chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain in the left arm where vaccine was injected; This is a spontaneous report from a contactable consumer. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Apr2021 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was unknown, whether the patient received any other vaccines within four weeks prior to the vaccination. On 12Apr2021, the patient experienced pain in the left arm where vaccine was injected. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event pain in the left arm where vaccine was injected was unknown at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Administer a vaccine  that expired on the 29-Apr-2022 to less than 5 patients; Dose 1 on 16-Nov-2021 and dose 2 on 06-May-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer a vaccine  that expired on the 29-Apr-2022 to less than 5 patients) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 16-Nov-2021 and dose 2 on 06-May-2022) in a 73-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 042J21A and 012F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Nov-2021 at 1:18 PM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 06-May-2022 at 10:39 AM, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to .5 milliliter. On 06-May-2022 at 10:39 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer a vaccine  that expired on the 29-Apr-2022 to less than 5 patients) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 16-Nov-2021 and dose 2 on 06-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer a vaccine  that expired on the 29-Apr-2022 to less than 5 patients) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 16-Nov-2021 and dose 2 on 06-May-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that on unknown date the vail was initially stored in refrigerator. The vial did not undergo any temperature excursion. No treatment medications were provided.   This case was linked to MOD-2022-573908 (Patient Link).
had diagnosed COVID; had diagnosed COVID; Hair loss; This is a spontaneous report from contactable consumer received via Pfizer sales representative.   An elderly female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single and via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. It was reported that, the patient experienced hair loss after having had diagnosed COVID and two doses of vaccine. The patient underwent lab tests and procedures which included COVID-19 test: unknown, COVID-19 test: positive on an unknown date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient developed cellulitis at the site of the varicella booster was administered (Right upper arm, given sub-Q)
has trouble getting up; phlegm/infection in the chest; phlegm/infection in the chest; first one leaked; Two doses of vaccine on same day; Feeling achy; tired; throat irritation; back pain; neck pain; headache; shingles; Pain from second shot; This spontaneous case was reported by a consumer and describes the occurrence of LOWER RESPIRATORY TRACT INFECTION (phlegm/infection in the chest) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 26-Feb-2021, the patient experienced SYRINGE ISSUE (first one leaked), INCORRECT DOSE ADMINISTERED (Two doses of vaccine on same day), PAIN (Feeling achy), FATIGUE (tired), THROAT IRRITATION (throat irritation), BACK PAIN (back pain), NECK PAIN (neck pain), HEADACHE (headache), HERPES ZOSTER (shingles) and VACCINATION SITE PAIN (Pain from second shot). On an unknown date, the patient experienced LOWER RESPIRATORY TRACT INFECTION (phlegm/infection in the chest) (seriousness criterion medically significant), ILL-DEFINED DISORDER (has trouble getting up) and PRODUCTIVE COUGH (phlegm/infection in the chest). At the time of the report, LOWER RESPIRATORY TRACT INFECTION (phlegm/infection in the chest), PAIN (Feeling achy), FATIGUE (tired), THROAT IRRITATION (throat irritation), BACK PAIN (back pain), NECK PAIN (neck pain), HEADACHE (headache), HERPES ZOSTER (shingles), ILL-DEFINED DISORDER (has trouble getting up), PRODUCTIVE COUGH (phlegm/infection in the chest) and VACCINATION SITE PAIN (Pain from second shot) outcome was unknown and SYRINGE ISSUE (first one leaked) and INCORRECT DOSE ADMINISTERED (Two doses of vaccine on same day) had resolved.            The patient provided a lot number 025A21A but did not specify as to which dose it is for. Treatments of this events include taking Prednisone.   Most recent FOLLOW-UP information incorporated above includes: On 12-Mar-2021: No specific follow-up information recorded.; Reporter's Comments: This report refers to a case of syringe issue and inappropriate dose administered for mRNA-1273, lot # unknown with associated AEs vaccination site pain, fatigue and ache/pain..
Fever up to 103.2F and vomiting since hours after shots were given until 1 1/2 day after.
numbness and tingling in extremeties, still experiencing every once in a while, more prevalent in the first six weeks after the shot muscle pain in various areas, still today have muscle pains involuntary arm and legs jumping, also more prevalent after shot
Patient identified "NO" to having had reaction to vax. Syncopal episode x 60 seconds. 911 called ~ 1033 & arrive 1044. Repeat syncopal episode x 30 seconds 1055. EMS staff assessed VS x 2. discharged to auto by EMS 1110.  Patient reported after her syncopal episode that she had passed out from a venipuncture earlier this year while in the clinic. Advised to not receive vax in a retail setting for future - only in a clinic.   Patient refused transport to ER & signed off with EMS.
Combined initial and follow-up report received on 29 Oct 2010 and 08 Nov 2010: This patient was trying to draw up and administer MENVEO on 29 Oct 2010. Some of vaccine accidentally squirted in her eye while trying to draw it up. The eye was burning. Eye wash flushing was given. Pain subsided in 45 minutes. No further treatment was given.
This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives), PRURITUS (Itching) and SWELLING (Swelling) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives), PRURITUS (Itching) and SWELLING (Swelling). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives), PRURITUS (Itching) and SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication include prednisone Concomitant product use was unknown by the reporter
Dull headache for three days Sudden onset of fever like symptoms - facial flushing for three hours  Fatigue
Fever as high as 103.5.  Chilling and dizziness.  Last about 12 hours.
Within  5 min of admin of 2nd dose of Moderna it was noted it was given at a 2wk interval of 1st dose. Charge nurse was noted immediately pt was which and CDC was contacted immediately for recommendation.
Pain in shoulder, decreased flexibility due to pain. MRI shows slight tear in rotator cuff and bursitis.
A pediatrician reported that an 18 month old female received her fourth injection of Prevnar on 8/6/02 and developed a fever and an injection site reaction characterized by *redness and swelling 2.5 hrs post vax.* The reporter stated that the fever persisted for 2 days, and, the leg that was injected swelled to two times the size of the child's other leg, was non-tender, and had a bluish hue within 2 days. The child reportedly refused to walk for 2 days, then started walking again. *She recovered. No further info was available at the date of this report.*
VARIVAX administered after temperature excursion; This spontaneous report was received from a nursing assistant, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.   On 13-AUG-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, vaccination scheme frequency, route of administration, and anatomical site of vaccination were not reported; lot number T002846 has been verified to be valid, expiration date reported and validated as 23-JAN-2022) as prophylaxis (product storage error).  The administered dose of the vaccine experienced a temperature excursion of -10.2 degrees Celsius (C) for 1 hour and 53 minutes, as recorded by a data logger. There was no previous temperature excursion reported.  This was one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA015018: US-009507513-2008USA014901: US-009507513-2008USA014937: US-009507513-2008USA014697: US-009507513-2008USA014767: US-009507513-2009USA000113: US-009507513-2008USA014757: US-009507513-2008USA014825: US-009507513-2008USA014888: US-009507513-2008USA014806: US-009507513-2008USA014798: US-009507513-2009USA000117: US-009507513-2008USA014803: US-009507513-2008USA015035: US-009507513-2008USA014820: US-009507513-2008USA014705: US-009507513-2008USA014950: US-009507513-2008USA014936: US-009507513-2008USA014871: US-009507513-2009USA000112: US-009507513-2008USA014869:
pt recv vax-7 small red bump-md dx w/chickenpox 13 days post vax;
Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 1805031) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) was resolving. Not Provided      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 reported. no treatment medications reported.
Ischemic stroke; not hypertensive, but supposedly is now.; Visual disturbances; Headache; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EM9810, expiry: unknown), via an unspecified route of administration in the left deltoid on 01Feb2021 14:15 at a single dose for covid-19 immunization at a Physician office. Medical history included asthma, irritable bowel syndrome, pneumonia and borderline high cholesterol. The patient's concomitant medications were not reported. The patient had no prior vaccinations within 4 weeks. The patient had her first COVID-19 vaccine on 01Feb2021 and second one is due on 22Feb2021. On 03Feb2021, the patient had a headache, but didn't think too much because it is a side effect. The headache lasted all through the weekend. Visual disturbances began 04Feb2021. She called her doctor on Monday and was seen by her doctor on Tuesday, 09Feb2021. The patient was referred to the eye center. Her headache was getting a little better. On 10Feb2021, the patient was seen at an institution, her retina and macula looked good, so she was referred to the ED. The patient was told she probably had a stroke. The patient was admitted to the hospital for an ischemic stroke. By looking at the MRI, the onset of the ischemic stroke would have been five to seven days prior, placing the onset on Wednesday, 03Feb2021, which was also the onset of her headache. There is no definitive cause of her ischemic stroke. The patient currently has an arrhythmia monitor on. MRI/MRA showed her vessels looked good. MRI showed evidence of the ischemic stroke. The patient has neurologists since being admitted to the hospital. It was thought that the headache was just because of the COVID-19 Vaccine. Causality was unknown, it was stated that they haven't found anything else as a cause. The patient's doctor stated she was borderline for high cholesterol. She was not hypertensive, but supposedly is now. The patient also had echocardiogram, EKG, manual neuro checks, and blood work but does not have the results. The outcome of the events was unknown. The has trouble reading now since the stroke.; Sender's Comments: Based on available information, the reported events are assessed as unrelated to the vaccine BNT162B2 and can be explained as intercurrent or underlying medical conditions in this elderly patient with excessive weight (BMI=29) and underlying elevated cholesterol. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sore right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore right arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis. Concomitant products included MONTELUKAST and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore right arm). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Pain, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE PAIN (Sore right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The other relevant concomitant medication was reported as injection for osteoporosis, twice a year.
Moderna COVID-19 Vaccine EUA arm discomfort day 2-4, painful axillary lymphadenopathy day 10-12
Hospitalized 4/27/22-4/30/22 Decreased appetite, sore throat, hypotensive, weakness, oral thrush, anemic, chill, weight loss >50lbs, hypoxia, GI bleed, fever, PNA, tachypnea, sepsis,
After having vaccinated the minor, the mother reports that she believes that she is allergic to eggs, since her other son is allergic to eggs. She also says that she believes that the minor is allergic because he gave it to her to eat and it made her want to vomit. Based on what mom specified, the next day we called to verify that patient had not presented any significant event that requires our attention, such as skin rashes and respiratory distress, which patient did not present. This report is sent is for corresponding action.
Patient developed chest pain 5 says after his second Pfizer vaccination. He was admitted to Hospital and diagnosed with myopericarditis. Has ongoing shortness of breath and chest pain currently. He was put on Colchicine, Ibuprofen, and Pepcid and advised to begin light walking daily.
Left arm swelled up to twice the size it should have been. Horrid itching, major headache and acute severe pain.
MR vax given 10MAY93 PM pt states devel tenderness @ inject site; 12MAY93 noc p/returning from beach pt had a progression of redness, pain, swelling, & fever in lt arm; c/o h/a, nausea, t101; dx infected inject site
patient received a total of 4 dose of GARDASIL 9; the patient received a total of 4 doses of Gardasil 9; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, concurrent condition and drug reactions/allergies were not provided.  On 15-NOV-2011, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose detail, strength, route, lot# and expiration date were not provided) for prophylaxis. On 10-FEB-2014 and 31-AUG-2014, the patient was respectively vaccinated with the second and the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose detail, strength, route, lot# and expiration date were not provided) (inappropriate schedule of product administration). On 24-JUL-2020, the patient received the forth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# 1637642, expiration date 28-MAY-2020; dose detail, strength and route were not provided) (extra dose administered). combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; manufactureraddress: ; manufacturercity: ; manufacturerstate: ; manufacturercountry: ; devicelotnumber: 1637642; expirationdate: 28-MAY-2022; 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
Few hours after vaccination, had multiple episodes of vomiting (12 to 15) which lasted for over few hours. Was re-examined in the office same day.
Case number PHEH2014US003826 is an initial spontaneous report from a pharmacist received on 21 FEB 2014 with a follow up report received from a health care professional on 19 MAR 2014. This report refers to a 12 year old male patient. His past medical history and concomitant medications were not reported. He was inadvertently vaccinated with FLUCELVAX (batch number 0041211A) at a dose of 0.5 ml intramuscularly into his right deltoid on 04 JAN 2014 at 16:15 hours. It was reported that he did not experience any adverse reactions since the maladministration (inappropriate age at vaccine administration).   Follow up report received from a health care professional on 19 MAR 2014: Reporter information , date of vaccination, dose and anatomical location of the vaccination were updated.   Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 19 MAR 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "Adult product administered to child".
Right arm with redness, very firm, hot 3 cm nodule over right deltoid, started on 6/26/08 but increased discomfort on 6/30/08
Has arthralgias/weakness with evidence of joint swelling in hand. Arthralgias included neck/shoulder/arms/hands.
No Adverse reactions. Pt was given Pfizer Bivalent instead of Pfizer Primar Dose.
No additional AE; GARDASIL 9 that were improperly stored and inadvertently administered; This spontaneous report was received from a nurse and refers to a 13-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 26-JUN-2023, the patient was vaccinated with improperly stored (Product storage error) dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, formulation, lot #, expiration date, site and route of administration were not provided) for prophylaxis. Temperature excursion details: above 47 degrees Fahrenheit (48.6 degrees Fahrenheit) for 16 hours 30 minutes; below 36 degrees Fahrenheit (28.0 degrees Fahrenheit) for 22 hours; cumulative: 38 hours 30 minutes; no previous temperature excursion. No additional adverse event reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2307USA008888:
Pt became ill about 11PM on the day DTP/OPV/MMR recvd; t101 w/nausea, vomiting & muscular tremors; Was fine next day;
Redness and swelling of right thigh down to right knee occurred on the next morning after vaccination. No other associated symptoms.
injection site pain, lymphadenopathy Narrative:  12/18 received the vaccine.  12/19 injection site and upper arm pain. 12/20 onset of supraclavicular lymphadenopathy. Still present 12/28. Nodes are palpable, mobile, and non-tender.
ear is still blocked; ear aches; ear aches and is numb; no hearing in my left ear; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: unknown), via an unspecified route of administration in the left arm on 25Feb2021 at 17:00 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history was none. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. The patient did not receive any other vaccinations within 4 weeks of the vaccine. On 27Feb2021 at 07:00, the patient woke up with no hearing in the left ear. Some hearing had come back but the ear was still blocked as of an unspecified date. The ear ached and was numb as of an unspecified date. The patient visited the ear nose and throat (ENT) doctor and was treated with steroids, twice, for the events. The patient was scheduled for an MRI. The patient reported that she was perfectly fine with no problems prior to the vaccine. Since the vaccination, the patient was not tested for COVID-19. The clinical outcome of "no hearing in my left ear", "ear is still blocked", "ear aches and is numb" was not resolved.  Information on the lot/batch number has been requested.