chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 08Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Negative, notes: I tested negative on days 6 and 7 post-first positive trestle; (Jun2022) Positive, notes: on day 11 and tested positive again that day; (Jun2022) Positive, notes: It's now day 15 and I'm still testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Covid-19 treatment with Paxlovid from 29May2022 to 31May2022.
joints were aching; nauseous; hot flushes that progressed; feeling really hot; can't recall names; had a glazed look; This is a spontaneous report from a contactable registered nurse  A 34-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: 9899, expiry date: Mar2021), intramuscularly  in left deltoid on 18Dec2020 at 10:20 am at 0.3 mL, single for COVID-19 immunization. Medical history included chronic lyme disease and anxiety both from an unknown date and unknown if ongoing. Concomitant drug included vivogen which is a stimulant to keep her awake during the day and took supplements, but reporter didn't have a full list. On 18Dec2020 at 10: 25, the patient had an adverse reaction within 5 minutes felt nauseous, hot flushes that progressed and feeling really hot, as it progress she started getting out of it, the patient also can't recall names, she had a glazed look, within 30 minutes (18Dec2020 10:50) joints were aching. She was asking for common adverse events during clinical trial study. The event was reported as seriousness for being other medically important condition. The reporter considered the events was related to the COVID 19 Vaccine. The patient still had the neuro symptoms. She was still very out of it and her joints were still hurting. The nausea had gone. The outcome of the nauseous was resolved in Dec2020, the outcome of joints were aching was not resolved, the outcome of other events was unknown.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, nauseous, hot flushes, feeling hot, can't recall names, glazed look and joints aching. there is a reasonable possibility that the events are related to BNT162 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient came in to receive a Pfizer booster dose. Patient was screened by one of our nurses and was vaccinated. Patient did have CDC card during her appointment with us. Per their CDC card patient received their 2nd dose of Pfizer on 10/6/2021 which means they got their booster dose 3 months too early. The immunizer reports that the patient felt fine after their 15-minute waiting period.
massive headache at center of her forehead; threw up; pain at injection site; felt dehydrated more than normal; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at injection site), DEHYDRATION (felt dehydrated more than normal), HEADACHE (massive headache at center of her forehead) and VOMITING (threw up) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Migraine. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site) and DEHYDRATION (felt dehydrated more than normal). On 15-Apr-2021, the patient experienced HEADACHE (massive headache at center of her forehead) and VOMITING (threw up). At the time of the report, VACCINATION SITE PAIN (pain at injection site), DEHYDRATION (felt dehydrated more than normal), HEADACHE (massive headache at center of her forehead) and VOMITING (threw up) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications listed.
Swelling at injection site, heat, rash on arm down to elbow.  Advised to see personal physician.  Initial report on 4/21/06.  At follow up call on 5/4/06 reports site still swollen, slight rash at injection site.  Did not seek medical help.
A report has been received from a Health Professional concerning a 10 year old, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The nurse reported that she had a patient who finished chemotherapy in June and was inadvertently given FLUMIST QUADRIVALENT which started on 24-Oct-2013. The outcome of the event PATIENT FINISHED CHEMOTHERAPY IN JUNE AND WAS INADVERTENTLY GIVEN FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by reporter.
Vial refrigerated on 18-Oct-2021 after expiry; Dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) and PRODUCT STORAGE ERROR (Vial refrigerated on 18-Oct-2021 after expiry) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial refrigerated on 18-Oct-2021 after expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) and PRODUCT STORAGE ERROR (Vial refrigerated on 18-Oct-2021 after expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No temperature excursion happened after vial was placed in refrigerator on 18-Oct-2021.  No concomitant medication was reported by reporter. No treatment medication was reported by reporter.  No adverse event was reported.
dizzy; trouble breathing; I can''t even walk now; severe rash; severe headache; I walked down the street and I just collapsed/I fall down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) at the age of 60 years as dose 2, single and administered in arm left (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "coughing" (unspecified if ongoing), notes: I was coughing for months, and then I got this shot (further clarification unknown; "COVID-19" (unspecified if ongoing), notes: I had the virus and two days after that I started feeling side effect and they got worse. Concomitant medication(s) included: OMEPRAZOLE; VENLAFAXINE. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; DYSPNOEA (non-serious), outcome "unknown", described as "trouble breathing"; GAIT INABILITY (non-serious), outcome "unknown", described as "I can''t even walk now"; RASH (non-serious), outcome "unknown", described as "severe rash"; HEADACHE (non-serious), outcome "unknown", described as "severe headache"; FALL (non-serious), outcome "unknown", described as "I walked down the street and I just collapsed/I fall down". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, dyspnoea, gait inability, rash, headache, fall.  Additional information: After the shot, the patient tried walking first time after five months and couldn't even do that because the patient was dizzy and had severe rash and muscles and head. And all the doctors told that everything was fine. The patient had two of them, didn't get the booster yet. The patient is going to get the booster. The doctor kept saying that rash will go away but it was really not going away. When the patient had the virus and two days after that started feeling side effect and they got worse. The patient had omeprazole for stomach.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient is less than 18 years of age when she received vaccine, however EUA is only for 18 years of age and older. No other adverse effects noted other than aches from vaccination.
About 5 pm on the date of my second shot, I became totally exhausted and mentally impaired. I had a headache and nerve pain throughout my body, but after a Tylenol and a heating pad that dissipated. I stayed in this stupor on the couch or in the bed the entire second day. I went to bed, then at 9;30 pm the evening after my shot, I realized my brain was putting thoughts together. I jumped out of the bed and told my husband:" I am myself again!" I have felt normal ever since.
Tinnitus in both ears.  It is a constant high-pitched ringing.  By my estimation it is approximately the same volume as music playing at 50 dB as measured by a smart phone.
Febrile, seizure on 10/08/2001. Hep B #3 given on 10/08/2001, fever that night, given Tylenol was restless with pains. Noticed legs shaking and eyes rolled back, lasted 1-2 minutes.
Fever, body aches, injection site pain and discoloration, nausea, coughing.  As it stands currently, I am still having some side effects, notably being fever and some body aches, but I am not as bad off as I was Wednesday evening.
105.2 degree fever the next day - took 3 rounds of Tylenol and fever finally broke on Saturday April 24th.  Since Friday April 23rd, I have had ringing in my left ear (tinnitus) and now have minor hearing loss in the left ear.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 06-NOV-2013, the patient was vaccinated with the first dose of GARDASIL 0.5 ml, intramuscular. The second dose was administered on 09-AUG-2014 and the third dose on 23-OCT-2014. Lot number and expiration date were not reported. No adverse effects reported. Additional information is not expected. No allowed to contact physician.
Consider administering Bexsero to a 62 YO; Consider administering Bexsero to a 62 YO; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 62-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient did not receive Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: Consider administering Bexsero to a 62 YO) and circumstance or information capable of leading to medication error (Verbatim: Consider administering Bexsero to a 62 YO). The outcome of the inappropriate age at vaccine administration and circumstance or information capable of leading to medication error were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-APR-2023 The reporter did not consent to follow-up. No vaccine details or date because event had not happened yet. No initials for the patient reported. The nurse was considering administering the patient with Bexero at the age of 62 years, which led to inappropriate age at vaccine administration and circumstance or information capable of leading to medication error.
11 hours after receiving the vaccine chills started, and a fever of 99.5.  Over the next 18 to 20 hours temp rose to 102. Chills were uncontrollable until I began taking tylenol to bring down tge fever.  Then I began to get very hot...sweating.  alternated chills and sweats during that 18 to 20 hour period.  Fever finally broke but ended with a slight headache.  Also during the same time period of the fever I experienced diarrhea.   Woke up less than 48 hours post vaccine feeling better, but extremely tired.
Left testicular swelling - moderate.  Started after both injections, approximately 12 hours later.  Patient noticed while in the shower.  Was concerned enough to ask his wife (me) to look and see.  Redness, swelling, heat evident in the left testicle.  Patient thought that he maybe had a hernia, but hernia check was done and negative.  Swelling subsided both times after a week.  Only change in health history both times was getting vaccinated.
Case number PHEH2016US023434, is an spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 48 years old patient of unknown gender. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number 1515701) at a dose of 0.5 ml intramuscularly in left arm on 12 Feb 2016. On 12 Feb 2016, FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursions was administered to patient. The nurse stated that, no adverse event was reported following this administration error (incorrect product storage). The case was assessed as non serious by the nurse.
- Chest pain after 1.5 months from the second shot - Left arm numbness - Shortness of breadth  - Hard to stay asleep - Lack of energy
This consumer spontaneous report (initial receipt 29-Jul-2014) concerns a 29-year-old female patient. On 27-Jun-2014, the patient received a total of four vaccines, which included 'flu vaccine' (Influenza virus vaccine, manufacturer and batch number not provided), and one VARIVAX subcutaneous injection (batch number not provided). On 22-Jul-2014, the patient went to her physician who performed 'blood work' and found out that she was pregnant. It was estimated that she was approximately four months pregnant. The reporter was unaware that they should not conceive until after three months of receiving the vaccines. No additional AE information was provided. Outcome was reported as unknown. Reporter comments: The reporter reported the AE onset date as 22-Jul-2014, and medical attention was sought.
Patient was administered a dose that had expired on 06Feb2022; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 12-month-old male patient who received DTPa (Infanrix) (batch number KG4M7, expiry date 6th February 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th March 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 29th March 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-MAR-2022 Reporter's Comments: Medical Assistant reported that a patient was administered a dose of Infanrix that had expired on 6th February 2022. The reporter consented to follow up. Additional Supportive Information: The patient received Infanrix which was already expired, which led to expired vaccine used.
Developed symptoms of peripheral neuropathy about 6 wk post second dose which peaked about 8-10 weeks out and are still persisting.  He had his flu shot in 10/2020- about 4 months prior to any symptoms.  He saw a neurologist - EMG and nerve conduction studies were performed and were normal with the initial symptoms.  The neurologist recommended  a skin and muscle biopsy and did not have a conclusive diagnosis.  He is taking neurontin, B12, vitamins D, still with tingling and numbness, decrease sensations especially feet.
3 days after receiving one dose of varicella virus vaccine live on 4/23/99, the pt experienced a rash with greater than 5 lesions. Additional information has been requested.
On 1/14 fever, chills,  diarrhea that lasted for 12  hours.  assumed this was  a vaccination reaction. On 1/19 she lost sense of taste and smell  and tested positive for  covid-19 by PCR
pretty bad flu symptoms, but no fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (pretty bad flu symptoms, but no fever) in a  patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (pretty bad flu symptoms, but no fever). At the time of the report, INFLUENZA LIKE ILLNESS (pretty bad flu symptoms, but no fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.  Reporter stated patient had 1st shot 10 days ago. That night patient woke up in the middle of the night with pretty bad flu symptoms, but no fever. Lasted 2 days. Then symptom free for 2 days. Then it hit the patient again 2 days later and lasted 4 days. Had to go to bed. It dissappred again   Reporter did not allow further contact
patient states she had normal arm soreness the first few days after the vaccine. woke up this morning on 10/27 and noticed swelling, rash, and arm warm to the touch around injection site area and a little below. took a benadryl before reporting reaction to the pharmacy.  will follow up with patient the following day 10/28 to monitor reaction and see if benadyrl helps. patient stated that she now remembers having the same reaction to the pfizer covid vaccine last year but never reported the event.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 10-DEC-2015, the patient was inadvertently vaccinated with ZOSTAVAX (lot number K011002 and expiration date 07-NOV-2015, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effects were reported. Additional information is not expected as the reporter refused additional contact.
Difficulty breathing and shortness of breath lead to hospitalization. Daughter said PUI's health is not improving.
Severe headache  Rapid heartbeat (155) Dizzyness Lightheaded Severe aches Shortness of breath
Tinnitus in right ear became very noticeable/impactful around a month after 2nf pfizer dose. It has continued for over a year with varying severity depending on the day.
About one week after her second injection, patient began to experience intense stomach pain after eating. On April 11, she went into the emergency room (once in the morning and again in the evening) due to right side abdominal pain. She was seen in the ER again on May 9th. She was referred to a pediatric GI specialist and advised to stop eating gluten. Removing gluten from her diet has completely resolved the issue.
Experienced temperature of 101-102, chills, sore arm, fatigue.  Two days after second vaccination my arm has large red, itchy rash...
right thigh hard bump, 2.5 cm induration taking ibuprofen and ice pack for four days
Mild tender (R) upper arm. Reaction secondary to inj. VARIVAX. No redness or evidence of skin soft tissue inf. Ice TID, ALEVE.
Mother reports patient complaints of muscle aches and headache, muscle aches impairing ability to ambulate.
Received vaccine at 9:30am on 3/19. That same afternoon at 2:00pm, I experienced intense pain in the jaw, shortness of breath, sweating, pressure/squeezing in chest, and uncontrollable shaking all throughout my body. Went to ER. EKG showed arrhythmia. Triponin tests did not show evidence of a heart attack. Admitted to the hospital for observation, but many symptoms subsided.
Patient came in about 8 hour after receiving the injection and reported an injection site reaction.  She reported swelling at the site of injection and it spread on her arm, warmth and soreness due to inflammation.  We told patient to follow up with a physician as soon as possible to get evaluated and seek treatment.  Patient was going to also ice the site of injection and and take ibuprofen to help with inflammation.