chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 05-JUN-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, LOT# R034700, expiry date 16-JUN-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 F for 4 hours and 54 minutes. This call was made because of a digital data logger. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000862: US-009507513-1907USA000882: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925: US-009507513-1907USA000927: US-009507513-1907USA000928: US-009507513-1907USA000929: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938:
flu like symptoms for 5-6 days; menstrual cycle was abnormal which meant a longer, heavier and earlier cycle; menstrual cycle was abnormal which meant a longer, heavier and earlier cycle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 44-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: ER8732), for Covid-19 Immunisation. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "flu like symptoms for 5-6 days"; POLYMENORRHOEA (non-serious), HEAVY MENSTRUAL BLEEDING (non-serious), outcome "unknown" and all described as "menstrual cycle was abnormal which meant a longer, heavier and earlier cycle".  Additional information: The patient received 2 doses and a booster dose (on 04May2022 evening). The patient did have a reaction after the second dose, but it was more concerning what happened after the booster dose. With the second dose she had typical side effects, flu like symptoms for 5-6 days, changes in the menstrual cycle. Reported that her menstrual cycle was abnormal which meant a longer, heavier and earlier cycle that she noticed after the second dose and with the booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200700271 same patient/drug, different dose/event
Within 5 mins I became very ill, warm feeling spread to head and I was faint, heart racing, hypertensive ensued, fever, shaking, weakness, cold hands and feet,  confussion, brain fog Paramedic diagnosed overactive immune reaction called ambulance.. 4hrs later I was taken to hospital discharged myself as no trolley or bed available and was to wait overnight in a chair. My sister collected me and I
started seeing double out of left eye on evening of May 8.   The morning of May 9 my eyelid was drooping and double vision out of left eye was a little bit worse.    Went to emergency room on May 9.   Tests included MRI, CAT scan, bloodwork, tested for stroke.   All tests normal.  I was sent home with a diagnosis of third nerve palsy.   My double vision out of left eye has remained the same.  No worse or better as of May 13.    I have not had any pain associated with this.   Just double vision out of left eye.
stated that her son got an allergic reaction to the first dose; hard time breathing; This is a spontaneous report from a contactable Consumer reported for a patient (reporter's son) via Pfizer Sponsored Program.  A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 30Apr2021, as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received first dose on 30Apr2021 and for the second dose 28May2021. The patient mother (reporter) wanted to know the waiting period for the doses and if the second has to be taken at the same time clockwise as the first dose. She also stated that her son got an allergic reaction to the first dose and had a hard time breathing on an unspecified date. She was a little worried about receiving the second dose because she heard it was a little more intense then the first dose. The outcome of both the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Normal labor and delivery on 11/13/2021. Hospital admission within 6 weeks of receiving the COVID vaccine.
This case was reported by a consumer via out of hour services and described the occurrence of dizziness in a female patient who received SHINGRIX for prophylaxis. On 16th July 2018, the patient received SHINGRIX. In July 2018, less than a day after receiving SHINGRIX, the patient experienced dizziness, muscle tightness, chills, injection site erythema, nausea and fever. The patient was treated with ibuprofen and Epsom Salt. On an unknown date, the outcome of the dizziness, muscle tightness, chills, injection site erythema and nausea were unknown and the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the dizziness, muscle tightness, chills, injection site erythema, nausea and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that she has redness at the injection site. On the day of vaccination (Monday) at night, the patient started getting dizziness, nausea, fever, chills, and muscle tightness. The patient took a bath in Epsom salt and took some ibuprofen, and was finally able to sleep at 4 am. On the next of vaccination (Tuesday), the patient woke up feeling better, but than she started feeling worse again. The patient took her temperature and which was recorded as 100.2 degrees F. The patient took another bath of Epsom salt and ibuprofen, and her fever has finally broken. No further details were left on the after hours voice message.
I had body ache and chills for three days and started with vertigo on 4th day morning. It was really bad and still continuing but slightly improved.
I had my first two Pfizer doses starting in April 2021 when I was pregnant (delivered 8/2021). Had a moderna booster and two months later began experiencing unusual symptoms that were eventually diagnosed as Graves? disease. I do have family history of autoimmune disorders- a brother with type 1 diabetes, a maternal grandmother with Hashimoto?s thyroiditis and a maternal aunt also with Hashimoto?s. Given this family history it isn?t totally surprising that I developed Graves? but given the booster?s proximity to my development of symptoms, I felt it was worth reporting as a possible autoimmune trigger.
Patient called this morning describing throbbing pain in arm. His words  "Pain feels like outside of arm, not back, not side, not inside" I asked if he had a rash or if it looks like site of injection is infected, he said it looks normal with no rash. His words "I can't sleep on the left side, having trouble putting on long sleeve shirts when putting arm back" I asked him about his arm range of motion by asking "Can you move your arm around in cirlcles?" He said he could do that fine its just trouble putting on long sleeve shirts where the pain bugs him. I asked him if the pain started right after vaccine, later that day or the next day following the vaccine and he responding by saying the next day is when he noticed the pain.  He got the Fluzone HD+ in the right arm the same day and has no complaints with that injection/arm.  I asked if the pain was from things rubbing on the skin but he said it doesn't bug him when it is touched; he just feels a throbbing pain. He called Doctor's office before calling us. Doctor's office advised him to call us first and I advised patient to try and use ice packs for no longer than 10 minutes at a time and try a OTC pain reliever for a few days and keep on eye on the pain. If no relief happens to call Doctor and schedule an appointment.
Developed "knot" and pain left deltoid area approx 6 days post-vaccination.  Palpable 1x1cm hard area, no redness or swelling, pain to palpation.  Referred to NP for follow-up.  No treatment required.
Initial information received on 18-Mar-2019 regarding an unsolicited valid non-serious case received from a non healthcare professional by phone. This case involves adult patient of unknown demographics who was vaccinated with a dose of MENACTRA (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided. It was a case of exposure during breast feeding. No Lab data was reported. It was not reported if the patient received a corrective treatment. Documents held by the sender: none.
high fever 102.6, severe body aches, chills,sweats, headache, neck pain,weakness, fatigue, nausea, runny nose, 48 hrs and going
This spontaneous report was received from a male patient of unknown age with diabetes mellitus, reporting on herself. The patient reported that he went to an unspecified Orthopedic Dr. because he had lots of problems and issues with both of his arms from years of multiple insect bites. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis. The patient stated that at injection site the skin looked and felt healthy, no joint breaks. Subsequently, the patient stated that he went to a fast food restaurant on an unspecified date and that he had a salad with bad bacteria from tomatoes and iceberg lettuce. The patient reported that the injection site did not look good anymore, there were breaks in the joints and it does not feel healthy anymore (arthropathy and injection site reaction). At the time of the report, the outcome of arthropathy and injection site reaction was unknown. The patient did not mention the causality assessment between the events and PNEUMOVAX 23 vaccination. Consumer left voicemail on SRP voicemail on 06/25/2018 at 9:43 PM. The primary reporter is Consumer. Consumer reporting that he goes to an unspecified Orthopedic Dr. because he has lots of problems and issues with both of his arms from years of multiple insect bites. Consumer reported receiving PNEUMOVAX 23 on an unspecified date and at the injection site "the skin looked and felt healthy, no joint breaks" on unspecified dates. Consumer reported "going to a fast food restaurant on an unspecified date and had a salad with bad bacteria from tomatoes and iceberg lettuce." The consumer reported the "injection site does not look good anymore, there are breaks in the joints and it does not feel healthy anymore." No additional information provided on SRP voicemail. This spontaneous report as received from a consumer refers to a male patient of unknown age with limb discomfort and diabetes mellitus. The patient's medical history included arthropod bite. On an unknown date the patient was vaccinated with PNEUMOVAX 23 for prophylaxis. On an unknown date the patient experienced arthropathy and injection site reaction. The outcome of arthropathy and injection site reaction is unknown. {Additional information has been requested. / Additional information is not expected.}
I have a headache, congestion, and a little bit of a cough.  My case has been very mild compared to January 2022. I contact my doctor via Telehealth.  They prescribed Paxlovid and asked me to take Valtrex, Vitamin D3, and she supported me taking Epothex Nasal Spray.
This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old non pregnant female patient received an unknown dose of BNT162b2 (COVID-19 MRNA VACCINE BIONTECH; Lot number: UNKNOWN) via unspecified route of administration, in left arm on 24Mar2021 at 12:00 PM (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient had medical history of allergy to sulfonamides. The patient did not receive any other medication within 2 weeks of vaccination. The patient did not receive any other vaccine within 4 weeks prior to vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since having the vaccine. On 24Mar2021 at 20:00, 8 hours after vaccination, the patient experienced fever. On 25Mar2021 08:00 AM, 20 hours after vaccination, the patient experienced nausea, at 14:00, the patient experienced vaccination site pain. Therapeutic measures were taken as a result of the event which included treatment with Tylenol. The clinical outcome of the events fever, vaccination site pain, and nausea were resolving.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This is an instance of breakthrough COVID-19 disease after which death occurred. The individual was vaccinated with the Moderna product on 02/02/2021, 03/02/2021, and 11/18/2021. The lot number,  clinic/facility, ordering provider, and injection site was NOT entered into the state immunization system for the third dose, so everything that is known to me regarding this dose is provided in this form. The individual tested positive for COVID-19 on 07/11/2022, when they presented to Emergency Department with a primary complaint of  general weakness and assessment after a fall. They individual did not report any COVID-19 symptoms at that time. They were admitted to hospital 07/12/2022 and discharged 07/21/2022. They then presented to emergency department again on 07/24/2022 for sudden onset unresponsiveness and hypoxia and admitted to hospital again.  They were found to have aspiration pneumonia. The detection of COVID-19 was described as "incidental." They remained hospitalized until their death on 07/26/2022.
experiencing DOB; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2, Solution for injection) (Batch/Lot number: unknown) 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: DYSPNOEA (non-serious), outcome "unknown", described as "experiencing DOB". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
paralyzed from the neck down, unable to turn in bed; fall, twice down multiple flights of stairs; Unable to even turn in bed; This serious case was reported by a consumer via interactive digital media and described the occurrence of paralysis in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced paralysis (Verbatim: paralyzed from the neck down, unable to turn in bed) (serious criteria hospitalization and GSK medically significant), fall (Verbatim: fall, twice down multiple flights of stairs) (serious criteria hospitalization) and bedridden (Verbatim: Unable to even turn in bed) (serious criteria hospitalization). The outcome of the paralysis, fall and bedridden were not reported.   It was unknown if the reporter considered the paralysis, fall and bedridden to be related to Shingrix.     It was unknown if the company considered the paralysis, fall and bedridden to be related to Shingrix.   Additional Information: GSK receipt date: 01-MAY-2023, 02-MAY-2023 This case was reported by patient via interactive digital media. The patient received the shingles vaccine (Shingrix by GSK) and was paralyzed. The patient reported that about a week after receiving the Shingrix vaccine, he started to fall hard around the house for no reason, twice down multiple flights of stairs. The patient reported that within 2 plus weeks he was paralyzed from the neck down, unable to even turn in bed and had to be hospitalized. Follow up would not possible, as no contact details were available.
Patient had a reaction at the injection site which blistered and had white pus. Pt followed up with her provider which initiated valcylovir  and clindamycin
He started not sleeping good and waking up in the middle of the night rubbing his legs together a lot when he was laying down and then the low grade fever started and then there was this really horrible rash that started and had lasted 3 days now also he has started to get a yeast infection on his peepee.
doesn't feel herself; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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: MALAISE (non-serious), outcome "unknown", described as "doesn't feel herself".  Additional information: The report is cross referenced to report ID: HCMS4A03. Received call from consumer regarding the Pfizer COVID vaccine. While reporting for herself, she mentioned that others who are in her family, her mom, had her shot. The only thing she is telling her is that she doesn't feel herself. Her sister had it and feels fine. This report is to capture information on her mother. She did not wish to complete a report on her mother. No further details provided. Unable to confirm if patient received Pfizer's COVID vaccine. Reason for no lot number: of Unspecified COVID vaccine: Caller unwilling to complete the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
24 hours post vaccination, infant developed fever of 103 degrees/Ax that lasted 12-24 hours. No other Sx.
The pt's skin felt itchy all over the day after immunization, followed by scattered hives, which persisted into the second day post vax. When the client took Benadryl the discomfort was reduced and the client notified private provider.
10/27/00, telephone call from client at 14:00, complaining of swelling in left arm that began at injection site and has now moved down to approx. 2" above elbow. Area is 3" wide and warm to touch. No redness or swelling now, at injection site. Symptoms began the evening, post vax. Temperature 96F. Complained of "night chills and general aches". No appetite for past 3 days and has only eaten chicken broth. Vomited "bile" this morning. Client reports receiving both the flu and pneumonia vaccines in the same arm, the same day. Consent form shows only pneumonia given.
heavy blood clots; really heavy bleeding during their period; everything else was as expected like fever; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (heavy blood clots), HEAVY MENSTRUAL BLEEDING (really heavy bleeding during their period) and PYREXIA (everything else was as expected like fever) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Moderna (Dose 1), Moderna (Dose 3) and Moderna (Dose 2). Past adverse reactions to the above products included No adverse event with Moderna, Moderna and Moderna. Concurrent medical conditions included Epilepsy, Fever and Immunocompromised (immunocompromised with neutropenia low white blood cell count). Concomitant products included LEVETIRACETAM and ZONISAMIDE for Epilepsy, PARACETAMOL (TYLENOL) for Fever.    In October 2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced THROMBOSIS (heavy blood clots), HEAVY MENSTRUAL BLEEDING (really heavy bleeding during their period) and PYREXIA (everything else was as expected like fever). At the time of the report, THROMBOSIS (heavy blood clots), HEAVY MENSTRUAL BLEEDING (really heavy bleeding during their period) and PYREXIA (everything else was as expected like fever) outcome was unknown.            Patient got the new Bivalent booster shot last Tuesday and experienced really heavy bleeding during her period, heavy blood clots, everything else was as expected like fever. No treatment information was provided by the reporter.   This case was linked to MOD-2022-667341 (Patient Link).
the injection site is extremely painful; bleed a lot; there was lot of blood, it was more than usual; I could barely move; Rest of the arm feels cold like really cold; This is a spontaneous report from a contactable nurse (patient). This 48-year-old female patient (weight 68.04 kg, height 160 cm) received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) on 22Dec2020, at single dose, for COVID-19 immunisation. Relevant medical history included asthma and allergy from an unspecified date and ongoing. Concomitant medications were none. On 22Dec2020, the injection site was extremely painful and bleed a lot; there was lot of blood, it was more than usual. She could barely move and rest of the arm felt cold like really cold. Patient put 3 band aids on injection site. Clinical outcome of the events was unknown at time of this report.   Information on the lot/batch number has been requested.
12 month old male infant presented to clinic office with mother after daycare called and infant had a fever of 101 with rash. Mother brought baby into clinic officeon 2-17-23 as rash now all over body. Rash onset was 2-15-2023 (one week following 12-month old MMR vaccine) and mom concerned if rash was related to recent vaccines or upper respiratory illness. Rash began on 2-15-2033 most prominantly on face (cheeks) and spreading over trunk and now all over body at time of clinic visit on 2-17-23. Diagnosed with URI and discharged from clinic. Parents and baby returned on 2-23-23 as rash worsened. Tests sent: Viral panel & Measles RT-qPCR, Measles IgM and IgG. Tests returned positive for Adenovirus & Measles RT-qPCR