chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shoulder Pain, sore shoulder; sharp pain on right side of rib cage; 2-dose series in 2018, in 2022 shingles/suspected vaccination failure; Shingles/diagnosed with shingles; Vacine given way too high in the shoulder area; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine  (received Shingles vaccine prior to Shingrix vaccine).   In October 2018, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. In October 2018, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. On 12th October 2022, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced shoulder pain and rib pain. On an unknown date, the outcome of the vaccination failure, rib pain and vaccine administered at inappropriate site were unknown and the outcome of the shingles and shoulder pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, shoulder pain and rib pain to be related to Shingrix and Shingrix.     Linked case(s) involving the same patient:  US2022AMR148225   Additional Information: GSK receipt date: 13-Oct-2022 Reporter's comment: The patient's wife reported that the patient had the 2-dose series of Shingrix vaccine in 2018.  The second dose was injected in the right arm.  The reporter stated that the injection was administered way too high in the shoulder area and this caused pain and soreness on the shoulder area. The reporter stated that still this day the patient had pain in the shoulder.  The reporter stated that they did not knew if this was related to the vaccine.  The patient had a sharp pain on the right side of his rib cage and was diagnosed with Shingles. The patient was prescribed 1 gram of Valacyclovir stat, then three times a day for 7 days.   No additional information was provided. Not all information was available.   Lot and expiration date was unknown. Consented to follow up with healthcare professional was provided. The case was linked with case US2022AMR148225, reported by same reporter for different product for same patient. Additional supportive information: The injection was administered way too high in the shoulder area and this caused pain and soreness on the shoulder area, which led to vaccine administered at inappropriate site. This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments:  US-GSK-US2022AMR148225:different product, same patient, same reporter
Information has been received from a HCP concerning a 12 month old male who on 27-OCT-2000 was vaccinated with Comvax IM in the right thigh. On 27-OCT-2000 the pt experienced small knot at the injection site. He developed no other symptoms, however the knot remained for five weeks. Additional information has been requested.
Initial information received on 21-Sep-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 78 years old female patient who had vaccine for 2017 season that had expired, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 21-Sep-2018, the patient received a first 0.5 ml once dose of suspect FLUZONE HIGH DOSE lot UI845AA via intramuscular route in the left deltoid (expiry 13-Apr-2018). It was a case of actual medication error due to expired vaccine used. (Other relevant tests included No lab test.) Final diagnosis was the patient was vaccinated with FLUZONE had for the 2017 season that had expired. It was not reported if the patient received a corrective treatment. It was unknown if patient had adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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.
Patient was given 5 doses of the Janssen vaccine instead of 1 dose. It is an  administration error. Follow up completed, aside from soreness in arm patient did not have any other symptoms or side affections.
About 5 minutes after receiving imms became pale & diaphoretic & near syncopal. Had to lie down & drink cold water & rest for episode to resolve.
he got sick 11 days later after he got the 1st dose; he got sick and wasn't sure if it is the flu; slipped off in the bathroom; went into the shower and had a fall; experienced some leg pain; felt light-headed; blood pressure is high but today his blood pressure went down; This is a spontaneous report from a contactable consumer reporting for himself from a Pfizer-sponsored Program. An 85-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), dose 1 via an unspecified route of administration on Jan2021 (at the age of 85-years-old) as 1ST DOSE, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced he got sick 11 days later after he got the 1st dose, he got sick and wasn't sure if it is the flu, slipped off in the bathroom; went into the shower and had a fall, experienced some leg pain, felt light-headed, blood pressure is high but today his blood pressure went down on an unspecified date. Upon follow-up on 05Feb2021, the caller said he had his first dose last 9th of Feb. 11 days after the first dose, the caller said he got sick and wasn't sure if it is the flu, mentioned that he slipped off in the bathroom and experienced some leg pain, and felt light-headed since yesterday and is getting better now. The caller said his blood pressure is high but today his blood pressure went down, main concern is if he should get the second dose. Upon additional follow-up on 05Feb2021, no new event was reported however patient had two questions and had been on the phone all day. Caller stated that he had the first dose of the COVID vaccine in the latter part of January, and since then, he went into the shower and had a fall. Caller stated that he also has gotten sick. Caller was wondering, if there was a recommendation for getting the second dose, after experiencing what he had, or was the three weeks still the recommendation. Caller was wondering because he was due for his second dose on Tuesday. Caller was also wondering if it was possible to get a side effect from a product, 11 days after that person gets the product. Caller stated that he had already completed two reports about this, and he was just trying to get his question answered. Clinical outcome of the events was unknown.  Follow-up (05Feb2021): New follow-up report received from a Pfizer-sponsored Program from a contactable consumer included: No new event however patient had called upon trying to get his questions answered.   Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Fever; Fatigue; Chills; Body aches/Pain at location of dermal fillers for 24-36 hours after the second vaccine; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no and expiration date: not reported) via an unspecified route of administration, in the left arm on 17Mar2021 at 15:30 (at the age of 48-year-old) as dose 2, single dose for COVID-19 immunization. Medical history included COVID-19. The patient had a history of allergy to sulfa. Since the vaccination, the patient had not been tested for COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included paracetamol (TYLENOL) and multi vitamin. Historical vaccine included of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no and expiration date: not reported) via an unspecified route of administration, in the left arm on 24Feb2021 at 14:30 (at the age of 48-year-old) as dose 1, single for COVID-19 immunization and experienced fever, chills, fatigue and body ache. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021 at 02:30, the patient experienced fever, fatigue, chills, body aches and pain at location of dermal fillers for 24-36 hours after the second vaccine. The patient did not receive any treatment for the adverse events. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The outcome of the events fever, fatigue, chills, body aches and pain at location of dermal fillers for 24-36 hours after the second vaccine was resolved in Mar2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Red swelling and hard knotting around the injection site, patient was told to ice area and take oral antihistamine.
Following receiving her COVID-19 Moderna vaccine, patient was seated in waiting room, went to stand up and briefly lost consciousness and hit her head either on the floor or chair and had a contusion on the left side of her forehead. EMS services were called but patient refused treatment.
On 02/24/2021 the day after the vaccine- My left arm was really tender, sore, red and kind of warm. I did a telehealth with my doctor- she told me to use a cold pack and to use ibuprofen and to rest.  On 02/24/2021, my symptoms resolved by the evening. It was not feeling nearly as bad.
Had difficulty urinating within a few weeks of second dose of Moderna, later developed significant swelling of right leg. 6 months after first dose had worsening urinary issues, elevated alkaline phosphatase. Received booster dose and within 24 hours had severe lower back pain, body aches all over, fatigue, elevated d-dimer and crp, abnormal kidney functions, worsening of elevated alkaline phosphatase, significantly worsened swelling of leg and urinary incontinence. Symptoms began following initial vaccination with 2 doses,  now diagnosed with prostate cancer that is wide spread with metastatic cancer to numerous lymph nodes, bladder and bone. Decline in health since first 2 doses and significant decline following booster dose. Within 7 months of symptoms onset of prostate cancer, he is now likely terminal.
Pfizer monovalent vaccine was administered instead of the Pfizer bivalent vaccine. Wrong vaccine.
Administration of an expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired dose) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an expired dose). On 03-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administration of an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.
Caller is an office manager reporting that an improperly stored dose of M-M-R II and VAQTA were administered to the patient on 26MAY2022 after experiencing a temperautre excursion. No additional AE reported.; Caller is an office manager reporting that an improperly stored dose of M-M-R II and VAQTA were administered to the patient on 26MAY2022 after experiencing a temperautre excursion. No additional AE reported.; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.   On 26-MAY-2022, improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (lot number: U033212 expiration date was reported as 28-OCT-2022, but upon internal validation established as 07-NOV-2022; strength, dose, route of administration, and anatomical location were not reported) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (rHA) (M-M-R II) subcutaneous injection (lot #T033814, expiration date: 05-OCT-2022; strength, dose, route of administration, and anatomical location were not reported) were administered to the patient for prophylaxis after a temperature excursion of 54.5 fahrenheit (F) for 11 hours (product storage error). There was no previous temperature excursion. No additional adverse event (AE) was reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2208USA006520: US-009507513-2208USA006720: US-009507513-2208USA006693: US-009507513-2208USA006700:
vaccine was administered to patient after a temperature excursion of minus 1.25 degree Celsius, no AE; Initial information was received on 03-Aug-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case is linked to cases 2020SA203233, 2020SA202232, 2020SA202350, 2020SA203126, 2020SA202832, 2020SA203422, 2020SA202831 and 2020SA207050 (same reporter).  This case involves an 11 years old female patient who was vaccinated with a 0.5 ml dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (batch number, expiry date not reported) in the right arm on an unknown date for prophylactic vaccination after a temperature excursion (product storage error).  The patient's medical history, past medical treatment, vaccination, and family history were not provided.  The patient did not receive any other vaccines or medications on that visit.  This was an actual medication error case due to product storage error temperature too low.  It was reported that, the refrigerator got too cold many times due to possible batteries issues, got to frozen temperatures several times, with a minimum of minus 1.25 degree Celsius.  No adverse event was reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.  There will be no information available on the batch number for this case.
Patient was immunized with vaccine that has beyond-use-date (BUD) of 7/15/22; MFG 11/20/21;EXP 10/31/22. No temperature excursion during this time period. We have reached out to Pfizer for additional information regarding vaccine viability past the BUD, currently waiting on response.
The patient started having itchiness at the back of her throat and tingling senses on her body. No signs of rash, hives, or any swelling on facials, neck, or body.   The observation continues to 2:00 pm, symptoms described above were still remaining but not elevated. Benadryl 25 mg, oral was administered at 2:10 pm. Self-monitoring for further reactions after taking medication was suggested.   During those times, the patient was alert and oriented.   The patient had Hx of sensitivity reactions from Moderna with itchy at the back of throat and body and received Benadryl 50 mg, oral.
vomiting; diarrhea; Initial information received on 20-Dec-2022 regarding an unsolicited valid non-serious courtesy case received from a consumer/non-HCP.  This case involves a 57 years old female patient who had vomiting and diarrhea after receiving vaccines covid-19 vaccine and influenza vaccine and while treated with treprostinil sodium [Tyvaso].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Pulmonary arterial hypertension.  Concomitant medications included macitentan (opsumit) and sildenafil citrate.  On 29-Oct-2020, the patient started taking treprostinil sodium Inhalation Gas 54 µg (9 breaths) four times a day (QID) via inhalation (IH) route (lot - 2102219, expiry date: 30-Nov-2023) (concentration of 0.6 mg/ml) delivered by Tyvaso Inhalation Device (TD-300/A) for Pulmonary arterial hypertension.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, dose, frequency, site, route: unknown, with an unknown batch number and expiry date: unknown) for influenza immunization(immunization).  On an unknown date, the patient received a dose of suspect covid-19 vaccine not produced by Sanofi Pasteur (form, strength, dose, frequency, site, route: unknown, with an unknown batch number and expiry date: unknown) COVID-19 immunisation  On 17-Nov-2022 the patient developed a non-serious events vomiting and diarrhea (latency: 2 years 19 days) following the first dose intake of treprostinil sodium and (unknown latency) following the administration of covid-19 vaccine and influenza vaccine.  Action taken with influenza vaccine and covid-19 vaccine was not applicable and unknown with respect to treprostinil sodium  It was not reported if the patient received a corrective treatment for the events   At time of reporting, the outcome was Unknown for the events
patient had starting having symptoms end of feb 2023.......patient states she was diagnosed with guillan barre post vaccination; numbness in extremities and face, weakness in extremities which caused her to be unable to walk. was hospitalized for nearly a month.
Patient was sitting for 15 minute observation and suddenly passed out for about 10 seconds.  He was sweaty and pale and mentioned being light headed.
Rash started on arm yesterday 3/11/21. Hot to the touch now encompasses most of arm above the elbow. Whole arm is sore. I have pictures of yesterday and today 3/12 to show progression.
Patient presented to the ED and was subsequently hospitalized on 3/22/21 and 4/6/21. These visits are within 6 weeks of receiving COVID vaccination.
noticeable shortness of breath, heart palpitations throughout the night. went away around 10 AM 10/21/2021
He got his vaccine, was fine for a couple of days, had a sore arm which he expected.   On the 21st he was sitting in his chair and his left hand was going numb and puffing up and moved up to his elbow.  He got up to walk across the room and was talking to somebody on the phone and then he could not talk.  It came back within a couple of minutes.  His wife took him to the hospital, they started doing a lot tests on him.  They did an MRI or anything concerning for a stroke, which he was not . He is now weak, loopy and eats normally but he just has no energy and wobbly when walking.  He had no symptoms prior to the vaccine.  He was walking in a walking pool every day for an hour prior to the vaccine, and now has no been there in weeks.   While he was in hospital on the day they released him that it was not a stroke, but he had not told them that he had the vaccines, and released him.  They did not give him any instructions or any medications.   He was told when he got to the hospital and saw him that they were going to keep him and run tests.    He went to hospital.    He has had all he COVID vaccines, and had no reactions to those or the flu vaccine that he gets every year.
pt recv vax 31JUL98 & 2 days post vax pt began to run a low grade fever 100-101, was cranky & had fine shaky movements w/eye moving back & forth horizontally when nursing;3 days post vax pt adm to hosp to r/o sz or convuls;
I noticed that Medical Assistant gave menactrea which is not in shot schedule for 15 mo. old. I questioned lady and she said she pulled up state Shots online tracking system and it said child was overdue for menactra so she gave vaccine. I called Dr. and then I called CDC and spoke with  agent who said no reason to believe it would be harmful. The vaccine is to be given 9 mos-55 years but children only get if they are high risk. I then called the immunization coordinator at State Shots and spoke with Agent.
Fever; chills; headache; muscle aches; tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 24 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3, SINGLE), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 2022, outcome "unknown", described as "Fever"; CHILLS (non-serious) with onset 2022, outcome "unknown"; HEADACHE (non-serious) with onset 2022, outcome "unknown"; MYALGIA (non-serious) with onset 2022, outcome "unknown", described as "muscle aches"; FATIGUE (non-serious) with onset 2022, outcome "unknown", described as "tiredness". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a physician refers to a 14 year old patient. On unknown dates the patient was vaccinated with two doses of VARIVAX (Merck) (lot#, expiration and dose unspecified). On an unknown date the patient experienced shingles. The patient sought medical attention via saw the physician. Antiviral medication was given for treatment. The event outcome was unknown. Additional information has been requested.
Left arm itching immediately after shot; resolving.  No respiratory distress.  Discharged 1:00 per MD.