chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 6/6/00, the pt received her 1st dose of Lymerix and 1 week later, on 6/13/00, she experienced flu-like symptoms, nausea and weakness which lasted 2 days. No treatment was given. The most recent information, received on 6/16/2000, reports the outcome of the event is resolved.
had grade two muscle tear in left pectoral muscle while performing normal weightlifting routine/torn pectoral; This is a spontaneous report from a non-contactable consumer (patient himself). A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: en6200), via an unspecified route of administration, administered in left arm on 18Feb2021 (age at vaccination: 49 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included cholesterol, high blood pressure and elevated uric acid. Patient had no allergies to medications, food or other products. The patient received other unspecified medications within 2 weeks of vaccination. The vaccine was administered in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Feb2021, 2 days after the first dose, the patient experienced grade two muscle tear in left pectoral muscle while performing normal weightlifting routine /torn pectoral. The patient received treatment for the adverse event. The patient visited the doctor office for torn pectoral. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 since the vaccination. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Blood presure went to 175; headache; chills; off balance; Redness on arm/ huge mark from the shot, halfway around the arm; This case was reported by a consumer via call center representative and described the occurrence of blood pressure high in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included metoprolol.   On 13th October 2019, the patient received the 1st dose of Shingrix. On 14th October 2019, 1 days after receiving Shingrix, the patient experienced blood pressure high. In October 2019, the patient experienced headache, chills, balance difficulty and erythema of extremities. The patient was treated with Tylenol. On an unknown date, the outcome of the blood pressure high, headache, chills and balance difficulty were recovered/resolved and the outcome of the erythema of extremities was recovering/resolving.   It was unknown if the reporter considered the blood pressure high, headache, chills, balance difficulty and erythema of extremities to be related to Shingrix.  Additional case details were provided as follows: The patient received Shingrix in the right arm, eleven days ago of the reporting date. The patient claimed that, she had quite a reaction to the vaccine. She reported that she was fine the first day she got the vaccination till around noon, however, the next day everything went downhill. The patient took her blood pressure medication which worked well, however, her blood pressure went to 175 so her physician increased her Metoprolol dose and then she was fine. She also experienced a headache, chills and she was a bit off balance and had to hold onto the door frame. The patient stated, she had a huge mark from the shot which was halfway around her right arm and 11 days later, the red circle was of the size of a baseball. The patient's other symptoms resolved quickly but she had to go the doctor's office twice. The doctor told her to take anti-inflammatory drugs but because of her blood pressure medication, she could only take Tylenol which she did and her redness on her arm was currently paler in color. The patient consented to follow up.
No adverse effects; One expired dose of MMR II was administered to patient on 8/9/2019.; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.       On 09-AUG-2019, the patient was vaccinated with an expired vaccine of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (expired product administered) lot # N020926 has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live expiration date reported and establish as 01-AUG-2019, for prophylaxis (strength, dose, frequency and route of administration were not reported).   No adverse effects reported.
Right hand has been tingling; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 18Mar2021 at 10:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 10Apr2021, the patient had undergone COVID-19 nasal swab test and tested negative. The patient did not receive any other medications within 2 weeks of vaccination.  The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 25Feb2021 at 12:30. On 18Mar2021 at 12:30, since a few hours after second dose of vaccine, the patient experienced right hand tingling even though the vaccine was administered in left arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event tingling in right hand was not resolved.  No follow-up attempts are needed. No further information is expected.
Developed dizziness 3-4 hours after immunization with Flumist, Hepatitis A and VZV immunizations. Dizziness described as "feeling unsteady" but no "room spinning." No N/V, change in MS, fever or ill-appearance. Seen in office the following morning. Normal neuro exam. Dizziness improved/resolved.
This spontaneous report was received from a pharmacist refers to a 22 year old female patient. Patient's pertinent medical history, drug reactions/allergies and concomitant medications were reported as none. On an unknown dates (at the age of 5 and 14 years), the patient was vaccinated with VARIVAX, (lot #, expiry date, dose, frequency and route of administration were not reported). Mother reported patient needed evidence of chicken pox immunity for nursing school. Pharmacist stated per patient's mother that patient had titers drawn at a recent unspecified time in preparation for school and these titers showed immunity to varicella to be low. No other symptoms reported. No treatment was given for the adverse events. The outcome of the "low immunity titers to varicella" was recovered. Causality assessment was not provided. No product quality complaint (PQC) was involved. Additional information is not expected as the reporter did not wish further contact.
Three days (Oct. 15) after my booster shot on Oct. 12  when I also received the FLU SHOT on the same day in my right arm, I had shooting pain down my left leg. I thought it was another episode of sciatic nerve pain and took some pain medication (at nights) to help allivieate the pain. I went in for my physical therapy appointment on Oct. 18 when I complained about the pain immediately behind my left knee. My therapist said that was not common for sciatic nerve pain and because of the tenderness wondered if I may have developed a clot. She called my physician who asked me to get to the ER/Urgent Care to get an echo of the leg and cancelled the rest of my PT appointment.
pt recvd vax & exp v; had hives & fever of 100; pt had headaches & dec appetite; advised to go to er; to er, labs w nl;
CRITICAL TEST/RESULTS: Acuity: Critical Finding: Pulmonary embolus
I developed a pulmonary embolus after my second Moderna covid-19 shot. My PSO2 dropped to 86% and Doppler found that i had an extensive DVT in my right leg, of which I was unaware. I have had no cardiovascular issues prior to this - I'm average weight, don't smoke and had no know risk factors at the time. I'm undergoing extensive testing now to see if there was a reason for my DVT and PE>
I, the patient am reporting this after speaking with my neurologist today, after receiving the first dose of the covid vaccine I starting experiencing excruciating migraines, migraines that felt like when I was NOT treated for my chronic migraines. Prior to the vaccine I had been stable on topiramate and was only experiencing about 1-2 migraines a month and was fine with sumatriptan. However, after the first dose of the vaccine I experienced muscle pain across my arms/shoulder/shoulder blades/neck that attributed to my head hurting. This pain has not subsided since the second dose but has decreased in its severity. Basically, the pain is still there, but it is not as excruciating. I am able to still go about my day, and I no longer have the arm/shoulder pain, but the migraines have not gone away. After speaking to my neurologist, he feels that the vaccine most likely triggered the muscle pain as that is a very common reaction which spiked the migraines to resurface, which is why I wanted to report this AE, especially because it has caused my prophylactic treatment (topiramate) and acute treatment (sumatriptan) to BOTH fail and I am needing to have my medications readjusted in order to deal with these migraines that have not subsided over the 3 weeks since the first vaccine. My neurologist feels that these migraines MAY subside, but he cannot rule out that they may never and I may need new/stronger therapy for them.
I had severe pain in right shoulder and couldn't move it anywhere that it didn't hurt. Today it's still sore but it's bearable.
pt recv vax 15AUG96 & 22AUG96 pt exp a fever & devel fever blisters & cold sores around lips & on tongue;
Headache, sore body, sore arm, nausea, tired, hot body.
No adverse event; dose administered from vial that underwent a temperature excursion; dose administered from vial that underwent a temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered from vial that underwent a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (dose administered from vial that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In September 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered from vial that underwent a temperature excursion). On 22-Sep-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered from vial that underwent a temperature excursion). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered from vial that underwent a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (dose administered from vial that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered from vial that underwent a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (dose administered from vial that underwent a temperature excursion).    No concomitant medications were reported.  It was reported that there was an temperature excursion on the 02-Sep-2022 for one hour and there were no remaining doses. The vials were under frozen condition at the time of the excursion and individual vials were in the box of vial size 2.5ml. The maximum temperatures reached was -12.5°C, the vials had not moved from freezer to refrigerator and there was no any vaccine state change found by visual inspection.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-654338 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2022: added patient initials, patients demographics and vaccine dose details.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654338:same reporter
flared up on the day 6-7 after the vaccination. It used to be local in two joints and now I am flared up all over my body; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Mar2021 at 10:30 (at 36 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included rheumatoid arthritis (RA) from unspecified date. The patient had no known allergies. Concomitant medications included methotrexate, prednisone, and etanercept (ENBREL); all from unspecified date for unspecified indication. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. The patient reported her RA that had been pretty much in remission flared up on the day 6-7 after the vaccination. It used to be local in two joints and now she was flared up all over her body. She did not see any other reason apart from the vaccination. Start date of the adverse event was 27Mar2021. The event resulted in physician office visit. No treatment received for the event. Outcome of the event was not recovered.  Information about batch/lot number has been requested.
No Menstrual yet (late); Vertigo; Dizziness; Headache; Tongue and gum swelling; gum swelling; Fever; Fever blisters in my mouth; Tiredness; Injection site pain (only w/the 1st doze); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Sep2021 15:00 (Lot number: FD0809) at the age of 38 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENSTRUATION DELAYED (non-serious) with onset 09Sep2021 15:30, outcome "not recovered", described as "No Menstrual yet (late)"; VERTIGO (non-serious) with onset 09Sep2021 15:30, outcome "not recovered", described as "Vertigo"; DIZZINESS (non-serious) with onset 09Sep2021 15:30, outcome "not recovered", described as "Dizziness"; HEADACHE (non-serious) with onset 09Sep2021 15:30, outcome "not recovered", described as "Headache"; SWOLLEN TONGUE (non-serious) with onset 09Sep2021 15:30, outcome "not recovered", described as "Tongue and gum swelling"; GINGIVAL SWELLING (non-serious) with onset 09Sep2021 15:30, outcome "not recovered", described as "gum swelling"; PYREXIA (non-serious) with onset 09Sep2021 15:30, outcome "not recovered", described as "Fever"; ORAL HERPES (non-serious) with onset 09Sep2021 15:30, outcome "not recovered", described as "Fever blisters in my mouth"; FATIGUE (non-serious) with onset 09Sep2021 15:30, outcome "not recovered", described as "Tiredness"; VACCINATION SITE PAIN (non-serious) with onset 09Sep2021 15:30, outcome "not recovered", described as "Injection site pain (only w/the 1st doze)". Therapeutic measures were not taken as a result of menstruation delayed, vertigo, dizziness, headache, swollen tongue, gingival swelling, pyrexia, oral herpes, fatigue, vaccination site pain.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101303886 same reporter/patient/product, different dose/event.
This spontaneous report was received from a physician via company representative and refers to a patient of unknown demographics. No pertinent medical history or concurrent conditions were reported. On an unknown date, the patient was vaccinated with GARDASIL. No concomitant medications were reported. On an unknown date, the patient experienced injection site pain after receiving GARDASIL. The product was confirmed to be GARDASIL and not GARDASIL 9. The outcome of injection site pain is unknown. The reporter did not assess the causality of the injection site pain with GARDASIL. Additional information has been requested.
On 1/17/2022, in the middle of the night, I had body aches, headache, and a cough. On 1/18/2022, I decided to take an at-home COVID-19 test; the result was positive, and I had a breakthrough case. On 1/21/2022, I took another at-home test, which also yielded a positive result. I finally got a negative result when I took another at-home test on 1/28/2022. Also on 1/28/2022, I began experiencing severe lower back pain. The pain was persistent, and when I finally went to the doctor to get it treated on 2/4/2022, I was asked if I had had COVID-19. Apparently, the doctor had seen other patients who also reported severe back pain when they had COVID-19. The doctor treated me by giving me a steroid shot, and my back pain was completely gone by 2/11/2022.
Didn't feel good; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Didn't feel good) and PYREXIA (Slight fever) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's medical history was not reported.  Concomitant products included ATORVASTATIN CALCIUM, PRAMIPEXOLE and TRAZODONE for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced MALAISE (Didn't feel good) and PYREXIA (Slight fever). The patient was treated with PARACETAMOL (TYLENOL) in January 2021 for Adverse event, at a dose of UNK dosage form. At the time of the report, MALAISE (Didn't feel good) and PYREXIA (Slight fever) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient felt "ok" again on 29-Jan-2021.   This case was linked to US-MODERNATX, INC.-MOD-2021-030561 (Linked Report).
Soreness that expanded to half of my arm. I couldn?t sleep last night from the pain, I would rate it 9/10 in severity. I feel fatigued and groggy
full body itch; Injection site itchy; Injection site redness/swelling and itchy; Injection site redness/swelling and itchy; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PRURITUS (full body itch) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy and Allergy to vaccine (Moderna vaccine).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (Injection site redness/swelling and itchy) and VACCINATION SITE SWELLING (Injection site redness/swelling and itchy). On 13-Jan-2021 at 2:00 PM, the patient experienced PRURITUS (full body itch) (seriousness criterion hospitalization). The patient was hospitalized from 13-Jan-2021 to 14-Jan-2021 due to PRURITUS. On 14-Jan-2021, PRURITUS (full body itch) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (Injection site redness/swelling and itchy) and VACCINATION SITE SWELLING (Injection site redness/swelling and itchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PRURITUS (full body itch) to be possibly related. No further causality assessments were provided for VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (Injection site redness/swelling and itchy) and VACCINATION SITE SWELLING (Injection site redness/swelling and itchy).    The patient took Diphenhydramine orally for a week for injection site redness, swelling and itch. The patient was administered epinephrine and methylprednisolone in ER (interpreted as Emergency room) in hospital. The doctor instructed the patient to avoid taking the second dose of vaccine.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Concomitant product use was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2021: Follow-up included patient details, vaccine information and treatment details of the reported events.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
mom reports pt woke up morning p/vax w/hives;pt seen @ clinic by RN;pt had urticaria of scrotum, perineal & groin area & lower abd area, ax area, bilat; pt referred to MD; given DPH
Rash neck to lower back 1-9-15. Hives on leg 1-8-15.
sick; Initial information received on 28-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a patient of an unknown age and gender who experienced sick (illness), while he/she received INFLUENZA VACCINE.  The patient's medical treatments, vaccinations, concomitant medications and family history were not provided.  The patient had no medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick (illness) (Unknown latency) following the administration of INFLUENZA VACCINE.  Reporter states that no, they make me sick. I will pass.  It is unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine: Not Provided. There were no lab data/results available.  It was not reported if the patient received a corrective treatment.  The outcome of event was reported as unknown.  There will be no information on the batch number for this case