chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sleepy; Pain at the injection site; This is a spontaneous report from a non-contactable consumer. A non-pregnant female patient of an unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 05Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. On 05Apr2021, around 3 hours after the vaccination, the patient became sleepy, the feeling of sleepiness persisted until the next morning and the patient also experienced with some pain at the injection site. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the events. The clinical outcome of sleepy and pain at the injection site was recovered on an unknown date in Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt called 12/7/15 - said shot hurt on administration and hours later had a knot on arm. Arm still hurts 2 days later - she can't sleep on it and has no strength in the arm. She is using a heating pad - that feels good.
Patient experience: COVID-19; Patient experience: COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4409043.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 20Aug2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple Sclerosis" (ongoing); "Balance Issues" (ongoing); "High Cholesterol" (ongoing); "High Blood Pressure" (ongoing). Concomitant medication(s) included: OCREVUS; LISINOPRIL; CRESTOR. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Dec2021, outcome "unknown" and all described as "Patient experience: COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2021) Unknown results.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 1:27 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021 at 1:27 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment medication was provided by reporter.
I am having often and sometimes intense asthma symptoms. I had mild random asthma as a child (maybe 5-10 times total in my life) and haven?t had any symptoms until this vaccine was taken. I can?t think of any other thing I have done that might have caused these asthma breathing issues
This spontaneous report as received from a physician refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On an unknown date the patients was vaccinated with  VARIVAX (dosing details were not reported) for prophylaxis. The reporter stated that multiple unspecified patients with unspecified ages received VARIVAX (lots unknown, expiry date: unknown) on unspecified dates and did not receive a second dose (inappropriate schedule of drug administration). No adverse effects reported. There was no product quality complaint involved. Additional information has been requested.
Nothing happened to the patient while I gave him the shot or right after but a few hours later he did have a seizure at work. EMS was called and he was taken to the hospital to be observed. When I followed up with the patient he did tell me he has gotten the flu shot before and never had a reaction. I actually gave him his flu shot last year at his employer office also. He did tell me he had brain surgery about 5 years ago for a non cancerous tumor. He sees his neurosurgeon once a year.
This spontaneous report as received from a pharmacist refers to a patient of unknown demography. On 25-FEB-2016, the patient was vaccinated with first dose of ZOSTAVAX. On 12-SEP-2016, the patient inadvertently received second dose of ZOSTAVAX (Lot# M024700, Expiry: 18-JUL-2017) (Extra dose administered). No adverse effects reported. No PQC involved. Additional information has been requested.
Temp-102 & 103 x 2 days. Temp start date: 6/26/06, 3 days post vaccination.
24 hours later, developed hives and itching of the face- mild, no shortness of breath
This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received ENGERIX B. Concomitant products included ENGERIX B. On an unknown date, the patient received 2nd dose of ENGERIX B. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown. Additional information received: HCP stated that a female patient over the age of 20 received the 1st dose of ENGERIX-B on 10/20/14 and is now presenting for the 2nd dose 12/19/14. Therefore, she is not getting the 2nd dose after the 1 month interval recommended in the package insert.
This case was reported by a consumer and described the occurrence of injection site movement impairment in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of FLUARIX (details unknown). At an unspecified time after vaccination with FLUARIX, the subject experienced injection site movement impairment and injection site discoloration. At the time of reporting the outcome of the events was unspecified. No further information was provided. This case was also reported as a pharmaceutical product complaint. The consumer reported a personal adverse event following FLUARIX vaccination (see case ID A0863089A). The consumer also reported that 3 other subjects at the same hospital where they received the vaccination experienced the same events. This is case 2 of 3, see case IDs A0860108A and A0863115A for the other reports. Follow-up received 18 June 2010: QA analysis revealed the complaint to be unsubstantiated.
Hives; Face red; Rash; This spontaneous case was reported by a health care professional and describes the occurrence of URTICARIA (Hives), ERYTHEMA (Face red) and RASH (Rash) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Obesity.    On 09-Feb-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021 at 1:00 AM, the patient experienced URTICARIA (Hives), ERYTHEMA (Face red) and RASH (Rash). On 09-Feb-2021 at 6:00 AM, RASH (Rash) had resolved. At the time of the report, URTICARIA (Hives) and ERYTHEMA (Face red) 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.   No concomitant medications were reported.  Patient was advised to take Benadryl but did not.   This case was linked to MOD-2021-026058, US-MODERNATX, INC.-MOD-2021-026058 (E2B Linked Report).; Sender's Comments:  MOD-2021-026058:Same reporter US-MODERNATX, INC.-MOD-2021-026058:Same reporter
Woke up this AM after receiving imm yest. with a pea size welt that has continued to get larger in size. Mod induration, warmth to touch with erythema (L) tricep. Dx: Cellulitis after inj. Ice TID 20 min, Cephalexin TID x 8d.
This spontaneous report as received from a pharmacist refers to 2 patients of unknown age. The patients were vaccinated with doses of ZOSTAVAX (Lot# not reported) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. The pharmacist mentioned that she heard that 2 other patients from other facilities developed similar symptoms like hers (the pharmacist's adverse event was captured in 1208USA010155). The pharmacist did not have any details for the 2 patients. It was unspecified if the patients sought medical attention. At the time of reporting, the patients' outcome was unknown. Attempts are being made to verify the existence of a patient. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
This spontaneous report as received from a nursing student via a company representative refers to an 80 year old male patient (the reporter's father). On 19-FEB-2015 the patient was vaccinated with PNEUMOVAX23 (route, dose, frequency and lot # not reported). On an unknown date, approximately in February 2015 the patient developed very bad bruising on an unspecified location. The outcome of the event was unknown. The patient sought medical attention and went to an unspecified urgent care. The relatedness between the event and PNEUMOVAX23 was not reported. Additional information has been requested.
Pt experienced soreness immediately after administration, which subsided 03/12/2021. On 03/14/2021 pt started experiencing redness, itchiness, soreness, and warmth at the injection site, which is still occurring. Pt denies fever and denies fatigue.Pt was advised to take Benedryl and Tylenol, and if the symptoms worsen or do not improve in 1-2 days to contact primary doctor and seek medical care. SPI was consulted and Dr. was notified.
Left 1st MTP joint gouty arthritis, treated prednisone x5 days then ibuprofen prn (2 days)
I woke up this morning (3rd day following the vaccine) with a rash & itching around my neck and across my upper chest area.
Large, red swelling on (L) arm at site of injection. Had fever of 102 F.
Patient seen in office 1/28/19. Started with fever on Saturday night. Runny nose since Saturday. Tmax to 101. Loose stools. Red spot appeared on leg on Saturday night. No significant cough. No other ill contacts. Slightly decreased appetite. Clingy. 2 cm erythematous rash on the upper left thigh. For the rash on the leg - Cool compress to the area (bag of frozen peas or corn works well). Topical hydrocortisone (1%) for redness and itching.
PT EXPERIENCED "EXTREME MUSCLE AND BONE PAIN, CHILLS, NAUSEA, SLIGHT FEVER/FLUSHING" THAT LASTED FROM EVENING OF VACCINE UNTIL 06/01/2014.
This case was reported by a physician via a sales representative and described the occurrence of influenza B in a 10-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included automatic implantable cardioverter defibrillator pacer, congenital heart defect repaired by heart surgery. On 29 October 2013, the subject received a dose of FLUARIX (administration site and route unknown). On 23 March 2014, 5 months after vaccination with FLUARIX, the subject experienced sore throat. No test for flu was conducted and no antivirals were given. No swab testing for culture or sensitivity was done. At that time, he was stable from cardiac standpoint. On 25 March 2014, he was found unresponsive. A culture was took around pronouncement of the death which showed positive results for influenza B which was considered as a vaccination failure. The subject died on 25 March 2014 from cardiac complications and influenza B infection.
Fever 100.2; headache; Body aches; Joint pain; chills; Diarrhea; Fatigue; This is a spontaneous report from a contactable other healthcare professional (patient). A 44-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in right arm on 04Jan2021 14:00 at single dose Covid-19 immunisation. The patient was not pregnant. Medical history included hypothyroidism, tachycardia, fibromyalgia, and Covid prior vaccination. No known allergies. No Covid tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications included unspecified medications with 2 weeks of vaccination. The patient experienced Fever 100.2, Headache, Body aches, Joint pain, Chills, Diarrhea, Fatigue on 05Jan2020 02:00. The outcome of events was not recovered. This case was reported as non-serious. No emergency room/physician office visit. No treatment received for the events.   Information on the lot/batch number has been requested.
This spontaneous report as received from the physician/husband refers to a 78 year old female patient with allergy to epinephrine (possible reaction). The patient's medical history included shingles, which was severe and caused neuropathy (prior to receiving ZOSTAVAX in 2006). In 2006 the patient was vaccinated with ZOSTAVAX. Route, dose, dose number, frequency and lot number were not reported. Concomitant medication: CRESTOR, ZETIA, fish oil and baby aspirin. The physician reported that his wife, the patient experienced six recurrences of shingles (dates not reported) after receiving ZOSTAVAX. The shingles was described as "a couple spots, like chicken pox, not a full blown rash". The patient experienced the last recurrence of shingles after lung surgery (medically significant), on 19-NOV-2013. Patient had been treated with VALTREX or (also reported as and) prednisone, by physician husband. The outcome of lung surgery and six recurrences of shingles were unknown. Reporter causality assessment was not reported. Case was linked to case MARRS# 1401USA001348 (same reporter link) (the physician experienced a mild case of shingles after receiving ZOSTAVAX). Upon internal review the event lung surgery was considered to be medically significant. Additional information has been requested.
20 y/o male received Typhoid Vaccine. began to feel ill late afternoon early evening 6PM. Began to feel chills, tired with headache and light headedness. Called a friend to take him to medical was found unconscious at 11:45. Was transported by 911 EMT to local ER. Woke up in route to ER 12:15. Evaluated in ER released at 0430 02FEB2016.
local rxn @ inj site w/facial swelling & pain in back of neck w/lymph nodes swollen;
I had arm pain the very next day. Each day it kept getting bigger and hard as a rock. It  was painful and red. About 5 days later, the roof of my mouth felt like sand paper, and I couldn't swallow because it felt like something was in my throat which caused me to gag a lot. My throat was swollen. It was scary not being able to swallow correctly. I was refused treatment from medical center and they told me to go to my primary doctor and then my primary doctor told me to go to medical center. I didn't go to the ER because I couldn't afford the $500 deductible.  Medical center is charging me $60 for the vaccine when I thought they were supposed to be free.
My daughter was a freshman (2006) in college when she fainted outside in the snow on campus in the month of January. She was taken to the student health center, then the hospital and released. She was mistakenly diagnosed with anxiety. The college nurse contacted me and insisted that something else was very wrong because my daughter's oxygen level was below normal. Upon the nurse's urging, I took my daughter to a pulmonologist. She was given a chest scan. I was told to admit her to the hospital immediately due to multiple pulmonary embolisms in her lungs. She was hospitalized for 5-7 days. She was then under the care of a hematologist who diagnosed her with an auto-immune disorder called anti-phospholipid antibody syndrome. Neither side of the family has any type of auto-immune disorder. Three years later she continues to take a blood thinner. We do not know how long she was functioning with the clots in her lungs before the fainting incident. I believe that the college nurse saved her life. This past August on the news, it was mentioned that GARDASIL has been found to cause fainting, clotting and auto immune disorders. I was suspicious that the vaccine caused this disorder in my daughter so when I heard the news report, my fears were confirmed. This clotting diagnosis occurred within 6 months of the time frame that she had the 2 of 3 recommended series of this vaccine. (The first dosage was in August. The second dosage was given in November). The manufacturer of this vaccine continues to aggressively market this product despite the problems associated with it.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 26-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up received -No new information was added.
Information has been received from a nurse practitioner concerning a 17 year old female who on 18-JUN-2007 was vaccinated with Gardasil. Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, tuberculin purified protein derivative and MENACTRA. On 18-JUN-2007 the patient experienced syncope. Subsequently, the patient recovered from syncope. Medical attention was sought. Additional information has been requested.
severe vomitting; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: unknown), via an unspecified route of administration on 27Mar2021 at 10:30 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Patient had no relevant medical history. The patient did not receive any other medications within two weeks. The patient had no known allergies to food, medications or other products. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 27Mar2021 at 12:15, the patient experienced severe vomiting. It was unknown if the patient received treatment for the event. The clinical outcome of severe vomiting was not resolved.   No follow-up attempts are possible; information about lot number cannot be obtained.
She is experiencing lot of vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the parent.  A child female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed, unknown manufacturer), for COVID-19 immunization. The following information was reported: VOMITING (non-serious), outcome "unknown", described as "She is experiencing lot of vomiting".  Additional information: Reporter stated, "I gave my child the Bivalent booster shot (Clarified as Pfizer Covid-19 Vaccine Bivalent) on Thursday afternoon. She is experiencing lot of vomiting and I would like to report it and I'd like to know where I can find the information or speak to someone about what to do about her symptoms." Reporter was suggested to contact nearest emergency room or any of the health care providers like a Nurse, Physician or a Pharmacist.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
LEFT OUR FACILITY FEELING FINE, HOWEVER HUSBAND CALLED LATER AND STATED THAT SHE PASSED OUT WHILE AT LUNCH. SOMEONE CALLED THE AMBULANCE AND THEY CAME BY AND CHECKED HER VITALS. CHECKED WITH HER AFTER WE RECEIVED THE CALL, PATIENT STATED SHE WAS OKAY AND JUST RESTING.
This spontaneous report as received from a physician refers to unknown patients of unknown age or gender. On an unknown date the patients might have been vaccinated with VAQTA (dose, route and lot# not reported) with an unsupported temperature excursion. No adverse effects reported. This is one of several cases from the same source. Additional information has been requested.
Next day noticed cognitive regression, increased loud self talk, increased OCD, aggression, more withdrawn and in her head more.  I am her mother and a nurse.
t102 8SEP95; rash on trunk 9SEP95-11SEP95; gen malaise/fatigue prior to inc T
Patient claims she woke up one day after receiving the injection in her left deltoid muscle and had an enlarged red area of skin approximately 4 inches below (and 2 inches interiorly) the original injection site (on top of the bicep muscle). Patient claims her deltoid muscle was sore at injection site, but denies pain/itching/swelling at enlarged site of redness. Patient states redness has decreased with application of ice.