chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a licensed practical nurse and refers to an unknown number of unspecified patients of unknown age and gender. There was no information about the patients' concomitant th`erapies, medical histories and drug reactions or allergies provided. On 18-APR-2017, the patients were vaccinated with improperly stored doses of ROTATEQ lot#: M018958, expiry date: 03-MAR-2018, orally (dose was not provided). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion with temperature between 47 degrees Fahrenheit to 77 degrees Fahrenheit for 2 hours. Data logger was used to capture temperature excursions. There were no previous temperature excursions. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA008154: US-009507513-1705USA000207: US-009507513-1705USA000205:
Itching all over the body, random red patches, hives around injection site that are persistent, pain at injection site, consistent nausea over the past 4 days.
A total of 40 pts completed the series of Engerix-B a yr ago; 3 of them were determined to be non-responders (titers of 10 or less);
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 25-JUN-2017, the patient was vaccinated with improperly stored dose of ZOSTAVAX lot # M042504, expiration date 30-NOV-2017 (dose and route of administration were not reported) for prophylaxis. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 11.4 degrees Fahrenheit for 2 hours. The vaccine experienced a previous temperature excursion of 8.6 degrees Fahrenheit for 30 minutes. The reporter stated that ZOSTAVAX also experienced a second excursion and no additional patients were administered. Data logger was involved. No product quality complaint (PQC) was involved. Additional information has been requested.
myalgias, malaise approx. 24 hrs after injection starting having chills unable to control hand shaking.  Stating just like with first shot - light headed - had to leave work and go home
pt recv vax OCT96 & 20DEC96 pt was tired & had chills & an asthma attack was triggered;pt was seen by MD & has recovered;
booster; tiredness; Elevated temperature (100.4); arm soreness; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 31-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1 Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2 Unknown Manufacturer), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021, outcome "unknown", described as "booster"; FATIGUE (non-serious) with onset 16Dec2021, outcome "unknown", described as "tiredness"; PYREXIA (non-serious) with onset 16Dec2021, outcome "unknown", described as "Elevated temperature (100.4)"; PAIN IN EXTREMITY (non-serious) with onset 16Dec2021, outcome "unknown", described as "arm soreness"; HEADACHE (non-serious) with onset 16Dec2021, outcome "unknown", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
YF-Vax given intramuscular, is the vaccine protective at all, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional and consumer/non-health care professional via Medical Information  (Reference number- 00735410) and transmitted to Sanofi on 20-Aug-2021.  This case involved an unknown (age and gender) patient given YELLOW FEVER VACCINE - [YF-VAX] intramuscular, is the vaccine protective at all (incorrect route of product administration)  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect YELLOW FEVER VACCINE - (lot number and expiry date were not reported) via intramuscular in unknown administration site for prophylactic vaccination (incorrect route of product administration)  It was reported,"If not valid and the dose needs to be repeated, is there a 30 day waiting period"?  This was an actual medication error due to inappropriate route of vaccination (latency: same day)  At the time of reporting, 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 the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Shortness of breath, tingling lips, erratic heartbeat, dizziness and near fainting 2x. Pulse 80, considered going to ER, but situation resolved in an hour with relaxation and breathing. Could be unrelated to vaccine, but thought reasonable to report.
Varicella-like rash at the site of the injection lasting 7-10+ days.
Administered expired vaccine to the patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration) in an 82-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported that it was unknown when the vial was initially stored in the refrigerator.  The vial did not undergo any temperature excursions.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live non-significant follow up.
This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), DIZZINESS (Dizzy/ dizziness), FATIGUE (feeling tired/ exhausted), PYREXIA (He had fever of 100 degrees/ experienced temperature) and EXTRA DOSE ADMINISTERED (he received the third dose) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Heart attack, Enlarged prostate and Non-Hodgkin's lymphoma (He had cancer 20 years ago). Concurrent medical conditions included Depression and Blood pressure abnormal (Blood pressure).On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ASTHENIA (Weakness), DIZZINESS (Dizzy/ dizziness), FATIGUE (feeling tired/ exhausted) and PYREXIA (He had fever of 100 degrees/ experienced temperature). On 23-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (he received the third dose). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 23-Aug-2021, EXTRA DOSE ADMINISTERED (he received the third dose) had resolved. At the time of the report, ASTHENIA (Weakness), DIZZINESS (Dizzy/ dizziness), FATIGUE (feeling tired/ exhausted) and PYREXIA (He had fever of 100 degrees/ experienced temperature) outcome was unknown.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 100 (High) 100 degrees. No concomitant medications were reported. Patient reported that he did not experience any adverse events with the first two doses.
Pt saw shooting stars immediately after injection. Then that went away and felt lightheaded and nauseous. BP 139/95 and pulse 104 which are both high for patient. No fever, no hives, felt warm, + nausea.
Problem with right eye/it was painful and red; Headache; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (Problem with right eye/it was painful and red) and HEADACHE (Headache) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 4782589) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to Severe Rheumatoid Arthritis).   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-May-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In September 2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient experienced EYE PAIN (Problem with right eye/it was painful and red) and HEADACHE (Headache). At the time of the report, EYE PAIN (Problem with right eye/it was painful and red) and HEADACHE (Headache) outcome was unknown.            Concomitant products were not provided. Treatment medication were not reported. It was unknown if patient was enrolled in COVID-19-Vaccine Trial.
Redness at site, swollen, sore muscle up to pec area, flushing of face, cannot move arm above head, headache.
Redness and swelling - spoke with patient's sister on Oct 31, 16 at 12pm. Told her to continue TYLENOL, take BENADRYL and apply compress. She is calling me back today. 11/1/2016 patient is doing better. Arm redness/swelling is better.
A non-serious spontaneous report of fever of 103 F has been received from a physician concerning his grandson, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. On 28-Oct-2009, the patient received H1N1, Intranasal for an unknown indication. On 28-Oct-2009, the patient received dose of H1N1 and spiked a fever of 103 F the night after vaccination. The fever diminished within days. The outcome for the reported event was recovered and resolved.
Two days post vax, which was received SQ in left arm, area red, warm to touch, induration of redness across back of arm, tender to touch.
Site of DTAP became red, raised and discolored the day after immunization was given. Had office visit on 3/14/01 and was given Keflex for cellulitis of leg. Developed blisters on 3/15/01 and had a recheck office call on 3/15/01. Is improving.
Vertigo and vomiting 04/18/2021 Dizziness/Loss of Balance 05/07/2021 followed by ongoing light headedness, dizziness, muscle weakness, fatigue, loss of balance, sleep disruptions, internal shaking during the night and upon waking.  Symptoms have been ongoing since 05/07/2021
10 days p/vax pt w/fever (101.6 in office) & diffuse morbilliform rash, v/d;
vaccine administered at 11:38AM at the off site clinic on 10-22-20. approx 11:55am she started to complain of her eyes burning, feeling hard to swallow, clammy, itching, and she was shaking (which is a normal body function). I asked many questions and she stated she has had the flu shot many times with no issues only to the tetnus vaccine. I placed a cool cloth on her neck and tried to get her to relax as she was responsive but the itching continued as I advised about an Epi-pen but she can't have them she stated. The other collegues in the office at the time had benadryl so she took one 25mg tablet at 12:10 as the itching is what bothered her. She sat and relaxed, went to the bathroom as she felt nauseous but did not vomit. It seemed to get better than about 1:00pm her eyes were burning again/appeared glassy and she felt very clammy so I called paramedics. They arrived on scene, took vitals, listened to lungs and were clear. Advised they could take her to the ER, it seemed the bendryl was helping but the delayed reaction one is not able to tell the severity of it. She delined the ER. I advised before leaving to keep the benadryl at home but should anything develop further she needed to go to ER, she agreed. I called her MD office and disclosed the incident per the MA he was going to follow up with her as well.
Blotchy rash on chest, neck, shoulders and arms; mild tingling tongue and fingers; mild tingling tongue and fingers; This is a spontaneous report from a contactable physician (patient). A 58-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration on 02Jan2021 at 09:45 at single dose in right arm for covid-19 immunisation. Medical history included hypertension, migraines. Concomitant medication included losartan 100mg/d, ergocalciferol (VIT D) 4000u/day, ascorbic acid (VIT C) 1000 /day. The patient experienced blotchy rash on chest, neck, shoulders and arms on 02Jan2021 at 10:05, mild tingling tongue and fingers in Jan2021. No urticarial lesions. Rash noted 20 minutes post injection. Took 25mg Benadryl and rash resolved. The outcome of the events was resolved in Jan2021. There was no other vaccine in four weeks. The patient was not diagnosed with COVID 19 prior vaccination, and was not tested for COVID 19 post vaccination. This case was reported as non-serious by reporter.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 72 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: "Meds for bp" (unspecified if ongoing), notes: Meds for bp and cholesterol; "cholesterol" (unspecified if ongoing), notes: Meds for bp and cholesterol; "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin, sulfa drugs; "Known allergies: sulfa drugs" (unspecified if ongoing), notes: Known allergies: penicillin, sulfa drugs. Concomitant medication(s) included: TRINTELLIX, start date: May2022; L METHYLFOLATE, start date: Jan2017; ATORVASTATIN, start date: Jan2018; LISINOPRIL, start date: Jan2014; DYAZIDE, start date: Jan2014. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Information: Reporter stated that, report was about covid treatment. age group was Elderly (65+ Years). Received Other medication in 2weeks. Anti viral details was reported, Product-COVID 19 Treatment, Brand-Paxlovid. Treatment started on 23un2022 and stop date was 28Jun2022. Covid vaccine details was reported as Pfizer / BioNTech. Other medication details was reported as, Other medication in 2weeks product was Trintellix, start date=May2022. Product=L-methyl folate, brand=Deplin, start date=Jan2017. product=atorvastatin, start date=Jan2018. product=lisinopril, start date=Jan2014. product=dyazide, start date=Jan2014. Adverse event details was reported as, Rebound of Covid symptoms 5 days after completing Paxlovid. Adverse event start date was 03Jul2022. patient was Not recovered. No treatment ae was reported. Other medical history was Meds for bp and cholesterol.  No follow-up attempts are possible. No further information is expected.
side effects from the vaccine; Hot to toucn sensation; Fever; Chills; Itchy at injection site; Rash at injection site; Redness Near the Injection; Fatigue; Arm pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Arm pain), VACCINATION SITE WARMTH (Hot to toucn sensation), FATIGUE (Fatigue), PYREXIA (Fever) and CHILLS (Chills) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 632L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm pain) and FATIGUE (Fatigue). On 05-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot to toucn sensation), PYREXIA (Fever), CHILLS (Chills), VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE ERYTHEMA (Redness Near the Injection). On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects from the vaccine). On 31-Jan-2021, PAIN IN EXTREMITY (Arm pain) and FATIGUE (Fatigue) had resolved. On 08-Feb-2021, VACCINATION SITE WARMTH (Hot to toucn sensation), PYREXIA (Fever), CHILLS (Chills), VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE ERYTHEMA (Redness Near the Injection) had resolved. At the time of the report, VACCINATION COMPLICATION (side effects from the vaccine) outcome was unknown.        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.
patient presented about 30 minutes after receiving her second dose of Pfizer covid vaccine with sharp pain in the left elbow.  Patient was provided with a cold compress and rested for about 10 to 15 minutes and reported improvement in symptoms.  patient left.
Shingles after 1st dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. In FEB-2023, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles after 1st dose). The outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt date: 24-Mar-2023 The pharmacist reported that the patient received the first dose of Shingrix on unknown date and then about a month ago from reporting developed shingles.  The shingles was clearing up at the time of reporting.  The healthcare professional stated that the first dose was not given at their pharmacy; he did not have vaccination information. The reporter consented to follow up via email.
On 12/6/99, the pt experienced a low grade fever and approximately 20 lesions. The p sought unspecified medical treatment and was diagnosed with a mild case of varicella. On an unspecified date the pt recovered.
pt felt light headed, stood up and then fell over. EMT came to assess. No difficulty breathing. Only lightedness. Experienced some nausea afterwards.
Patient recieved her second dose of the Pfizer vaccine at noted facility .  During her drive home her heart began racing and she was  sweating and gasping for air because she could not breathe. There was a mini ER nearby and she ran inside for help.  They called an ambulance  transported me to ER.  At ER my BP was ~175/105.  I had a headache, chest pain, sweating and anxiety and felt generally unwell. They administered IV benadryl and ativan.
she had a tiny bit of sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "she is allergic to eggs" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization, reaction(s): "she had a tiny bit of sore arm"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization, reaction(s): "she had a tiny bit of sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "she had a tiny bit of sore arm".  Additional information: She was suggesting that Pfizer's researchers might consider having the next booster without any egg based in it or other options because she is allergic to eggs, she also did not take her flu shot because of that. Caller mentioned she already took the primary series and two booster shots from Pfizer and scheduled for the fifth shot. The patient had a tiny bit of sore arm after that four shots from Pfizer other than that she had no problem with the vaccines.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Fever, chills, headache, exhaustion, pain at site of injection, dizziness Took ibuprofen 48 hours after receiving the vaccine completely better
pale p/inj given instructed to sit-refused;pt stated became gray visually, felt SOB, chest pain;states got out of van, crawled to port-a-john @ site of road, fainted for 5-10mins;felt fine p/episode;
Widespread rash and ulceration. H1N1 inj and Seasonal flu injec. given 12/3/09. On 12/4/09, fever=105. 12/5/09, fever 103-105 and widespread rash with mouth ulcerations noted.
This medically confirmed spontaneous report (initial receipt 21-Oct-2014) concerns a female patient. On an unspecified date in Oct-2014, the patient received influenza vaccine injection (manufacturer and batch number not reported) via intradermal route (medication error). No adverse reactions were experienced since administration. Outcome was reported as recovered. Reporter causality: The reporter assessed the case as non-serious.
I had pain on my left arm where I got the shot and I experienced fever, headache, and tiredness. The fever started 12 hours after I got my shot, and my body temperature was at high as 101.9 F.  I didn't take any medicine, but drank water and took rests frequently. In about 36 hours after I got my shot, almost all the symptoms disappeared.