chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient Brought to the ED by EMS because he was partially submerged in the icy River after slipping on the ice.  He was warmed up.  He was noted to have demand ischemia which was evaluated w/ a lexiscan was negative. Pt will follow up with neurology as outpatient to undergo formal cognitive testing.  In the meantime his family was engaged to provide for supervision. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Severe sinus headaches daily for ~2-2.5 weeks that did not respond to decongestants, humidifiers, neti pot, hot liquids, etc.   Sought treatment on 12/7 at urgent care and was prescribed a 7-day course of antibiotics (amox-clav 875-125 mg) and oxymetazoine nasal spray. Headaches finally began to lessen after approx 4 days on antibiotics and went away by day 6.
Headache, Myalgia, Fever, Fatigue, shortness of breat, nasal congestion Narrative:
Information has been received from a physician concerning a 12 year old female who on 21-FEB-2008 was vaccinated intramuscularly in her left arm with a first dose of GARDASIL (Lot # unknown) and vaccinated subcutaneously in her left arm with a second dose of VARIVAX (Lot # unknown). Less than 24 hours later, on approximately 21-FEB-2008, the patient's bicep became very painful and very red. She also experienced syncope and dizziness. It was also reported that the patient's brother (WAES No. 0803USA03075) experienced similar symptoms with a 2nd dose of Varicella virus vaccine live. Outcome unknown. There was no product quality complaint involved. Additional information has been requested.
Marked pallor, generalized depression central nervous system, central respiratory depression and cold skin. Diagnosed with hypotensive, hyporesponsive reaction.
This spontaneous report was received from an office manager concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with imporperly stored doses of VARIVAX lot # M045204, expiration date: 11-NOV-2018, lot # M046924, expiration date: 28-NOV-2018, lot # M042858, expiration date: 26-OCT-2018, lot # M036272, expiration date: 17-AUG-2018 and lot #M043305, expiration date: 26-OCT-2018, as prophylaxis (Strength, dose and route were not reported), which experienced a temperature excursion between -14 and - 10 Celsius degrees for 14 days. No previous temperature excursion were reported. Data logger was involved. No adverse symptoms were reported. Lot number M045204, M046924 and M043305 have been verified to be a valid lot number for varicella virus vaccine live (oka/merck). Additional information has been requested. Follow-up information was received for this spontaneous report on 01-JUN-2017 from a registered pediatric nurse regarding patients (23) who received VARIVAX from 19-APR-2017 - 03-MAY-2017, while the vaccine may have been improperly stored (temperature issue). On 27-APR-2017, VARIVAX (Strength, dose, route, and site of administration were not reported), while the vaccine may have been improperly stored (temperature issue), was administered to a female patient of unknown age for prophylaxis. [It was not further specified which Lot number the patient received.] The patient had not experienced any adverse side effects of any kind. No additional information is expected. This is one of several reports from the same reporter. This is an amended report, as corrected. The reference type for US-009507513-1705USA002199 was changed to E2B Linked Report (previously reported as E2B company number). Sender's Comments: US-009507513-1705USA002199: Original source case.
Fever of 100; headaches; twitch in my eyelid; This spontaneous case was reported by a consumer and describes the occurrence of BLEPHAROSPASM (twitch in my eyelid), PYREXIA (Fever of 100) and HEADACHE (headaches) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced BLEPHAROSPASM (twitch in my eyelid). On an unknown date, the patient experienced PYREXIA (Fever of 100) and HEADACHE (headaches). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, BLEPHAROSPASM (twitch in my eyelid), PYREXIA (Fever of 100) and HEADACHE (headaches) had resolved.            No Concomitant  information was  provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Event outcome was updated.
red rash on both forearms, red rash and itchy/tingly feeling on both cheeks. started about 20 minutes after administration, lasted about half an hour
Waves of Nausea and Lightheadedness for 2 hours. Went to ER around 12:30PM on 4/9/21.
Moderate neck pain for over 72 hours. No relief from rest, towel neck roll, ibuprofen /tylenol/naproxen. Pain is present in base for head/neck area whenever I move my head slightly to the left or right, and then when I lower my chin.
Passed away; This is a spontaneous report from a contactable consumer received via a Pfizer-sponsored program, Pfizer RXPathways. A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history included stage 4 cancer.  The patient's concomitant medications were not reported.  The patient passed away on an unspecified date. It was not reported if an autopsy was performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Passed away
This spontaneous report was received from a consumer refers on behalf of herself as a 63 year old female patient. No pertinent medical history was reported. On 24-MAR-2015, the patient was vaccinated with ZOSTAVAX VIAL (dose and lot# were not reported) in the upper right arm for prevention of Shingles. Concomitant medications includes blood pressure medications (brand, manufacturer & dose unspecified). On 27-MAR-2015, the patient experienced red itchy rash that began on her hands and legs and now progressed upward throughout her body from inner thighs, stomach and shoulder area. The patient contacted her physician and set an appointment on 10-APR-2015. The patient attempted to treat the itchiness with an over the counter ointment cream (brand, dose & manufacturer unspecified). The cream works for short period of time and then the itchiness returns. Action taken was not applicable. The outcome of events was reported as not recovered/not resolved. Causality was not assessed by the reporter. Additional information has been requested.
After receiving the second dose of the Gardasil vaccine, I had a large lump under the skin at the injection site that felt almost like a marble. The skin was not hotter than usual or red, it was just a lump. It does not hurt all the time, only when bumped or touched. The bump decreases in size, but it is 8 days after the injection and it is still present.
Rash L thigh X 2 days, post varicella/DTaP immunizations.
I had a severe sinus infection with nasal drip. I also had facial fullness with a headache and stuffiness. By the end of that week, I tested myself to see if I had COVID-19. I believe I contracted the virus around the 10th of September. I spoke to my doctor who called in a Z-PAK and told me to take vitamin C and zinc. Within a few days, I got better. At this point I have completely recovered from all my symptoms.
swollen arm for 2 weeks; This non-serious case was reported by a consumer via call center representative and described the occurrence of swelling arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced swelling arm (Verbatim: swollen arm for 2 weeks). The outcome of the swelling arm was resolved (duration 2 weeks).   It was unknown if the reporter considered the swelling arm to be related to Shingrix.     It was unknown if the company considered the swelling arm to be related to Shingrix.   Additional Information: GSK Receipt date: 12-NOV-2023 It was reported that patient had swollen arm for 2 weeks after the Shingrix vaccine. The reporter stated that the latest covid vaccine was doing the same and questioned what do these 2 have in common.
After I got the shot April 1 2021..less that 2 mins I felt my lips swollen and had a hard time breathing I ask for help the. They put me on the side.my lips gets more swollen and my tongue all the way to my throat that I can't breathe paramedics give me 2 benadryl and pepcid and oxygen my BP went high as well..stayed there for long hours to make sure ill.be back to normal.im reporting this incident that happen to Me, coz I don't knw if someone will report this incident. DR  was the attending physician that day and she took care of me.today is my 2nd day after I got vaccine I'm feeling chest pain and episodes of difficulty breathing.i hope someone will get in touch with me about my severe reaction to the Moderna vaccine.they didn't tell.me what to do after I got home..if I need to see my family doctor?they just said continue to take benadryl. I really don't knw what to do.and I don't want to panic.
he had the same symptoms as me/he said it was worse than the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (he had the same symptoms as me/he said it was worse than the 2nd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (he had the same symptoms as me/he said it was worse than the 2nd dose). At the time of the report, VACCINATION COMPLICATION (he had the same symptoms as me/he said it was worse than the 2nd dose) outcome was unknown.            The concomitant history was not reported. The treatment history was not provided.
pt recvd vax;could not move arm w/out feeling pain,pain from elbow to shoulder,used heating pad & aspirin;felt better 21jan;23jan arm began hurting again;24jan arm still sore; visited MD;
ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXEMIA 6/17/2022,  7/24/2022,  10/19/2022  -- RECURRENCE OF SAME SYMPTOMS
LOST SAVORY TASTEBUDS; NECK TIGHTNESS; SHOULDER TIGHTNESS; CHILLS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported 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 subject experienced lost savory tastebuds, neck tightness, shoulder tightness, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lost savory tastebuds, and the outcome of chills, neck tightness and shoulder tightness was not reported. This report was non-serious.
hives; hives are still present. Very itchy and painful.; hives are still present. Very itchy and painful.; off label use; Product use for unapproved combination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 at 11:30 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 18Sep2022 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). Concomitant medication(s) included: FLOMAX [MORNIFLUMATE]; GEMTESA; SPIRONOLACTONE. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 18Sep2022, outcome "unknown", described as "Product use for unapproved combination"; OFF LABEL USE (non-serious) with onset 18Sep2022, outcome "unknown"; URTICARIA (non-serious) with onset 19Sep2022, outcome "not recovered", described as "hives"; PRURITUS (non-serious), PAIN (non-serious) all with onset 19Sep2022, outcome "not recovered" and all described as "hives are still present. Very itchy and painful.". The events "hives" and "hives are still present. very itchy and painful." required physician office visit. Therapeutic measures were not taken as a result of urticaria, pruritus, pain.  Additional information: Facility type vaccine: Pharmacy or Drug Store, If other vaccine in four weeks: No, Other medications in two weeks: Flomax, Gemtesa, Spironolactone. Adverse Event: I began to break out in hives the day after the vaccine and the hives are still present. Very itchy and painful. I had a flu vaccine given in my right arm at the same time as the bivalent booster. I have never had a reaction to the flu vaccine. If covid Prior vaccination: No, If covid tested post vaccination: No.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Suspected vaccination failure; I have the shingles now; Very Painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I have the shingles now) and pain (Verbatim: Very Painful). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved and the outcome of the pain was not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 26-Jul-2023 This case was reported the patient via interactive digital media. The patient now (at the time of reporting) had shingles, even got the 2nd shot. The 2nd shot was very painful. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting Follow-up not possible as no contact details provided.
something was leaking onto his arm from the syringe; concerned he did not receive full dose of the moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEVICE CONNECTION ISSUE (something was leaking onto his arm from the syringe) and UNDERDOSE (concerned he did not receive full dose of the moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced DEVICE CONNECTION ISSUE (something was leaking onto his arm from the syringe) and UNDERDOSE (concerned he did not receive full dose of the moderna vaccine). On 25-Mar-2021, DEVICE CONNECTION ISSUE (something was leaking onto his arm from the syringe) and UNDERDOSE (concerned he did not receive full dose of the moderna vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.
nausea; became so ill; throwing up like twice a day; not able to get out of bed,being really fatigued; not able to eat; extreme headaches; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (became so ill), VOMITING (throwing up like twice a day), FATIGUE (not able to get out of bed,being really fatigued), FEEDING DISORDER (not able to eat) and HEADACHE (extreme headaches) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced ILLNESS (became so ill), VOMITING (throwing up like twice a day), FATIGUE (not able to get out of bed,being really fatigued), FEEDING DISORDER (not able to eat) and HEADACHE (extreme headaches). On 19-May-2021, the patient experienced NAUSEA (nausea). On 30-Apr-2021, ILLNESS (became so ill), VOMITING (throwing up like twice a day), FATIGUE (not able to get out of bed,being really fatigued), FEEDING DISORDER (not able to eat) and HEADACHE (extreme headaches) had resolved. At the time of the report, NAUSEA (nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medication reported. patient wanted to know the side effects of the second dose and possible consequence of have only the first shot.
Cellulitis around vaccine site, in otherwise well appearing child will began oral KEFLEX. Patient will schedule follow up visit in 2 days.
they gave a booster dose of the Moderna Covid-19 Vaccine to a patient today (30Mar2022) at 1:37pm from a vial that was first punctured yesterday (29Mar2022) at 1:48 pm; they gave a booster dose of the Moderna Covid-19 Vaccine to a patient today (30Mar2022) at 1:37pm from a vial that was first punctured yesterday (29Mar2022) at 1:48 pm; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they gave a booster dose of the Moderna Covid-19 Vaccine to a patient today (30Mar2022) at 1:37pm from a vial that was first punctured yesterday (29Mar2022) at 1:48 pm) and PRODUCT STORAGE ERROR (they gave a booster dose of the Moderna Covid-19 Vaccine to a patient today (30Mar2022) at 1:37pm from a vial that was first punctured yesterday (29Mar2022) at 1:48 pm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2022 at 1:37 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2022 at 1:37 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (they gave a booster dose of the Moderna Covid-19 Vaccine to a patient today (30Mar2022) at 1:37pm from a vial that was first punctured yesterday (29Mar2022) at 1:48 pm). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (they gave a booster dose of the Moderna Covid-19 Vaccine to a patient today (30Mar2022) at 1:37pm from a vial that was first punctured yesterday (29Mar2022) at 1:48 pm). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they gave a booster dose of the Moderna Covid-19 Vaccine to a patient today (30Mar2022) at 1:37pm from a vial that was first punctured yesterday (29Mar2022) at 1:48 pm) and PRODUCT STORAGE ERROR (they gave a booster dose of the Moderna Covid-19 Vaccine to a patient today (30Mar2022) at 1:37pm from a vial that was first punctured yesterday (29Mar2022) at 1:48 pm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  On 29-Mar-2022, the vial was initially stored in the refrigerator. On same day at 01:48 pm vial was first punctured. On 30-Mar-2022 at 1:37 pm, dose administered more than 12 hours post puncture. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature was reported as for 6 minutes.  No treatment information was provided.
Soreness at shot site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at shot site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Drug allergy (Allergy to codeine.), Drug allergy (allergy to Quinalones), Drug allergy (allergy to sulfa drugs), Drug allergy (allergy to muscle relaxants), Rheumatoid arthritis, Hypothyroidism, Arteriosclerosis, Chronic fatigue and Hypertension. Concomitant products included ENALAPRIL from 10-Feb-2005 to an unknown date, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) from 12-Mar-2015 to an unknown date, APIXABAN (ELIQUIS) from 15-Jan-2020 to an unknown date, DILTIAZEM (CARDIZEM [DILTIAZEM]) from 15-Jan-2020 to an unknown date and ASPIRIN [ACETYLSALICYLIC ACID] from 20-Feb-2019 to an unknown date for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness at shot site). In May 2021, VACCINATION SITE PAIN (Soreness at shot site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided.   This case was linked to MOD-2021-029776 (Patient Link).