chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 27-MAR-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number reported as R021930 with expiration date in 18-JUN-2020) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  Lot number R021930 is an invalid lot number for Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA001848: US-009507513-1907USA001849: US-009507513-1906USA011434: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA001847: US-009507513-1907USA000952: US-009507513-1907USA000989: US-009507513-1907USA000962: US-009507513-1907USA000988: US-009507513-1907USA000963: US-009507513-1907USA000953: US-009507513-1907USA000959 : US-009507513-1907USA000968: US-009507513-1907USA000967: US-009507513-1907USA000964: US-009507513-1907USA000966: US-009507513-1907USA000954: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000965:
Pink eye; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Apr-2021 and was forwarded to Moderna on 07-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CONJUNCTIVITIS (Pink eye) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) 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 CONJUNCTIVITIS (Pink eye). At the time of the report, CONJUNCTIVITIS (Pink eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. The patient received unspecified antibiotics for the event as a treatment.
Patient presented for her last Hep B vaccination. Nurse accidentally administerd pediatric dose of Hep B instead of adult dose of Hep B.  No adverse reactions noted.
Pt noticed rash developing evening of 6/13, same day as Shingrix. Noted that rash covered whole body, not localized to arm. Itchy in nature and slightly raised. Pt also noticed left arm swelling and warm to the touch. Pt currently using OTC hydrocortisone and her seasonal allergy pill daily. Unable to take oral benadryl (jittery) so recommended topical between hydrocortisone doses. Pt will call if any further changes.
Employee went to ER the evening of vaccine with chest pain, shortness of breath,  painful red arm, fever of 101 degrees, and Ringing in ears.
At the time of injection, there was slight redness and a slightly raised bump. Approximately one hour from injection, she started to have soreness to the bone. This shot also possibly resulted in shooting pain down her left arm with numbness in her fingertips. Her initial reaction was normal. Adverse reaction started one hour later. She also had red striations on the inner part of her left arm. This area was not painful. She said it appeared the morning after getting flu shot.
A non-serious spontaneous report of individual over 49 year old received FLUMIST was received from a health professional concerning a 52-year-old female. Neither relevant past medical history nor concomitant medications were reported for this patient. The patient who was over 49 years of age received FLUMIST on 11-Oct-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessment are not applicable, and the event is considered resolved.
Case number PHEH2014US015001 is an initial spontaneous report from a nurse received on 24 Jul 2014. This report refers to an 18-year-old female patient. The patient was an intolerance to gluten. Concomitant medications were not provided. The patient was vaccinated with MENVEO (batch number: unknown) intramuscularly on an unknown date. On unspecified date, the patient experienced swollen lymph nodes down her back. The issue resolved after about three days. The seriousness was not reported. The patient's mother stated that the patient had a possible reaction to MENVEO. Following an internal review on 31 Jul 2014 of the data received on 24 Jul 2014, it was found that the event of intolerance to gluten was erroneously coded as event instead of concurrent condition. Hence correction was performed.
1 dose of Moderna COVID 19 vaccine given to a patient who is 17 years old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1 dose of Moderna COVID 19 vaccine given to a patient who is 17 years old) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1 dose of Moderna COVID 19 vaccine given to a patient who is 17 years old). On 17-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1 dose of Moderna COVID 19 vaccine given to a patient who is 17 years old) 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 provided.
I had pain in my chest - sharp pain on right side. It occurred in morning when I would move. It would be intermittent - like a pinched nerve. It would typically go away by late afternoon. I had it for about a week and I went to see the doctor. The pain went away on it's own shortly after that.  No treatment
did not complete the series; No additional AE reported.; This spontaneous report was received from a pharmacist, referring to a male patient of unknown age. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On an unknown date in 2018 (also reported as three years ago), 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, strength, route, lot# and expiration date were not provided) for prophylaxis but did not complete the series (inappropriate schedule of product administration). No additional adverse event reported.
fever 103.6 10 days p/vax w/mild rash; next day extensive rash, feverish, anorexia;
Began feeling stomach discomfort/bloating on or before Sunday, 5/16.  Symptoms worsened over next few days.  Went to doctor on Wednesday, 5/19, who indicated I might have appendicitis, and recommended I go to the ER.  Went to the ER on Wednesday, 5/19.  They took a CT scan and labs, and determined I had appendicitis.  I was admitted to the hospital that day and was released on Saturday 5/22.
patient was positive; patient was positive; This is a spontaneous report from a contactable nurse. A 34-year-old female patient (nurse's daughter) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EK9231), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. Medical history was none.  There were no concomitant medications. The nursed reported that "The patient was positive, the whole family had COVID and they all came down which was about the same time which was 29Dec. She was treated in the ER with steroids and since that point we have all recovered until she went for the 2nd dose. Probably close to 10 days ago, they did do some lab work at the hospital". The outcome of events was unknown.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported events.
Given Tdap vaccine (R) deltoid 6/6/2011. Developed (R) supraclavicular LN seen 6/10/2011. Resolved with 1-2 weeks more.
Pain in arm, headache, pain in lymph nodes, nausea for 48 hours after injection.
Pt received Trumenba vaccine on Saturday - that night noted redness to the area. Today co increased erythema, pruritis, and tenderness. No increase in size. No fevers, pain, cough, sob, vomiting. Good appetite.  Feeding well with good urine output.  Active, happy, sleeping well.
This spontaneous report was received from a 66 year old female consumer regarding herself with hypothyroidism and none drug reactions or allergies. On 14-JAN-2016, the patient was vaccinated with a dose of PNEUMOVAX 23, one time injection, intramuscular, (dose, anatomical location, lot number and expiration date were not reported) for immunization for pneumonia. The patient's concomitant therapies included SYNTHROID. On the same date, approximately 8 hours after vaccination, the patient experienced pain and noticed a rash at the injection site. The rash was treated with a unspecified dose of BENADRYL, additionally none lab diagnostics studies were performed. The patient sought medical attention by contacting the nurse practitioner on 18-JAN-2016. At the time of the report, the outcome of the pain was recovering and the outcome of the rash at the injection site was reported as recovered described as the patient's condition improved as the rash went away on 18-JAN-2016. The relatedness between the events and therapy with PNEUMOVAX 23 was not reported. Additional information has been requested.
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 a 12-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided.   On 21-JAN-2021, the patient was vaccinated with improperly stored doses of hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status: recombinant Human albumin (rHA)) (M-M-R II) lot # S037500 has been verified to be a valid lot number, with expiration date reported as 20-NOV-2021 (strengths, exact doses, doses #, anatomical locations and routes of administration were not reported) as prophylaxis. Administered doses of vaccines experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. 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 cases # 2102USA004059 and 2102USA003923). 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:
No adverse symptoms reported; Nurse reported the patient received an improperly stored dose of VARIVAX on 5/4/2020; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history and drug reactions or allergies was provided.  On 04-MAY-2020, the patient received an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot#S030223 with expiration date: 26-SEP-2021; route, dose and strength were unknown) with sterile diluent for prophylaxis (incorrect product storage). No adverse symptoms reported.  Administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) experienced the temperature excursion under -14 degrees Celsius (C) to -10 degrees Celsius (-12.9C) for 1 hour and 8 minutes. There was no previous temperature excursion. The digital data logger was involved to capture the temperature excursion.
Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccine on 1/21/21 and 2/11/21. COVID + 2/17/22 and 3/12/22. Presented 3/11/22 shortness of breath x3/days, dyspnea exertion, associated cough, no hemoptysis and generalized weakness. Admitted for CHF exacerbation c/b acute hypoxic resp failure. Became more hypoxic the following morning and placed on BiPAP. Course c/b NSTEMI, acute encephalopathy, intubated 3/17/22, secondary pneumonia and shock. Placed on comfort care. Treated with remdesivir (2/22), ceftriaxone, doxycycline, cefepime, vacomycin, and zosyn. Pt expired on 3/18/22.
TOOK DOSES WITH FOOD; TOOK UNREFRIGERATED VIVOTIF; This spontaneous case report was received from a pharmacist (PVX2019-275) on 29-Jan-2019. The report describes a female consumer who "took doses with food" and "took unrefrigerated Vivotif". The consumer was receiving oral Vivotif for typhoid fever prophylaxis.  It was reported that the consumer left Vivotif unrefrigerated for 12 hours before taking Vivotif and she completed the Vivotif course. She also took it with food.  The action taken with Vivotif with respect to the events "took doses with food" and "took unrefrigerated Vivotif" was not applicable.  The clinical outcome of the events "took doses with food" and "took unrefrigerated Vivotif" was unknown.  Company's Comment: The causality of the event "took doses with food" and "took unrefrigerated Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took doses with food" and "took unrefrigerated Vivotif" was considered as not applicable.
FEVER Muscle or body aches and Headaches DIZZINESS DIARRHEA
Breakthrough case admission after 2 vaccines Moderna 1/12/21 Lot# 025J20A;  Moderna 2/9/21 Lot# 028L20A
vaccinated and boosted an got COVID.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (vaccinated and boosted an got COVID.) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 025L20A and 043120A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (vaccinated and boosted an got COVID.). At the time of the report, COVID-19 (vaccinated and boosted an got COVID.) outcome was unknown.            No concomitant information was reported. It was reported that they are finishing their quarantine at the time of reporting. No treatment information was provided.  Company comment: This spontaneous case concerns an elderly male patient with no reported medical history who experienced the unexpected non serious AESI of COVID 19 which occurred unknown after the administration of third dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received 2 more doses of mRNA-1273 vaccine 9 and 10 months prior to the last dose. Details about date of diagnosis, investigations, treatment, clinical course and event outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an elderly male patient with no reported medical history who experienced the unexpected non serious AESI of COVID 19 which occurred unknown after the administration of third dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received 2 more doses of mRNA-1273 vaccine 9 and 10 months prior to the last dose. Details about date of diagnosis, investigations, treatment, clinical course and event outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Very sore right arm. Hot to touch, red swollen area, and  lump in area of shot
After pt got shots, she stated 5 minutes after got cold and sweaty then vomited and had diarrhea. She described both as severe for several minutes then she felt better.  At time of reporting to us she felt fine. Had not had reactions to any other Covid or Flu vaccines. Pt is a physician and will report if has further problems.
Information has been received from a physician concerning a 71 year old male patient who was vaccinated with a dose of Zostavax. It was reported that the patient experienced nausea and fatigue after vaccination. Additional information has been requested. This is one of several reports received from same source. 09/24/2007 This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a physician concerning a 70 year old male with high blood pressure, increased lipids and decreased vitamin D and a history of melanoma, bundle branch block right, prostatic specific antigen increased, right eye retinal detachment, raised liver function test, gout, cataract and appendectomy who on 09-MAY-2007 was vaccinated SC with a dose of ZOSTAVAX (Oka/Merck) (Lot # 656859/0357U). On 09-MAY-2007 in evening the patient experienced nausea and fatigue after vaccination. Additional information has been received from health professional who stated that patient had a wave of nausea and fatigue the night of vaccination. This is one of several reports received from same source. No further information is expected.
Developed shortness of breath (dyspnea) upon exertion, saw primary care physician, given cardiac stress test with echo, diagnosed with 2nd degree atrioventricular block, next step is to see cardiac electrophysiologist, treatment to be determined but it seems likely I will need a pacemaker
This spontaneous report as received from a pharmacist regarding his wife refers to a 52 year old female patient. The patient's medical history included high cholesterol. Concomitant therapies included aspirin (manufacturer unknown) and LIPITOR. On 07-JUL-2014 the patient was vaccinated with ZOSTAVAX lot # J011548, expiration date 19-DEC-2014, dose 0.65 ml, route subcutaneous. The reporter stated that on 08-JUL-2014, the patient developed redness at injection site after receiving ZOSTAVAX and injection site was tender to touch. The reporter also mentioned that the patient was with friend of hers on 08-JUL-2014, and then the friend of the patient informed the patient on 10-JUL-2014 that she developed shinlges due to coming in contact with the redness on patient's arm and now has to take an unspecified medication for developed the shingles. The outcome of events reported was reported as not recovered/not resolved. The patient had not sought medical attention. No product quality complaint was involved. This case is linked to the case 1407USA006479 via same reporter link. Additional information has been requested.
Redness, swelling & hard knot to injection site. Redness size of nickel. Continuing to monitor for increasing size.
Initial unsolicited report received from a nurse on 21 July 2015. A female patient (age not reported), whose medical history and concomitant medications were not reported, had received a dose of Tdap vaccine (batch number, route, dose in series not reported) in left deltoid and also received a dose of MCV4 (batch number not reported) in left deltoid on an unspecified date. On an unspecified date after the vaccination the patient experienced redness, swelling and pain at the injection site. The patient was vaccinated at a clinic. Laboratory investigations and corrective treatments were not reported. At the time of this report the event outcome was not reported. Documents held by sender: none.
RASH ON LT LEG. DR GAVE BENDRYL 1 TSP EVERY 6 HRS
Given vaccine at time indicated above 11:00 AM. By 3:00 PM (4 hours later) experienced severe stomach cramps & diarrhea and by 6:30 PM had projectile vomiting. After vomiting experienced continued severe cramps/pain & severe diarrhea with diarrhea being totally liquid. Considered seriously making a trip to the ER in the middle of the night, but around 4:30 AM in morning 12/15/2017 cramps/pain in gut subsided a bit. Diarrhea continues over 24 hours after vaccine. To this point have not sought medical attention and won't as long as continued improvement if felt.
No adverse reaction. Per Dept of Health, vaccine administered after 04/18/2023 when it was no longer approved for use.
heart rate is steadily between110-120; body aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (heart rate is steadily between110-120), PAIN (body aches) and CHILLS (chills) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced TACHYCARDIA (heart rate is steadily between110-120), PAIN (body aches) and CHILLS (chills). At the time of the report, TACHYCARDIA (heart rate is steadily between110-120), PAIN (body aches) and CHILLS (chills) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  Patient take At 11 took one Tylenol and at 1 pm took another Tylenol
Found lump in left axilla. Came to our office on 8/2/16 and was treated with Bactrim DS one tab twice a day for 10 days.