chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chills; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 34 year-old male patient received bnt162b2 (BNT162B2), administration date 06Feb2022 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 08Feb2022, outcome "unknown", described as "chills"; PYREXIA (non-serious) with onset 08Feb2022, outcome "unknown", described as "fever". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients of unknown demographics. No patients' concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with improperly stored doses of ROTATEQ oral injection (lot #, expiry date, strength and dose were unspecified). The administered vaccine underwent the temperature excursion at 34.5 degrees Fahrenheit for 15 minutes. There was no previous temperature excursion. It was not the case of a "data logger". No concomitant medications were reported. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
have noticed an unusual feeling in my right abdomen just below the ribs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 66 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunisation; Bnt162b2 (Dose 2), for Covid-19 immunisation. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "have noticed an unusual feeling in my right abdomen just below the ribs".  Additional information: Serious: No. Patient did some online research and saw that some people had a possible side effect of kidney problems especially if like him they had a history of high blood pressure. Patient had received the 2 initial Pfizer COVID vaccines and the first booster.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Did start with chicken pox disease on 7/16/05. Few spots scattered over body. Some crusted, some just starting. "Felt warm" over weekend.
76 y.o. male presented to ER on 1/26 with chief complaint of shortness of breath, generalized weakness.  chest x-ray did show either increasing infiltrate, atelectasis or worsening effusion left lower lung.  He was Covid positive. Persistent small/moderate left pleural effusion with an increase in adjacent subsegmental atelectasis and/or infiltrates. Patient developed multi system organ failure and chose to be placed on Hospice. Patient died on 1/30/22
Information has been received from a physicians assistant concerning a 13 year old male with no known drug allergies who on 03-Jan-2002 was vaccinated with the second dose of hepatitis B vaccine recombinant (yeast). There was no concomitant medications. On 04-Jan-2002, the patient seen in the emergency room with a hive-like rash on his trunk, arms and neck and was also noted to have some facial edema At the time of this report, the outcome of the events was unknown.   Additional information has been requested. The pt was treated with Benadryl. Follow up info was received from the physician's assistant on 2/22/02. It was determined that the rash was "probably not related to the vaccine." The pt was referred to his primary care physician. Additional info has been requested.
High cholesterol detected in next bloodwork.  Bloodwork was run a second time with same results. Referred to dietician, but diet was already good. No other treatments.  Condition persists so far.  Patient is 20 yrs old, slim, athletic, with healthy diet.  Gets bloodwork done multiple times per year, has never had high cholesterol before.
Supposed to have second shot on 6/3 and missed date; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Supposed to have second shot on 6/3 and missed date) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Supposed to have second shot on 6/3 and missed date). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Supposed to have second shot on 6/3 and missed date) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Treatment medications were unknown.  Patient received second dose on 17-JUN-2021 and had sore arm after second shot.   This case was linked to MOD-2021-259904 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Followup received on 16-JUL-2021 contains no new information.
This spontaneous report as received from registered nurse refers to an unspecified number of patients of unknown age and gender. On unknown date the patients were vaccinated with an improperly stored dose of GARDASIL (dose, lot# and route of administration were not reported). The vaccine had been exposed to 33F for a maximum of 36 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Dizziness, Headache, Myalgia, NauseaVomiting, loss of appetite, tingling of lips and extremities immediately after injection, chills,fatigue, 3 days later. Narrative:   Other Relevant History:
Employee states left arm redness, swelling after COVID booster of Moderna. Symptoms began one hour after injection. Employee states 4 days after injection she went to ER with clammy hand, waves of hot flashes, continued red/swelling of left arm. ER prescribed antihistamine. Employee reports improved symptoms with antihistamine.
Major fatigue and body inflammation which were exasperated with the second dose.  I have developed a major case of Lichen Planus, which indicates that my body has kicked into hyper immunity.  My mouth is full of sores, my gums bleed, rashes, my nails got wavy, I bleed in places I don't want to talk about, it takes me hours to get moving, I am uncomfortable 24/7.  It started about 3 weeks after my first Moderna.  I had my second shot months later and that's when I started to go very downhill.  Yesterday a doctor and I did a timeline and connected the dots.  I have begun an aggressive treatment of prednisone which in just one day has lessened the bleeding in my mouth.  Another note:  3 weeks after my first shot I kept trying to fight off what I heard is described as Covid Fog.  I got in a car accident for the first time in decades.  My blood pressure soared after the first dose from 135/82 to 200/100.  I am responding to a low dose of BP medicine which my GP feels will not be necessary once the LP is under control.
Redness, swelling at injection site-Blocked-hives note on chest and arms. Benadryl 25mg given at 0923 Epipen given at 0930. Parent called and picked up.
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Hypotension-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: Patient was administered vaccine in left deltoid. Patient was seated in chair when vaccinated. Patient walked about 5 or 6 steps to waiting room chair to sit down and wait post vaccination. About 90 seconds to 3 minutes post vaccination the patient was seated in chair and fainted forward. Was holding conversation with father in the next chair to him and fainted from chair to the floor. Patient was aware after about 5 to 7 seconds post fainting, arms and hands were rigid.
3/17/21   Chills from 12;30 am until 7:30 am.   7:30 am  felt very very ill.  had temp of 101.7.    All of a sudden I had Urinary incontinence.  I started peeing in my bed. Asked my husband to help me to bathroom because I felt so sick.  I fainted in his arms Got back into bed and had a horrible migraine.   had to have my eyes covered and dark room  I felt as though I was going to throw up for hours.  Did not eat anything until 8 pm.  some toast and tea. 3/18/21  Still sick but not as bad.  Stayed in bed for 1/2 day.  it was a slow go. 3/19/21   Still not myself.   3/20/21.  Felt more myself.
Reported numbness on the left side of face after receiving first dose of vaccination and left deltoid. Was transferred to emergency department at local hospital.
leg itching/groin itching; groin itching and discomfort; legs discomfort; Jock itch; condition aggravated; systemic hives, itching, inflammation; systemic hives, itching, inflammation; Systemic itching; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 14th March 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 14th March 2019, not applicable after receiving Shingrix and immediately after receiving Shingrix, the patient experienced condition aggravated, hives, inflammation and generalized pruritus. On an unknown date, the patient experienced pruritus, groin discomfort, leg discomfort and tinea cruris. The patient was treated with antifungals for topical use. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pruritus, groin discomfort, leg discomfort and tinea cruris were not recovered/not resolved and the outcome of the condition aggravated, hives, inflammation and generalized pruritus were recovering/resolving.   It was unknown if the reporter considered the pruritus, groin discomfort, leg discomfort, tinea cruris, condition aggravated, hives, inflammation and generalized pruritus to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination for the 1st dose was not reported but it could be 61years or 62 years. At the end of summer of last year, the patient had his 1st dose of Shingrix. Within one week, the patient developed itching and discomfort throughout his legs and groin. He thought it was jock itch and treated with an anti-fungal spray but was not resolved.  On 14th March 2019, the patient received dose 2 of Shingrix and immediately the previous symptoms got worse. Additionally less than a day after 2nd dose, systemic hives, inflammation and itching started. These symptoms had improved but not resolved.  Emergency visit was required and the patient sought medical care for this. The patient consented to follow up and also provided healthcare professional's address. The patient did not have vaccine information and some details were missing which he did not know.
Patient reports  dime sized red rash and lump at injection site (left deltoid) 2 days after moderna Covid-19 vaccination 5/19/2021.  States it had been was resolving  over the following 5 days, until yesterday when size increased, became more red, inflamed and itchy.
Currently waiting for dental work (crown removal and replacement to treat cavity).    2/18/21 Started to experience toothache (R) which got worse as the day progressed.  Tylenol didn't help.  Took one tab of Percocet (5-325) to allow me to sleep.    2/19/21 Contacted dentist and was prescribed Penicillin VK 500 mg. Started Penicillin around 3 pm.   2/19/21 ~6 pm onset shakes, chills, sweating, low grade fever (~100.2), nausea, headache, weakness,  difficulty in standing.  Took more tylenol, lay down, fell asleep for approximately 3 hours. Woke briefly took my nighttime meds (atrovastatin, metoprolol, ranolazine, baby aspirin.) Additional information for Item 18:  2/20/21 Felt better when I woke up.  Temp normal. Ate breakfast.  Mild stomach ache. Around 3 pm onset of sweating and chills, shakes. Low grade temp (~100)   2/22/21 Fully recovered.  No lingering issues.  Not sure whether what I experienced is related to the Moderna vaccine or a reaction to the Percocet I took to alleviate the severe pain associated with my toothache.
Red itchy spots under arms around 9pm and spread throughout the night and early morning to groin, thighs, buttocks, neck, scalp, and face. Was seen at 6:28am with diffuse urticarial lesions in axilla, groin, thighs, back and legs  Facility-Administered Medications:  o  diphenhydrAMINE Inj 50 mg (BENADRYL), 50 mg, intraVENOUS, X1,  o  methylPREDNISolone Sod Succ (PF) Inj 125 mg (SOLU-Medrol PF), 125 mg, intraVENOUS, X1,  o  Famotidine (PF)-NaCl 20 mg/50 mL IV Premix 20 mg (PEPCID), 20 mg, intraVENOUS, X1 "8:15am - feeling better. Rash not has erythematous or raised. No pruritus." ASSESSMENT: Allergic Reaction- etiology Pfizer covid vaccine- labs and medication.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 05-DEC-2016, the patient was vaccinated with improperly stored dose of PROQUAD lot # M021731 with expiration date 29-OCT-2017 (dose and route of administration were not reported). The reason of the call was temperature alarm received via a Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 degrees Celsius for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA004113: US-009507513-1611USA011831: US-009507513-1705USA009742.
I feel like I have a fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (I feel like I have a fever) in a  patient of an unknown age and gender 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 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 PYREXIA (I feel like I have a fever). At the time of the report, PYREXIA (I feel like I have a fever) outcome was unknown.            Reporter did not allow further contact
No additional AEs.; inadvertent administration of GARDASIL 9 to a 6 month old male.; This spontaneous report was received from an office manager referring to a 6 months old male patient. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported.  On 20-APR-2021, the patient was inadvertent administration of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # T026168, expiration date was reported as 04-DEC-2022, 0.5 milliliter, strength, route and indication were not reported) (inappropriate age at vaccine administration). No additional adverse event. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.   devicelotnumber: T026168; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Extreme cellulitis in the left leg; swelling; was warm to the touch; severe redness; Pain in his joints; Developed a fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CELLULITIS (Extreme cellulitis in the left leg) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. LTH037A213) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Dialysis since an unknown date. Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for Diabetes, SEVELAMER CARBONATE and FERRIC CITRATE (AURYXIA) for Dialysis, ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced ARTHRALGIA (Pain in his joints) and PYREXIA (Developed a fever). On 20-Mar-2021, the patient experienced CELLULITIS (Extreme cellulitis in the left leg) (seriousness criteria hospitalization and medically significant), SWELLING (swelling), VACCINATION SITE WARMTH (was warm to the touch) and ERYTHEMA (severe redness). At the time of the report, CELLULITIS (Extreme cellulitis in the left leg), SWELLING (swelling), VACCINATION SITE WARMTH (was warm to the touch), ERYTHEMA (severe redness), ARTHRALGIA (Pain in his joints) and PYREXIA (Developed a fever) outcome was unknown.        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.   Treatment of the events included, vancomycin 1.25 g IV
IMPROPER INJECTION PLACEMENT: Injection missed deltoid muscle and entered the shoulder joint causing inflamed Bursa/possible Rotator Cuff injury.  Woke up with Extreme pain in shoulder, could not lift arm to side or forward from shoulder - range of motion about 30 degrees. Pain even at rest. Contacted physician who prescribed Methylprednisolone, UPS 4 mg, 21 tablets, resting of shoulder, icing/heat, follow up after completing round of Rx to decide on further action (PT, referral to orthopedic, etc.). As of today, range of motion still extremely limited - no pain unless there is movement beyond the mentioned range, sudden movement of shoulder joint, or repeated small movements, or any weight is born by shoulder (pulling open a drawer, opening fridge, lifting a blanket, etc.).
second moderna vac, been over 2 weeks now,still have severe fatigue, weak painfull legs, and very painfull joints <arththriris >in joints,had blood work done on fri march 5th, all blood work normal, still feel like this 2 weeks after receiving vaciine, moderna says says side effects should be gone in a few days , called them and they can give me no answer as to why i still have side effects from  vac, also had covid end of dec of 2020 , recieved first vac , a month later, with no problems just mild fever the next day which went away
Erythema, swelling, multiple vesicles at site of Varicella #2.  Pain.
Swelling, redness/cellulitis, warmth still worsening, 5 days post injection burning sensation.
This spontaneous report was received from a medical assistant refers to unspecified patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with improperly stored GARDASIL (lot # K011562, exp. 08-APR-2017). No concomitant therapy was reported. No adverse effect was reported. The outcome of the events was unknown. No product quality issue was involved. This is one of the two reports from the same reporter. Additional information has been requested.
2 days after vaccine patient developed intermittent ringing in her ears. Had continued up till 8/17. Now the tinnitus is continuous in both ears.
Day of shot Chills, shivering, muscle aches (back, neck), headache Next day - muscle aches and headache, fatigue- responded to Tylenol and Ibuprofen Following day - shoulder and neck aches; chest tightness- using albuterol
Patient came in to show her arm.  A bruise at the injection site was her chief complaint.  She was sore in the area also.
This spontaneous report has been received from a nurse referring to a patient of unknown age and unknown gender. Information of concurrent condition, pertinent medical history and drug reactions/allergies was not provided. Concomitant medication included sterile diluent. On 04-JAN-2019, the patient was administered 1 dose of improperly stored VARIVAX (three lot numbers and expiration dates (lot# R019235 with expiration date 04-JUL-2020, lot # R018932 with expiration date 02-JUL-2020 and lot # R013565 with expiration date 13-MAY-2020) were provided, but which lot was administered to the patient was unknown; strength, dose detail and route were not reported) (product storage error) for prophylaxis. Three lots of VARIVAX were exposed to temperature excursion of 6 Fahrenheit degree to 14 Fahrenheit degree for 3 hours, 15 Fahrenheit degree to 46 Fahrenheit degree for 5 hours and 30 minutes and 47 Fahrenheit degree to 77 Fahrenheit degree (also reported as 49.6 Fahrenheit degree) for 30 minutes. No previous temperature excursion. No adverse effects was reported. Data logger was not involved. This is one of the four reports from a same reporter. Sender's Comments: US-009507513-1901USA007256; US-009507513-1902USA004204; US-009507513-1902USA004205.
TINNITUS HAS INCREASED IN AMPLITUDE BY 3-4 TIMES, UNBEARABLE; POSSIBLY WORSENED DISC DISEASE AND BONE SPURS CONDITION SINCE VACCINATION; This spontaneous report received from a patient concerned a 57 year old male. The patient's weight was 260 pounds, and height was 77 inches. The patient's concurrent conditions included: mild tinnitus, bone spurs, medically controlled hypertension, mid range hearing loss, and neck/back pain with disc disease, and other pre-existing medical conditions included: Patient did not had any known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, expiry: 11-APR-2022) dose was not reported, administered on 05-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On NOV-2021, the patient experienced possibly worsened disc disease and bone spurs condition since vaccination. On 05-NOV-2021, the patient experienced tinnitus has increased in amplitude by 3-4 times, unbearable. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tinnitus has increased in amplitude by 3-4 times, unbearable, and the outcome of possibly worsened disc disease and bone spurs condition since vaccination was not reported. This report was non-serious.
His heart rate went up repeatedly while resting (laying down) to 100- 115 several days after the vaccination.