chrisvoncsefalvay/vaers-outcomes huggingface dataset:
left tonsil got swollen; left tonsil got swollen and developed white spots; Bitter taste in mouth; 1st dose, 06Apr2021; 2nd dose, 07Sep2021; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Sep2021 13:00 (Lot number: EW0217) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "covid-19" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (dose number=1,, Lot number=EW0153,, administration time=12:00 PM,, vaccine location=Left arm), administration date: 06Apr2021, when the patient was 43 years old, for COVID-19 Immunization. The following information was reported: TONSILLAR HYPERTROPHY (non-serious) with onset 07Sep2021 22:00, outcome "recovered" (Sep2021), described as "left tonsil got swollen"; TONSILLAR DISORDER (non-serious) with onset 07Sep2021 22:00, outcome "recovered" (Sep2021), described as "left tonsil got swollen and developed white spots"; DYSGEUSIA (non-serious) with onset 07Sep2021 22:00, outcome "recovered" (Sep2021), described as "Bitter taste in mouth"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 07Sep2021 13:00, outcome "unknown", described as "1st dose, 06Apr2021; 2nd dose, 07Sep2021". The events "left tonsil got swollen", "left tonsil got swollen and developed white spots" and "bitter taste in mouth" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tonsillar hypertrophy, tonsillar disorder, dysgeusia.   Additional information: It was reported as no for serious, seriousness criteria-results in death, seriousness criteria-life threatening, seriousness criteria-caused/prolonged hospitalization, seriousness criteria-disabling/incapacitating, seriousness criteria-congenital anomaly/birth defect. No other medications in two weeks and other vaccine in four weeks. It was reported as covid prior vaccination and covid tested post vaccination. Known allergies reported as none. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination.   Follow-up attempts are completed. No further information is expected.
Client became pale, fainted approx 5 sec unconscious easily aroused. Tdap inject site red, swollen, raised area 6" x 4 1/2". Ice applied area decreased to 2" x 3" by discharge from clinic. States received tetanus years ago as wound care - no problem- ? Pertussis in Tdap.
Pt. received VARIVAX on 7/25/08.  On 7/26 injection site red, hard & warm.  On 7/27 went to ER due to vomiting x1 & development of blisters, tx'd with clindamycin.
each time I got sick; Initial information received on 19-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves a patient of unknown demographics who reported each time i got sick while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a  dose of suspect Influenza Vaccine (form, strength, frequency, route, administration site, batch number and expiry date: unknown) produced by unknown manufacturer for immunization.  On an unknown date the patient developed a non-serious event of each time i got sick (malaise) (unknown latency) following the administration of Influenza Vaccine.  Action taken was not applicable.  Corrective treatment: not reported   Outcome was Unknown.
Patient received pfizer original formulation versus bivalent. CDC recommended no action needed and bivalent dose can be given in 2 months
This non-serious initial Spontaneous case, was received on 03-Oct-2017, concerning a 27-year-old adult female pregnant patient. The patient had no maternal medical history relevant to pregnancy and no paternal medical history. There were no evidence of a defect/adverse finding from a prenatal test. The patient's concomitant medication included: Prenatal multi-vitamin for unknown indication. The patient had not used any contraceptives. The patient's last menstrual period (LMP) date was on 13-Jan-2017. On 03-Oct-2017, the patient was administered with FLUVIRIN THIOMERSAL (dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number, expiry date: not reported). It was reported that FLUVIRIN vaccine was administered to the pregnant woman (explicitly coded as vaccine exposure during pregnancy) and everything was fine with her. The estimated date of delivery of the patient was on 20-Oct-2017. The outcome of the event was not reported. The reporter assessed the event as not related.
About 12 hours after vaccine she felt like she had COVID all over again.  She had fever of 101, and then the body aches that were very painful.  She took Tylenol #3 for the pain and didn't notice the arm hurting yet.  The main thing was the body aches and fever.  She had chills off and on and a headache.  She felt like she just couldn't get up, wiped out.  She did not eat or drink much.  Through the day Saturday and by Sunday the body aches left, the chills went down during the day but returned Sunday night 2/28/21.  On 3/1/21 she went to the doctor and her temp was down, and is down now 3/4/21.  Through the night Sunday night started having terrible pain in her chest/esophagus, which she could not get the pain to go away.  She did the remedy that she read online, and has had some GERD over the years, but nothing like this.  She could hardly even swallow her own saliva without pain.  She got a prescription for Nexium from the doctor, and started taking that today.  She is trying to eat something, little bity bits to go down without pain in her esophagus.  The pain does get better at times during the day.  She read that it may take 2-3 weeks to heal and the Nexium should be working by then.  She is very fatigued and dealing with the acid reflux issues.   She did also notice redness on her arm was about 3" x 2" down her arm.  It was not at the site of the injection, was a little lower and it was hot to touch.  She kept putting a cold washcloth on it.  She took regular Tylenol.  The body aches went away but was left with such a heavy headache that she took up to 4 Tylenol #4 due to pain.  The redness had faded to about a square " by the time she went to the doctor on Monday, and is still really sore.
Red, swollen and sore upper arm 2-3 hours, post vax. Seen here, 2 days later and was +4cm, flat erythematous area (increased warmth) in SC vaccine of LUE. No signs or symptoms of systemic reaction. Advised to use ice and Benadryl and to call if she has any other concerns.
pt reports sore arm and decreased range of motion in shoulder. on follow up via phone conversation she feels like she has a stiff neck and now wonders if due to chiropractic issues. due to timing with vaccination, she was encouraged to seek care from her primary doctor to rule out adverse effect from flu shot.  she will see md on friday november 5.
exposed to a low temperature of 31.5 degrees Fahrenheit on 15Jun2023 was administered between 15Jun2023 and 21Jun2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 13-month-old female patient who received HAV (Havrix) (batch number PB5JA, expiry date 14-FEB-2025) for prophylaxis.   In JUN-2023, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: exposed to a low temperature of 31.5 degrees Fahrenheit on 15Jun2023 was administered between 15Jun2023 and 21Jun2023). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt date: 3-AUG-2023 The reporter reported that the Havrix vaccines exposed to a low temperature of 31.5 degrees fahrenheit on 15Jun2023 was administered between 15Jun2023 and 21Jun2023. Reporter did not have specific date of administration for each patient. The reporter reported that at the time of reporting, the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. The reporter reported that the Havrix vaccines exposed to a low temperature of 31.5 degrees fahrenheit, which lead to incorrect storage of drug. The case had been link to US2023105916, US2023105928, US2023105927, US2023105925, US2023105923, US2023105921, US2023105918, US2023105917 reported by same reporter.; Sender's Comments:  US-GSK-US2023105916:same reporter US-GSK-US2023105928:same reporter US-GSK-US2023105927:same reporter US-GSK-US2023105925:same reporter US-GSK-US2023105923:same reporter US-GSK-US2023105921:same reporter US-GSK-US2023105918:same reporter US-GSK-US2023105917:same reporter
On Thursday 3/8/07, left arm red and swollen, felt achy all over. Today, 3/12/07 arm still red and warm from elbow to shoulder.
A non-serious spontaneous report of positive reaction to the rapid antigen influenza test manifested by fever and cough has been received from a non-health professional concerning a male patient, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. On 06-Nov-2009, the patient received H1N1, Intranasal for an unknown indication. On 07-Nov-2009, the patient experienced fever and cough which were not present after 24 hours. Oseltamivir phosphate was administered after a positive reaction to the rapid antigen influenza test for the patient. The outcome was resolved.
Patient vaccinated on 4/10/2021 with Janssen. Requested Janseen for 2nd booster dose. Received Pfizer dose instead.
tested positive for COVID; tested positive for COVID; flu-like symptoms ; it wasn't getting better; This is a spontaneous report from a contactable consumer. A consumer reported for patient (daughter). A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 06Jul2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced tested positive for covid, and flu-like symptoms; it wasn't getting better on an unspecified date. It was reported that reporter daughter and reporter went and got our first vaccination with the Pfizer last week Tuesday which was this 06Jul anyways, she started having like flu-like symptoms everything and it was not getting better and two days ago (Further clarification unknown) and she went to the urgent care and, she got tested for a COVID, well the result came back today and shows that she tested positive for COVID. Reporter asking question is we were both Scheduled to receive the second shot of second vaccination about the end of this month, which is the 27, can she well I am so far, I am COVID negative but if she, can she get the second shot or she has wait sometime before she can get the second shot since now, they are saying she has COVID. The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive on unknown date. Dates for she went to the urgent care: Unspecified. Reporter seriousness for events: Unspecified. The outcome of events was unknown. Information about batch/Lot number has been requested
This spontaneous report as received from a nurse refers to a 12 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 06-SEP-2017, the patient was vaccinated with improperly stored GARDASIL 9 (dosing details were not reported) (lot # N007931, expiry date: 17-NOV-2019) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054.
tested positive twice; tested positive twice; This is a spontaneous report received from a non-contactable reporter (Consumer or other non-HCP), Program ID: A 5-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive twice". A caller calling for her grandson about getting a letter saying that the Pfizer Covid-19 Vaccine doesn't stop transmission and doesn't stop from getting Covid because his 5 years old grandson tested positive twice. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive twice; positive, notes: tested positive twice.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from the nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had administered dose of GARDASIL on 10-JUN-2013 (lot # H011350, Expiration Date: 21-FEB-2015). No adverse event was reported. This is one of the report from the same source. Additional information is not expected.
Information has been received from a registered nurse concerning a 32 day old patient who on 11-DEC-2009 was vaccinated with the first dose of ROTATEQ at 4 weeks of age. On 12-JAN-2010 and 20-FEB-2010, the patient received the second and third dose of ROTATEQ, respectively. No adverse effect was reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Best use date recorded by HD as 3 months from receiving. Received on 3-2-2021. Marked to discontinue use on 6-2-2021. Maintained in cold chain management 36 to 46 degrees F. Administered on 6-1-2021 Vial opened for the client. The other 4 doses were discarded at the end of the clinic.  On 6-2-2021 an e-mail from DH was noted with expiration of Lot 1802068 on 5-25-2021.  Johnson & Johnson was contacted and reported to Pharmacist. Reference ID EZR20210078918(VO) case # 02242111. Client has a Developmental Disability. His guardian (mother) was contacted expiration date reported. The mother states that client c/o sore arm 6-1 with difficulty sleeping. Today he is feeling back to normal. No problems or concerns.
A physician reported that a 43 year old female inadvertently received an injection of Diphtheria and Tetanus toxoids adsorbed for pediatric use on 3/3/00 and developed a fever of 105, arm swelling and "got sick." She was seen at the ER on 3/6/00. A dx of cellulitis was made and she was treated with IV Rocephin. The pt was later admitted. White blood cell count was 10,800 and x-ray finding were negative for gas or foreign bodies. She was treated with Vancomycin. The pt was discharged 3/9/00 on Keflex and Motrin or Tylenol for fever. At home she continued to have low grade fevers and chills. On 3/15/00 she was seen in the emergency room for a follow-up visit. Her left bicep was characterized by a 10-cm area of tenderness induration and warmth. Blood pressure was 110/90, pulse 99 and respiratory rate 16. Blood cultures and CBC were ordered, results not provided. This is one of five patients from this facility who inadvertently received Diphtheria and Tetanus toxoids adsorbed for Pediatric use lot 462-357.
Had the shot, still got the shingles/suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had the shot, still got the shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2023 This case was reported by a patient via interactive digital media. The patient reporter reported that he or she received Shingles vaccine and still experienced shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
1 &1/2 to 2 weeks following injection I began to have mild to moderate bilateral lower extremity swelling that did not go away completely with elevation. It was not associated with any redness, warmth, or shortness of breath. It lasted for about 2 weeks with signs of improvement after about a week, and completely  resolved at the 3 week point after onset.
Patient fainted at home 2 hours after vaccine and hit her head and ear. She had a CT scan in ER that was negative but since then has presented to ER and primary care with lightheadedness, dizziness, weakness.
No adverse events reported. We realized after we had administered the vaccine to the patient that he was only 15 years old.
SADDLE PULMONARY EMBOLISM 4/29/2023 ACUTE DVT OF LEFT FEMORAL VEIN ACUTE DVT OF LEFT FEMORAL VEIN 4/29/2023 ACUTE DVT OF LEFT FEMORAL VEIN
very bad light sensitivity to eyes and vision was affected. Felt like her eyes were dilated; very bad light sensitivity to eyes and vision was affected. Felt like her eyes were dilated; Fever; Chills; Body aches; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient). A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 31Aug2021 16:00 (Batch/Lot Number: FE3592) (at the age of 49 years old) as single dose for Covid-19 immunisation. The patient medical history was not reported. Family history and relevant tests were none. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 09Aug2021 (Batch/Lot Number: FA7484) (at the age of 49 years old) via an unspecified route of administration in left upper arm for Covid-19 immunisation. There were no concomitant medications. After the second dose of vaccine, on 01Sep2021, the patient had fever, chills, and body aches. On 03Sep2021, the patient had very bad light sensitivity to eyes and vision was affected. Felt like her eyes were dilated. She consulted her ophthalmologist. Now with her eyes, she was worried and hoping it will go away. The patient had not recovered from light sensitivity to eye and vision abnormal. Outcome of the other events was recovering.    No follow-up attempts are needed. No further information is expected.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Reporter stated that no adverse reactions were reported by any patients. No treatment medications were reported.
nearly daily dull headaches. Mainly behind the eyes but can also migrate to the back of the head. Dry eyes, espsecially in the afternoon
Within 10 minutes of receiving Pneumovax, she began to struggle for breath.  She was still able to speak, was sitting upright in chair, but was holding her chest saying she was having difficulty breathing.  Administered Epipen as manager dialed 911.  I continued to monitor her as manager continued call to 911.  About 5-7 minutes after Epipen, she stated that her breathing was becoming easier.  Fire and Paramedics arrived shortly after this.  They decided to go ahead and take her to Hospital because they were afraid her breathing may have become difficult again as the Epipen left her system.
Under 50 YO  prescription of Vx; Under 50 YO  prescription of Vx; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in an unspecified numbers of patients who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, [the patient experienced inappropriate age at vaccine administration (Verbatim: Under 50 YO  prescription of Vx) and drug use for unapproved indication (Verbatim: Under 50 YO  prescription of Vx). The outcome of the inappropriate age at vaccine administration and drug use for unapproved indication were unknown.   Additional Information: GSK receipt date: 07-MAR-2023  The pharmacist asked if there was any data on administering Shingrix to patients who were under 50 (not immunosuppressed or immunocompromised) with recurring shingles, which led to inappropriate age at vaccine administration and drug use for unapproved indication. The reporter stated that this question was not in regards to a specific patient but physician were writing orders to admin to patients who are under 50 with recurring shingles. No additional details as decision to file adverse event was made after call was disconnected.  Unknown if follow up was permissible due to this.