chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I was informed that I was exposed to COVID-19 on 7/9/2022 after coming home from a trip. In the late evening I started to feel slight chills, fatigue, nasal congestion, and a slight sore throat. I took a PCR test that day. The next morning I woke up, and my symptoms were worse. I took an at home test that day that came back positive. I called my doctor, and he prescribed PAXLOVID and ZYRTEC D. After about 2 days later I started to feel about 60 percent better. On 7/14/2022 I started to feel much better I just feel fatigued. I am still in isolation until 7/21/2022.
Patient presented to the ED and was subsequently hospitalized for chronic kidney disease, GI hemorrhage within 6 weeks of receiving covid vaccination booster.
received the first dose of the Pfizer BioNTech Covid 19 vaccine on 5Sep2021/A week later they both tested positive for Covid; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 42-year-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on 05Sep2021 (at the age of 42-years-old) as dose 1, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. On an unspecified date in Sep2021, the patient received the first dose of the pfizer biontech covid 19 vaccine on 5sep2021/a week later they both tested positive for covid. The event resulted in the emergency room visit. The patient was scheduled for second dose on 26Sep2021, could she push back the appointment. Not let them schedule it past 42 days. The Regeneron pharmacist said they had to restart the series. Asked was there any information on how the second dose may feel after having Covid. Will there be an interaction with the antibodies. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date in Sep2021. Therapeutic measures were taken as a result of event that included patient was given Regeneron antibody infusion, to help fight off the virus in the emergency room on 14Sep2021 and was released from the emergency room after the infusion. He had read conflicting information if she should get the vaccine on that date, after having Covid and the Regeneron infusion. The outcome of the event was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101227463 same reporter/product/event, different patient
Headache, Myalgia & Fever Narrative:  Employee reports headache, fever and chills 12 hours after receiving 1st dose, resolved within 24 hours.
I mysteriously have unusually elevated heart rate today. I regularly drink coffee and tea and don't usually get such elevation in heart rate from caffeine. Normally my heart rate is in the low 60s bpm when seated, but today my heart rate is around 80 bpm when seated and I feel the pounding heart beats and slight shortness in breath, which sounds like myocarditis or pericarditis. I kind of wonder if it's related to the vaccine I received yesterday. It doesn't seem severe and doesn't significantly affect normal activities. I'll just rest and see.
Vaccine stored at lowtemperature of 31.5 degrees Fahrenheit and administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 1-year-old male 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: Vaccine stored at lowtemperature of 31.5 degrees Fahrenheit and administered). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 03-AUG-2023 Nurse reported that patient was administered with Havrix vaccine. On 15Jun2023 vaccine was exposed to a low temperature of 31.5 degrees Fahrenheit . The reporter was not sure on which date vaccine was administered.  According to reporter it was administered between 15Jun2023 and 21Jun2023. At the time of reporting, the dose has not been repeated. The vaccine administration facility was the same as primary reporter. The patient was administered with vaccine which was stored at low temperature which led to, Incorrect storage of drug. The reporter consented to follow up. This is 1 of 8  linked report, reported by same reporter.; Sender's Comments:  US-GSK-US2023105916:same reporter US-GSK-US2023105921:same reporter US-GSK-US2023105926:same reporter US-GSK-US2023105917:same reporter US-GSK-US2023105918:same reporter US-GSK-US2023105923:same reporter US-GSK-US2023105925:same reporter US-GSK-US2023105927:same reporter
Dose of .05 ml given to patient, instead of .5 ml. patient called back in and given .45 ml IM to equals to the .5ml dose
Initial information received on 13-Dec-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves greater than 18-years female patient who experienced bruising and arm pain, swelling and redness with a diameter of 3 inches, while she received vaccine MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 06-Dec-2018, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious bruising and arm pain, swelling and redness with a diameter of 3 inches following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. (Other relevant tests included no lab data.) Final diagnosis was arm pain, swelling and redness with a diameter of 3 inches and bruising. It was not reported if the patient received a corrective treatment. The patient was not recovered from the events.
Information has been received from a pharmacist concerning a patient who on 27-JUL-2008 was vaccinated with PNEUMOVAX (Lot # 662042/0622X) (route, site of administration not reported).  The patient experienced injection site reaction after receiving the vaccine on the same day.  The injection site became red and swollen.  The patient sought unspecified medical attention. The patient was recovering.  This is one of several reports from the same source.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the  agency and was released.  Additional information has been requested.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 11-FEB-2017, the patient received an expired dose of M-M-R II Lot # K011317 and expiration date: 13-AUG-2016, subcutaneously (dose was not reported) for prophylaxis. The patient had not experienced an adverse effect. There was no product quality complaint involved. Additional information has been requested.
5 minutes post vaccination, client left an "adrenalin rush" and "tightness on his chest and tingling and tense all over his body." Client felt very anxious today and he reports having history of anxiety. His BP is 155/97 p 101, after 5 minutes manual BP is 142/90 p 110. 911 was called and medics performed an EKG on site. Client indicates that his symptoms are improving and was not transported to the hospital.
second dose of the vaccine was administered to a patient at 20 days instead of 28 days.; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of the vaccine was administered to a patient at 20 days instead of 28 days.) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of the vaccine was administered to a patient at 20 days instead of 28 days.). On 01-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of the vaccine was administered to a patient at 20 days instead of 28 days.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products reported  No treatment products reported
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a noncontactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 72-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 at 13:15 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in right arm for covid-19 immunisation; bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 at 12:00 as dose 4 (booster), single (Lot number: GH9693), in right arm for covid- 19 immunisation; bnt162b2 (BNT162B2), on 11Feb2021 at 12:00 as dose 1, single (Lot number: EL9264), in right arm, on 06Mar2021 at 12:00 as dose 2, single (Lot number: EN6205), in right arm and on 08Nov2021 at 12:00 as dose 3 (booster), single (Lot number: FG3527), in right arm for covid- 19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs, honey bee venom; "honey bee venom" (unspecified if ongoing), notes: Known allergies: Sulfa drugs, honey bee venom. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARSCoV- 2 test: Positive, notes: Tested positive for Covid 4 days after completing Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 26Sep2023 to 01Oct2023.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Painful arm; headache; chills; fever of 100.2; stiff neck; nausea; fainting; overall muscle aches; weakness.
Pt. developed swelling and redness at the site of the injection, within 2-3 hrs of the vaccine adm. The redness and swelling and local warmth progressed over the next 48 hrs.
Mom called 1 week after varivax and said child had a low grade fever for a day or two, then broke out with red areas all over body.  some hove blisters estimated 250 areas - child not ill, playing.  Nurse at District Office told mom it was chickenpox, unknown if child was exposed to CP before shot - is in daycare, mom had copy of VIS re-rash and fever.
1130AM pt became sleepy & was moaning, turned white & had some trembling; pt was given APAP by MD then went to ER; pt had diffuse macular rash-given Phenergan; pt was drowsy for several hrs; t104;
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 25-FEB-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). The vaccine was in excursion with a sum of hours of 972 and 336. The lowest recorded temperature was -3. The highest recorded temperature was 59. The vaccine was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
scorching case of herpes; Initial information was received on 21-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via social media.  This case involved adult (unknown gender) patient who experienced scorching case of herpes (herpes simplex) while receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Past medical treatment(s), vaccination(s) concomitant medication and family history were not provided.  It was 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 QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious scorching case of herpes (herpes simplex) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Increased frequency and pitch of ringing in the ears; pain is pressure points; Headache; Whole body is hurting; Pain in glands underneath neck; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Increased frequency and pitch of ringing in the ears), PAIN (pain is pressure points), HEADACHE (Headache), MYALGIA (Whole body is hurting) and LYMPHADENOPATHY (Pain in glands underneath neck) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0041CA) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ALPRAZOLAM (XANAX), BISOPROLOL FUMARATE (ZEBETA), CELECOXIB (CELEXA [CELECOXIB]), HYDRALAZINE, FUROSEMIDE SODIUM (LASIX LIQUIDUM), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), EVOLOCUMAB (REPATHA), ROSUVASTATIN CALCIUM (CRESTOR), ZOLPIDEM TARTRATE (AMBIEN) and GLYCERYL TRINITRATE (NITROGLYCERINE) for an unknown indication.   On 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced TINNITUS (Increased frequency and pitch of ringing in the ears), PAIN (pain is pressure points), HEADACHE (Headache), MYALGIA (Whole body is hurting) and LYMPHADENOPATHY (Pain in glands underneath neck). At the time of the report, TINNITUS (Increased frequency and pitch of ringing in the ears), PAIN (pain is pressure points), HEADACHE (Headache), MYALGIA (Whole body is hurting) and LYMPHADENOPATHY (Pain in glands underneath neck) outcome was unknown.            No treatment medications was provided  Action taken with mRNA-1273 in response to the event was not applicable.
Redness and swelling to site the same day of vaccine. Site continue to remain red and swelling three days after vaccine with redness and swelling spreading.  Mother giving child Tylenol and motrin. Child has follow up visit.
The pt experienced a fever of 103.7 the night of the vax and also redness at the injection site of polio.
Severe flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Severe flu like symptoms) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient stated that she got infected  with COVID-19) on 15-Dec-2020. Concurrent medical conditions included Breathing difficult (Patient had to go to a pulmonologist and a physical therapist to get better).    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Severe flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Severe flu like symptoms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were provided  On an unspecified date Patient's primary care physician referred her to a  spine specialist, and they ordered her to get X-Ray and CT- Scan. Patient stated that her  spine doctor told her that her X-ray and CT-scan both were fine, and she might have arthritis. Patient went to physical therapist and acupuncture therapist but she has not felt any improvement.    This case was linked to MOD-2021-291122 (Patient Link).
While checking on the patient I noticed she was lathergic and unable to use her words to communicate with me. I proceeded to ask her name and she was unable to give me an answer. During this time she placed her hands on her head several times as if she was thinking of things to say.  Her manners at this time were totally different from our initial conversation. Upon her arrival to the clinic she was able to answer all questions and make small talk before she received her booster. We communicated a several times during her monitoring time and before s/s were presented before discharge from the vaccination clinic.
Initial unsolicited report received from a pharmacist on 28-Aug-2017. This case involves a female patient (age not reported), who was vaccinated FLUZONE HD via intramuscular route (batch number, expiry date, dose and dose in series not reported) on an unknown date of Aug-2017. Patient's medical history and concomitant medication was not reported. On an unknown date of Aug-2017, after the vaccination, patient had an injection site reaction. Patient was seen by her PCP (patient required ER/doctor visit) and it was diagnosed as a cellulitis. Lab test and concomitant medication was not reported. Outcome of the event was unknown. Documents held by sender: none.
Abdominal Pain, walking slow due to pain in stomach, lump on neck, flushing of cheeks, nausea, fatigue.
The adverse event is undiluted covax administer to client. At this time no reports of needed treatments.
Approx 4 hours after receiving the vaccine, he "shook" all over. His throat felt "like it was closing and I could not swallow." He vomited for 1 - 2 hours. His eyes were very pink and full of pus "like I had pink - eye." He felt itchy but saw no hives. Still felt bad the next day. (He did not seek emergency treatment).
Narrative: Report originator physician hospitalist 's not on August 1st, 2021 included The patient got vaccinated on 1/30/21 and 2/20/21 but tested positive on 7/31/21, after exposure to caregiver with COVID19. The patient was asymptomatic a time of diagnosis
10 minutes after injection developed numbness and tingling in left arm and left foot. Stayed in observation an extra 15 minutes and the returned to work. Symptom persisted for the day
My symptoms began as a cough and irritation in my chest.  I had a low fever and a lot of fatigue.  My fever lasted about a week.  I tested positive on 3/16/2023.  I had a rebound after 3 days of testing negative and now I have tested negative again.  I feel better but I still have a lot of fatigue and I've lost my stamina for fitness.
Infection from source unknown - ears or sinuses; A spontaneous report was received from a consumer concerning a 72-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced infection from source unknown-ears or sinuses/infection.  The patient's medical history was not provided by the reporter. Concomitant product use was not provided by the reporter.  On 03 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unspecified date, patient experienced infection from source unknown-ears or sinuses.   Lab details were not provided by the reporter.  Treatment information was not provided. Patient's doctor wanted him to take a mix of steroids and saline.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, infection from source unknown - ears or sinuses was unknown.
got the flu shot last week felt bad a day, this week got the Covid shot felt really bad yesterday; Initial information received on 19-Sep-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non-healthcare professional) via social media.  This case involves an unknown age and unknown gender patient who got the flu shot last week felt bad a day, this week got the covid shot felt really bad yesterday after receiving Covid-19 Vaccine and Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in SEP-2023, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (formulation, strength, dosage, expiry date, lot number -not reported) for prophylactic vaccination (Immunisation) and a dose of suspect covid-19 vaccine not produced by Sanofi Pasteur (formulation, strength, dosage, expiry date, lot number -not reported) via unknown route in unknown administration site for Covid-19 immunisation. Information on the batch number was requested.  In SEP-2023 the patient got the flu shot last week felt bad a day, this week got the covid shot felt really bad yesterday (feeling abnormal) (latency- few days approximately) following the administration of influenza vaccine and covid-19 vaccine.  Reportedly, Patient stated Hopefully today will be better, However this was nothing compared to my friends almost dying with flu and Covid last year, Their thoughts: Wouldn't get the shots, government trying to kill you.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
COVID 19 Treatment; COVID 19 Treatment; vaccine dose number=5, vaccine brand other=Modena BIV; This is a spontaneous report received from a non-contactable reporter (Consumer) from product quality group. The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Lot number: EP6955), in left arm, on 19Apr2021 as dose 2, single (Lot number: EW0153), in left arm, on 09Nov2021 as dose 3 (booster), single (Lot number: FG3527), in left arm and on 07Apr2022 at 11:15 as dose 4 (booster), single (Lot number: FP4554) at the age of 55 years, in left arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 06Sep2022 at 19:15 as dose 5 (booster), single (Lot number: AS714UB), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hepatitis  B carrier" (unspecified if ongoing). There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 06Sep2022 at 19:15, outcome "unknown", described as "vaccine dose number=5, vaccine brand other=Modena BIV"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.