAZOLE and CICLESONIDE for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PRURITUS (Itching all over body), NAUSEA (Nausea), FLUSHING (Warm flush over my head), THROAT TIGHTNESS (Throat was tightening), ABDOMINAL PAIN (Abdominal cramping), DRY MOUTH (Super dried mouth) and PAIN IN EXTREMITY (Pains and needles in hands and feet). The patient was treated with OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) at a dose of UNK dosage form. On 07-Jan-2021, FLUSHING (Warm flush over my head), THROAT TIGHTNESS (Throat was tightening), ABDOMINAL PAIN (Abdominal cramping) and DRY MOUTH (Super dried mouth) had resolved. On 17-Jan-2021, PRURITUS (Itching all over body) and PAIN IN EXTREMITY (Pains and needles in hands and feet) had resolved. On 21-Jan-2021, NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jan-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
severe rxn swelling & redness in both arms (worse on tetanus side as stated per pt mom) tx w/steroid pill & cipro;
soreness / achiness; lethargy; This case was reported by a consumer and described the occurrence of pain in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pityriasis rosea (1st dose received on 2nd September 2020 Intramuscularly in left arm, batch number T7S73, expiry date 30th June 2021, refer case US2020215496.).   On 10th December 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced pain and lethargy. On an unknown date, the outcome of the pain and lethargy were unknown.   It was unknown if the reporter considered the pain and lethargy to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix in left arm. After receiving 2nd dose of Shingrix, the patient experienced soreness, lethargy and achiness. The reporter consent to follow up. This is 1 of the 4 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020248584:same reporter US-GLAXOSMITHKLINE-US2020AMR249123:same reporter US-GLAXOSMITHKLINE-US2020215496:same patient (2nd dose)
Within 24hrs erythema and swelling at site of injection. Suspected to be around site of Kinrix injection. By 48h post vaccine, tennis ball size area of redness, itching and swelling. By 72hrs, erythema had spread to entire anterior thigh, was hard and warm to touch. No fevers. Mom did try giving motrin but did not improve symptoms.
Rt. deltoid/immunization site area is red,swollen, warm, tender to touch. "Painful". Has good neuro-circ. as well as sensory perception to RUE. Strong radial pulse. Guarded R.O.M. D/T pain. Swelling from immunization site to Rt. elbow. Area is marked with surgical marker and dated. Patient will monitor area. Will try ice and Motrin. Will report to the ER ASAP if he develops any worsening/changing S/S.
Pt reports fever and injection site reaction on arm given PNEUMOVAX 23. Pain spread from deltoid muscle into bicep. Pt. lost day of work.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 15:30 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Batch/Lot number: unknown), on 25Mar2021 as dose 2, single (Batch/Lot number: unknown), on 29Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 31May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing), notes: Other medical history Obesity; "SVT" (unspecified if ongoing), notes: Other medical history SVT. Concomitant medication(s) included: FOSAMAX; DILTIAZEM. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 Paxlovid started on 02Oct2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Patient medical history and drug allergies were not reported. On an unknown date, an unspecified number of patients received improperly stored PROQUAD lot number: K020750, exp date: 30-APR-2016 (dose, strength and route were not reported). No concomitant medications were reported. It was reported that all of the remaining doses of the improperly stored PROQUAD from the office stock were administered to an unspecified number of patients on unspecified dates. No adverse effects were reported. Lab tests were reported as unspecified. The outcome of incorrect product storage was unknown. There was no product quality complaints (PQC) involved. The reporter's causality assessment was not provided. Additional information has been requested.
I got my menstrual cycle 2 weeks early. And then again after 2 weeks.
Every year I get migraine headaches, including double vison, neck pain, head pain 10/10, nausea, and pain for 3 days currently.  I get the pediatric dose  every year
This case was reported by a other health professional via patient support programs and described the occurrence of fainting in a female patient who received MENVEO (batch number M17076, expiry date 31st July 2019) for prophylaxis. On 17th September 2018, the patient received the 2nd dose of MENVEO .5 ml. On 17th September 2018, less than a day after receiving MENVEO, the patient experienced pain in arm. On 18th September 2018, the patient experienced fainting. On an unknown date, the outcome of the fainting and pain in arm were unknown. It was unknown if the reporter considered the fainting and pain in arm to be related to MENVEO. Additional information received as follows: The caller had been informed that they had reported an experience with a GlaxoSmithKline product that needs to be shared with GlaxoSmithKline. This case was received from the healthcare provider via the vaccine patient assistant program. The case was reported by the medical assistant. The age at vaccination was not reported. The patient received MENVEO on the right arm. After the patient left the clinic, she felt pain in her left arm. Next morning of the vaccination day, the patient went to the bus stop and she fainted. The patient went to the hospital. This event did not include a product complaint.
Systemic: Flushed / Sweating-Mild, Systemic: Vomiting-Medium
11/27/2021 I developed itching on my hands around 9:30pm. Itching became severe around 12:30am. I took Benadryl and all seemed okay until the next evening November 28, 2021 around 5:30pm. I developed hives on neck, behind ears, and on upper back. I took more Benadryl, which helped the itching and calmed the hives a bit, but rash did not go away. I woke up around 12:30am with severe itching and by 2:00am I decided to go to the ER as the hives were increasing and spreading over my body and the itching was increasing as well. The ER treated me and sent me home with prescriptions for anti-histamines and prednisone. I went to an allergist and my primary Care Dr.. They both stated I have Urticaria. Both Doctors stated that if the Urticaria continued for 6 weeks, it would be considered chronic. I have now had rashes/hives everyday for six weeks. I am currently taking Pepcid 2x/day, Allegra in the morning and afternoon, Singular in the morning, and Zyrtec at night. In addition, there are days where I need to take Benadryl as well.
a 12 years old patient came in and the pharmacist gave her Flublok, no AE; Initial information received on 15-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 12 years old patient who received a 0.5 ml dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1930, expiry date: 30-Jun-2020 via intramuscular route in unknown administration site on 12-Oct-2019.  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 inappropriate age at vaccine administration.  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
Sore arm next day with redness. About 5 days later memory problems. Can't find things I just had in my hand or forgot where I put it. Go to get something and totally forget what I was looking for. Being asked to do something. Then being asked if I had done it. And can't remember that I was even asked. Left one item in food cart after shopping. Continue to have small episodes of forgetfulness . But have not seen doctor yet.
J96.00 ACUTE RESPIRATORY FAILURE 9/16/2022 PRESENCE OF BIVENTRICULAR IMPLANTABLE CARDIAC DEFIBRILLATOR R57.0 CARDIOGENIC SHOCK 9/16/2022 PRESENCE OF BIVENTRICULAR IMPLANTABLE CARDIAC DEFIBRILLATOR J96.00 ACUTE RESPIRATORY FAILURE 9/16/2022 CARDIOGENIC SHOCK R57.0 CARDIOGENIC SHOCK 9/16/2022 CARDIOGENIC SHOCK
Newly pregnant during vaccination, with EDD 4/29/22. Normal ultrasound at 8 weeks (9/16/21) with developing fetus and yolk sac observed with heart rate measured at 164 bpm. Two weeks later (9/28/21), no cardiac activity seen x 3 ultrasounds; estimated fetal size ~9 weeks, suggesting demise one week prior.
Headache; fever; aches; sleepiness; brain fog; flu-like symptoms (Just like Covid that I had); This is a spontaneous report from a contactable consumer (patient).   A 62-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right (at the age of 62) on 22Feb2021 10:00 (Lot Number: EL9267) as single dose for covid-19 immunisation. The patient medical history included covid prior to vaccination. No known allergies. Concomitant medications included imipramine, propranolol. The patient experienced headache on 22Feb2021 14:00, fever on 22Feb2021 14:00, aches on 22Feb2021 14:00, sleepiness on 22Feb2021 14:00, brain fog on 22Feb2021 14:00, flu-like symptoms on 22Feb2021 14:00. No treatment received. No covid tested post vaccination. The events outcome was recovering.     No follow-up attempts are possible. No further information is expected.
MIGRAINE; BODY ACHES; RUNNING A FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced migraine, body aches, and running a fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the running a fever, migraine and body aches was not reported. This report was non-serious.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies and concomitant medications were not provided. On 19-MAR-2018, the patient was vaccinated with VARIVAX intramuscularly, for prophylaxis (strength, dose, lot # and expiration date were not reported) which was reconstituted with a Sterile Diluent intramuscularly (strength, dose, lot # and expiration date were not reported). No adverse effects were reported.