chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer concerned a white male of unspecified age with Hispanic or Latino ethnicity. The patient's height, and weight were not reported. 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: 1805025, expiry: Unknown) dose was not reported, 1 total, administered on 10-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in APR-2021, the patient got the Covid-19 infection (suspected Covid-19 infection and suspected clinical vaccination failure). On an unspecified date, patient was hospitalized for 9 days with serious covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This report was associated with product quality complaint: 90000203200. This case, from the same reporter is linked to 20211142018.; Sender's Comments: V2: 20211142112 -Covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS V2: 20211142112-Covid-19 vaccine ad26.cov2.s -Suspected covid-19 infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Worst shot ever given- hurt immediately and for approx 4 to 5 days after.  Got really sick after for 4 days - puking etc.  Started noticing that arm aches all the time/area given is sore to touch-hard to lift above a certain height for last 2 months
Patient developed a red bump or welt immediately after injection at site but did no experience anaphylactic shock. Patient has monitored for 30 mins, no Tx needed.
at 12:24 pm, 10 minutes after receiving vaccine, pt reports feeling dizzy and throat tightness. pt denies short of breath, or any pain 12:29 pm pt evaluated by EMS BP 122/87, P 70, O2 Sat 100%  12:33 pm pt transported to hospital for evaluation
Numerous small red bruises or blotches (ecchymoses) on left flank, chest, and back.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Jul2021 (Lot number: FA7484) at the age of 49 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of pain in extremity.  Follow-Up (29Sep2021): Follow-up attempts are completed. No further information is expected.
One of three children immun fr the same vial & experienced an inject site reaction. Reaction included swelling, redness & pain. Tx included tylenol & ice packs.
Injection site was sore/Vaccination site pain; injection site was red/Vaccination site erythema; swelling size of tennis ball at injection site/Vaccination site swelling; injection site was warm/vaccination site warmth; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 40-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Oct2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 40 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy: Iodine" (unspecified if ongoing). Concomitant medication(s) included: PHENTERMINE; SPIRONOLACTONE. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 09Oct2023 at 13:15, outcome "recovered" (Oct2023), described as "Injection site was sore/Vaccination site pain"; VACCINATION SITE ERYTHEMA (non-serious) with onset 09Oct2023 at 13:15, outcome "recovered" (Oct2023), described as "injection site was red/Vaccination site erythema"; VACCINATION SITE WARMTH (non-serious) with onset 09Oct2023 at 13:15, outcome "recovered" (Oct2023), described as "injection site was warm/vaccination site warmth"; VACCINATION SITE SWELLING (non-serious) with onset 09Oct2023 at 13:15, outcome "recovered" (Oct2023), described as "swelling size of tennis ball at injection site/Vaccination site swelling". Therapeutic measures were not taken as a result of vaccination site pain, vaccination site erythema, vaccination site swelling, vaccination site warmth.  Additional information: Did not had covid prior to vaccination. Did not tested positive with covid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache after injection. 6 hours after dose, cold chills. An hour after that, a fever of 101F.
Date of start of drug (1st dose): 15Apr2021, 2nd dose, Dose received - 06Jun2021; broke out on her chest, face, and  everything turned beat red; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 42-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0167, NDC, Expiration date - unknown) via an unspecified route of administration on 06Jun2021 (at the age of 42-year-old) at dose 2, single for covid-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8731) via an unspecified route of administration, administered in right arm on 15Apr2021 (at the age of 42-year-old) at dose 1, single for covid-19 immunisation. Patient experienced did not feel well (Didn't feel well: start - beginning of Mar, she thought she had an infection in her hand, and she went to the local urgent care and her doctor ruled that out. She wasn't feeling great and had a hard burning ear drainage and got a covid test on 28Mar2021, the end of Mar it came back negative. Caller stated she is not sure if it was 28Mar2021, she clarified it was the last week in Mar), she was shaking and her heart rate went up to 185 and dropped pretty suddenly down to 36, lost a significant amount of weight, neurological and muscle problems, GI problems, difficult time walking, muscles are very weak, back and spine pain and neck, broke out on her chest, face, and everything turned beat red, shaking after taking first dose. On an unspecified date the patient experienced date of start of drug (1st dose): 15apr2021, 2nd dose, dose received - 06jun2021 and on an unspecified date in Jun2021 the patient experienced broke out on her chest, face, and everything turned beat red. The patient underwent lab tests and procedures which included on an unspecified date colonoscopy result was unknown, 3 CT scans result was unknown, scope result was unknown, Heart rate was 185 dropped pretty suddenly down to 36, MRI of neck and head Everything came back normal and on 28Mar2021 covid test was negative. She got 3 CT scans but does not know the dates or the results. She had a colonoscopy and a scope, and has a scheduled EMG (muscle, nerve study) can't get in until Oct. She had the CT scan a day before one of the vaccines. Treatment - She has been going to the doctors almost four or five a week, blood work like crazy and the ER nine times. Two times were prior to her first vaccine. Outcome of the event broke out on her chest, face, and everything turned beat red was resolved with sequel and another event was unknow.   Follow up (PRD/SRD 02Aug2021): No follow-up attempts are possible. No further information is expected.
lungs hire; 100.4 temp; Headache; chills; 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 LUNG DISORDER (lungs hire), PYREXIA (100.4 temp), HEADACHE (Headache) and CHILLS (chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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, the patient experienced LUNG DISORDER (lungs hire), PYREXIA (100.4 temp), HEADACHE (Headache) and CHILLS (chills). At the time of the report, LUNG DISORDER (lungs hire), PYREXIA (100.4 temp), HEADACHE (Headache) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: other (Inconclusive) 100.4.
threw up all night; feeling cold; nausea; having chills; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of FEELING COLD (feeling cold), NAUSEA (nausea), CHILLS (having chills) and VOMITING (threw up all night) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced FEELING COLD (feeling cold), NAUSEA (nausea) and CHILLS (having chills). On 31-Jan-2021, the patient experienced VOMITING (threw up all night). At the time of the report, FEELING COLD (feeling cold), NAUSEA (nausea), CHILLS (having chills) and VOMITING (threw up all night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter. No treatment medications were reported.
Summary: I broker out in large rashes within a few days of each injection. More Detail: Bright pink rash showed up over night under each arm on the 5th day after the first injection of the vaccine. I began applying antifungal cream twice daily to the affected area (Lotrimin Ultra - Butenafine Hydrochloride). 4 days later it had spread to below, behind and all around the underarm. The spread including many bumps and much itching. I utilized a Clindamyacin (antibiotic) wipe that I had left over from an infection 5 months prior. I then flew to California for a business trip. The next day (10th day after the injection, and 5th day after the rash appeared) the rash had gotten significantly worse over night.  The entire area had turned into welts, the bumps and redness had spread down the side of my body, into my back, up to my shoulders and neck, and across my chest. Over the following 3-4 days hives broke out across my torso and progressed downward stopping at my navel.  When I returned from my business trip I visited my Dermatologist and she sent me to urgent care.  I began taking 10 mg of Prednisone 3 times daily, and antihistamines morning and night. 20 days after the initial injection the rash had cleared up over 90% with only some remaining redness and hives.  That day, 20 days after the first injection, I received my 2nd injection. The morning I woke up 2 days after the 2nd injection I had a large red rash under each arm and a small reddish pink rash across my lower rib cage.  The rib cage rash grew in size and color over the next 2-3 days, while I continued taking Prednisone and antihistamines. I stopped taking antihistamines 5 days after the 2nd injection to prepare for a Patch allergy test that I hoped for the following week, but which did not occur. On the morning of the 7th day after the 2nd injection the rashes under my arms and across my lower rib cage and under my breasts was 95% gone. Today is the 8th day after my 2nd injection. I still have some discoloration, some residual small and itchy hives. I took 10mg of Prednisone today and will reduce down to 5mg for 3 days over the coming days.
This spontaneous report was received from a registered nurse referring to an unknown number of patients of unknown age whom on an unknown date, were vaccinated with a dose of VARIVAX (Merck) (dose, route of administration and lot # not reported). The registered nurse reported that the patients may have been vaccinated with VARIVAX (Merck) stored at a higher than recommended temperature. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
tested positive for Covid 19; This is a spontaneous report from Pfizer-sponsored program COVAX US Support. A contactable female consumer reported that she received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine; Solution for injection), via an unspecified route of administration on 11Mar2021. The patient's medical history and concomitant medications were not reported. It was reported that, on 13Mar2021, the patient tested positive for COVID-19. The patient was quarantined after that and dont know the exact date for her 2nd dose and was told her to postpone the 2nd dose. The outcome for the event was reported as unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Became extremely fatigued and began to have sore throat on 3/16. Daughter also became ill and tested positive for COVID 19 on 3/16. Tested on 3/17 via rapid test and was determined to be positive. Over the course of the next few days developed increased HR, SOB, dizziness, fatigue, nausea, and heart palpatations that have lasted approx 1 week.
Case number PHEH2012US021823 is an initial spontaneous report received from a physician on 26 Oct 2012: This report refers to an adult female patient. She was vaccinated with the first dose of post exposure series of RABAVERT (batch number: unknown) intramuscularly on an unspecified date in Oct 2012 and experienced migraine-like headache and exhaustion (see related case: PHEH2012US021623). The pharmacy delayed her second dose of vaccine due to the adverse reactions she was experiencing. She was vaccinated with the second dose of RABAVERT (batch number: unknown) intramuscularly on 25 Oct 2012. Later on, in the same day, she began experiencing redness and swelling at the injection site that measure about 3 inches in diameter, a worsening of her migraine-like headache, fatigue and swollen lymph nodes. The final outcome was reported as condition unchanged at the time of reporting. No further information about seriousness and causality was reported.
EXPIRED HIB GIVEN TO PT.  WILL ORDER A PRIVATE HIB TO ADMINISTER TO PT WITHIN A MONTH
Sporadic for a couple of hours and really goofy; Sweating like a stuffed pig; Shakes; Ran a mild fever/ highest was 101.F/ fever/ starting to run another fever; Chills; Sudden headache; Nausea; Could not lift the arm; Diarrhea; Destruction in head; Swelling; Tenderness; Fatigue; Joint pain; Somewhat muscle pain; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Sporadic for a couple of hours and really goofy), HYPERHIDROSIS (Sweating like a stuffed pig), LIMB DISCOMFORT (Could not lift the arm), DIARRHOEA (Diarrhea) and HEAD DISCOMFORT (Destruction in head) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Oct-2021, the patient experienced MYALGIA (Somewhat muscle pain). On 09-Oct-2021, the patient experienced LIMB DISCOMFORT (Could not lift the arm), DIARRHOEA (Diarrhea), HEAD DISCOMFORT (Destruction in head), SWELLING (Swelling), TENDERNESS (Tenderness), PYREXIA (Ran a mild fever/ highest was 101.F/ fever/ starting to run another fever), CHILLS (Chills), HEADACHE (Sudden headache), NAUSEA (Nausea), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain). On 12-Oct-2021, the patient experienced FEELING ABNORMAL (Sporadic for a couple of hours and really goofy), HYPERHIDROSIS (Sweating like a stuffed pig) and TREMOR (Shakes). The patient was treated with NAPROXEN SODIUM (ALEVE) on 12-Oct-2021 for Headache, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Sporadic for a couple of hours and really goofy), HYPERHIDROSIS (Sweating like a stuffed pig), TREMOR (Shakes), PYREXIA (Ran a mild fever/ highest was 101.F/ fever/ starting to run another fever), CHILLS (Chills), HEADACHE (Sudden headache) and NAUSEA (Nausea) had not resolved, LIMB DISCOMFORT (Could not lift the arm) was resolving and DIARRHOEA (Diarrhea), HEAD DISCOMFORT (Destruction in head), SWELLING (Swelling), TENDERNESS (Tenderness), MYALGIA (Somewhat muscle pain), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Oct-2021, Body temperature: 101 (High) mild fever, highest was 101 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was reported.  Additional treatment medication was pain pills.
Patient was given a PED's dose of Pfizer. There was no signs and/or symptoms of any adverse reactions. Patient, along with parent waited at the clinic for  minutes after vaccine was given.
p/vax pt exp congestion, nasal & lung then devel diabetes insipidus
17 minutes after injection my left arm began to feel hot then the rest of my body did too and my throat stared to feel itchy. Dr. started to monitor me to see if symptoms worsened. Then 15 minutes later my chest felt hot and heavy and throat was more itchy.  Dr. took vitals then administered epi , monitored throat became even more itchy then Benadryl was given and emergency services was called. Paramedics evaluated and symptoms began to get better, there was no transfer to the ER
body ache; stomach sore like I had done crunches; knee is swollen; knee is red; being sick to stomach; Fever; temp 101 in the knee; cant walk or put pressure on my legs; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (cant walk or put pressure on my legs), MYALGIA (body ache), ABDOMINAL PAIN UPPER (stomach sore like I had done crunches), SWELLING (knee is swollen) and ERYTHEMA (knee is red) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fibromyalgia and Knee replacement (4 replacement on same knee). Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal), DULOXETINE HYDROCHLORIDE (CYMBALTA) for Fibromyalgia, METOPROLOL for Heart disorder, ALPRAZOLAM for Nerve pain.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2020, the patient experienced GAIT INABILITY (cant walk or put pressure on my legs). On 06-Mar-2021, the patient experienced MYALGIA (body ache), ABDOMINAL PAIN UPPER (stomach sore like I had done crunches), SWELLING (knee is swollen), ERYTHEMA (knee is red), NAUSEA (being sick to stomach), PYREXIA (Fever) and ARTHRITIS (temp 101 in the knee). The patient was treated with TRAZODONE ongoing since an unknown date for Sleepy, at a dose of 300 mg once; IBUPROFEN at an unspecified dose and frequency and NAPROXEN (MOTRIN [NAPROXEN]) at an unspecified dose and frequency. On 07-Mar-2021, MYALGIA (body ache), ABDOMINAL PAIN UPPER (stomach sore like I had done crunches), SWELLING (knee is swollen), ERYTHEMA (knee is red), NAUSEA (being sick to stomach), PYREXIA (Fever) and ARTHRITIS (temp 101 in the knee) had resolved. At the time of the report, GAIT INABILITY (cant walk or put pressure on my legs) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: ADR Form
One week after immunizations patient presents to our office with complaining of swelling and soreness to left deltoid area. Slight swelling with a 1/2 inch in diameter red area noted. 3-26-07 after attempts x2 to reach guardian of child, Grandpa phoned to state child saw Dr. Patient on Benadryl and Ibuprofen, arm improving, doing well.
p/vax pt office visit lt upper arm redness; swelling & pain; T97.5; symptoms worse in AM; redness; swelling below inj site; ER PM; rx not filled; Dx: cellulitis from ER MD
Itches; Rashes on the body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itches) and RASH (Rashes on the body) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itches) and RASH (Rashes on the body). At the time of the report, PRURITUS (Itches) and RASH (Rashes on the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
A few days after getting the shot I got covid and my throat was sore and it got worse. I also had a low grade fever. I had a serve cough and I called urgent treatment center.
The following day I began having signs of a miscarriage. I had severe cramping the following day I began spotting and saturday only 2 days after having the H1N1 vaccine I had major bleeding and went to the doctor and had confirmed miscarriage . Everything was fine before I had the shot. The heart beat was there and strong and no signs of any trouble at all
Patient stated that pain developed around injection site within 30 minutes of administration. After an hour, the skin around the site began to swell. For the rest of the day, patient complained of one-sided "swelling" feeling on her nerve on the same side as the site. Patient felt "lightheaded and dizzy" during the rest of that day. Also reported mild fever.
Dizziness, Headache, Myalgia, Fever, Rash, HYPERtension, Syncope, Unresponsiveness, paralysis of limbs, aphasia  Narrative: employee became unconscious and transported to local Emergency Facility.
Large knot under injection site that has quadrupled in size. Red, itchy, and extremely painful.
Patient stated that the area where she received the SHINGRIX vaccine (left deltoid) was hard, red, and swollen. The swelling and redness was about the size of her palm. She said that her arm felt weak.  Symptoms were all localized to injection site. Patient treated discomfort with Tylenol and ice pack.  Provider suggested using OTC antihistamine (IE Allegra, Zyrtec, Benadryl) as well.