chrisvoncsefalvay/vaers-outcomes huggingface dataset:
very thirsty; Day number 7, one of my eyes (left eye) got bright bright bright red , It was deep deep red; really sick for like 5 days [after second shot]; This spontaneous case was reported by a consumer and describes the occurrence of THIRST (very thirsty), OCULAR HYPERAEMIA (Day number 7, one of my eyes (left eye) got bright bright bright red , It was deep deep red) and ILLNESS (really sick for like 5 days [after second shot]) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0251321A and 010A21A) for COVID-19 vaccination.     The patient did not have any allergies and was never tested or diagnosed for Covid-19. The patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Myalgic encephalomyelitis (since she was 25 years old, did not flare after the Moderna doses).   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OCULAR HYPERAEMIA (Day number 7, one of my eyes (left eye) got bright bright bright red , It was deep deep red). On an unknown date, the patient experienced THIRST (very thirsty) and ILLNESS (really sick for like 5 days [after second shot]). At the time of the report, THIRST (very thirsty) and OCULAR HYPERAEMIA (Day number 7, one of my eyes (left eye) got bright bright bright red , It was deep deep red) outcome was unknown and ILLNESS (really sick for like 5 days [after second shot]) had resolved.            No concomitant medication information was provided. The patient did not experience a similar event in the past. The patient stated that her red eye never turned into conjunctivitis and It was experienced around sunday. The patient did not seek medical care. The patients stated that she was over 50 years old. The variant in her area was the omicron B.A.2. She asked what was the vaccine that was being administered in pharmacies right now. The patient also asked if Moderna was making new vaccines for the new variants and stated that she was not sure if she should get the second booster. The patient asked how often people get rash or the red eye after the Moderna vaccine. No treatment medication were provided.   This case was linked to MOD-2022-532802, MOD-2022-532815 (Patient Link).   Reporter did not allow further contact
Erythema multiforme (allergic rash) began 4 days after immunizations; treated with Prelone and Benadryl.
Initial and follow up information has been received from a physician and a healthcare professional, concerning an 18 year old male patient, with no pertinent medical history, who on 14-JUN-2007 was vaccinated subcutaneously in the upper right arm, with a dose, 0.5ml, of PNEUMOVAX (lot # 655501/1035F).  There was no concomitant medication.  On approximately 15-JUN-2007, at 12 hours after vaccination, he "gradually developed an injection site reaction," with cellulitis involving redness and warmth that spread over the next 2 days to include the upper right forearm with induration and a fever of 102.6 degrees.  Treatment included prednisone (manufacturer unspecified) and KEFLEX; the patient was referred to an infectious disease specialist (details not provided).  At the time of this report, the patient's symptoms had resolved.  The physician considered the injection site reaction to be serious as other important medical events.  Additional information is not expected.
BOWEL ISSUES; BRUISING ON THE ARM/SHOULDER/ LEG; LOW PLATELET COUNT; UPPER BODY PAIN; SHOULDER PAIN; SHARP HEADACHE; RIGHT/LEFT LEG PAIN; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: chronic migraine, and stress syndrome. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1806029 expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. Concomitant medications included topiramate for migraine. On 24-MAR-2021, the patient experienced right/left leg pain. On JUN-2021, the patient experienced bruising on the arm/shoulder/ leg. On JUN-2021, the patient experienced low platelet count. On JUN-2021, the patient experienced upper body pain. On JUN-2021, the patient experienced shoulder pain. On JUN-2021, the patient experienced sharp headache. Laboratory data included: Platelet count (NR: not provided) Low. On an unspecified date, the patient experienced bowel issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right/left leg pain, sharp headache, bruising on the arm/shoulder/ leg, low platelet count, upper body pain, and shoulder pain, and the outcome of bowel issues was not reported. This report was non-serious.
erythema with demarcation, warmth, firm, tenderness to Left deltoid. Generalized fever. Refused IM steroids but will use topical Triam cream.
No side effect as of yet- patient given vaccine although he is not in the approved age range to receive it
Fever; Chills; soreness; soreness at shot location; cough; This is a spontaneous report from a non-contactable consumer (patient). A 38-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Lot Number unknown), via an unspecified route of administration on 03MAR2021,13:00 PM (at the age of 38-years-old) as DOSE 2, SINGLE into left arm for COVID-19 immunization. The patient medical history was not reported. No known allergies. The concomitant medications included Montelukast sodium (SINGULAIR) and Fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]). The patient took Historical Vaccine BNT162B2 (COMIRNATY, Solution for injection, Lot Number unknown), via an unspecified route of administration as DOSE 1, SINGLE for COVID-19 immunization. The patient did not received any other vaccine in four weeks. It was reported no covid prior vaccination and covid tested post vaccination. On 04Mar2021 at 02:30 AM the patient experienced Fever, Chills, soreness, soreness at shot location, cough. The patient did not received any treatments. The clinical outcome of the events were not recovered.     No follow-up attempts are possible; information about lot/batch number cannot been obtained
Have pulmonary fibrosis; Have caught covid; I am fully vaccinated have been for over a month, have caught covid; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY FIBROSIS (Have pulmonary fibrosis) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PULMONARY FIBROSIS (Have pulmonary fibrosis) (seriousness criterion medically significant), COVID-19 (Have caught covid) and VACCINATION FAILURE (I am fully vaccinated have been for over a month, have caught covid). At the time of the report, PULMONARY FIBROSIS (Have pulmonary fibrosis), COVID-19 (Have caught covid) and VACCINATION FAILURE (I am fully vaccinated have been for over a month, have caught covid) outcome was unknown.            No concomitant products were reported.  No treatment information was provided.  For the event Pulmonary fibrosis, based on the current available information; although the use of the product and the start date of the event was more than 30 days apart, a causal relationship cannot be excluded. Nevertheless, the event COVID-19 could a potential confounder /co-suspect for this event.  For the event lack of efficacy of the product and COVID-19, based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.; Sender's Comments: For the event Pulmonary fibrosis, based on the current available information; although the use of the product and the start date of the event was more than 30 days apart, a causal relationship cannot be excluded. Nevertheless, the event COVID-19 could a potential confounder /co-suspect for this event.  For the event lack of efficacy of the product and COVID-19, based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.
Chills, headache, fever, muscle aches, swollen lymph node in armpit.
Child awoke with swollen face and vesicles on hands. Mother treated with Benadryl.
side effects are mild for ll three shots; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (side effects are mild for ll three shots) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (side effects are mild for ll three shots). At the time of the report, IMMUNISATION REACTION (side effects are mild for ll three shots) outcome was unknown.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.   No concomitant medications were reported. It was reported that the patient took the first two Moderna shots and third booster shot with Pfizer and the patient was wondering which shot the patient should take when the patient would be eligible. No treatment medications were reported.   This case was linked to MOD-2022-570194 (Patient Link).
Pt recv vax & devel inj site rxn of swelling, redness, warmth & pain. This is 1 of 5 pts from this site to devel site rxn with this same lot #.
Red mark for 5 days about the size of a baseball, Red mark Returned on 8th day much more red and iritated
1) SOB 2) Throat felt like it was swelling 3) Increased BP (160/100) - numbness in arms/legs 4) Administered EPIPEN 0.3 mL.
Since the second shot, my left arm muscle is very sore. The soreness is still there. I cannot lay on that side to sleep without pain, have limited movement in the arm when I hold it over my head, still have to take aspirin  everyday to help with the pain.  Never had any issues with my arm before, the shot.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 4:30 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 4:30 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 77.17. Concomitant products were not provided. On 07-Jan-2021, Excursion time were 09 AM and 10 AM, temperature was 34, total doses given for the day was 96, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-Jan-2021, vial was moved to clinic on 07-Jan-2021. 20 vials were sent to clinic. Vaccine BUD date was 27-Jan-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
Condition aggravated; Dizziness; Headache; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Condition aggravated), DIZZINESS (Dizziness), HEADACHE (Headache) and PAIN IN EXTREMITY (Pain in arm) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa and Plaque psoriasis.    No Medical History information was reported.   In October 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen, Citrate Free. On an unknown date, the patient experienced CONDITION AGGRAVATED (Condition aggravated), DIZZINESS (Dizziness), HEADACHE (Headache) and PAIN IN EXTREMITY (Pain in arm). At the time of the report, CONDITION AGGRAVATED (Condition aggravated) was resolving and DIZZINESS (Dizziness), HEADACHE (Headache) and PAIN IN EXTREMITY (Pain in arm) had resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Concomitant medications and treatment medications were not reported.   Causality for HUMIRA(ADALIMUMAB)  The reporter's causality for the events of dizziness, flare ups, headache and sore arm with HUMIRA(ADALIMUMAB) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 15-Feb-2022: Live significant FU (Event added)
Deep vein thrombosis in right calf; received bnt162b2, dose 2 on 15Jan2021/first dose on 29Dec2020; received bnt162b2, dose 2 on 15Jan2021/first dose on 29Dec2020; This is a spontaneous report from a contactable physician (patient). A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 15Jan2021 (Batch/Lot number was not reported) at a single dose for covid-19 immunisation. The patient received the first dose on 29Dec2020 in the left arm for covid-19 immunisation. The patient did not receive any other vaccines in four weeks. Medical history included allergies: Sulfa. Patient was not pregnant at the time of report. The patient has not had COVID prior vaccination and was not tested post vaccination. Concomitant medication included ethinylestradiol, levonorgestrel (SEASONIQUE) taken for birth control. The patient experienced deep vein thrombosis in right calf on 13Feb2021 with outcome of recovering. The event deep vein thrombosis in right calf resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received aspirin regimen as treatment for the event deep vein thrombosis in right calf.; Sender's Comments: Based on the information currently available, the event deep vein thrombosis most likely represents an intercurrent medical condition and was unrelated to Bnt162b2 vaccine. A possible contributory role of concomitant drug ethinylestradiol, levonorgestrel to the event can not be totally excluded. Case will be re-assessed upon the additional information provided. 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.
Chronic cough; runny nose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EM9809) at the age of 79 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: COUGH (non-serious) with onset Mar2022, outcome "not recovered", described as "Chronic cough"; RHINORRHOEA (non-serious) with onset Mar2022, outcome "recovered" (2022), described as "runny nose". The events "chronic cough" and "runny nose" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of cough, rhinorrhoea.  Additional information: Age of onset 79.5 years old. Patient who reported that she developed chronic cough that got worst three weeks after her first Pfizer BioNTech Covid shot. Stated that she was supplied with a Z-pack for five days but the cough did not go away. She was supplied with a Z-pack for five days but the cough did not go away. Later stated that the Z-pack subsided the cough and runny nose for almost three weeks. Stated that she still has the cough. Stated that the cough has improved but she still gets a chronic cough. Stated for almost a whole year was constant with mucus and a runny nose. Stated that the mucous was clear and it still. Stated that the cough comes first and then the runny nose. Later stated that the Z-pack subsided the cough and runny nose for almost three weeks. Stated that she still has the cough. Stated that she has never had Covid and gets tested every month. Product strength and count size dispensed: Unknown strength; 10 count. Dosage text: Two either 100mg or 500mg for five. Treatment: Stated that she went to her primary doctor first. Stated that she went to ear, nose and throat doctor then pulmonologist. Stated went back to ear, nose and throat doctor for follow up. Stated that she reported about the medication and what was going on with it right now. Stated that she took steroids once a day for the inflammation. Stated that the doctor prescribed the steroids for five more days. Product: Stated that she was sure that she threw the packaging away. Investigations: Stated that her pulmonologist had blood work of her lungs done, a CT scan of her sinuses and a breathing test. Stated that her medical doctor sent her to get a asthma test. Stated that she does not have asthma, her sinuses are fine, she does not have breathing issues and her blood work was okay. Stated that all of this was done before she was prescribed the Z-pack.   No follow-up attempts are possible. No further information is expected.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: After recieving 1st dose patient fainted and unresponsive for a few seconds but was able to leave without any other intervention.
L arm has two welt sites one aprox.  4 cm & improving 2nd site 6 cm & warm to touch & red.  with discomfort lasting 2 days - improving with MOTRIN.  Continue with MOTRIN & ice if worsens outline area for monitoring and return to physician.
it has been too long since my first dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (it has been too long since my first dose of the vaccine) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (it has been too long since my first dose of the vaccine). On 03-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (it has been too long since my first dose of the vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient got 1st dose on 3Mar2021 but vaccination card has 18Mar2021 recorded.  The health department scheduled a 2nd appoint date of 15-Apr-2021, which they called and rescheduled for 18-Apr-2021.  Concomitant product used was not provided by the reporter.  Treatment given is not provided.   This case was linked to MOD-2021-074932 (Patient Link).
Pt went home from visit, c/o headache, took ibuprofen and threw up once. Didn't eat anything prior to the visit or after the vaccine for at least 2 hours. Pt laid down and started to feel better, PNP recommended food and drink and told her to follow up for any further symptoms.
My husband had Shingrix yesterday. Fever today; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th June 2021, the patient received Shingrix. On 16th June 2021, 1 days after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were reported as follows: The case was reported by the wife of the patient. The age at vaccination was not reported. The patient received dose of shingrix and experienced fever and the patient was asking how long it would usually last. Follow up was not possible as no contact details were provided.
This spontaneous report has been received from a Registered Nurse refers to an infant patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 18-SEP-2017, the patient received an improperly stored dose of RECOMBIVAX HB (lot # M031574, expiration date: 11-NOV-2018; dosing details unknown) for prophylaxis. The temperature excursion occurred on an unknown date at a temperature of 35.4 Fahrenheit (F) for a time frame of 8 hours. The previous temperature excursion occurred at 34.9F for a time frame of 2 hours. The call was because of a data logger. No adverse effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1710USA004063.