chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; This spontaneous case was reported by a non-health professional and describes the occurrence of HEADACHE (headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
No adverse events were reported.; received one improperly stored dose of PNEUMOVAX 23 on an unspecified date.; This spontaneous report has been received from a pharmacist referring to three unspecified patients without identifiers. The patients' historical condition, concomitant medications and drug reactions or allergies were not reported.  On an unknown date, the patients were vaccinated with improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # R018732, expiration date: 27-FEB-2020, dose, frequency, route were not reported) for prophylaxis (Product storage error). The administered doses experienced a temperature excursion at lowest temperature below 36-degree Fahrenheit (32F) for 6 hours. Previous excursions were unknown by reporter. The temperature excursions were not detected by a data logger. No adverse events were reported.  Follow up information has been received on 09-MAR-2020.  The call was answered by Pharmacy Technician, who transferred the call to the pharmacist. While speaking with the pharmacist, patient identifiers were requested for the 3 patients who received pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) that had undergone a temperature excursion.  The call was placed on hold by the pharmacist and then the Pharmacy Technician, came back on the phone stating the pharmacist wanted the fax number so that she could send the requested information.  Follow up information has been received on 11-MAR-2020, where the pharmacist reported the 2 lot numbers of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) that had undergone temperature excursion, patient identifiers and administration dates for 19 patients who received the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccines.    The pharmacist reported (1 of 19) an 85-year-old male patient. The patient's pertinent medical history, concurrent conditions and concomitant therapies were unknown by the reporter.       On 11-SEP-2019, the patient was vaccinated with an improperly stored dose (product storage error) of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route and frequency were not reported) lot # R018732, the expiration date: 27-FEB-2020 for prophylaxis.  This is one of several reports received from the same reporter. Marrs# 2003USA005392, 2003USA005393, 2003USA005394, 2003USA005395, 2003USA005396, 2003USA005397, 2003USA005398, 2003USA005399, 2003USA005400, 2003USA005401, 2003USA005402, 2003USA005403, 2003USA005404, 2003USA005405, 2003USA005406, 2003USA005407, 2003USA005408 and 2003USA005409.; Sender's Comments:  US-009507513-2003USA005392: US-009507513-2003USA005393: US-009507513-2003USA005394: US-009507513-2003USA005395: US-009507513-2003USA005396: US-009507513-2003USA005397: US-009507513-2003USA005398: US-009507513-2003USA005399: US-009507513-2003USA005400: US-009507513-2003USA005401: US-009507513-2003USA005402: US-009507513-2003USA005403: US-009507513-2003USA005404: US-009507513-2003USA005405: US-009507513-2003USA005406: US-009507513-2003USA005407: US-009507513-2003USA005408: US-009507513-2003USA005409:
Large, growing red, itchy, raised area around injection site that came up on the second day and has been growing each day and becoming more red and inflamed. It is the 8th day and it is now 3-4 inches across in diameter.
Patient came in for a second COVID vaccine. He did not have his vaccination card but reported that he had received Moderna for his first vaccination. He was given a second vaccination of Moderna. After a while, the patient came back and said that he had actually gotten Pfizer for the first dose.
About 24 hours after the administration of the vaccine, patient developed a rash that was warm to the touch on left deltoid, below the injection site. The rash spanned all the way down to just above the elbow. It did not span the circumference of the arm, it only appeared on the outside of the deltoid, below the injection site. The patient did not experience any hives or itching. As of the week of 10/8/17  the rash was starting to disappear.
Vaccine site sore then along with soreness, turned red/itchy.  After over a week I have a red (almost looks sunburnt), warm area on my arm.
12/1/10 HPV - really bad headache x 4 days starting the day of the vaccine went to school, took TYLENOL later developed EBV mono approximately 1/1/11.
10MINS AFTER THE VACCINATION  LEFT SIDED FACIAL NUMBNESS . HIGH B/P 172/112 O2 SAT 98% HR 72, RR18. ANXIETY. SMILE  SYMETRICAL PROTRUDING TOUNG CENTERED. @10:45AM B/P 153/93 @10:58 AM  B/P 146/89 @11:15AM EMERGENCY SERVICES WERE OFFERED SEVERAL TIMES  BY RPH ( PATIENT REFUSED) . PCP WAS NOTIFIED BY FNP - B C . MEDICAL DIRECTOR DR SPOKE TO PATIENT OVER THE PHONE DIRECTLY.  NO PARLYSIS  WAS DETERMINED. PATIENT COULD FEEL A PINCH IN THE AFFECTED AREA. PATIENT STATED THE REACTION ABATED BEFORE THE END OF THE CLINIC @12:30PM
Eighteen hours post vax, this four-year-old woke in night with a fever of 104, ill appearing and refusing to walk.
diarrhea first three days; headache; fatigue; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea first three days), HEADACHE (headache), FATIGUE (fatigue) and ARTHRALGIA (joint pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included OMEPRAZOLE for an unknown indication.    On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced HEADACHE (headache), FATIGUE (fatigue) and ARTHRALGIA (joint pain). On 01-Aug-2021, the patient experienced DIARRHOEA (diarrhea first three days). At the time of the report, DIARRHOEA (diarrhea first three days) had resolved, HEADACHE (headache) and FATIGUE (fatigue) had not resolved and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
colds; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), described as "colds".  Additional Information: Patient was due to get the 2nd dose of the vaccine tomorrow which was  06May2021 and she was currently experiencing colds. Patient wanted to know if it was safe to proceed in getting the second dose of the vaccine. Call got disconnected while confirming the date of the 1st dose so call was not transferred. Created Manual AE Form.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The vial did not undergo any temperature excursions. The patient did not experience any other adverse reactions. The nurse said that when the lot number of Moderna Covid-19 vaccine of 010A21A was entered into the expiration date lot number look up finder the expiration date was 14-Aug-2021. The nurse said that she had a screenshot of the above lot number 010A21A entered into the lot number expiration date check program that shows the expiration date as 14-Oct-2022.  No treatment information was provided.
Pt. received H1N1 shot on 11/15/09 - on 11/20/09, his mother phoned stating pt. had behavioral changes such as indecisiveness, sullen, violent outburst. These emotions are up and down.
live in (Name) had symptoms and tested positive on 15Feb2022, he had not symptoms but tested Ag positive on 16Feb2022 prior to work; live in (Name) had symptoms and tested positive on 15Feb2022, he had not symptoms but tested Ag positive on 16Feb2022 prior to work; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 33 year-old male patient received bnt162b2 (BNT162B2), administration date 19Oct2021 (Lot number: FF2589) at the age of 32 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Previous dose details , Prev dose product=COVID 19, Prev dose brand=Pfizer, Prev dose brand unknown=False, Prev dose lot number= EL3247, Prev dose lot unknown=False, Prev dose administration date= 23Feb2021, Prev dose dose number=2), administration date: 23Feb2021, when the patient was 32 years old, for Covid-19 Immunization; Bnt162b2 (Previous dose details , Prev dose product=COVID 19, Prev dose brand=Pfizer, Prev dose brand unknown=False, Prev dose lot number= EL3247, Prev dose lot unknown=False, Prev dose administration date= 03Feb2021, Prev dose dose number=1), administration date: 03Feb2021, when the patient was 32 years old, for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), ASYMPTOMATIC COVID-19 (medically significant) all with onset 16Feb2022, outcome "unknown" and all described as "live in (Name) had symptoms and tested positive on 15Feb2022, he had not symptoms but tested Ag positive on 16Feb2022 prior to work". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Feb2022) positive, notes: Other. It was unknown if therapeutic measures were taken as a result of drug ineffective, asymptomatic covid-19. COVID -19 prior vaccination was unknown reported.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available.
SOME BODY ACHES; FEVER 100; 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. The patient's pre-existing medical conditions included the patient had no known allergies and unknown drug abuse or illicit drug usage. Patient never had covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced some body aches, and fever 100. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever 100, and some body aches. This report was non-serious. This report was associated with product quality complaint: 90000185398
Patient developed swelling, redness, and pain from injection site down to elbow and wrapping around arm. Patient saw physician, was diagnosed with an infection and given an oral antibiotic.
Approximately 10 minutes after being vaccinated with Moderna vaccine for his 2nd dose, the patient said his throat was closing up a little and itching and he felt nauseous. The patient was told to sit down and wait for 20 minutes after administration. The patient was walking around the pharmacy and talking. The covid ambassador reinteriated to the patient to sit back down. A few minutes after sitting down, he admitted he should have listened and proceeded to tell the pharmacist of his symptoms. The pharmacist clarified if his throat was closing up or was it itchy. The patient said it was a little itchy and a little difficult to breathe. The pharmacist gave the patient 25mg of liquid benadryl. The pharmacist continued to monitor the patient. The patient said he felt chills in his hands a few minutes later but he was no longer feeling nauseous. The patient did not claim to have any allergies on his form or any previous allergies he was aware of. The pharmacist followed up with the patient 5 minutes after his claim of chills. He said he can breathe better but still had the chills. The patient sat in the chair for approximately one hour while the pharmacist monitored him. He called a relative to come pick him up. He told the pharmacist his ride was there and he felt much better before leaving. The pharmacist told him to rest and monitor his symptoms. If the symptoms came back or got worse he needs to call 911 or go to the emergency room.
site of injection is red and at times warm to touch.  Started at small 25cent,  has grown to 50 cent red circle
Fever / temperature was 100.0°F; nauseated; just a head ache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever / temperature was 100.0°F), HEADACHE (just a head ache) and NAUSEA (nauseated) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced HEADACHE (just a head ache). On 12-Mar-2021, the patient experienced PYREXIA (Fever / temperature was 100.0°F) and NAUSEA (nauseated). At the time of the report, PYREXIA (Fever / temperature was 100.0°F), HEADACHE (just a head ache) and NAUSEA (nauseated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided by the reporter.
BNT162B2 Dose 1: 13Mar2021 and Dose 2: 31Jul2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 31Jul2021 as dose 2, single (Lot number: ER8733, Expiration Date: 31Jul2021) at the age of 61 years, in arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EN6208, Expiration date: 30Jun2021, Anatomical location: Arm), administration date: 13Mar2021, when the patient was 61-year-old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 31Jul2021, outcome "unknown", described as "BNT162B2 Dose 1: 13Mar2021 and Dose 2: 31Jul2021".  Additional information: Concomitant drug was reported as Eliquis.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201235979 same patient, different drug, different event;
An incorrect dose of Pfizer COVID-19 vaccine was administered to this patient, and three others. (A total of 4 patients were affected by this vial/reconstitution error.)  A pediatric 5-11yr vial was used in error.  MA was intending to draw up infant vaccine doses. Ped (5-11yr) vial was reconstituted with 2.2mL of diluent. (The amount used to reconstitute infant vials)  This resulted in 10 syringes being drawn up of an incorrect dose of 6.9mcg/0.2mL dose.  The syringes were then labeled with light blue infant labels and placed back into the refrigerator in the location of the peds (5-11yr) vials, where the vial was pulled from.  The lot information for the vial used (Ped 5-11yr) was recorded on those stickers. A in incorrect dose was then administered to this patient.
several weeks to month post vaccine began have significant low back pain spanning whole low back. Continuous for several weeks and then intermediate ever since.
This spontaneous report as received from an office manager refers to a patient of unknown age and gender. On 04-NOV-2014, the patient was vaccinated with M-M-R II (route, dose and lot # were not reported) which underwent a temperature excursion (on an unspecified date). This is one of several reports received from the same reporter. Additional information has been requested.
cold chills; hot flashes; body aches; runny nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose), for Covid-19 immunization. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "cold chills"; HOT FLUSH (non-serious), outcome "unknown", described as "hot flashes"; PAIN (non-serious), outcome "unknown", described as "body aches"; RHINORRHOEA (non-serious), outcome "unknown", described as "runny nose".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a healthcare professional and described the occurrence of therapy non-responder in an unspecified number of adult subjects of unspecified gender who was vaccinated with ENGERIX B (GlaxoSmithKline). From 01 January 2009 to 01 June 2009, an unspecified number of a group of approximately 32 adult subjects received an unspecified pediatric dose of ENGERIX B (.5 ml, unknown) (Please see case A0931532A for the report of vaccine underdose). On 01 June 2009, the mistake was discovered. Some subjects had seroconversion (therapy non-responder-for the subjects that did not seroconvert). All subjects received ENGERIX B on the correct schedule.
Fever lasting 8 hours straight, resolved for 4 hours, returned for 2,  chills with fever, severe muscle aches for 24 hours, headache for 24 hours, N/V with headache.
COVID-19; Interchange of vaccine products; revaccination with different COVID-19 vaccine; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (revaccination with different COVID-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) 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, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (revaccination with different COVID-19 vaccine). At the time of the report, COVID-19 (COVID-19), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (revaccination with different COVID-19 vaccine) outcome was unknown.            No concomitant medications was reported. No treatment medications was 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.  Company Comment: This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, after receiving a dose of mRNA-1273 vaccine. Exact date of vaccinations, onset date of the event (had COVID 2 times), clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. Revaccination with different COVID-19 vaccine and Interchange of vaccine products were also reported as the patient received other COVID-19 vaccine (Pfizer as booster dose). The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, after receiving a dose of mRNA-1273 vaccine. Exact date of vaccinations, onset date of the event (had COVID 2 times), clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. Revaccination with different COVID-19 vaccine and Interchange of vaccine products were also reported as the patient received other COVID-19 vaccine (Pfizer as booster dose). The benefit-risk relationship of mRNA-1273 is not affected by this report.
Muscle is tight, area where vaccine was administered is red and hot. The red area is a large circle about 2 1/2 inches in diameter and a solid red color.
Vomiting, dizziness, weak and couldn't stand up straight. She stated she vomited so much she was dry heaving. She also burp alot.
Lt arm deltoid area extremely edematous, reddened, warm to touch.  Redness/edema measure 18 cm x 12 cm.