chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via call center representative and described the occurrence of malaise in a adult patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced malaise, dizziness and feeling anxious. On an unknown date, the outcome of the malaise, dizziness and feeling anxious were unknown. It was unknown if the reporter considered the malaise, dizziness and feeling anxious to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that the patient reported that with each dose of vaccine they are feeling sense of malaise, dizziness, unsettling feeling. The healthcare professional's call disconnected while providing this information. Tried to call the healthcare professional back but was unable to reach the healthcare professional. This case is linked with US2018156153, reported by the same reporter.
This spontaneous report as received from a nurse via a company representative refers to a 64 year old female patient with unspecified allergies. On 05-APR-2014 the patient was vaccinated with 1 shot of ZOSTAVAX (dosage, route and lot# not reported) at a retail pharmacy. On 05-APR-2014, almost immediately after vaccination, the patient had allergic reaction with a significant rash and swelling at injection site. On 07-APR-2014 patient sought medical attention and an unspecified provider, and she was given amoxicillin (for 7 days) and fluconazole, but on 08-APR-2014, her symptoms didn't improve, and patient was prescribed prednisone. No lab test was performed. The outcome of events were not reported. Additional information has been requested.
At 5:30 pm on April 4, one day subsequent to my 2nd dose, I lost hearing in my left ear accompanied by a feeling of pressure and  severe tinnitus.  No other known factors occurred prior to onset of deafness and tinnitus.   I am not experiencing any sinus symptoms, or am I aware of any blockage of my ear canal.  Attempts to clear the eustachian tube are unsuccessful, no crackling, popping, etc.  I have had light to moderate tinnitus in both ears for decades, but the sudden (instantaneous) onset of deafness accompanied by a very severe ringing is unprecedented. It is now 6:36 pm and the pressure is subsiding but the ringing and deafness continues.
Initial information received on 26-Jun-2018 regarding an unsolicited valid non-serious case received from an other non-health care professional. This case involves a six months old female patient who received ACT-HIB with expiry 03 Jun 2018. The patients past medical history and concomitant medication were not provided. It was an actual medication error due to Expired vaccine used. On 26-Jun-2018, the patient received a 0.5 ml dose, 3rd in series of suspect HIB (PRP/T) VACCINE lot UI796AA, expiry date 03 Jun 2018 via unknown route in the left thigh. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender - none.
Fever of 100.3, achiness, running nose, cough beginning 1-1-22.  Symptoms resolved gradually within 12 days, tested negative on 1-11-22.
Bruising at injection site (1 month later) Irregular menstrual cycle (bleeding over a month) shortness of breath  Severe debilitating migraines chest pain severe cramping in ovaries and lower back
Pain in left eye and eye socket. Ache when moving pupils to lateral extremities. No impact to vision or headache. onset was 36 hours after vaccine.
Weakness and feeling woozy upon waking and during non-strenuous activity (standing, reaching, bending down) Mild chest wheezing all day Blood pressure 110/60 at 9pm (normally about 120/74)
Fatigue, soreness at injection site, stuffy head, body aches, dizziness, loss of appetite.
pt to ED 8/22/21 testing positive for COVID; AHRF; given steroids; Remdesivir not given due to elevated Liver Function Tests; O2 supplementation; DNR/DNI; worsening respiratory status; comfort measures; in patient hospice where pt passed away
This case was reported by a nurse via call center representative and described the occurrence of adverse event in a patient who received FLULAVAL quadrivalent (batch number 3L9LD, expiry date 16th June 2016). In 2015, the patient received FLUARIX quadrivalent. On an unknown date, an unknown time after receiving FLUARIX quadrivalent, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to FLUARIX quadrivalent. Additional details were provided as follows: The office reported 3 separate adverse events for the vaccine. The nurse reported 2 of the adverse events via fax to VAERS but did not report the 3rd event because of some type of non-traditional treatment. This case has been linked to other 2 cases (US2015151594 and US201511595), reported by the same reporter.
This spontaneous report was received from a health care professional refers to a patient of unknown age and gender. On 01-JUN-2015 the patient was vaccinated with improperly stored PROQUAD (Merck) (lot # K008868; expiry: 19-DEC-2015) (dose, route and frequency unspecified). No concomitant medications were reported. No adverse effects reported. There was no product quality complaint involved. The outcome of incorrect product storage was unknown. No further information provided. This is one of several reports received from the same source. Additional information has been requested.
still got the flu; Initial information received on 27-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a patient.  This case involves an unknown age and unknown gender patient who still got the flu after receiving INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. . It is unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received a  dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination  On an unknown date the patient still got the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if there were lab data/results available.   Reportedly, I got the shot, still got the flu. lot of good the shot was.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (still got the flu).  At time of reporting, the outcome was Unknown for the event still got the flu.
Small hives over entire body. Solu-Medrol 125 mg IM given.
This spontaneous report as received from a pharmacy technician refers to a 1-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 29-JAN-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. Sender's Comments: US-009507513-1802USA001558.
Vaccine error, Administered After available Date to be used. Notification of Pfizer Bivalent to end received 9/12/23 late afternoon.
Patient had syncope right after vaccination. She came back conscious about 3 seconds later. No other adverse reactions occured
Sore arm starting 30 minutes after vaccination, lasting 1.5 days.  Severe headache starting 45 minutes after vaccination lasting 1 hour.
Severe vertigo; Inappropreiate route of administration; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Severe vertigo) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropreiate route of administration) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form once. On an unknown date, the patient experienced VERTIGO (Severe vertigo) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropreiate route of administration). At the time of the report, VERTIGO (Severe vertigo) had not resolved and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropreiate route of administration) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) was unknown.       Young, healthy male, no significant health history, no allergies, non smoker, occasional drink.  There was no treatment medication reported.
A non-serious spontaneous report of itchy scalp, palm and feet, red palms, red feet and hives on forearms, legs, ears and trunk has been received from a consumer concerning a 40-year-old female, subsequent to FLUMIST. The patient's past medical history included mild reaction to cat dander. No concomitant medications have been reported for this patient. The patient received FLUMIST on 15-Sep-2011. On 17-Sep-2011, the patient experienced itchy scalp. Days later patient had very itchy and red palms and feet, which lasted a week. It stopped for one day. Then patient had red and itchy hives on forearms, legs, ears and trunk of the body. The outcome of events red palms and red feet were recovered and the outcome of events itchy scalp, palm and feet and hives on forearms, legs, ears and trunk was unknown.
Chills, sweating, headache, loss of appetite all resolved within 36 hours.
Child became chronically constipated. Odd behaviors began. Child withdrew socially; lost all communication skills and eye contact.
administered shingrix believing it was the patient's 1st shingles shot; upon further investigation when the patient asked about pneumonia vaccines, we discovered she had already received the complete series of 2 vaccines.  dose 1 01/22/2019 and dose 2 07/27/2019
Perioral numbness and anxiousness starting 11 minutes after administration and terminating approximately 1 hour later soon after presenting to the emergency department.
The nurse said I had to stay for 30 minutes. At 15 minutes, they made us leave. My reaction happened at 20 minutes while we were on our way home. I got sick to my stomach. Then my cheeks swelled up. I had some troubles breathing.  The next day, my arm was swollen and painful, and I ached all over and was tired.
No date of time onset for adverse reaction. Under-dose or possible second dose was given. Vaccination error.
4 days after receiving the second injection on Feb20, 2021, I experienced  significant weakness in my legs which caused me to be unable to stand upright for any extended period of time and prevented me from taking care of my self.  This condition has persisted since then and has not improved significantly.
Approximately 72 hours after receiving Zostavax, patient develop diffuse, pruritic vesicular rash on arms, legs, trunk, face. Diagnosed with acute Varicella infection (chickenpox) and treated with Valtrex 1 gm tid x 7 days.
Client reported pain a injection sites in right arm and with swelling in axillary area of right arm. Fever 102.2 at 9 PM on 6/2/2010.
first Shingrix shot in Jan 2019, do they need to start over?; This case was reported by a other health professional via media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in January 2019).   On an unknown date, the patient received 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 details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, if the patient had 1st shot of Shingrix, do they need to start over with 2 shots or just need to get one more Shingrix dose. Till the time of reporting, the patient did not receive the 2nd dose of the Shingrix, which led to incomplete course of vaccination. The follow-up would not possible as no contact details were available.
A 16 month old received both PROQUAD and VARICELLA at the same time; This spontaneous report was received from a nurse concerning a 16-month-old patient of unknown gender. The patient's concurrent conditions, medical history, historical drug, drug reactions/allergies and concomitant therapies were not provided.  On 09-SEP-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) 0.5 mililliter and varicella virus vaccine live (oka/merck)(manufacturer unknown) (Overdose) both for prophylaxis. Dosage regimens, lot numbers and expiration dates were not provided.
PT'S WIFE IS A NURSE. DESCRIBED SYMPTOMS AS THOSE OF A CELLULITIS. RED, SWOLLEN, WARM TO TOUCH, INFLAMMED. PT WAS CALLING DOCTOR AND/OR GOING TO URGENT CARE FACILITY.
About 13:00 body ached, eyes started to swell, then left arm swelling, hot to touch, fever (not taken with thermometer) ears swollen (lobes) mom gave her "painkiller" and stayed in bed for two days.  No appetite.  No one else ill.  second telephone call reported difficulty swallowing and breathing and rash also.
Unknown LOT number for second dose in vaccine series. Symptom onset of 7/30/2021. Tested positive on 8/3/2021. Patient admitted to hospital on 8/2/2021 and is currently hospitalized.
This case was reported by a non-health professional and described the occurrence of pain in arm in a female patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: The age at vaccination was not provided. The patient experienced more severe arm soreness after Flu vaccination as compared to arm soreness after SHINGRIX vaccine. This case has been linked to the case US2018GSK032231, reported by the same reporter for the same patient.
He developed a fever of 104.9 the evening following the vaccine, even with receiving children Tylenol and ibuprofen (alternating between the 2) every 4 hours.  Mom contacted the local emergency room department and was instructed to monitor and continue the Tylenol and Ibuprofen and bring him to the emergency room with a fever of 107 degrees.  His temp never went any higher and mom continued the Tylenol and ibuprofen.  The next day his temp was lower at 102 degrees.  He continued to run a fever the next day.  He was feeling better by 10/31/2009, but still very tired.
Initially after injection, the site on my arm was sore for several days.  I am not sure that what follows is related to the vaccine, but my mother received the vaccine at the same time I did at the same location and she fell ill on June 4 June 3 around 1pm.  I had abdominal pain.  During a bowel movement I broke out into a cold sweat with shaking of limbs.  That bowel movement turned into diarrhea.  Then finished with nothing but dark blood.  I rested for a bit as I was having abdominal pain and still having dark blood as a bowel movement.  2-3 times.  When I got a change, I phoned my Primary Care Physician's office.  It was after hours and I spoke with a colleague that suggested I go to the ER to get checked out.
Covid arm  Today is day 2. Worse today. Large round red swelling at injection site (4? in diameter). Swelling is hard and hot. Arm is red - itching at swollen area.
This spontaneous report was received from a pharmacy intern concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 09-JUL-2018 the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 Lot R005344 with expiration date of 01-MAR-2020, (dose, route of administration and anatomical location were not reported) for prophylaxis which were stored in the range of 47 Fahrenheit degrees to 77 Fahrenheit degrees for 72 hours. No previous temperature excursion was reported. No adverse effects were reported. Digital data logger was involved. The reporter inquired if the patient needed to be revaccinated.
Patient claims to have felt dizziness, extreme fatigue, chills blurred vision, had extreme thick lacrimation. Felt faint and slight fever 99F. Family members wanted to take him to the hospital. Took Tylenol and felt better next day. Four days later still complaining of vision problems.
Bright red rash over injection site, itching x 1 wk. Benadryl.
5/15/03: Second anthrax vaccine, red knot at injection site, size of a quarter, lasted a few weeks. 6/3/04: third anthrax vaccine: red welt at injection site, size of baseball, 3/4 inches tall, lasted 3 months. Numbness and tingling in hands and feet, lasted 3 weeks. Arthritis like pain lasted 3 weeks. Headaches, fire in veins.
Headache, Myalgia, CoughWheeze, CHILLS,BODY ACHES,SWOLLEN GLANDS,DIZZINESS Narrative:
Child developed a rash on the back of her right arm, at the site of the MMR vaccination.  The vaccine was given on the 22 of April.
Pt. experienced lightheadedness, dizziness, flushing of the face and slurred speech approx. 30 min after receiving the flu vaccine IM. Nurse administered a dose of BENADRYL P.O. and s/s resolved with an hour.
light headed, headache, dizzy, vomiting ,sore throat, ,hard to swallow, weak,  felt like someone sitting on her chest lost sense of smell and taste. Taken by medics to local hospital, , Placed on IV , GI cocktail, chest x rays 2 views, EKG,
This spontaneous report as received from a Nurse Practitioner refers to a 21 year old female patient with no drug reaction and allergies reported. Information regarding concomitant therapy, concurrent conditions and medical history was not reported. On an unknown date the patient started therapy with GARDASIL. On 15-MAY-2014 the patient received an expired dose of GARDASIL (lot #666929/0331Z, expiration: 20-NOV-2012, 0.5 ml, intramuscular) as her third dose in the series. No adverse effects reported. The outcome was unknown. Additional information has been requested.
The patient was administered a dose of GARDASIL 9 that was shipped late.; The patient was administered a dose of GARDASIL 9 that was shipped late.; No additional adverse effect reported.; This spontaneous report was received from a Medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) that was shipped late,  with  lot # 1621934, and expiration date 29-JAN--2022 via intramuscular route for prophylaxis. Patient did not had any symptoms. No additional adverse effect were reported.
Headache; Fatigue; Muscle aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 20May2021 (Batch/Lot number: unknown) at the age of 32 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 20May2021, outcome "recovering", described as "Headache"; FATIGUE (non-serious) with onset 20May2021, outcome "recovering", described as "Fatigue"; MYALGIA (non-serious) with onset 20May2021, outcome "recovering", described as "Muscle aches". Therapeutic measures were not taken as a result of headache, fatigue, myalgia.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
SECOND DOSE MIX UP. PFIZER COVID-19 WAS GIVEN AS SECOND DOSE INSTEAD OF MODERNA
pt began to c/o pain the following morning lt arm swollen & red; temp 99.6; APAP given; cold compresses applied to lt arm; swelling down the next morning; Monday AM 21JUn sx completely gone;
3-4 cm round swollen area at injection site, 100.3 fever, headache.
shot in May 2018 when am I due for the next shot; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose in May 2018).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Received 2nd dose of Moderna on 1/26/2021.  Had a hospital visit 2/1/21-2/4/21 for anemia and colitis.
Patient was given HEP B vaccine in error - should have received HPV (Gardisil) - no reactions or harm done to patient