chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He had his second dose of vaccine on May2021/tested positive for Covid; He had his second dose of vaccine on May2021/tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient in his 50's received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetic" (unspecified if ongoing), notes: diabetic patient in his mid 50s. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "He had his second dose of vaccine on May2021/tested positive for Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive; no negative, notes: after a second test he is no negative. Therapeutic measures were taken as a result of covid-19. Clinical course: Caller is a consumer who tested positive for Covid and he has already finished his course of Paxlovid treatment. and after a second test he is no negative (Wednesday) He had his second dose of vaccine on May2021 and He wants to know when he can get his booster for Pfizer BioNTech vaccine? The lot number for bnt162b2 was not provided and will be requested during follow up.
Pt accidentally got three doses . Two at one facility and one at another facility. 1/19/21 1/26/21 2/8/21. No reaction occurred per pt
11/10/01, hives on back and continued through the date of the report. 11/13/01, axillary temperature of 102.7F; lack of appetite and lethargic. 11/14/01, Tylenol given; temperature normal. 11/15/01, red and swollen eyes; fussiness; pale; weakness and unsteady gait.
NauseaVomiting chills on 1/30 and arm pain Narrative:   Other Relevant History:
Untimely menstrual bleeding occurred two days after the first shot. First day of last menstrual period before the first shot was 3/4/2021.  Received second dose on 4/13/2021 (Lot No. EW0151), and did not experience any untimely bleeding following the second dose, but cycle is now off and have not had another period. Did experience low-grade fever (100.6), chills, body aches, and substantial injection site soreness the next morning, which abated by the following day.
Moderna vaccine  (NDC  80777-0273 -98) lot# 039D21A  * GTIN 00380777273983 was administered  after the beyond date 10/23/2021. Contacted Manufacturer Moderna + no need to repeat the dose  .
A report has been received from a Health Professional concerning an 8 year old, Female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on 14-Jan-2014. The nurse reported that the patient had received expired FLUMIST which started on 14-Jan-2014. The outcome of the event of expired FLUMIST is unknown. The report was considered to be non-serious.
patient complained of a headache about 2 minutes after vaccination. She became hot and flushed and soon began vomiting. Patient's mother contacted ems which took her to the local emergency department. Patient was given ondansetron and diphenhydramine and sent home.
vial was initially stored in the refrigerator on 04-Jun-2022 and administration of vaccine was on 09-Jul-2022; No adverse event; Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 04-Jun-2022 and administration of vaccine was on 09-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 04-Jun-2022 and administration of vaccine was on 09-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 04-Jun-2022 and administration of vaccine was on 09-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 04-Jun-2022 and administration of vaccine was on 09-Jul-2022).    No concomitant medications were provided by the reporter. Date the vial was initially stored in the refrigerator was 04-Jun-2022. The vial did not undergo any temperature excursions. Patient received half dose on 09-Jul-2022.  No treatment medications were provided by the reporter
Fever 101.5; body aches; chills; headache; This is a spontaneous report from a contactable other health professional (patient). A 32-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular on 27Dec2020 08:45 at single dose at right arm for COVID-19 immunization. Medical history reported as none, no Allergies to medications, food, or other products. Concomitant medication was none, the patient did not receive any medications within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Dec2020 21: 30 (09:30 PM), the patient experienced fever 101.5, body aches, chills, headache. Treatment received for the adverse events included Tylenol. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was not recovered.
9 days after vaccination, left shoulder is slightly swollen, hot to touch, pink in color, and firm to touch. Feels sensitive but not painful. Possibly ?COVID arm?
Numbness, Tingling and nerve spasms in fingers of the same arm and hand that injection was given.
Case number PHEH2015US024818, is an initial spontaneous report received from a healthcare professional on 23 Nov 2015. This report refers to a 46 year old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLURIVIN (batch number: 1515701) multi dose vial (MDV) into left deltoid, intramuscularly at a dose on 0.5 ml on 23 Nov 2015 at 08:48 am. It was reported that the vaccine administered was out of temperature range at 46.8 degree Fahrenheit for 24 hours. The case was reported as non-serious. No adverse events were reported following the medication error. Follow up report received from a healthcare professional on 21 Jan 2016: added suspect drug information (batch number, vaccination site and time).
arm turned red/ still has a red mark at the injection site; she had like a bruise; she never had her second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (arm turned red/ still has a red mark at the injection site), VACCINATION SITE BRUISING (she had like a bruise) and PRODUCT DOSE OMISSION ISSUE (she never had her second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (arm turned red/ still has a red mark at the injection site), VACCINATION SITE BRUISING (she had like a bruise) and PRODUCT DOSE OMISSION ISSUE (she never had her second dose). At the time of the report, VACCINATION SITE ERYTHEMA (arm turned red/ still has a red mark at the injection site) had not resolved, VACCINATION SITE BRUISING (she had like a bruise) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (she never had her second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.  It was reported that patient took first dose 3 months ago and did not take second dose as she was nervous about the reactions.
This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A female patient of an unspecified ethnicity and age (described as 67 no units provided) received PREVNAR 13, via an unspecified route of administration on an unspecified date at 0.5 ml single for immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient could not move her arm after receiving the vaccine. The outcome was unknown.
This spontaneous case was reported by a pharmacist and describes the occurrence of INJECTION SITE REACTION (Injection site reaction), PARAESTHESIA (Arm is tingling from the injection site to the elbow), HYPOAESTHESIA (Arm is numb), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (A little bit of swelling) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced INJECTION SITE REACTION (Injection site reaction), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (A little bit of swelling). On 13-May-2021, the patient experienced PARAESTHESIA (Arm is tingling from the injection site to the elbow) and HYPOAESTHESIA (Arm is numb). At the time of the report, INJECTION SITE REACTION (Injection site reaction), PARAESTHESIA (Arm is tingling from the injection site to the elbow), HYPOAESTHESIA (Arm is numb), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (A little bit of swelling) was resolving. 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.
Existing facial dermal filler (restylane) became inflamed and sensitive. Swelling lasted throughout the day and had mostly resolved by the same evening with ibuprofen, while still tender to the touch. No medical attention was sought as I determined it was a non-emergency.
Dizziness, Myalgia, Fever & ErythemaMultiform Narrative:
About 6 hours after shot, began having chills. Chills lasted 12 plus hours. Fever followed chills. Couldn?t get warm enough but fever was high. Mouth thermometer indicated  fever of 101.5* for several hours (24 plus); non oral thermometer indicate parts of body were 105.0*. Despite chills.  Terrible headache  and aches so bad I couldn?t sleep.  Finally took some Advil PM so I could finally sleep.  Next day,  still have fever, aches, and headache.
4 days p/vax pt 15 sec fine rhythmic shaking event upon onset of sleep; repeated 2 or 3 other briefer episodes 1 wk later;
Redness is getting worse; Feel feverish; This case was reported by a consumer via call center representative and described the occurrence of erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2020, the patient received the 2nd dose of Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced erythema and feeling hot. On an unknown date, the outcome of the erythema was not recovered/not resolved and the outcome of the feeling hot was unknown.   It was unknown if the reporter considered the erythema and feeling hot to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient himself or herself. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient made an inquiry about how long do the side effects last after vaccination with Shingrix. The patient reported that redness was getting worse and he or she also felt feverish.
Patient attending immunization clinic at Public Health Department to catch up on school required vaccinations. Patient had received two vaccines listed above, when administering nurse realized patient also needed a polio vaccine. She stopped administering vaccines to draw up polio vaccine, and at that time the patient's aunt called out to patient. Nurse looked at patient, who had turned pale and appeared to be starting to pass out. Nurse assisted patient's aunt and mother in  holding patient in chair, when patient began to have seizure like episode including both arms shooting out and up and in front of patient. Patient then relaxed, but almost immediately went into second episode of seizure like activity. Nurse called for help from other nurse in clinic, patient was moved to the floor, 911 was called. Patient recovered from both seizure like episodes, but continued to look pale and state she felt bad.  No loss of consciousness after being moved  to floor. Blood pressure remained stable,  breathes even and unlabored.  Patient and family Spanish speaking. Spanish speaking staff member translated for nurses. Patient history to include epilepsy. Last seizure two years ago. Was on seizure medications when living in another country (mother didnt know exact name but had magnesium in it), but moved from another country and last had medications about six months ago. Hasn't seen a doctor since moving here as she did not have insurance and hadnt had any seizures or other health issues. Patient transported by ambulance to local hospital. Outcome unknown.
Bad headache, chills, nausea, loose stools, achy Injection site itchy and hard
States Wednesday started experiencing dull headache that became progressively worse. Thursday experiencing dull headache, blurred vision, nausea, and dizziness. Presented to clinic on Friday 03/06/2020-states still has dull headache on top of head.
10/09/2021- 8 hours post vaccine- initially fever joint pain and muscle aches and then turned into confusion and hallucinations. And also chest pain. Most of these symptoms lasted for a few days, but the chest pains have still continued as well as the confusion, off and on. I did see a doctor regarding these symptoms; no outcome or treatments given.  I have a cardiologist appointment in a couple of weeks.
8 days after first dose. Low grade fever. Red inflamed arm. Slight itchiness. Still red and inflamed days 9, 10 and 11.
Initial misuse report received from a healthcare professional on 16 January 2014. The cases were received at agency on 21 March 2014. It was reported that 15-year-old patient had received FLUZONE ID inadvertently. The patient experienced 3-4cm of erythema. List of documents held by sender: none.
Information has been received from a 50 yr old male pt with penicillin allergy and allergies to some antibiotics and no relevant medical history who at the end of Oct 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot unk). Concomitant suspect therapy administered on the same day included an unspecified tuberculosis test (manf unk). Additional concomitant suspect therapy included "meklazine" (meclizine) (dates, dose and indication not reported). The consumer reported that he began to feel feverish, nauseated, drained of energy and weird on the inside right after pneumococcal 23v polysaccharide vaccine was administered. The consumer also stated that he believes that he may be having an allergic reaction with the polysaccharide content. No outcome was reported. There was no product quality complaint involved. Additional information is not expected.
Change of taste and smell of certain foods and flavors to include most meats and other various foods.
Information has been received from a registered nurse regarding an unspecified number of patients of unknown age and genders. For up to three years, approximately in 2010, temperature recordings of up to -3 for ZOSTAVAX have not been assessed. Unspecified doses of ZOSTAVAX have been administered to unspecified patients. At the time of this report, the nurse does not known the patient identifiers and she does not have the specific details to provide. She was attempting to organize the lot numbers, the dates of excursions, the length of time and the temperature out of range, and the dates of administration with patient identifiers. She will collate her data and send it. She would like to know if revaccination is appropriate. No adverse experience has been reported at this time. This is one of several reports from the same source (MARRS # 1312USA001395). Additional information has been requested.
Any time she has to pee, she has something brown/ small spots when she pees/ she can see on the water brown spots/ anytime she goes to pee she sees something like brown/ brown blood; Pain in her left arm where she took the shot; symptom of menstrual cycle changes/ she was in the middle of her cycle and her period didn't have to come in 15 days; This is a spontaneous report received from a contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Jul2021 (at the age of 27-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient received her first dose the day before the present report (29Jul2021) then she had pain on left arm where she received the shot. Caller (patient) was currently in the middle of her menstrual cycle, she said that any time she had to pee, she had something brown as if the menstrual cycle is beginning or ending. Caller wanted to know if side effect was normal. She said that she found that pain on left arm is regular side effect of the vaccine. She thought that her symptom of menstrual cycle changes may be a side effect, but she couldn't find it on google and that this never happened to her. She added that it was not like bleeding bleeding (as reported) and that she saw small spots when she pees. Reiterated that she was in the middle of her cycle and her period didn't have to come in 15 days. Every time she went to pee, she could see on the water brown spots. She was concerned about what she was experiencing. She thought it was related to the vaccine and she got the first shot the day before the present report (29Jul2021) and she had a pain in her left arm where she took the shot. She had been having not like menstrual bleeding, she was in the middle of her cycle but since the day before the present report (29Jul2021) anytime she went to pee she saw something like brown. As if it was her menstrual cycle in the beginning or finishing, brown blood. She didn't know if this is a side effect because it never happened to her. She did do research on google and she hadn't seen anything. It hadn't happened to her before. The outcome of the events was unknown.
Pt. given MMRV, Hep A, PREVNAR today which was given 2/10/11 was not in pt's electronic chart shot record was not avail to nurse at time of shot. Also given HIB & DTaP which pt was due to receive.
p/vax pt woke up around 9AM c/o feeling tired;nauseated, aching, T99.8 PO; to MD;lab work done;pt seen by hematologist who feels not vax related;
Information has been received from a nurse and physician concerning a female patient who on approximately 19-JUL-2010 ("last week sometime"), was vaccinated with a single 0.65 ml dose of ZOSTAVAX (Merck). Subsequently, the patient experienced a localized reaction, swelling around the injection site. The patient was given prednisone. On an unknown date, the patient recovered. The patient sought unspecified medical attention. Additional information has been requested.
Moderna booster administered early. Moderna series started 5/20/2021 and completed 6/17/2021.
Patient experienced neurologic adverse events, including numbness/loss of feeling in hands/legs, stiff neck and back pain, difficulty breathing
RIGHT SIDE FACE SWOLLEN, NUMB AND PARALYZED. BLURRY VISION ON RIGHT SIDE ONLY. SEVERE HEADACHE.
Patient experienced dizziness, sweating, and nausea in the 15 minutes following vaccination. Patient was taken to the emergency department, all vital signs were normal, no symptoms of anaphylaxis. Patient stayed in emergency department for further monitoring
Red Rash covering 5 inch Diameter Area Around injection site, Raised Lump At injection Site.
This spontaneous report was received from a physician via a Company representative concerning to an unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On 19-JAN-2016, the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB lot # K020336 (dose, route and the expiration date were not reported). The total cumulative hours out of range were 24 hours with 34 degrees C as the lowest recorded temperature and the storage type was a refrigerator. There was no concomitant medication provided nor no Product Quality Complaint(PQC) involved. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Pt c/o itching of the skin of the arms, legs and trunk. Wheel like lesions on thighs. Tx: DEPO MEDROL 80 mg.
9/19/2008 4:50 pm. Right thigh has an erythema and that measures 45x40 mm. There is a hard one that measures 11 mm.
Initial unsolicited report received from a patient (consumer) on 18-Oct-2017. This case involves a 68-year-old male patient, who was vaccinated once with FLUZONE HIGH-DOSE via intramuscular route (batch number: UI691AA, expiry date: Apr-2017; dose not reported) in left arm on 24-Oct-2016. Patient's medical history was not reported. Concomitant medications were not reported. Patient denied receiving any other vaccinations at the time. On an unknown date, following the vaccination, the patient developed myocarditis and A-fib that required hospitalization on 06-Dec-2016. Multiple diagnostic tests were performed. As part of corrective treatment patient took ELOQUIS and SOTALOL. On an unknown date, patient recovered from the events fully and discharged from hospital on 09-Dec-2016. Documents held by sender: none. Sender's Comments: The patient experienced events myocarditis and atrial fibrillation post vaccination with FLUZONE HIGH-DOSE. Time to onset is too long with the role of the vaccine. Myocarditis which may suggest a possible underlying cardiac condition hence needed investigation results ruling out a concurrent infection, past medical history, any cardiac disorder and other etiologies would be helpful to further assess this case.
Complains of feeling very emotional, could cry easily.  Also having thought/speech impairments, not profound, begins to say something and words comes out differently
Pt got vaccine 11/17, evening 11/18 went to ER with blood pressure 210/90+, pulse 100+, violent shaking. Treated for BP & sent home. 11/19 to ER again with same symptoms & vomiting & fever - ER suspected influenza infection.