chrisvoncsefalvay/vaers-outcomes huggingface dataset:
get the shot, but I got it /suspected vaccination failure; got shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, had shingles, doctor told to get the shot. I did but I got it a second time. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Trouble breathing; Throat swelled; Lips and tongue felt numb and swollen; Lips and tongue felt numb and swollen; Lips and tongue felt numb and swollen; Had a lot of pressure in my nose/face like when I have migraine; Allergic reaction; This spontaneous case was received on 01-Nov-2021 from other non-health professional via Seqirus' Customer services and concerned a 57-year-old female patient.  The patient's medical history and concomitant medications were not reported. The patient never had a reaction to any vaccine before.  On an unspecified date in 12-Oct-2021, the patient was vaccinated with Afluria Quadrivalent (influenza Vaccine; dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm; indication: not reported). The batch number reported was P100365587.  On an unspecified date in 2021, an unknown amount of time after receiving Afluria Quadrivalent, the patient had an allergic reaction to the flu vaccine. Her throat swelled, lips and tongue felt numb and swollen, she had trouble breathing, and had a lot of pressure in her nose/face like when she had migraine. The patient went to the emergency room (ER) and was treated with Benadryl (diphenhydramine hydrochloride). Patient will go to the allergist.   The outcome of the events was not reported.  The reporter considered events to be related to Afluria Quadrivalent.  All events were considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  Company comment: A 57-year-old patient was vaccinated with Afluria Quadrivalent. An unknown amount of time after receiving Afluria Quadrivalent, the patient had an allergic reaction to the flu vaccine. Her throat swelled, lips and tongue felt numb and swollen, she had trouble breathing, and had a lot of pressure in her nose/face like when she had migraine. The patient went to the emergency room (ER) and was treated with Benadryl (diphenhydramine hydrochloride). Due to unclear time relationship, causal role of the suspect vaccine is unassessable. As per Brighton collaboration criteria, presented information may suggest hypersensitivity reaction and correspond to level 2 diagnostic certainty for anaphylaxis.; Reporter's Comments: Had an allergic reaction to the flu vaccine.; Sender's Comments: A 57-year-old patient was vaccinated with Afluria Quadrivalent. An unknown amount of time after receiving Afluria Quadrivalent, the patient had an allergic reaction to the flu vaccine. Her throat swelled, lips and tongue felt numb and swollen, she had trouble breathing, and had a lot of pressure in her nose/face like when she had migraine. The patient went to the emergency room (ER) and was treated with Benadryl (diphenhydramine hydrochloride). Due to unclear time relationship, causal role of the suspect vaccine is unassessable. As per Brighton collaboration criteria, presented information may suggest hypersensitivity reaction and correspond to level 2 diagnostic certainty for anaphylaxis.
Started at 5 am throwing up, sore, weak, headache, freezing On Sunday 2 days after shot felt better, still weak and started canker sores in mouth and swelling. Still have symptoms as of today 2/18/21. Doctor calling in steroid.
Patient had received 3 vaccines. patient was sitting in lobby and started feeling dizzy. we took her into the counseling room and gave her some water and some orange juice. she said she had a headache and felt nauseous and had a scratchy throat. we gave her a 25mg benadryl. we took her blood pressure twice and it was high, 205/120. After the second reading we called the paramedics to take her to the hospital.
BAD HEADACHE; NON HEALING ULCER; NON HEALING ULCER; This spontaneous case was reported by a consumer and describes the occurrence of ULCER (NON HEALING ULCER), IMPAIRED HEALING (NON HEALING ULCER) and HEADACHE (BAD HEADACHE) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free, Solution for injection in pre-filled pen. In September 2021, the patient experienced ULCER (NON HEALING ULCER) and IMPAIRED HEALING (NON HEALING ULCER). On an unknown date, the patient experienced HEADACHE (BAD HEADACHE). At the time of the report, ULCER (NON HEALING ULCER) and IMPAIRED HEALING (NON HEALING ULCER) was resolving and HEADACHE (BAD HEADACHE) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Colonoscopy: COLONOSCOPY: Ulcer.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       It was unknown if patient was enrolled in a COVID-19 vaccine trial.  No concomitant medication were reported.  The reporters causality for the events of NON HEALING ULCER onset in September 2021 with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of BAD HEADACHE and NON HEALING ULCER onset in September 2021 was not provided.  No treatment medication were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
2wk p/vax pt devel macular papular rash;no signs or sx of illness;
Bouts of vertigo; Dizziness; Weakness; Nausea; This is a spontaneous report from a contactable nurse (patient). A 52-years-old female patient started to receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: e10142) via an unspecified route of administration on 13Jan2021 09:15 at single dose in left arm for COVID-19 immunisation. She received the first dose (Lot number: Ej1658) in left arm on 23Dec2020 06:30 PM for COVID-19 immunisation. Medical history included diabetes, hypertension. The patient was not allergic to medications, food, or other products. Concomitant medication included metformin, metoprolol tartrate (METPROLOL), triamterene, rosuvastatin, pyrvinium (TRU). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had the 2nd dose on 13Jan2021, experienced weakness, dizziness and nausea at around noon next day (14Jan2021 12:00 PM) then at around 6:00 pm bouts of vertigo. Up to now 5 day after the onset dizziness and vertigo still present. The adverse events result in doctor or other healthcare professional office/clinic visit. No treatment received for events. Events outcome was not recovered.
Started experiencing fever, chills, and joint pain about 12 hours post vaccine.  Symptoms lasted about 24 hours, and now appear to be gone.  Awaiting treatment plan from provider.
Sore arm at site of injection;101 fever; Nauseous ;Chills; Headache, Feels like the front of my heads going to explode.
Fourteen days after the second dose I had chills, fever, body aches, headache, and nausea followed by sever diarrhea.  After two days without much improvement I contacted  the  nurse who referred me to the on call doctor.  She recommended Immodium over the counter and GatorAde.  Also, she advised me to get a covid 19 test.  Results still unknown.   My concern is the delayed reaction and severity when the stated norm is 2 to 4 days after the second shot.
Anaphylactic reaction; This is a spontaneous report from a contactable consumer (patient).  This 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK9231), via an unknown route, on 19Jan2021 at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. On 22Jan2021, the patient developed an anaphylactic reaction. She went to the doctor and he was reluctant to give her steroids which was the normal way of treating the anaphylactic reactions because he said that the steroid would interfere with the effect of the vaccine. So, he gave her diphenhydramine hydrochloride (BENADRYL). She had to go back to the emergency room later that day and they used epinephrine (EPIPEN) and she had to have an intravenous (IV) and other than that some medications, it had prednisolone in it. Then she had to go back yesterday and she had another IV and they sent her home with an EPIPEN. The event was assessed serious as medically significant. The patient had recovered from the event in Jan2021.
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. There was no information about patients' concomitant medications, pertinent medical histories, drug reactions and allergies provided. On unspecified dates, the patient's were vaccinated with improperly stored PNEUMOVAX 23 (lot# K006681, expiration date 21-OCT-2015, doses, routes and sites of administration were not reported). No adverse events were reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a health professional concerning a 1 year old male who on 15-Jun-2006 was vaccinated with SC with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live.  The patient had concomitant medications however the reporter didn't "know which ones".  On 22-Jun-2006 the healthcare worker reported that she "just found out today" the patient experienced redness and swelling at the injection site.  Unspecified medical attention was sought.  At the time of the report the patient was recovering.  There was no product complaint involved.  Additional information has been requested.
LIGHT HEADED, NAUSEA, HEADACHE, TREMORS, CHILLS STARTING 15 MINUTES AFTER INJECTION
Patient had mild swelling to the bicep and bruising at the injection site. The swelling went down and the there was still a little brusing at the injection site as of 12/4/2017.
dizzy; sleepy; This is a spontaneous report from a contactable consumer (patient).  A 67-year-old male consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Jan2021 at single dose for COVID-19 immunisation at the age of 67-year-old. Medical history included blood pressure diagnosed year before the report (3-5 years). Concomitant medications were unspecified. The patient took the Covid-19 vaccine on 21Jan2021, and he has been feeling a little dizzy and sleepyin the afternoon of 21Jan2021, his wife was concerned so he was wondering what could be going on. The patient did not recover from the events. Information on the Lot/Batch Number has been requested.
This spontaneous report was received from a medical assistant, concerning unspecified patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with an improperly stored dose of VAQTA (lot #, expiration date, strength, dose, route of administration or anatomical location were not reported) for prophylaxis. The storage temperature was reported as 9 to 25 degrees Celsius (°C) for a time frame of 32 hours and 19 minutes. There was no previous temperature excursion reported. No adverse effects were reported. This is one of two reports received from the same source. No product quality complaint (PQC) was involved. Additional information is not expected as there was no consent to contact the reporter.; Sender's Comments: US-009507513-1706USA002365:
Pt did not respond to primary series of Hept-vax, recv 1 booster dose of vax.  Lab values cont to show no titers.
Rash, hives, itching - sporadic - red, swollen, some blistered - all at different times, some recurring - on left side neck, jaw line, reddish cheeks, itched occasionally, lower arms to wrists, under left breast and toward back on left side waking - lasted thru. Wed., Oct. 2, 2019. Pain, redness, swelling at injection sight.
After receiving shot the patient stood for a minute then while talking became lightheaded and sweaty. She stated she was on Phentermine and not eaten since 1:00pm so I ran to get O.J. thinking she was hypoglycemic. After another two minutes she lost color in her face and was getting hot flashes, 911 was called. BP approximately 110/70 after hot flash. Ambulance arrive approximately 7:58pm.
This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 24-month-old subject of unspecified gender who was vaccinated with HAVRIX (GlaxoSmithKline). On 8 March 2012 the subject received unspecified dose of HAVRIX (details unknown). In March 2012, less than one week after vaccination with HAVRIX, the subject experienced swelling injection site and injection site redness. The subject had a "large swollen red area" at the injection site. At the time of reporting the outcome of the events was unspecified.
Fever, chills, muscle aches, joint soreness, headache, and nausea and vomiting.
Redness, swelling, fever, baseball sized firm area of erythema at injection site with stiffness of right arm.  Patient's mother took her to urgent care 5 days after injection.  Patient was given Rx for Cephalexin 500mg QID and hydrocortisone cream.  Both prescriptions were started 9/29/21 after released from urgent care.
congestion; She got sick; She then tested positive for COVID-19 on November; She then tested positive for COVID-19 on November; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program . The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: PAXLOVID taken for illness, stop date: 05Feb2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2021, outcome "unknown" and all described as "She then tested positive for COVID-19 on November"; NASAL CONGESTION (non-serious), outcome "unknown", described as "congestion"; ILLNESS (non-serious) with onset 27Jan2022, outcome "recovered" (28Jan2022), described as "She got sick". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Nov2021) positive; (Jan2022) positive; (Jan2022) negative. Therapeutic measures were taken as a result of illness.  The lot number for bnt162b2 was not provided and will be requested during follow up.
No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous was received from a certified medical assistant (CMA) referring to 2-year-old male patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 20-DEC-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S009943, expiration date: 26-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S009943; expirationdate: 26-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1910USA012749:
After HPV vaccination patient felt dizzy. Escorted patient to lie flat. BP 104/68. Patient stated was feeling better. Raised to a sitting position. BP 110/72. Escorted patient to take 5 steps and BP 109/55. 2 min after 114/60. Escorted patient to car and notified if dizziness reoccurs to lie patient to a flat position.
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypertension-Mild, Additional Details: patient was given pfizer and flu shot, one on each arm. while waiting patient started coming to the pick up register and got dizzy and fainted. temperature was normal bp: 162/ 108 and hr: 104 bpm. Emergency serivces came in about 10 minutes to take a look at the patient and they cleared him stating his vitals were returning to normal. Pt stated for another 20-30 min and left stated he was feeling better.
This case was reported by a pharmacist and described the occurrence of unable to move arm in an adult female subject who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  The subject's medical history included "oncology patient".  On 12 October 2007 the subject received 1st dose of Fluarix (.5 ml, intraarticular, left arm).  On 12 October 2007, less than one day after vaccination with Fluarix, the subject experienced severe immobilization in arm and extreme pain of the left arm.  The reporter indicated that the reaction was systemic.  The subject also experienced wrong route of administration as the pharmacist reported that the physician indicated to him that he believed that the subject was vaccinated into the intraarticular space of the shoulder.  The subject required medical attention that was not specified at the physician's office.  At the time of reporting the events were unresolved.  The pharmacist considered the events were probably related to vaccination with Fluarix.
Starting the day of the vaccine 7/15/19 - patient reported feeling dizzy and unsteady, fatigue/malaise, extremely sore arm/shoulder, tingling in lips/tongue (no swelling of throat/tongue or difficulty swallowing/breathing) - pt said she spent all day in bed.  As of 7/18/19, pt said she is slowly getting better. Pt said that she did not have any reaction at all to the first dose given 5/16/19.
56 adults patients received doses after its expiration date 13-Jul-2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13-Jul-2022) 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 (56 adults patients received doses after its expiration date 13-Jul-2022).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Caller mentioned that "the CDC had just approved extended expiration dates" and wanted to know if it was extended. When asked the caller stated that there were no remaining vials unused of that lot number and agent reminded the caller that no patients should receive doses from expired vials. Dose was administered after 30-day Use by Date or after manufacturer date of expiry. Vial did not undergo any temperature excursions. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case
Hospitalized for refusal to take his home medications or communicate with group home providers after dialysis treatment. Covid 19 positive.
Vaccine administered from the syringe that was withdrawn the day before; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered from the syringe that was withdrawn the day before) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered from the syringe that was withdrawn the day before). On 25-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered from the syringe that was withdrawn the day before) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant & treatment medications were reported by the reporter.
10/25/22 I noticed bald patches on my scalp, that got more and more. I lost 35% to 40% of my hair. I went to the Dermatology clinic the end of October or first of November. I was diagnosed with Alopecia Areata.
Hive like area at injection site, 3inx2.5in in size, reddened and itchy, slightly raised appearing 9 days after receiving the vaccination, still present on 1/21/21, but less itchy