chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shortly after my shot, my left breast started to enlarge as if infected, so I made a doctor appointment for July 8th.  I was referred to an ultrasound, then biopsy which turned out positive for inflammatory breast cancer.  A mammography in March of 2021 was clear.  I have started chemotherapy and will need surgery and radiation then reconstructive surgery
Hive around injection site on 8th day after shot.  It began as itchy and small and over the course of the weekend into today, Monday, and  has evolved to raised, warm, hurts at points  to about 3x3 wide.  It is localized to the injection arm.
Client was given adult dose of Hep A and Hep B vaccine; Client should have received pediatric dose.
1330 recevied pfizer covid vaccine, lot # EW0153 right deltoid 1345 walked to tent, due to lightheadedness,  anxiety, feels itchy at throat, VSS 1352 scratchy throat, rash at throat, ENT clear , HR RR,lungs clear A&P 1355 worsening symptoms , clearing throatt, sob,  wheals on neck,  epinephrine 1:1000 0.5ml IM given , 02 10 L via mask, 1402 throat symptoms resolved, no sob, pulse ox 100 , VSS  ENT : clear, cardio rr without murmur,lungs clear A&P  diphenhydramine 50mg IM left deltoid, IV hep lick  Right antecubital  1413transported via ambulance sse progress note scanned into chart
A report has been received from a Health Professional concerning a 28 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT, 2 full doses, one in each nostril. FLUMIST QUADRIVALENT started on 17-Sep-2013. It was reported that the patient was administered two full doses of FLUMIST Quadrivalent, one in each nostril on 17-Sep-2013. The outcome of the event of TWO FULL DOSES OF FLUMIST QUADRIVALENT, ONE IN EACH NOSTRIL is unknown. The report was considered to be non-serious.
A nurse practitioner reported that a 4 month old female received her first dose of Prevnar vaccine on an unspecified date. concomitant vaccines included DTaP and IPOL. She subsequently developed a febrile seizure. An electroencephalogram was performed; the results were negative. This event was considered medically important (OMIC). No further information was available at the date of this report. MANUFACTURERS COMMENT: Information regarding this event has been forwarded to the manufacturer of IPOL.
Armpit is hurting; I had pain in my arm for a day; This is a spontaneous report from a Pfizer-sponsored program COVAX Support. A contactable male consumer reported for himself.  A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/lot number was not reported), via an unspecified route of administration, on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced Pain under her armpit and pain in arm for a day. The patient stated that her armpit is hurting due to the side effect after getting the dose of the Pfizer Covid-19 Vaccine. The patient stated that she got her COVID vaccine, Pfizer shot last Thursday and she just been having pain under her armpit since then she was wondering is that normal. The patient had pain about a week. The reporter confirmed and stated that pin under armpit when she got the vaccine, she had pain in her arm for a day. The out-come of the events were unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
had the same side effect from the Moderna COVID19 vaccine that lasted upto week; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had the same side effect from the Moderna COVID19 vaccine that lasted upto week) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (had the same side effect from the Moderna COVID19 vaccine that lasted upto week). At the time of the report, VACCINATION COMPLICATION (had the same side effect from the Moderna COVID19 vaccine that lasted upto week) had resolved.            Concomitant medications was not reported.  Treatment medications was not reported.    This case was linked to MOD-2021-265482 (Patient Link).   Reporter did not allow further contact
R arm, then L (1st) at inject area ache/pain that remains 5/20 & gets worse; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (PFIZER COVID-19 VACCINE, lot number: ER8729), at the age of 79 years old, in right arm on 14Apr2021 14:00 at single dose for covid-19 immunisation. Medical history included low thyroid and high blood pressure. Both were medicated. The patient's allergies were unknown. The patient was not pregnant at time of vaccination. The patient was not diagnosed with covid-19 prior to vaccination. Concomitant medications included lisinopril at 20 mg and levothyroxine sodium (SYNTHROID) at 112 ug the patient received within 2 weeks of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to vaccination. On 16Apr2021, the patient experienced R arm, then L (1st) at inject area ache or pain, that remains 20May2021 and got worse. The patient had not been tested for covid-19 since the vaccination. No treatment was received. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (exposure during pregnancy) in a 40-year-old female patient (gravida 5, para 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 024M20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (Casual drinker prior to pregnancy) on 01-Aug-2020, Pregnancy (still birth) on 06-Mar-2002, Pregnancy (Live,Full-term birth) on 16-Jan-2003, Pregnancy (Live, Full-term birth) on 25-Feb-2010 and Pregnancy (Live, Full-term birth) on 22-Sep-2013. Concomitant products included PRENATAL 1+1 FE from 09-Jan-2020 to an unknown date for Pregnancy, IRON (IRON ORAL) from 09-Feb-2021 to an unknown date for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 03-Aug-2020 and the estimated date of delivery was 10-May-2021. On 12-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-third week of the pregnancy.  On 12-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (exposure during pregnancy) had resolved. not provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Sep-2020, Pregnancy test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient underwent glucose tolerance test on 05 Feb 2021 and sonogram 01 Jan 2021, but results were not provided. The number of fetuses was reported as 1 and had established prenatal care. The patient had no complications and acute illness during this pregnancy to date.  The patient had no maternal history of subfertility.  No treatment information was provided.
Left arm redness, heat, swelling. Redness completely around arm L and 5 1/2 inches in length. Itching noted. Tx Atarax and Lipocream Rx copies attached.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On 15-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported.
unable to confirm if either were injected in the muscle, because she did not feel either one; Having bug sounds in ears/Tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 70-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Apr2021 (Lot number: ER8734, Expiration Date: Jul2021) at the age of 70 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Peanut allergy", start date: 2005 (unspecified if ongoing), notes: verbatim: Allergic to Peanuts diagnosed 2005. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Lot: EL9263, Expiration: May2021, Anatomical location: left arm, unable to confirm if given in the muscle), administration date: 02Mar2021, when the patient was 70 years old, for COVID-19 immunization. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 03Apr2021, outcome "unknown", described as "unable to confirm if either were injected in the muscle, because she did not feel either one"; TINNITUS (non-serious) with onset Apr2021, outcome "not recovered", described as "Having bug sounds in ears/Tinnitus". The event "having bug sounds in ears/tinnitus" was evaluated at the physician office visit.  Additional information: Two weeks ago, patient had a problem with bug sounds in her ears. Patient cannot remember the exact date and it is a constant sound. Patient went to see her doctor on Monday. Patient was examined and diagnosed with Tinnitus and said it could be not for sure and doctor gave her an antibiotic (Amoxicillin 875mg tablet, one tablet twice daily for 7 days) and said it could be a reaction. She advised her to contact Pfizer and report it. At the time of report, it was reported that, patient never had any soreness in either arm. Patient did not want to end up getting COVID. No relevant test reported at the time of report. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Additional vaccines administered on same date of the Pfizer suspect, Family medical history and AE following prior vaccinations reported as none.   No follow-up attempts are possible. No further information is expected.
Within several seconds of administration, developed white, raised wheal at site of injection, approx 2" x 3" in area. Cleared in <1 minute. No other symptoms, no respiratory changes. Observed for 1/2 hour and fine, no treatment necessary.
This spontaneous repor as received from the Healthcare worker refers to a 65 year old male patienr. On 13-JUN-2013 the patient was vaccinated with ZOSTAVAX (lot # 0069AE, expiration date 03-APR-2013) 0.65 ml, subcutanoeusly in the right arm. The Healthcare worker reported that two patients were vaccinated with expired ZOSTAVAX (related to MARRS case 1306USA007128). No adverse effects were reporred. This is one of two reports from the same source. Additional information is not expected.
No adverse event; Patient received 0.25 ml of vaccine instead of 0.5 ml; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Patient received 0.25 ml of vaccine instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 25-May-2023, the patient experienced UNDERDOSE (Patient received 0.25 ml of vaccine instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient received 0.25 ml of vaccine instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient received 0.25 ml of vaccine instead of 0.5 ml).    The patient had their monovalent and a previous booster dose of bivalent vaccine.  The patient was over 65 years old.  No concomitant medications were reported.  No treatment medications were reported.  This case contains information for the 20 of 20th elderly patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-726464 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726464:Patient no - 1
On day 8 after receiving the vaccine, a red swollen spot appeared, similar to how a mosquito bite looks, but there were two close together, about the size of a quarter. A few hours later, another appeared farther up my arm. These spread to the point of connecting and a third spot appeared, farther up my arm. These spread together, too. It has continued to grow, up my arm/shoulder. The edges are red and swollen like a ridge. It?s now (5 days of spreading) an oval shape measuring 3.5 inches by 2.5 inches. Ice on it made the puffiness subside for a few hours, but didn?t stop the spread. Tea tree essential oil (for hives) did nothing. Benedryl before bed didn?t do anything by morning either.
More than 6 months since 1st dose; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (patient had the first injection but it had been greater than 6 months).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.      Additional Information: GSK receipt date: 20-JAN-2023 Reporter's comment: The reporter had asked that, if the patient had the first injection, but it had been greater than 6 months, so do they need to start the series over. The reporter had consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the second dose of Shingrix, which had led to incomplete course of vaccination.
Client reports temp 100 deg. F. last night and diarrhea then and today.
headache; gotten red; painful, tender; site of injection started itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (site of injection started itching), VACCINATION SITE ERYTHEMA (gotten red), VACCINATION SITE PAIN (painful, tender) and HEADACHE (headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049EL1A) for COVID-19 vaccination.     The patient's past medical history included Rheumatoid arthritis in 1990 and Ankylosing spondylitis in 1990. Concomitant products included MAGNESIUM and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced VACCINATION SITE PRURITUS (site of injection started itching). On 27-Aug-2021, the patient experienced VACCINATION SITE ERYTHEMA (gotten red) and VACCINATION SITE PAIN (painful, tender). On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, VACCINATION SITE PRURITUS (site of injection started itching), VACCINATION SITE ERYTHEMA (gotten red), VACCINATION SITE PAIN (painful, tender) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was provided.  No Treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: Non Significant Follow up appended. Concomitant medications were updated. Medical history was updated.
no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to an 2-year-old patient of unknown gender. Their concurrent conditions, medical history and concomitant therapies were not provided.   On 22-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot number: T013204, expiration date: 03-DEC-2021 (strength, dose, frequency and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA003923: US-009507513-2102USA004059:
Patient is receiving third dose of Covid Vaccination, 0.3 mL of Pfizer. Prior to administration, patient states that she experienced adverse reactions on doses 1 and 2 of Moderna but was cleared by allergy department to receive third dose in series after department performed allergy test. Pt states, "Nothing bubbled and they told me to get my third dose." Pt received vaccine at 1353. At 1417 patient notifies me about how she is, "Experiencing everything that she experienced in her first and second doses, but only worse this time." C/O redness on arms, coughing, difficulty breathing, chills. Pt states, "It feels like there is a vice grip grabbing my sides." V/S at 1417 are 126/84, 97% o2 sat, HR 108, 16 RR. Pt states she took "3 pills of benadryl" prior to appointment because of previous experiences. Pt instructed to remain under observation. Lung sounds clear, no wheezing noted as patient stated. Airway patent upon observation. V/S @ 1430 BP 125/85, HR 108, o2 97%, 16 RR. Patient states that she is still feeling lightheaded and wants to lay down, but I instructed her to remain in sitting position to improve breathing. I instructed that we had albuterol and benadryl on hand if needed, she declined administration for both. V/S @ 1444: 123/84 BP, 96 hr, o2 96%, 16 RR. Redness on arms still present but did not spread. I offer the patient to call emergency number because she states she is still having trouble breathing despite v/s readings and auscultation of lung sounds, but she deferred offer stating that she was talking to her husband and "There is a co-pay of five hundred dollars." Manager of the day notified of emergency call decline and we agree to offer her an visit to urgent care, and pt agrees. Pt is sent downstairs to urgent care with an escort.
Fever 101.5 , chills, fatigue, muscle soreness, arm pain at injection site.  Some tingling in jaw and tongue. Tylenol starting at 11:30 pm.  Next day fever 101.7 missed work. Muscle pain, injection site tenderness. Mild blotchiness above site.  Motrin and lots of sleep.  Thursday Motrin am. Worked. Felt a lot better at first. 5 pm started sweating but not hot. 7 pm started shivering again. Fever 102. Muscle aches returned. Motrin at 9pm Friday Motrin am worked. Saw a silver dollar sized welt on upper inner arm, away from injection site. Itchy.  Saturday, everything better except the welt was much larger, redder, and itchier.  I had similar skin reaction with second dose of Moderna in February. Don't remember how long it lasted.
possibly administered an expired shot; possibly administered an expired shot; weakness of his whole body; stated that he does not feel well; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Lot number: FD1189) at the age of 22 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (First dose, Lot No: FF8726), for COVID-19 Immunization. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious), outcome "unknown" and all described as "possibly administered an expired shot"; ASTHENIA (non-serious), outcome "not recovered", described as "weakness of his whole body"; MALAISE (non-serious), outcome "unknown", described as "stated that he does not feel well". Therapeutic measures were taken as a result of asthenia.  Additional information: The patient took the Covid shot and does not feel well. Stated that he was told that the shot may have been expired. Stated that it may be nothing and he may be recovered. Stated that his is lasting longer and he hoped to recover. Wanted to know the expiration date. Wanted to know if the Covid shot had expired. Patient Weight is 170-180. Stated that he had weakness of his whole body 1.5 weeks after the shot. Stated that it was his second dose. Stated that he is better than before but still weak. Stated that he took Advil and Tylenol for the weakness. Stated that the lot number for the first dose was FF8726. Stated that he does not have the expiration date  No follow-up attempts are possible. No further information is expected.