chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient passed away after receiving vaccine; This is a spontaneous report received from contactable reporter(s) (Nurse).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Patient passed away after receiving vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The reported event of death is considered related due to lack of information. The company processes "death cause unknown" cases as possibly related and documents them as related in the database unless information is provided that allows the Company to exclude that there is a reasonable possibility of relatedness to the suspect product. The absence of clinical details precludes a more meaningful assessment. This case will be reassessed if additional information becomes available.    The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: passed away
This medically confirmed spontaneous report (initial receipt: 04-Nov-2014) concerns a female patient. On 06-Oct-2014, the patient received intramuscular AFLURIA, (batch number T59607) at 0.5 mL once on the left arm. AFLURIA was stored correctly. On 06-Oct-2014, sometime later on the same day as the vaccination, the patient noticed itching and redness at the injection site. The injection site also swelled up to the size of an orange. The patient followed up with the physician and received a corticosteroid pack. The redness and swelling completely resolved with treatment on an unknown date. The outcome was reported as recovered. Reporter comments: The reporter assessed the events as non-serious and the causality as probable in relation to AFLURIA.
bullous pemphigoid; This case was reported by a physician via sales rep and described the occurrence of bullous pemphigoid in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced bullous pemphigoid (serious criteria GSK medically significant). On an unknown date, the outcome of the bullous pemphigoid was unknown.   It was unknown if the reporter considered the bullous pemphigoid to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was selected adult as per vaccine indication. The patient developed bullous pemphigoid after receiving the Shingrix vaccine. The permission to follow up was denied. This case has been linked with US2021AMR001850, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR001850:same reporter
PT HAD A INJECTION SITE REACTION TO PNEUMOVAX 23  WITH RED RASH, SWELLING AND FEVER OF 101.
Monday 6/27/22: arm pains, sore eye muscles, fatigue. Tuesday 6/28/22: fatigue, headaches, eye pain, nasal congestion, sore throat. Wednesday 6/29/22: fatigue, headaches, nasal congestion, sore throat, nausea. Thursday 6/30/22: headaches, fatigue, nausea, heartburn and stomach pains. Friday 7/1/22: heartburn and stomach pains (intense) every 5 min or so. Lasted about a minute. Continues into today (Saturday).
Patient states experiencing fatigue, throat hurts, can't sleep, increased blood sugar, increased bowel movements.  He has tried taking tylenol and vitamin C. He cannot take NSAIDs due to being a kidney transplant patient.
On 3/7/2023, I had blocked vision in the left eye. On 3/9/2023, I went to my optometrist, who told me to go to a specialist. On 3/10/2023, I went to an ophthalmologist. I was examined. When I went to ophthalmologist, my vision was already starting to improve, but I was diagnosed with branch retinal artery occlusion. My vision is still improving, and the ophthalmologist doesn't recommend any treatment and suggests that I continue going to my PCP. The ophthalmologist said that my vision should keep improving and that I should recover my vision completely. I have been taking anastrozole for infertility for a couple of months now, though I don't know if it is in any way related to my health event. At the time of this writing, I feel that I have recovered about 95%.
The patient noticed redness and puffiness on her arm approximately 4 days after receiving the vaccination and came into the pharmacy for it to be looked at. The patient said it did not itch and it did not show any rash-like bumps in the area. The patient did not have a fever or pain and did not have any trouble breathing or swelling outside of the area on her arm.
ust little sore; very sore arm for a few days; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (ust little sore) and PAIN IN EXTREMITY (very sore arm for a few days) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 17-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 MYALGIA (ust little sore) and PAIN IN EXTREMITY (very sore arm for a few days). At the time of the report, MYALGIA (ust little sore) and PAIN IN EXTREMITY (very sore arm for a few days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-071061 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071061:Crossed linked
A reddish, tender rash is noted on the right arm and indurated; minimal pimple like with no break in the skin.
Woke up in the middle of the night thinking that my arm was asleep; Numbness; on my left arm down to my fingers/tingling; A spontaneous report was received from a healthcare professional concerning a 40-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events woke up in the middle of the night thinking that my arm was asleep, numbness, tingling, on my left arm down to my fingers.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unavailable) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 12 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: Unavailable) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 22 Feb 2021, the patient experienced the events woke up in the middle of the night thinking that my arm was asleep, numbness, tingling. On my left arm down to my fingers.  Treatment details were not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of events woke up in the middle of the night thinking that my arm was asleep, numbness, tingling, on my left arm down to my fingers was unknown.
Developed swelling with pain left deltoid around 1-2 days after receiving Td booster. Last Td reportedly 1990 and no reaction then.
Hives approximately 16 hours after vaccine administration. Treatment: Benadryl injection x1, then oral Benadryl as needed, rashes.
shaky, tachycardic, pulse 150-spontaneously resolved in 45min; exp w/immun 1/2hr of vax;
This case was reported by a other health professional via call center representative and described the occurrence of general body pain in a adult female patient who received SHINGRIX for prophylaxis.  On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain, pain in arm and gastrointestinal disorder. On an unknown date, the outcome of the general body pain, pain in arm and gastrointestinal disorder were unknown. It was unknown if the reporter considered the general body pain, pain in arm and gastrointestinal disorder to be related to SHINGRIX. Additional details were provided as follows: This case was reported via click to chat. The reporter was a healthcare worker in a facility for medical coding, work as a certified nursing assistant (CNA) and was a nursing student, who was also the patient. The reporter asked if there was any average time delay before side effects on the second dose, for example 6 hours or 12 hours. The patient had noticeable side effects with the 1st dose. At the time of report, she worked and she needed to plan ahead. The reported called back and mentioned that, she experienced pain (body pain and arm aches), and gastrointestinal (GI) issues.
Information has been received from a health professional concerning a 7 month old patient who on 05-NOV-2009 was vaccinated oral with the first 2 ml dose of ROTATEQ. On 21-APR-2010 the patient received their last dose of ROTATEQ, at greater than 32 weeks of age. It was unknown if the patient sought medical attention. Additional information has been requested.
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Severe
Pain on her chest; Fever; Headache; Chills; soreness; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Pain on her chest), PYREXIA (Fever), HEADACHE (Headache), CHILLS (Chills) and VACCINATION SITE PAIN (soreness) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included LISINOPRIL for Blood pressure.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PYREXIA (Fever), HEADACHE (Headache), CHILLS (Chills) and VACCINATION SITE PAIN (soreness). On 14-Jan-2021, the patient experienced CHEST PAIN (Pain on her chest). At the time of the report, CHEST PAIN (Pain on her chest), PYREXIA (Fever), HEADACHE (Headache), CHILLS (Chills) and VACCINATION SITE PAIN (soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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. Further information has been requested; Sender'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. Further information has been requested
Migraine; Body ache; Condiiton worsened; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 13:00 (Batch/Lot number: unknown) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1, administration time: 10:00 AM, vaccine location: Left arm), administration date: 01Mar2021, when the patient was 42 years old, for COVID-19 Immunization, reaction(s): "migraine", "chills", "fatigue". The following information was reported: MIGRAINE (non-serious) with onset 22Mar2021 13:05, outcome "not recovered", described as "Migraine"; PAIN (non-serious) with onset Mar2021, outcome "not recovered", described as "Body ache"; CONDITION AGGRAVATED (non-serious) with onset Mar2021, outcome "not recovered", described as "Condiiton worsened"; FATIGUE (non-serious) with onset Mar2021, outcome "not recovered", described as "Fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of migraine, pain, fatigue.  Additional information: Patient received most recent Covid-19 vaccine in Health Clinic facility. Patient did not received any other vaccines within 4 weeks prior to Covid-19 vaccine. Patient was not diagnosed with Covid-19 prior to vaccination. Patient was not tested for Covid-10 since vaccination. Patient did not have any known allergies to medications, food or other products.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hive-like lesion (R) thigh 5" x 4 1/2" tiny lesions back of thigh & front of thigh papules (L) wrist x 14 days face & back of knees.
pt c/o dry throat. given gatorade. evaluated by onsite md  and medical staff. pt stated felt better . observed for 3o mins and discharged in care of family
Shingles reactivated 2/6/2021, as of 2/11/2021 on course of acyclovir 800 mg tablets
Information has been received from a healthcare worker (certificated medical assistant) concerning a patient of unknown age and gender. On 08-DEC-2015 the patient inadvertently was given a dose of (Merck) VARIVAX (lot # and expiration date unspecified), when ZOSTAVAX was the intended vaccine to be administered (wrong vaccine administered). The healthcare worker reported that ZOSTAVAX was not administered. No adverse effects were reported. Additional information has been requested.
buzzer sound in both ears or water filled/left ear is worse than the right/left ear is worse than the right/States the left ear is worse which was the same side; smell and taste is terrible; smell and taste is terrible; balance issue; cloudy memory; brain fog; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (buzzer sound in both ears or water filled/left ear is worse than the right/left ear is worse than the right/States the left ear is worse which was the same side), PAROSMIA (smell and taste is terrible), TASTE DISORDER (smell and taste is terrible), BALANCE DISORDER (balance issue) and MEMORY IMPAIRMENT (cloudy memory) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient was not diagnosed or tested positive for COVID-19. It was reported no any other vaccines was given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Thyroid disorder (no change in status) and Allergic reaction to drug excipient (had water blisters all over body(no change in status)). Concomitant products included VITAMINS NOS for Thyroid disorder.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TINNITUS (buzzer sound in both ears or water filled/left ear is worse than the right/left ear is worse than the right/States the left ear is worse which was the same side), PAROSMIA (smell and taste is terrible), TASTE DISORDER (smell and taste is terrible), BALANCE DISORDER (balance issue), MEMORY IMPAIRMENT (cloudy memory) and FEELING ABNORMAL (brain fog). At the time of the report, TINNITUS (buzzer sound in both ears or water filled/left ear is worse than the right/left ear is worse than the right/States the left ear is worse which was the same side), PAROSMIA (smell and taste is terrible), TASTE DISORDER (smell and taste is terrible), BALANCE DISORDER (balance issue), MEMORY IMPAIRMENT (cloudy memory) and FEELING ABNORMAL (brain fog) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       It was reported all the doses which patient had received was of moderna. It was reported that the patient received vaccine in left arm No treatment information was reported.
On 12/15/21, patient stated that she had felt weak and started having nausea on 12/14/21 in the evening
Swollen left armpit for 2 weeks, Muscle pain, Chills, Fever, Headache, Tiredness, and Ongoing Nervous system issues with random sharp pain in joins
Left arm continued to get more sore, the the point I could not lift it. Two day head ache followed by daily head aches of unknown origin
Thursday night chills and achy, Friday beyond exhausted couldn?t keep eyes open, friday night spiked a fever of 101.8, fine on Saturday . Red, itchy spot on arm with a knot. Still have small area of red as of 4/10
Pt is a 54-year-old female who presents for evaluation of right arm injection site. Patient had flu and hepatitis injections on 10/3/18. Patient is unsure of which vaccination was given in the right arm, but states that the area above the right deltoid muscle where the injection was given has increased in size and erythema since injection. Denies drainage, fever, sweats, chills. Denies ever having a reaction like this before. States the area of the injection site on her left arm has no problems. States the pain is 8/10 at its worst. I&D performed.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from company representative, via social media (a media news article) concerned multiple (4) patients of unspecified age, sex, race and ethnic origin. No past medical history or concurrent conditions were reported. All of them were fully vaccinated with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patients experienced covid-19 infection (Suspected Covid-19 Infection and Suspected clinical vaccination failure), and were hospitalized (date unspecified). Number of days hospitalized and discharge dates were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected Covid-19 Infection and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210801922-Covid-19 vaccine ad26.cov2.s-Suspected Clinical Vaccination Failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS 20210801922-Covid-19 vaccine ad26.cov2.s-Suspected Covid-19 Infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
This is a spontaneous report from a contactable consumer or other non hcp (patient herself) reported that a female patient of an unspecified age received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration in Arm Left on an unspecified date in Jan2021 as a single dose for COVID-19 immunisation. Medical history included ongoing arthralgia. The patient's concomitant medications were not reported. Caller states a week ago today she had the COVID 19 vaccine shot, and is calling to ask, she is having, not related to the shot, she has had this before, pain in her right shoulder, can she take Aleve? Clarifies she got the vaccine a week ago today, this just came because of the way she slept, she had it before, pain in her right shoulder, she got the vaccine in her left arm, she usually takes Aleve, and just wishes to know if she can take Aleve? States the pain is bad this morning. The outcome of the event was unknown.  Information about batch/lot number has been requested.  Follow-up (19Apr2021): 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.
Light-headed, dizzy, slighty disoriented, pale, weak kneed, unbalanced.  Began to diminish at 0440.
Patient came up to pharmacy window and reported that she had a reaction to the ZOSTAVAX vaccine. She said she had a red and tender elongated hard spot where the vaccine was given. Patient said she was going to call Merck & ask if the vaccine would still be effective.
Black out, fainting spell after vaccination of HPV. Rash around the inj site.
Body Aches, loss of appetite, fever of 102.0 F. Body aches better and fever reduced to 100.0 F by Tuesday 3/20/2012.
Nauseated, migraine, flu-like symptoms, diarrhea. Symptoms started evening of injection. Worsened next day (8-12-10) feeling better today (8-13-10).
This spontaneous report was received from a nurse prescriber refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II which had lot # M002419 with 12-JAN-2018, (dose and route not reported). No adverse effects reported. The vaccine was exposed to a temperature of 8.5 degree Celsius for 1 hour and 35 minutes and 11 degree Celsius for 8 hours, and it had no previous excursion. The call was because of a data logger. Additional information is not expected as the reporter did not give consent for follow up.
Patient sleeping and had seizure for 3-5 minutes (full body) stiff, tongue and lip biting.  Regained shallow breathing.  Drowsiness.  No fever.  Glucose ok.  CT scan clear. 11/23/09 Medical records received for DOS 11/22/09. Final DX: Childhood seizure Grand mal seizure w/lip biting. Post ictal phase.   4 days S/P vaccine. Had episode of amnesia w/confusion 7 weeks prior, unusual behavior but no sz activity. Back to baseline. D/C to home.
Within 3 hours had abnormally sore arm. 12 hours after injection administration I woke up with chills, fever, vomiting. Fever greater than 101 degrees lasted longer than 24 hours and reached u pl to 102.5 degrees. Vomiting lasted for approximately 12 hours from first onset. 36-48 hours later I have warmth, redness and soreness on entire upper arm where injection was given.