chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 79-year-old male patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) 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).    Patient age was reported as 79 Year 1 Month.  No concomitant medication was provided.  NDC ID number was reported.  It was reported that patients received vaccine at facility between 08-Apr-2022 and 15-Dec-2022.  Treatment medication was not provided by the reporter.
Fever started evening of February 16 and persisted through February 17. Fever got as high as 102. Was unable to do any normal activities on February 17.
Had a sore left arm where the injection site was, after about an hour later i began to have a mild headache and became tired (i took 2 aleve liquid gel pain killers and that didn't do much). The next day the pain in my arm got about 50% better, and the head ache was gone right when I woke up. I still felt tired throughout the 2nd day and my left under eye lid began to start twitching for about a minute long every 30 minutes. On the 3rd day, I was no longer tired and my arm no longer hurt but the under eye lid twitch is still occurring and at the same frequency.
I noticed an increase heartrate and increased blood pressure with feeling exhaustion. I contacted my doctor to seek treatment. They initially didn't want to put on medications and I was advised to monito my blood pressure at home. I have been back to the doctor twice since then and my blood pressure was still elevated. I do have a follow up in April for possible medications to control blood pressure.
neck pain; some sleeplessness; This case was reported by a consumer via call center representative and described the occurrence of neck pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced neck pain and sleeplessness. On an unknown date, the outcome of the neck pain and sleeplessness were unknown.   It was unknown if the reporter considered the neck pain and sleeplessness to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-SEP-2022 Reporter's Comment: The case was reported by the patient. The patient stated that, he received his first dose of Shingrix in March or possibly April of 2022.  The reporter stated that, he experienced neck pain later that day and also some sleeplessness.  Less than 6 months, after receiving Shingrix, the patient experienced sleeplessness. The reporter consented to follow up.
I got my second dose on 15Jan and yesterday 09Feb I tested positive on two separate tests for covid-19; I got my second dose on 15Jan and yesterday 09Feb I tested positive on two separate tests for covid-19; This is a spontaneous report from a contactable other HCP (patient). A 21-year-old female non-pregnant patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: EL3247) via intramuscular in left arm on 15Jan2021 at 13:00 (at the age of 21-years-old) as a single dose and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: unknown) via an unspecified route of administration on an unknown date, as a single dose, both the doses for COVID-19 immunisation. The patient medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The concomitant medication included desogestrel, ethinylestradiol (APRI) for birth control. The patient did not't receive any other vaccine with four weeks of prior to the vaccine. Since the vaccination, the patient had been tested for COVID-19. The patient reported that "I got my second dose on 15Jan and yesterday 09Feb2021 I tested positive on two separate tests for covid-19 (as reported) ".  The patient underwent two separate nasal swab tests on 09Feb2021 which resulted in positive. The patient did not receive any treatment for the events. The outcome of the events was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of vaccination failure and other event  due to temporal relationship  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  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.
1st dose on July 2021, Jun 16th 2022 2nd dose has not been administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (1st dose received in July 2021).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 17-Jun-2022 Reporter's comments: The patient that received Engerix B first dose in July 2021, would like to receive the second dose but first of all pharmacist wanted to check with GlaxoSmithKline. Till the time of reporting, the second dose had not been administered. The consent to follow up was given. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of Engerix B, which led to incomplete course of vaccination.
Started with nausea, then chills, unbalanced, tiredness, chest pain, cold arm, rapid heartbeat, muscle fatigue, headache, diarrhea.
swelling  and rash at the site of the injection 8 days after  first dose. Stiffness and mild shoulder pain near vaccine site 7 days after. symptoms continue 9 days after.
Dizziness, Myalgia, NauseaVomiting Chills  Per nursing report: "reports receiving J&J vaccine on Saturday 3- 13-21. States Monday [3/15] started having dizziness and body pain. States Tuesday [3/16] had shivering and nausea so states took off work yesterday."
Severe vertigo; Anxiety; Heart felt fast; Sweating; Drowsy; Nauseous; Sore arm; Threw up; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Severe vertigo), ANXIETY (Anxiety), PALPITATIONS (Heart felt fast), HYPERHIDROSIS (Sweating) and SOMNOLENCE (Drowsy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VERTIGO (Severe vertigo), ANXIETY (Anxiety), PALPITATIONS (Heart felt fast), HYPERHIDROSIS (Sweating), SOMNOLENCE (Drowsy), NAUSEA (Nauseous), PAIN IN EXTREMITY (Sore arm), VOMITING (Threw up) and HEADACHE (Headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, VERTIGO (Severe vertigo), ANXIETY (Anxiety), PALPITATIONS (Heart felt fast), HYPERHIDROSIS (Sweating), SOMNOLENCE (Drowsy), NAUSEA (Nauseous), PAIN IN EXTREMITY (Sore arm), VOMITING (Threw up) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.
Sudden onset of intrusive thoughts like constant blinking. Extreme anxiety, panic attacks and brain fog lasting weeks. Originally went to ER for one day ruled out physical symptoms got an mri and blood work completed, went to primary care doctor after and was told it would go away in a couple days but continued for weeks right before getting second vaccine I started seeing a psychiatrist to work on brain fog/ anxiety.
The patient developed redness and warmth in a 5cm area at the injection site six days after the vaccine was given.
Patient's wife says he had a purpura reaction to vaccine, starting the day after vaccination, in which he was hospitalized. She states he had a similar reaction when younger after flu vaccination as well.
Client felt dizzy and while grabbing the front desk counter and sliding down on the wall to the floor.
A bump at the site of administration of the vaccine; A 3 inch rash at the site of administration of the vaccine; This spontaneous case from  was received on 24-Sep-2020 from other non-health professional via The Agency (reference number: SEQW20-02263) and concerned a patient of an unknown age and gender.  The patient's medical history and concomitant medications were not reported.   On 17-Sep-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) for influenza prophylaxis. The batch number reported was 283849, expiry date: 30-Jun-2021.   On the same day, after receiving Flucelvax QIV, the patient developed a bump and a 3-inch rash at the site of administration of the vaccine.  On an unspecified date in Sep-2020, the patient recovered from the events.  The reporter did not provide a causality assessment.   The case was assessed as non-serious.  This case is linked with cases: 202004697, 202004698, 202004699, 202004706, 202004701, 202004702, 202004704, 202004705, 202004678, 202004696 and 202004700 (same reporter).  Additional non-significant information received on 06-Jan-2021 from other non-health professional via The Agency (reference number: SEQW21-00065) with additional information received on 12-Jan-2021 from other health professional via The Agency (reference number: SEQW21-00149) (being processed together): Two additional reporters added. Additional reference numbers added. No changes in narrative.  Company comment: The patient developed vaccination site mass and vaccination site rash on the same day after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. No information regarding concomitant medications and medical history was provided. Considering all information above, causal relationship for both events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed vaccination site mass and vaccination site rash on the same day after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. No information regarding concomitant medications and medical history was provided. Considering all information above, causal relationship for both events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).
Fever, diarrhea, body aches, fatigue,  stomach cramps, vomiting, loss of appetite
No other AE.; temperature excursion; This spontaneous report was received from a registered nurse and refers to a patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with one dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # S038178, expiration date: 26-NOV-2021 (formulation, strength, dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at -14.5 Celsius degrees (C) for 1 hour 56 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
Patient received a Jansen vaccination a year ago.  Patient then boosted with a Moderna.  Patient is experiencing pain at injection site and swelling of lymph nodes.  Pain and swelling are resolving, but patient had no symptoms with her Jansen vaccination.
This is a spontaneous report from a contactable pharmacist reporting for two patients (husband and wife). This is the first of two reports (wife). An elderly (reported as over 65-year-old) female patient received on 16Oct2017 PREVNAR 13, intramuscular in deltoid at single dose, and FLUZONE (Lot UI890AA, exp date 05Jun2018) in the same arm of pneumococcal 13-val conj vac (dipht crm197 protein), both for immunisation. Medical history and concomitant medications were not reported. The patient experienced redness, itching and soreness all in Oct2017 with outcome of not recovered. The reporter did not know if the events were related to pneumococcal 13-val conj vac because the reporter also gave influenza vaccine in the same arm as the pneumococcal 13-val conj vac injection. The reporter didn't know if the reaction happened because of the combination of giving both products.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017452872 same reporter/drug/event, different patient.
Pt vax'd 14JAN93 & had allergy 15JAN93 & started exhibiting sx of cold, congestion, runny nose, etc-On checking pts ears they were sl red w/fluid in them; MD was called felt may have been getting ear infect-pt given med; allergic resp;
Got flu shot Monday day & by the evening all the way up & including today Saturday Sept. 29th I've gotten these symptoms on & off: sore arm still sore, body aches, chills, sweating, sore throat, congestion, headaches.
Recurrent blistery spot on anterior chest wall that itches/postvaccination, noninjection site zoster-like rash, anterior chest wall. This is in follow-up to report(s) previously submitted on 9/24/2008. Information has been received from a physician's office member concerning a 60 year old female consumer with osteoporosis and allergic to penicillin and erythromycin (rash), who on 23-MAY-2008 at 8-9 am was vaccinated with 0.65 mL of the first dose of ZOSTAVAX (Merck) IM in the left arm. Concomitant therapy included alendronate sodium (+) cholecalciferol. The patient did not have any illness at time of vaccination. On 27-MAY-2008, the patient developed blood blister on her chest. The office member reported that the patient had a recurrent blister spot in anterior chest wall that itched. Post vaccination, the patient had a non injection site zoster like rash on her anterior chest wall. The patient has seen the dermatologist, he performed biopsies. The patient now had blisters in the mouth. At the time of the report, patient had not recovered. The patient sought unspecified medical attention. There was no product quality complaint. Additional information is expected.
Within 5 minutes of vaccination, I had tachycardia with pulse of 98.  I  then felt lightheaded and dizzy.  EMS was on site on took had to lie down.  When sitting upright my symptoms would reappear.  EMS checked my vitals in supine, sitting and standing.  My systolic BP dropped 160 to 110.  He took me to the ER.  They gave me IVFs with some correction of my orthostasis and symptoms.
Pt rcvd HIGH DOSE flu vaccine on 11-14-13. Pt returned to clinic 11-15-13 reporting localized redness 3" x 5", warmth, swelling, bruising 1 x 2 in. No systemic sxs reported. Pt was treated with KEFLEX 500 tid x 7d, instructed to apply ice and a mild compression bandage was applied to arm instructed to follow up 24 hours.
Information has been received from a consumer concerning her 18 year old daughter with allergic reaction to antibiotics who in January 2007, was vaccinated with her first dose of GARDASIL.  Concomitant therapy included doxycycline hyclate (DORYX).  In January 2007, the patient experienced pain in her arm.  Subsequently, the patient recovered from pain in her arm.  No further information available.  Additional information has been requested.
This spontaneous report as received from a other health professional refers to an unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with RECOMBIVAX HB for prophylaxis. On an unknown date the patients experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event was unknown.   The reporter considered incorrect product storage and no adverse event to be not related to RECOMBIVAX HB. This was one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1708USA004081: US-009507513-1708USA003517: US-009507513-1708USA004080.
Back side of right upper arm, warm pink/red 3 cm circle. Local reaction: heat/ice, ibuprofen.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (strength, dose, frequency and route of administration were not provided) lot # N026073, expiration date 20-SEP-2019 for prophylaxis. Concomitant therapies included sterile diluent (MRK). The doses of VARIVAX were exposed to a temperature excursion of 6°Fahrenheit (°F) to 14°F (8.8°F) during a time frame of 1 hour and 18 minutes, which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported. Sender's Comments: US-009507513-1804USA003063: US-009507513-1804USA003064: US-009507513-1804USA003065: US-009507513-1804USA003066: US-009507513-1804USA003067: US-009507513-1804USA003068: US-009507513-1804USA003069: US-009507513-1804USA003070: US-009507513-1804USA002453: US-009507513-1804USA003072: US-009507513-1804USA003073: US-009507513-1804USA003074: US-009507513-1804USA003075: US-009507513-1804USA003062.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 15-MAY-2016, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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.
1 hour aft started feeling weak--needle entry was sore--2 hrs aft felt feverish, throat tightened up, coughed a little and began wheezing a little--3 hrs aft eyes became red and warm and developed low grade fever (1.5 degree about normal temp)-4 hrs after had all symptoms of conjunctivitis and yellow phlegm came out of both eyes, right eye was a little worse--took Advil PM and slept--eyes were a little crusty next morning and still felt tired and weak--slept most of day and felt OK within 24 hours and eyes were almost clear...just a little bloodshot--1 week later (today) is the first time I haven't felt tired--
Information has been received from a licensed practical nurse concerning a 12 month old female with no known allergies who on 04/16/2001 was vaccinated with varicella virus vaccine. Concomitnat therapy included albuterol. On 04/25/2001, 5-10 lesions on her trunk and face. The pt's outcome was unknown. Additional info has been requested.
I had a doctors appointment in February, my blood pressure was taken reading 168/92. It has never been that high, my doctor told me to monitor it for the next week. Every time I took my BP it was getting higher and higher 210/101 at one point. I was told to call my doctor, he immediately put me on a low dose BP medication. It started to come down but not fast enough so they doubled the dose of medication. My blood pressure came back down but I am currently still on the blood pressure medication. I am prescribed Olmesartan Medoxomil 40mg tablets once per day.  This is the first time I have ever been on any medication in my life.
Blood pressure was high; On the 2nd dose; Patient reported having a headaches that came and went for about a week; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood pressure was high) and HEADACHE (On the 2nd dose; Patient reported having a headaches that came and went for about a week) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Tremor (pre-exciting condition of tremors.), Hypothyroidism and Osteoporosis NOS. Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for Hypothyroidism, PROPRANOLOL for Tremor.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced HYPERTENSION (Blood pressure was high). On an unknown date, the patient experienced HEADACHE (On the 2nd dose; Patient reported having a headaches that came and went for about a week). At the time of the report, HYPERTENSION (Blood pressure was high) had not resolved and HEADACHE (On the 2nd dose; Patient reported having a headaches that came and went for about a week) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Blood pressure measurement: 140/90 (High) 140/90 to 130/100 blood pressure was high. The bottom number was very high.         Treatment activities for event was done  with increased the dosage of propranolol to help with blood pressure.  The action taken for mRNA-1273 was not applicable.   This case was linked to MOD-2021-072785 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow-up information was received  and the reporter information, patient demographic, past medical history, vaccine dosage information, route of administration of the vaccine,concomitant medication , outcome of the events were updated.