chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sudden Dry mouth; This spontaneous case was reported by a nurse and describes the occurrence of DRY MOUTH (Sudden Dry mouth) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, the patient experienced DRY MOUTH (Sudden Dry mouth). At the time of the report, DRY MOUTH (Sudden Dry mouth) outcome was unknown. 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 considered DRY MOUTH (Sudden Dry mouth) to be possibly related.    The concomitant history was not reported. The treatment history was not provided. Patient  Patient experienced sudden dry mouth after first dose, another patient also experienced the same with same vial. No incidents found of improper storage refrigeration r freezing. Two remaining vials of same lot number are set aside. Clinic utilized a different lot number 047B21A no reported symptoms of dry mouth since implementation.
Woke up with terrible headache, body aches, chills and nausea. Slept all day taking ibuprofen and acetaminophen as needed, lots of fluids. Lasted until 1130 pm same night. Next day did not have headache but still had body aches and  chills, above medication helped. Felt  better later that night but finally felt 100% on day 2.
Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.      It was reported that the patient received 1st dose of Moderna vaccine on 11-Feb-2021.  No concomitant medication was reported.  It was not reported if the patient was received any corrective treatment for the event.  The action taken with response to the drug is not applicable.
This is a spontaneous report from a contactable consumer reported for herself. A 77-year-old female patient received PREVNAR 13 via an unspecified route of administration at 0.5ml, single at the left arm and DTAP via an unspecified route of administration at 1 DF, single at the right arm, both on 23May2016 for immunization, received at the clinic. Medical history included ongoing blood pressure high diagnosed quite a long time before. Concomitant medication included atenolol oral 25mg tablet by mouth daily for years and ongoing for blood pressure high. The patient previously took TDap for immunisation. The patient received the PREVNAR 13 vaccine back in May2016 but soon after the injection she has been having and pain at the injection site in May2016. Two to 3 days after the injection, in May2016, she started to have a sharp pain in the left arm at the injection site. The sharp pain improved but continued to have discomfort and pain at the injection site with certain movement and 2 to 3 months before discomfort affected her writing. She discussed it with her doctor, the doctor did not think that it is due to the injection but the patient thought so. The outcome of the events was not recovered. The patient had blood test every 6 month to check for blood sugar and blood pressure. Her doctor assessed the arm to see if it was her rotator cuff and did not think it is her rotator cuff but recommended therapy. She had no problem with right arm.
Patient developed hives and itching about 3 hours after Flu vaccine. Treated w/ 50mg Diphenhydramine and told to follow up if necessary.
still i got covid again in 11 months; still i got covid again in 11 months; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: I had covid -19. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "still i got covid again in 11 months"; IMMUNISATION (non-serious), outcome "unknown", described as "booster". The patient got the COVID-19 in 11 months.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient reported nausea and lightheadedness and was vomiting in the bathroom 2-3 later. He ambulated standby assist to the bathroom, turned pallor, diaphoretic. Accompanied to the bathroom with an LVN and RN. Patient had 1 episode of emesis. Patient has a history of hypertension and takes meds for it.
A patient received a Gardasil 9 that underwent an unevaluated temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant therapies and drug reaction or allergies was provided.  On 03-MAR-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (product storage error) injection, at a dose of 0.5 milliliter (ml), lot number S028738, expiration date reported and validated as 03-APR-2022 (route of administration, anatomical site of vaccination, and vaccination scheme frequency were not reported)  as prophylaxis.   The vaccine underwent an unevaluated temperature excursion on an unspecified date, the excursion was supported. The vaccine was stored at 35.8 degrees Fahrenheit (F) for 14 hours and 0 minutes. There was a previous temperature excursion on an unspecified date, and the storage temperature was: 35.4 F for 15 hours and 10 minutes. The call was due to a digital data logger.  This is one of several reports received from the same reporter. 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.; devicelotnumber: S028738; expirationdate: 03-APR-2022; 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-009507513-2103USA002215:
This spontaneous report was received from a nurse and refers to an unspecified patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 10-JAN-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # M005974, expiration date 02-FEB-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine were exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because all information was obtained.; Sender's Comments: US-009507513-1611USA004113:
The evening of the vax, the pt began getting feverish, fussy, vomiting. Later in the week she was encephalopathic and was dx with herpes encephalitis. There is no known link between the shots and the illness except temporally related although complete neurologic recovery will take time.
Headache, high temperature, and body aches Tylenol every six hours, 32 oz water to 16 oz Powerade Temperature and head aches: two days in duration, body aches one day duration
Incorrect vaccine administered.   Meningiococcal Conjugate - Menveo  was ordered however staff administered the Meningococcal B
Swelling at injection site Pain Fatigue Fever - 102 deg F Chills Muscle Aches Hallucinations
Had fatigue and myalgias and low-grade fever, so stayed in bed most of the next day. Developed calf pain 2 daysafter that. Was diagnosed with DVT via Doppler ultrasound on Monday, March 8, 2021.
Feeling bad; An intense intense heartburn in my ribcage in the front and breast area , and in between the breast and out , lasted probably for 3 hours/lay out in the couch and intensified the symptom/¨But is still there , not as intense,  it has subsided¨; Feeling achy; Headache; Tired; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Feeling bad), DYSPEPSIA (An intense intense heartburn in my ribcage in the front and breast area , and in between the breast and out , lasted probably for 3 hours/lay out in the couch and intensified the symptom/¨But is still there , not as intense,  it has subsided¨), PAIN (Feeling achy), HEADACHE (Headache) and FATIGUE (Tired) in a 62-year-old female patient who received mRNA-1273 (batch nos. 032B21A, 032B21A and 032B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Apr-2021, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On 09-May-2021, received second dose of mRNA-1273 (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (unknown route) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced FEELING ABNORMAL (Feeling bad), DYSPEPSIA (An intense intense heartburn in my ribcage in the front and breast area , and in between the breast and out , lasted probably for 3 hours/lay out in the couch and intensified the symptom/¨But is still there , not as intense,  it has subsided¨), PAIN (Feeling achy), HEADACHE (Headache) and FATIGUE (Tired). At the time of the report, FEELING ABNORMAL (Feeling bad), PAIN (Feeling achy), HEADACHE (Headache) and FATIGUE (Tired) outcome was unknown and DYSPEPSIA (An intense intense heartburn in my ribcage in the front and breast area , and in between the breast and out , lasted probably for 3 hours/lay out in the couch and intensified the symptom/¨But is still there , not as intense,  it has subsided¨) had resolved.        For mRNA-1273 (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable Concomitant products include medicines for constipation. No treatment medication was mentioned.
Child received vaccine on 8-18-23 at her pediatrician's office. She came home and complained of being tired. She did not rest well that night, as well as the following 2 nights. Monday morning, she woke up with a rash on her arms and some bumps on her legs, and she was scratching them, making her arms red. The rash/bumps continued to grow and cover more surface area. Very noticeable by Wednesday on both arms and legs, and she was complaining that they hurt. 8-25-23 she went to the dermatologist, where he confirmed it was a reaction to the MMR vaccine. She was prescribed Triamcinolone Acetonide Cream 0.1%
patient only received the liquid component of Menveo; patient only received the liquid component of Menveo; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA419A, expiry date 31st August 2022) for prophylaxis.   On 19th May 2021, the patient received Menveo. On 19th May 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The age at vaccination was no reported. The pharmacist reported that the patient was administered only with the liquid component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  The health care professional did not have patient demographics to provide. The reporter consented to follow up. The reported batch number AMXA419A was not available in sales data sheet, hence updated to AMVA419A . No further information was reported.
day p/inject pt awoke feeling weak & drained, felt feverish, but did not check temp until 8 hrs later & it was 102; I also felt nauseated; denies emesis; lt deltoid area red, warm to touch;
Right arm pain, swelling and hot. 10 x 10 induration DTaP injection site area.
No adverse effects reported; the patient was vaccinated with the first dose of an improperly stored VARIVAX and M M R II; This spontaneous report was received from a medical assistant, regarding a 23 month old male patient. The patient's illness at the time of vaccination were reported as none. Pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. Concomitant medications included hepatitis A virus vaccine (unspecified).  On 30-SEP-2019 (reported as 30-SEP-2018), the patient was vaccinated with an improperly stored Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dose and location of administration were not reported) (lot # R028382, expiration date 10-MAR-2020) and with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose and location of administration were not reported) (lot # R033660, expiration date 20-NOV-2020). Both vaccines were administered intramuscularly (IM) for prophylaxis. The patient was vaccinated at a private doctor's office hospital and the vaccine was purchased with public funds.  The Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was exposed to a temperature of 13.13 degree Celsius since 23-MAY-2019 to 02-OCT-2019. There were no previous temperature excursions, however, on an unknown date the vaccine had a temperature excursion with a highest temperature above 9 degree Celsius (58.96 degree Celsius) for 8299 and 45 minutes. The varicella virus vaccine live (Oka/Merck) (VARIVAX) was exposed to a temperature of 13.28 degree Celsius from 30-MAY-2019 to 02-OCT-2019. There were no previous temperature excursions, however on an unknown date, the vaccine was exposed to a temperature from 9 to 25 degree Celsius (25.4 degree Celsius) for a time frame of 8290 hours and 30 minutes. The call was because a digital data logger. No adverse effects were reported  This is one of several reports from the same reporter.  ; Sender's Comments:  US-009507513-1910USA007637: US-009507513-1910USA012351: US-009507513-1910USA012352: US-009507513-1910USA012357: US-009507513-1910USA012354: US-009507513-1910USA012355: US-009507513-1910USA012359: US-009507513-1910USA012349: US-009507513-1910USA012240: US-009507513-1910USA012360: US-009507513-1910USA012981: US-009507513-1910USA012358: US-009507513-1910USA012353: US-009507513-1910USA012356:
ZOSTAVAX shot admin. 4/23, 3 days later pt. still had redness, swelling in area of admin., pt states day 4, diagnosis with cellulitis, receiving abx.
Pt came to office on 4/7/01 complaining of right should pain and swelling. Dx'd with cellulitis. Treated with Keflex 500mg tid #30. Return to check-up appt. in 2 days. No show. Unable to contact.
On June 1, I was hospitalized for pancreatitis although I had none of the preexisting conditions for it such as a history of drinking alcohol or anything else that the hospital could find.  Next on June 16, I began feeling lightheaded.  I went to an internal medicine doctor who referred me to a specialist.  After some testing, Doctor informed me that my heart was beating lower than the normal range.  I just had a heart stress test done a few years earlier and my heart was more than fine.  It is hard for me to understand how my heart health could have such a dramatic reversal so quickly.
Cellulitis of the left lateral upper arm, started the day after her flu vaccine and was worse day 2. The area has warmth, erythema, and induration measuring approx. 6 x 7 cm. She was started on KEFLEX 250 mg/5 ml, 8 ml BID for 10 days.
ADMINISTRATION OF EXPIRED DOSE OF THE JANSSEN COVID-19 VACCINE; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 07-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-SEP-2021, the patient experienced administration of expired dose of the janssen covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired dose of the janssen covid-19 vaccine was not reported. This report was non-serious.
This spontaneous report was received from a registered nurse concerning an unknown number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX, ROTATEQ (oral administration), and VAQTA, all administered for prophylaxis. The doses of VARIVAX was reconstituted with properly stored sterile diluent, and was stored between -14 Celsius degrees and -10 Celsius degrees for 48 hours. The doses of ROTATEQ and VAQTA were stored below 0 Celsius degrees (-0.56) for 24 hours. There were no previous temperature excursions. The temperature excursions were detected by a data logger. No adverse effects were reported. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. Follow up information was received from an other unspecified reporter on 11-JUL-2018. This report concerned a 6 month old patient of unknown gender. Pre-existing allergies, birth defects, medical condition and illness at the time of vaccination was reported as none. Patient's birth weight was reported as 6 lb12 oz. Previously, on 25-JAN-2017 and 18-JAN-2018, the patient was vaccinated with 2 doses of ROTATEQ, PREVNAR, DTAP, hib conj vaccine (unspecified carrier)(HIB) and poliovirus vaccine inactivated (unspecified)(IPV). On 17-MAR-2018, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # N005078, expiry date 22-NOV-2018) dose 3, orally for prophylaxis. On 17-MAR-2018, the patient was also vaccinated with improperly stored doses of PREVNAR (via intramuscular route), diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid(DTAP) (lot# C5157AA, via intramuscular route), hib conj vaccine (unspecified carrier)(HIB) (lot# 41787AA, via intramuscular route) and poliovirus vaccine inactivated (unspecified)(IPV) (lot# m1453, via intramuscular route). No adverse event was reported. On 28-FEB-2018, the temperature excursion occurred in the refrigerator, and it was not known if the temperature excursion occurred as result of a reading from a digital data logger.
Throbbing sore throat; Felt like extreme tonsillitis; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other and describes the occurrence of OROPHARYNGEAL PAIN (Throbbing sore throat) and TONSILLITIS (Felt like extreme tonsillitis) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Throbbing sore throat) and TONSILLITIS (Felt like extreme tonsillitis). At the time of the report, OROPHARYNGEAL PAIN (Throbbing sore throat) and TONSILLITIS (Felt like extreme tonsillitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medication was provided. No treatment  was provided.
Patient stated she lost her hearing in one ear within 2 weeks of receiving vaccine. She was seen by an ENT doctor who gave her a prescription but it did not help her hearing.
Received 2nd shot on April 2, 2021 that night had headaches, Hot flashes,.  Saturday April 3 rd headaches all day and.  Tuesday April 6 woke up itchy all over body and later that day developed rash and hives.
ZOSTAVAX administered 1/17/17. Presented 1/19/17 with swelling, seeping rash at injection site. Physician did not recommend exam. Advised cold compresses, ZOSTRIN for symptoms.
Have had joint pain in feet, knees, wrists, fingers, elbows, shoulders, ringing in both ears, dry cough
Patient had syncope after his first dose of the pfizer covid vaccine. The patient was pale, sweaty and passed out. We elevated the patients legs put cold water bottle on patient's neck and called EMS. The patient came around after a few minutes and was feeling better by the time EMS arrived. Patient  was checked out by EMS and was not transported to the hospital.
fever 103.5; Vomiting; exhaustion; headache; severe chills; arm ache; This is a spontaneous report from a non-contactable consumer.   A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Right Arm on 06Apr2021 10:30 (Batch/Lot Number: EP6955) as SINGLE DOSE (at the age of 49 years) for covid-19 immunisation.  The patient had the first dose of BNT162 lot number EN6208 for Covid-19 immunization on 16Mar2021 10:30 in right arm at the age of 49 years.  Medical history included drug hypersensitivity from an unknown date (known allergies: Sulfa), drug hypersensitivity from an unknown date (known allergies: Penicillin).  The patient was not pregnant at the time of the vaccination. Patient did not have Covid-19 prior to vaccination.  The patient's concomitant medications were not reported.  No other vaccine taken in four weeks.  The patient previously took cipro [ciprofloxacin] and experienced drug hypersensitivity (known allergies: Cipro).  The patient experienced fever 103.5 on 06Apr2021 23:00 with outcome of recovering, vomiting on 06Apr2021 23:00 with outcome of recovering, exhaustion on 06Apr2021 23:00 with outcome of recovering, headache on 06Apr2021 23:00 with outcome of recovering, severe chills on 06Apr2021 23:00 with outcome of recovering, arm ache on 06Apr2021 23:00 with outcome of recovering.  The patient was not Covid-19 tested post vaccination.  No treatment was required.  The patient underwent lab tests and procedures which included body temperature: 103.5 on 06Apr2021.    No follow-up attempts are possible. No further Information expected.
patient  was at work and called the pharmacy 3 hours after receiving the vaccine and reported arm numbness from the shoulder to her fingers and also nausea. Spoke with nurse and she applied a cold compress to patients arm for 15 minutes and the patient returned to work.
received Moderna dose 2 at 9:50am. Chills, dizziness, fever, muscle pain all began approximately 10 hours after receiving Moderna dose 2. The next day, 2/10/2021, I was too dizzy and nauseated to drink or eat. At around 8pm on 2/10/20, I walked a few feet to attempt to eat and drink, sat down, and fainted to the floor.  Regained consciousness within seconds. Was transported by rescue squad to hospital ED, where I received nearly 2 liters of IV fluids, held for about 4 hours, and released.