chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 20-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced COVID-19 (tested positive). On 14-Jan-2022, COVID-19 (tested positive) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive. 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. Concomitant medications were not reported. Treatment medications were not reported. Sender's Comments: This is a spontaneous case concerning a 52-year-old male patient with no reported medical history, who experienced the non-serious unexpected AESI event of COVID-19. The event occurred approximately 15 days after the first dose of mRNA-1273 vaccine administration and recovered in 12 days. Causality for the event of COVID-19 was not applicable. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Pt developed shingles on 8/16/01 and had Varivax on 03/16/1999.
Redness, swelling, elevated temperature. pain developed after shots were administered in evening of 9/7/11. Treatment: AUGMENTIN, 24 hours UNASYN in-patient IV.
vaccine was expired, no temperature excursion occurred and Moderna determined the vial "maintained the activity necessary to protect against the SARS CoV-2 virus at the time of administration".  Patient reported no adverse reactions.
patient received the tdap shot first, then requested the shingrix shot in same arm. He claims immediately following getting both vaccinations he felt the sensation of the liquid in his arm shooting downwards. No pain, just sensational.
Patient admitted to hospital, positive for COVID-19; developed COVID-19 pneumonia while in the hospital; placed on BiPAP but would not wear it consistently; patient experienced cardiac arrest and required intubation; transferred to ICU; family made patient a DNR; eventually requested to withdraw support; patient was extubated and died shortly afterwards
Immediately after vaccine was administered and a band aid placed on the site, patient loss consciousness, fell to side and began snoring. About 20-30 seconds later he awakened and stated "Sorry I fell asleep". Patient aware of his location. Patient remained laying down for 30 minutes. Vitals stable. We attempted several times to sit him up, but he became dizzy each time. Vitals remained stable. Patient states he has no history of syncope with vaccines or medical procedures. This was the third vaccine in this series and has had no previous adverse events with vaccine #1 and #2. Patient's father was called to drive him home since he was still feeling a bit dizzy and off upon discharge.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
2 weeks after Pfizer booster given on 10/06/21 at local Pharmacy, developed pain in left mid back. Was minimal when I saw doctor on 10/18/21, but within a week became very severe. Went on for 6 weeks so went to pain doctor thinking it was a disc issue and scheduled epidural for next day. At epidural I was informed I had shingles lesions on my back and pain was due to shingles. Was confirmed by my back surgeon 2 weeks later. I have had both original and newer shingles vaccine. Found several journal articles indicating Pfizer can trigger latent herpes zoster virus. Articles indicate there are other cases, though not in the very high numbers. I wanted this on the record.
Around 1:00pm a small, round, hard lump at the injection site formed with swelling and redness in an area about 1x2 inches that also itched.  By 4:00pm, the redness was darker, the swelling continued and the itching was worse.  The next morning, the redness was even darker red, covering an area about 2x3 inches, was still swelli and was now extremely itchy.  After about a week, the swelling had abated, the redness had shrunk a little (1.5x2.5 inches) and the itching started to ease.  At 10 days after the injection, the redness was finally diappearing and the itching was almost gone.  At 12 days after the injection, the skin started peeling in the area.
High fever, probably 103, Chills, strong headache. Nausea, inability to sleep, very sore arm. Fever dropped some by next day, but not completely, headache remained, tiredness, sore arm, nausea continues as I write.
Client was vaccinated with Pfizer vaccines for Covid on or about April 15 and May 15, 2021.  Client developed symptoms of Covid on 10/8 - nasal congestion and cough.  Tested positive PCR for Covid on 10/8.
I am experiencing pulsatile tinnitus in my ears that started on Saturday morning after my vaccination. The symptoms have not subsided as of Tuesday morning.
This spontaneous report was received from a healthcare worker and refers to a 20 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 28-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # L011846 and expiration date 16-JUN-2017) (dose and route of administration were not provided). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
No Adverse event; Received 0.25 ml of bivalent dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No Adverse event) in a 29-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml of bivalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25 ml of bivalent dose).    No concomitant medications were provided. Reporter saw that the dosage was changed to 0.5 ml. For the past month, reporter had been giving 0.25 ml. 19 patients received the half doses on 15-Sep-2022, 22-Sep-2022, 29-Sep-2022 and 06-Oct-2022. No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-662887, US-MODERNATX, INC.-MOD-2022-662970, US-MODERNATX, INC.-MOD-2022-662973, US-MODERNATX, INC.-MOD-2022-662974, US-MODERNATX, INC.-MOD-2022-662991, US-MODERNATX, INC.-MOD-2022-663001, US-MODERNATX, INC.-MOD-2022-663009, US-MODERNATX, INC.-MOD-2022-663012, US-MODERNATX, INC.-MOD-2022-663015, US-MODERNATX, INC.-MOD-2022-663040, US-MODERNATX, INC.-MOD-2022-663041, US-MODERNATX, INC.-MOD-2022-663044, US-MODERNATX, INC.-MOD-2022-663045, US-MODERNATX, INC.-MOD-2022-663047, US-MODERNATX, INC.-MOD-2022-663091, US-MODERNATX, INC.-MOD-2022-663128, US-MODERNATX, INC.-MOD-2022-663137, US-MODERNATX, INC.-MOD-2022-663147 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662887:Same reporter US-MODERNATX, INC.-MOD-2022-662970:Same reporter US-MODERNATX, INC.-MOD-2022-662973:Same reporter US-MODERNATX, INC.-MOD-2022-662974:Same reporter US-MODERNATX, INC.-MOD-2022-662991:Same reporter US-MODERNATX, INC.-MOD-2022-663001:Same reporter US-MODERNATX, INC.-MOD-2022-663009:Same reporter US-MODERNATX, INC.-MOD-2022-663012:Same reporter US-MODERNATX, INC.-MOD-2022-663015:Same reporter US-MODERNATX, INC.-MOD-2022-663040:Same reporter US-MODERNATX, INC.-MOD-2022-663041:Same reporter US-MODERNATX, INC.-MOD-2022-663044:Same reporter US-MODERNATX, INC.-MOD-2022-663045:Same reporter US-MODERNATX, INC.-MOD-2022-663091:Same reporter US-MODERNATX, INC.-MOD-2022-663128:Same reporter US-MODERNATX, INC.-MOD-2022-663137:Same reporter US-MODERNATX, INC.-MOD-2022-663147:Same reporter
Injection site- sore arm one hour post vaccination  and resolved within 24 hours 16 hrs after vaccination woke up with hives from waist to feet- "sizzling hot"  "itchy" "burning"   Used cold cloths on legs.  Consulted with family physician the next  morning who recommended oral Benadryl which caused her to vomit.   Family physician then recommended Allegra which seemed to improve hives.   Had an incidental appointment with pulmonologist 2 days later who recommended follow up with her family physician regarding second dose of Covid-19 vaccine.  Pulmonologist consulted with family physician and they recommended she not receive another Covid-19 vaccination.  Hives completely resolved after 3 weeks.
4 months old patient received PPSV23 instead of Prevnar 13; This spontaneous report was received from a other healthcare professional refers to a 4 month old patient of unknown gender.The patient's medical history, concurrent conditions and concomitant medications were not reported. On 04-DEC-2018, the patient was vaccinated with first dose of pneumococcal 13v conj vaccine (crm197)(PREVNAR 13) (lot# not reported)for prophylaxis. On 05-MAR-2019,the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot# not reported) for prophylaxis instead of pneumococcal 13v conj vaccine (crm197)(PREVNAR 13).
Rash all over my body started, 5/2/21. Went to urgent care was given prednisone and started to disappear but as of yesterday 5/6/21 it's back and worse this time. Went to urgent care again today 5/7/21. Was given a second prescription of prednisone but stronger dosage this time.
suspected vaccination failure; got it; All I did was sleep; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and sleepiness. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the sleepiness was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and sleepiness to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. The patient stated that, all he/she did was sleep. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Red covering on upper stomach/chest area with tiny dots consistently spread out especially on mid stomach area, hot burning feeling on abdomen, light headed, violent vomiting.
menstrual cycle change; menstrual cycle day 5 continued and additional 8 days; axillary lump; Axillary lymph node began swelling with mild pain; Axillary lymph node began swelling with mild pain; Headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 11Aug2021 13:30 (Lot number: EW0172) at the age of 31 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism", start date: 2006 (ongoing). Concomitant medication(s) included: LEVOTHYROXINE SODIUM; VYVANSE; ACETAMINOPHEN. Past drug history included: Cephalexin, reaction(s): "allergies". The following information was reported: HEADACHE (non-serious) with onset 12Aug2021, outcome "recovered" (03Sep2021), described as "Headache"; MENSTRUAL DISORDER (non-serious) with onset 13Aug2021, outcome "recovered" (20Aug2021), described as "menstrual cycle change"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 13Aug2021, outcome "recovered" (20Aug2021), described as "menstrual cycle day 5 continued and additional 8 days"; AXILLARY MASS (non-serious) with onset 13Aug2021, outcome "not recovered", described as "axillary lump"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 13Aug2021, outcome "not recovered" and all described as "Axillary lymph node began swelling with mild pain". The events "menstrual cycle change", "menstrual cycle day 5 continued and additional 8 days" and "axillary lump" were evaluated at the physician office visit. Therapeutic measures were taken as a result of headache. Therapeutic measures were not taken as a result of menstrual disorder, heavy menstrual bleeding. It was unknown if therapeutic measures were taken as a result of axillary mass.  Additional Information: The vaccine was administered in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since vaccination, the patient has not been tested for COVID-19. Treatment for headache included acetaminophen. The axillary lump was continuously monitored. The patient received the second dose on 01Sep2021 at 11:30, intramuscularly administered in the left deltoid  No follow-up attempts are possible. No further information is expected.
1st MMR date 06-08-84. New hire MMR 03-15-17 SQ RUA. Sat 03-18-17 staff report to ER excuse from work x 5 days. (R) parotid swelling, tenderness. Denies temp. Reports afebrile . + red. 03-23-17 Thurs report to office bilateral R and L parotid swelling, tenderness. Report afebrile.
her neck is hurting; neck stiffness; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (her neck is hurting) and MUSCULOSKELETAL STIFFNESS (neck stiffness) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced NECK PAIN (her neck is hurting) and MUSCULOSKELETAL STIFFNESS (neck stiffness). At the time of the report, NECK PAIN (her neck is hurting) and MUSCULOSKELETAL STIFFNESS (neck stiffness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that she doesn't think the events are from the vaccine, but possibly due to working from home. patient has not taken any treatment medications.  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.   Reporter did not allow further contact; 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.
Started with back pain, going to left and ride sided flank pain. No UTI sypmtoms prior to vaccine. Prescribed Antibiotic for kidney infection.
Fever soire arm, flu-like symptoms, body aches, nausea Employee states: initially he noticed upper arm was sore at the injection site. The next day the soreness spread to the entire arm. By 5pm on 1/8/2021 he began feeling progressively worse as if he had the flu. His entire body ached  and he was running a mild fever of 99.2 F and alternated between feeling hot and cold. He experienced a bit of nausea and upset stomach. By 1/9/2021 all symptoms had subsided except the soreness at the injection site.
24hr p/vax pt devel soreness @ shot site w/redness;then 2 days later devel lt supraclavicular node rt epitrochlear node that progressivly became more tender & swollen;shot site is almost back to fully nl but 11 days gen lymphadenopathy;
yellowing in eyes; Bilateral yellow discoloration on elbows, knees, toes, fingers.; Yellowing of hard palate in mouth; hair thinning/loss; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Jun2021 as dose 2, single (Lot number: EW0179) at the age of 30 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, lot number: EW0173,, Location of injection: Arm Left), for COVID-19 Immunization. The following information was reported: SKIN DISCOLOURATION (non-serious) with onset 01Nov2021, outcome "not recovered", described as "Bilateral yellow discoloration on elbows, knees, toes, fingers."; ORAL MUCOSAL DISCOLOURATION (non-serious) with onset 01Nov2021, outcome "not recovered", described as "Yellowing of hard palate in mouth"; ALOPECIA (non-serious) with onset 01Nov2021, outcome "not recovered", described as "hair thinning/loss"; OCULAR ICTERUS (non-serious) with onset 01Nov2021, outcome "not recovered", described as "yellowing in eyes". The events "yellowing in eyes", "bilateral yellow discoloration on elbows, knees, toes, fingers.", "yellowing of hard palate in mouth" and "hair thinning/loss" required physician office visit. Therapeutic measures were not taken as a result of ocular icterus, skin discolouration, oral mucosal discolouration, alopecia.  Additional information: Most recent dose details Product: COVID 19, brand: Pfizer, Brand unknown: False, is bivalent: False, Lot number: FJ5682, lot unknown: False, Administration date: 06Jan2022, Dose number: 3, Vaccine location: Left arm. If Other vaccine in four weeks was no. Other medications in two weeks birth control, zegerid OTC. The patient did not have COVID to prior vaccination. The patient was not tested for COVID post vaccination. Adverse event: Bilateral yellow discoloration on elbows, knees, toes, fingers. Yellowing of hard palate in mouth, yellowing in eyes and hair thinning/loss.
Pt received PREVNAR 13 vaccine IM in right deltoid 8/8/16 at 0900. On f/u visit 8/10/16, patient c/o redness and warmth at right arm (deltoid area). She able to move her arm but does cause some pain. Area is swollen to size of grapefruit, warm and tender, with no drainage. Also noticed small nodule to area. Has not applied cold pack or taken OTC pain meds. Advised to apply ice pack to injection site for 20 mins every 2 hrs throughout a 24hr period to help reduce swelling and discomfort and to take OTC pain medication (aspirin, acetaminophen, or ibuprofen) as needed.
A spontaneous report received from a consumer concerning a 4 years old child. No information was provided regarding medical history and concomitant medications and concurrent disease of the patient. Patient was prescribed FLUMIST QUADRIVALENT (Intranasal), 0.2 millilitres on 15-Jan-2016. Patient had a seizure and was hospitalized after receiving FLUMIST on 15-Jan-2016. Action taken with FLUMIST QUADRIVALENT was unknown. The outcome of seizure was unknown. The company physician assessed the event of seizure to be serious with the seriousness criteria of hospitalization.
itchy rash on left shin and calf; After second dose, rash continued in these areas and spread to left forearmand hand, right hand, behind bothknees, chest, lower back; This is a spontaneous report from a consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6199) via an unspecified route of administration in the left arm on 11Mar2021 at 09:45 (at the age of 65-year-old) as dose 2, single for COVID 19 immunisation. Medical history included hypertension and fibromyalgia. Concomitant medication included atenolol, simvastatin and diphenhydramine Hydrochloride, all for an unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL9269) via an unspecified route of administration in the left arm on 15Feb2021 at 09:45 (at the age of 65-year-old) as single dose for COVID 19 immunisation and experienced diffuse bumpy intensely itchy rash on left shin and calf where her rash continued to spread right leg. The patient had history of allergy to erythromycin. Prior to the vaccination,the patient was not diagnosed with COVID-19 and did not receive any other vaccine within four weeks. The patient was not pregnant at the time of vaccination. After taking the second dose, on an unspecified date in Mar2021, the patient had experienced itchy rash on left shin and calf and spread to left forearm and hand, right hand, behind both knees, chest, lower back. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient was not tested positive for COVID-19 since the vaccination. Therapeutic measures in response to the events included, topical and oral steroids. The outcome of the events was not resolved at the time of report.  No follow-up attempts are needed. No further information is expected.
Vaccine was stored after the expired date; Dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was stored after the expired date) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored after the expired date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was stored after the expired date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment medications were reported  Vaccine was placed in refrigerator on 27-nov-2021 Vaccine had not undergone any temperature excursion No Adverse events were reported
EXPIRED VACCINE ADMINISTERED TO 11 PATIENTS; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: 21-SEP-2021) dose was not reported, administered on SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced expired vaccine administered to 11 subjects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered to 11 patients was not reported. This report was non-serious.