chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by a health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021 at 9:03 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021 at 9:03 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 63.22.  No concomitant medications were reported.  Batch number 031L20A administered on 14-Feb-2021 with temperature 32 at 09:00 AM, 10.00AM and 11.00AM and 35 at 02:00 PM and 03.00 PM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 13-Jan-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On 06-JUN-2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M003659, expiration date 20-SEP-2017 (dose and route of administration were not reported) as a part of immunization series. There was no adverse effect reported. Administered doses of vaccine were stored in a freezer and experienced the temperature excursion of 34.1 degrees Fahrenheit for 13 hours. This is one of several reports received from the same reporter. Additional information has been requested.
flu-ish symptoms; body aches; Vomiting; fever; Nausea; Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-ish symptoms), MYALGIA (body aches), VOMITING (Vomiting), PYREXIA (fever) and NAUSEA (Nausea) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was provided.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 18-Dec-2021. On 14-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On 13-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA LIKE ILLNESS (flu-ish symptoms), MYALGIA (body aches), VOMITING (Vomiting), PYREXIA (fever) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of 1 dosage form four times per day. On 14-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flu-ish symptoms), MYALGIA (body aches), VOMITING (Vomiting), PYREXIA (fever) and NAUSEA (Nausea) outcome was unknown.            Patient reported that the events can be because she was pregnant.   This case was linked to MOD-2021-211534 (Patient Link).
Tiredness; Headache; Muscle ache; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6201), via an unspecified route of administration in left arm on 11Feb2021 at 17:45 as single dose for COVID-19 immunization. The medical history of patient was included asthma, high blood pressure, obesity, allergies from Penicillin. Patient did not receive any other vaccine in four weeks. The concomitant medications of patient included triamterene, trazodone, citalopram and potassium (Other medications in two weeks). On 12Feb2021 at 06:00 AM, patient experienced tiredness, headache, muscle ache. Patient did not have COVID prior vaccination and also patient was not tested for COVID post vaccination. Patient did not receive any treatment. The outcome of event was recovering.
Information had been received on 19-OCT-2016 from a field representative who reported that, according to a nurse practitioner, a 68 year old male patient developed shingles after he received ZOSTAVAX. Patient started therapy with ZOSTAVAX injection "about a year and a half ago". The patient had first come into the office on 17-OCT-2016 for "ear pains and no rash". The patient did not see the nurse practitioner but another healthcare professional in the office. The patient was given an unspecified treatment for this. The patient came in on 19-OCT-2016 for "a vesicular rash on the left side of the head by the ear and lots of pain". The nurse practitioner diagnosed this rash as shingles. The patient was given a high dose of an unspecified pain medication for treatment. Patient's present status was not recovered. Limited information was provided to the reporter. No further adverse event information was reported. Additional information has been requested.
Narrative: Patient received one dose of covid vaccine before testing positive for covid in nursing home outbreak. PMH includes RLL pulmonary fibrosis/bronchiectasis, HTN, T2DM, HLD transferred to the ICU for hypotension and hypoxia likely due to septic shock 2/2 aspiration PNA vs COVID PNA. Reporting per instruction.
35 y/o female with past medical history of Migraines and Venous Insufficiency who presents with numbness to left side of tongue, shortness of breath and some difficulty breathing post vaccination. Patient received the J&J vaccination (1 dose). Patient states that she did not mention to registration or nursing staff of her medical history of Venous Insufficiency. Patient denies reactions to previous vaccinations. Patient denies chest pain, itch or rash. NP and Paramedics at bedside. Patient provided with Benadryl 25 mg PO x1 and a bottle of water. Patient vitals within normal limits, 112/73 BP, 75 HR, 97% RA, Resp 12. Patient monitored by the NP over 30 minutes with resolution of symptoms. Patient with improvement of difficulty swallowing and difficulty breathing within 10 mins of Benadryl administration, but tongue numbness didn?t improve until 25 mins post medication administration. Patient was able to eat a protein bar without difficulty (patient requested). Patient last set of vitals also within normal limits, 115/77 BP, 65 HR, 98%, Resp 12. Patient advised on concerning symptoms and when to seek ER evaluation. Patient discharged home in stable condition.
Pt screamed for 3 hrs approx 5 hrs after administration, with assoc fever to T101. Tylenol not administered.
Within minutes of receiving first dose of Pfizer vaccine, pt had a vasovagal episode and fainted. Vital signs were obtained; pulse was 40. Pt's lower extremities were elevated and pt was given juice and crackers. Within several minutes, pt verbalized feeling good and left facility with her attendant/grandfather.
Typical arm soreness after the shot then flu-like symptoms the following day. Persistent/recurrent  pain at/near injection site with extension/radiation inferiorly.(Pain is in the middle portion of the upper arm).Pain is typically  a sharp, sometimes shooting, sometimes burning pain  with movement of that arm - difficulty performing ADL (such as getting dressed and undressed) due to pain. OTC help temporarily but due not prevent sudden intense pain with certain movements.
Painful joints started at 430PM 1/14/21 started in hands and progressed to entire body. By 630 PM I was in bed with muscle aches, chills, headache, nausea, extreme fatigue, slept 12 hours. Got up 1/15/21 in AM still no relief felt heart palpitations and some dyspnea on exertion with noted drops in pulse ox levels. SpO2 fluctuated from high 90s, then hovered in low 90s and had intermittent irregular drops to as low as 84%. Went to Urgent care at Primary's recommendation, O2 91%, CXR negative, Covid PCR done. SpO2 increased to 96% on ambulation, sent home.  Symptoms resolved 1/16 except for O2 drops. Covid negative report 1/17/21. SpO2 still fluctuating, Primary called 1/18/21 referred me to ER r/o PE. DDimer drawn, slightly elevated, CTA done negative for clot, discharged home.
My daughter woke up in the middle of the night complaining of chest pain/pressure and difficulty breathing. I propped her up on her pillows and gave her Ibuprofen 600 mg. The pain and pressure resolved within an hour. She's had a couple syncopal episodes since then and more chest pain/pressure in Nov 2021. She was evaluated by her Dr.
pt recv vax & exp a burning-type pain @ the inj site;pain persisted as of 8DEC & the MD suspected a psychological component;reporter indicated that pt stated vax was injected higher in arm than in past;
Tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Allergy to Keflex) and Blood pressure.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced TINNITUS (Tinnitus). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK dosage form. At the time of the report, TINNITUS (Tinnitus) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included blood pressure medications (unspecified).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Outcome of the event Tinnitus was changed from Unknown to recovered.
Patient states that her lips felt tingly, site was sore, raised and slightly red. C/O painful arm x 2 days.  No hives or SOB.  Lasted til about 10:00pm.  She also felt "hot" initially.  Bandaids applied to both sites.  Flu shot site ok.  Latex free.
Vomiting 11/15/09- took to ER-was given pills to stop vomiting and some TYLENOL- then sent home.
Patient presented to vaccine clinic. She reported a reaction to a flu vaccine that resembled rheumatoid arthritis several years ago. No other vaccines since that time. Patient had questions regarding immune system and how the body reacts to the vaccine. Reviewed vaccine mechanism and side effects with patient. She proceeded to fill out consent and received her vaccination. After vaccine, she proceeded to the back of the room to wait her 30 minutes. Patient stable and did not alert staff to any symptoms. Afterwards, patient left waiting room and told nursing student that her tongue was swelling and she felt like her throat was closing. Nursing student alerted LPN who walked patient to urgent care. At that time, urgent care took over patient care.
INADVERTENTLY VACCINATE WITH MODERNA INSTEAD OF USING PFIZER, AS RECOMENDED.
Pt recvd vax & devel hives approx 1 hr after vax; under MD care;
Expired dose given; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 48-year-old female patient who received HBV (Engerix B) (batch number 5L27A, expiry date 11th February 2022) for prophylaxis.   On 24th February 2022, the patient received Engerix B (intramuscular). On 24th February 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient received Engerix B in right deltoid. The patient inadvertently received an expired dose of Engerix-B, which led to expired vaccine used. The reporter consented to follow up. No further details were provided on call.
Child had redness, warmth, and induration the next day. Left arm from shoulder to mid forearm on the lateral aspect with streaks from deltoid to axilla and neck 24 hours after immunizations and lasted for 10 days. Mom said the PMD prescribed Benadryl.
This case was reported by a nurse and described an adult male who did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series. The pt's medical history, concurrent conditions, and concurrent medications were not reported.  On unspecified dates, the pt received three injections of Engerix-B.  The pt inadvertently received the pediatric dosage for all three injections.  At an unspecified time after the third injection, the pt was "found to be non-responsive" to the vaccine.
pharmacist not sure if there was liquid or air in the needle; This spontaneous case was reported by a consumer and describes the occurrence of NEEDLE ISSUE (pharmacist not sure if there was liquid or air in the needle) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NEEDLE ISSUE (pharmacist not sure if there was liquid or air in the needle). At the time of the report, NEEDLE ISSUE (pharmacist not sure if there was liquid or air in the needle) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided  by the reporter.  Treatment information was not provided.
SOB and total body itching.   flared up  asthma  needed inhalers and steroids
Narrative:  The patient received three doses of Pfizer COVID 19 Vaccine in Mar/Apr/Sep 2021. The patient tested positive for COVID 19 on 27 Feb 2022. The patient presented to the ED with chest pain and shortness of breath. The patient was admitted on 27 Feb with respiratory failure and afib. The patient was treated with dexamethasone and beta blockers. The patient was discharged in stable condition on 4 March 2022. Reported per EUA.
Got vac. 1-7-10 approx 10am. 1-8-10 patient began itching around brain evening Sat got worse and involve abdomen took Benadryl and it subsided.
fever/chills, red/swollen mark on arm, nausea,  headache, body aches lasted around 24hrs-still has arm pain
Dose was placed into the refrigerator initially on 4-MAY-202 and was administered between 6-JUN-2023 to 9-JUN-2023.; No adverse event; Patient received vaccine after the 30 day BUD between 6-JUN-2023 to 9-JUN-2023.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the 30 day BUD between 6-JUN-2023 to 9-JUN-2023.), PRODUCT STORAGE ERROR (Dose was placed into the refrigerator initially on 4-MAY-202 and was administered between 6-JUN-2023 to 9-JUN-2023.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    In June 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In June 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the 30 day BUD between 6-JUN-2023 to 9-JUN-2023.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose was placed into the refrigerator initially on 4-MAY-202 and was administered between 6-JUN-2023 to 9-JUN-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the 30 day BUD between 6-JUN-2023 to 9-JUN-2023.), PRODUCT STORAGE ERROR (Dose was placed into the refrigerator initially on 4-MAY-202 and was administered between 6-JUN-2023 to 9-JUN-2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the 30 day BUD between 6-JUN-2023 to 9-JUN-2023.) and PRODUCT STORAGE ERROR (Dose was placed into the refrigerator initially on 4-MAY-202 and was administered between 6-JUN-2023 to 9-JUN-2023.).    No concomitant information was reported. Suspect product dosage text was reported as unknown. It was reported that patient did not report other symptoms and no additional doses medications or treatments administered in response. This case is reported for patient 2 out of 9 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-729624 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729624:Master case
Uncontrolled SVT,cardiac arrhythmia went to the Er by ambulance
103-103.5 fever for 18 hours even after dosing with ibuprophen and tylenol every two hours. Joint pain and lethargy going on since injection (over two weeks). Trouble sleeping due to shortness of breath when I lie on my back. Getting better but has lasted for two weeks. Slight pain above my heart area. Urgent care gave me ibuprohen and told me to report.  Also, slight tingling in fingers in my left hand.
Patient complained of tingling around his forehead and numbness in his fingertips apx. 5 minutes after receiving vaccine.  Was given some water to drink and taken to an area where he could be appropriately distanced from other people but remove his mask so he could breath better.  No specific treatment or remedies given.  Patient went back to work and still had symptoms, although less intense, an hour later.  No sequelae noted or reported.
Shingles; Shingles pain; Shingles itch; Shingles burning; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 27Mar2021 at 08:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other medications or vaccines within 4 weeks prior to the COVID vaccine. On 01Apr2021 at 13:15, the patient experienced shingles pain, itch and burning. The event did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were taken as a result of shingles pain, itch and burning included treatment with Valtrex. The clinical outcome of the event shingles pain, itch and burning was recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Syncope as patient was leaving the office. Patient fell into mother's arms and no injury sustained in fall.  Immediately responsive and oriented, but pallor and lightheadedness with initial attempts to stand. Patient recovered on exam table over course of an hour. He took water and applesauce without difficulty. Orthostatic vital signs on discharge were stable. Patient discharged to home, and follow up phone call confirmed pt doing well.
1 day after receiving Tetanus Booster, patient developed a quarter size hard lump at site of inj. She described the site a itchy red and hot.
Flu shot Oct. During hair cut in Dec, noted quarter sized bald spot on back of head.
ELEVATED LIVER LEVELS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unknown) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-JUN-2021, the subject experienced elevated liver levels. Laboratory data included: Blood test (NR: not provided) Elevated liver levels. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of elevated liver levels was not reported. This report was non-serious.
Pt devel erythema, warmth, & swelling  of the entire upper arm @ site of inject p/receiving Td;
Patient experienced swelling, redness, itchiness in the left arm within 24 hours of injection. Follow up received on 07/23/2004:  Physician said that the patient recovered.
No adverse event. Pt called 7/24/2000 stating she was pregnant. Pt had a baby 4/01 with no defects.