chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a Registered Nurse (R.N.) concerning a 17 year old female patient who on 26-JUN-2007 was vaccinated IM in deltoid with Gardasil lot #0469U.  Concomitant therapy included ORTHO TRI-CYCLEN LO.  The patient developed hair loss after the vaccination.  The patient saw a dermatologist who said the hair was growing back underneath.  No further information was available.  The patient was recovering.  Additional information has been requested.
A MISSING VACCINE REQUIRED BY THE ELEMENTARY,  I was notified by phone that pt. needed the record updated as he was missing a shot.   We went to the health department, received the vaccine and began holiday. On the day to return to school he awoke in severe pain and swelling on one side the extent of his neck. The administrator stated there was only one vaccine left in stock. As time continued it was very clear that it was purposely done. I have received mailings regarding such as we were domestic violence victims under a protective order, whom have since endured targeted harassment, attacks, and environmental experimentation,   Crime, and terrorisms. Sterilizing was the motive
This spontaneous case reported by a consumer, describes the occurrence of decreased appetite (lost of appetite), pain in jaw (even the jaw hurt), bone pain (bone ache), chills (severe chills) and headache in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced decreased appetite (lost of appetite), pain in jaw (even the jaw hurt), bone pain (bone ache), chills (severe chills) and headache. At the time of the report, decreased appetite (lost of appetite), pain in jaw (even the jaw hurt), bone pain (bone ache), chills (severe chills) and headache outcome: unknown. No concomitant medication or treatment information provided. The patient developed effects from the booster dose of the vaccine and prefers not to take the vaccine again.
Received her Moderna vaccine on March 12 at approximately 5pm.  Within moments her arm and face began to itch.  The nurse administered Benadryl.  The symptoms did not go away or worsen so she left when released.  Around 7 the symptoms had progressed to tongue feeling heavy, sore throat, and some difficulty breathing (although her O2 fluctuated between 96-99).  She went to the ER, they administered IV fluids, Benadryl, Pepcid, and steroids.  Within a couple hours the symptoms had subsided.  As directed, we continued Benadryl and Pepcid for 24 hours.  After being off the Benadryl and Pepcid for 12 -15 hours the symptoms returned, she took one dose of both and now seems to be fine.
Received second dose of Pfizer vaccine towards end of January.  Subsequently developed palpitations and skipped beats approximately 1 month later. Seen by cardiologist,  Zio patch monitoring showed PVC?s, echocardiogram with EF 50% which is borderline low. Cardiac MRI confirmed myocarditis. Subsequent blood work was completely negative.  Presumed myocarditis as a side effect of Pfizer vaccination per discussion with cardiologist.
Approximately 16 hours after vaccine, right side of body swelled, including right leg, arm, foot, toes, and hand. Swollen lymph node on right side of body underneath jaw.
Initial case was retrieved from the scientific literature on 08 June 2011. "The agency was established in 1986 in response to vaccine safety concerns. A unique feature is a table of compensable injuries, the Vaccine Injury Table (VIT). Anaphylaxis is a listed adverse event with an interval of 0 to 4 hours for vaccines containing Td, DPT, DTaP, MMR II, IPV, and HBV. In 2009, the agency charged the Institute with the task of completing a comprehensive review of the medical literature regarding adverse events related to vaccines so that the VIT could be updated. Concurrent with the Institute's review, we undertook a systematic analysis of the agencies anaphylaxis case experience. The agency administrative database was queried for all cases submitted to the agency alleging "anaphylaxis or anaphylactic shock" for the 10-year period from January 1, 2000, through December 31, 2009." The patient captured in this case was one of 8 noted in the above reference that experienced anaphylaxis after vaccination. A geriatric male patient (age not reported) with a medical history of type 2 diabetes mellitus, hypertension (HTN), coronary artery disease (CAD) after coronary artery bypass graft, dementia, and dysrhythmia, received an injection (route and site not reported) for Diphtheria and Tetanus Toxoids, lot number and manufacturer not reported, on an unknown date. On an unknown date within 30 minutes after receiving the vaccine, the patient developed anaphylaxis with symptoms of choking, shortness of breath, and face/neck/whole body swelling. The Emergency Medical Service (EMS) was unsuccessful in intubation. The patient became hypotensive and went into respiratory arrest. The patient received epinephrine x 3, atropine x 3, and remained an unsuccessful intubation. The patient died (date not reported). The outcome was reported as fatal. The reporter in this case is the same as cases: 2011-03327, 2011-03328, 2011-03329, 2011-03330, 2011-03331, 2011-03332, and 2011-03333. Documents held by sender: None.
Skin rash all over body. Comes and goes. Seems to worsen after showering. Itching /reddening.
Redness around the injection site that continues to spread 2 days after vaccine and is hot to touch. Temp 103 after Tylenol and Ibuprofen. Chills with uncontrolled shaking x 1-2 hours.
c/o pain shoulder x 1 week with limited ROM.  Denies c/o fever or redness.
skin was bruised; skin was scraping off; skin underneath is super white; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Jan2021 at single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. Patient stated that she got the first dose of vaccination two weeks ago (as of 21Jan2021). Supposed to get second dose on Monday. Stated that she was bruised (skin was bruised) and after two weeks skin was scraping off and skin underneath was super white, in Jan2021. Stated was a reaction. Wanted to know if should get it again. Stated that she worked at hospital (stated that she does vascular and echo on heart and legs) and needed to get immune. Wanted to know if there was an email to show her pictures. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
A non-serious spontaneous report of partial dose administration of FLUMIST was received from a physician concerning a child. Neither the patient's medical history nor the concomitant medications were reported. On 05-Dec-2011, during FLUMIST administration the child pulled on the nurse's arm for both nostrils so she only got about half in each nostril. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of two years to 59 months of age.
This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. No concurrent or historical conditions were reported. On 03-FEB-2016 the patient was vaccinated with expired dose of RECOMBIVAX HB (Lot 3 J012520, expiration date 30-JAN-2016) pediatric/adolescent formulation of 5 mcg, 0.5 ml, intramuscular, anatomical location was unspecified. No concomitant medications were reported. The reporter noted it was unspecified when this patient was administered the first dose of RECOMBIVAX HB but she stated that the dose administered on 03-FEB-2016 was not the first dose. No adverse effect reported, no further information was provided, no product quality complaint was involved. Additional information has been requested.
This solicited report was received from a 67-year-old male patient, who refers to himself. He was enrolled in a market research program. The patient's concurrent condition included service. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (dose, route of administration, lot# and expiration date were not reported). The patient reported that he recalled how sick the shot made him when he got it (date unspecified). The outcome of the event was not reported. The reported considered the event to be related to PNEUMOVAX 23. This is one of two reports received from the same reporter. Additional information is not expected, as there was no consent to follow-up. Sender's Comments: US-009507513-1701USA003984.
6 3/4 x 3 3/4 area of erythema and redness, warmth treated with Augmentin (600) 6ml PO BID x 10 days.
Vaccine was administered after the beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after the beyond use date after the thaw process) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after the beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after the beyond use date after the thaw process) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported  Patient age was reported as 27 year 8 Month.   It was reported that vaccine was administered beyond use date to patients. There was no adverse reaction noted or reported regarding these administrations.  Vaccine number 1 NDC code was reported as 80777027399.  No treatment drug information was provided.
Noticed rash on shoulders, injection site, chest, andtorso. Red and hot and bumpy in certain spots; Noticed rash on shoulders, injection site, chest, andtorso. Red and hot and bumpy in certain spots; Noticed rash on shoulders, injection site, chest, andtorso. Red and hot and bumpy in certain spots; Noticed rash on shoulders, injection site; Left underarm swollen; Severe headache; Jaw pain; Body aches; Chills; The patient received the third/booster dose of BNT162b2; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the left arm on 07Oct2021 at 11:45 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. The patient did not have relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified antibiotic (MANUFACTURER UNKNOWN) within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 14Jan2021 at 13:00 (at the age of 57-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the left arm on 04Feb2021 at 08:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. On 08Oct2021 at 23:45, the patient experienced severe headache, jaw pain, body aches and chills, till the half of 09Oct2021. On 09Oct2021, the patient noticed rash on shoulders, injection site, chest and torso rash, red and hot and bumpy in certain spots and left underarm swollen. The events did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 08Sep2021, the patient underwent SARS-COV-2 test (Polymerase Chain Reaction (PCR)) through nasal swab and the result was negative. The clinical outcome of the events severe headache, jaw pain, body aches and chills were resolved on 09Oct2021 while rash on shoulders, injection site, chest and torso rash, red and hot and bumpy in certain spots, left underarm swollen was resolving at the time of this report.
Arm Swollen; Arm Hurting; Arm red; All Bones Ached; All Muscles Ached; Severe Headache; Chills; Fever; Neck Hurt; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), NECK PAIN (Neck Hurt), PERIPHERAL SWELLING (Arm Swollen), PAIN IN EXTREMITY (Arm Hurting) and ERYTHEMA (Arm red) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). On 10-Mar-2021, the patient experienced NECK PAIN (Neck Hurt), BONE PAIN (All Bones Ached), MYALGIA (All Muscles Ached), HEADACHE (Severe Headache), CHILLS (Chills) and PYREXIA (Fever). On 11-Mar-2021, the patient experienced PERIPHERAL SWELLING (Arm Swollen), PAIN IN EXTREMITY (Arm Hurting) and ERYTHEMA (Arm red). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore Arm), NECK PAIN (Neck Hurt), PERIPHERAL SWELLING (Arm Swollen), PAIN IN EXTREMITY (Arm Hurting), ERYTHEMA (Arm red), BONE PAIN (All Bones Ached), MYALGIA (All Muscles Ached), HEADACHE (Severe Headache), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had her 1st Shot 08MAR2021. On the first day, her arm was sore. The next day she had chills, fever, her neck was hurting, severe headache, all muscles and bones were aching and she had chills really bad. She took Tylenol and following day she had no chills she was still aching. Her arm was swollen, hurting and red from shoulder to elbow.   This case was linked to  INC.-MOD-2021-046455, INC.-MOD-2021-046518 (E2B Linked Report).; Sender's Comments:  INC.-MOD-2021-046455:Daughter case  INC.-MOD-2021-046518:Aunt case
G62.9 NEUROPATHY 8/29/2022 BILE DUCT OBSTRUCTION G62.9 NEUROPATHY 8/29/2022 DEHYDRATION G62.9 NEUROPATHY 8/29/2022 UPPER GI HEMORRHAGE G62.9 NEUROPATHY 8/29/2022 SMALL BOWEL OBSTRUCTION
Splenic infarct. Otherwise health male with no prior medical Hx, beside ruptured appendectomy in approximately 2010. No history of any chronic medical conditions, no use or prescription or over the counter medications, no drug use.
Injection site pain, feeling unwell Tiredness, swollen lymph nodes Headache, light headedness Chills Fever
Individual received Fluarix Quad Influenza vaccine that is eligible for those between 6 months to 64 years old. Individual was observed for 15 minutes and did not exhibit any signs/symptoms of acute anaphylaxis.
Mild heart palpitations for several days after vaccination; Fever for several days after vaccination; Fatigue for several days after vaccination; This spontaneous case was reported by a patient and describes the occurrence of PALPITATIONS (Mild heart palpitations for several days after vaccination), PYREXIA (Fever for several days after vaccination) and FATIGUE (Fatigue for several days after vaccination) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Mild heart palpitations for several days after vaccination), PYREXIA (Fever for several days after vaccination) and FATIGUE (Fatigue for several days after vaccination). At the time of the report, PALPITATIONS (Mild heart palpitations for several days after vaccination), PYREXIA (Fever for several days after vaccination) and FATIGUE (Fatigue for several days after vaccination) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PALPITATIONS (Mild heart palpitations for several days after vaccination), PYREXIA (Fever for several days after vaccination) and FATIGUE (Fatigue for several days after vaccination) to be related.    Patient will play golf and walks 3 miles (4 times weekly).  No concomitant medications were provided by the reporter. Other treatment medications includes Paxlovid, Shingrix, Escitalopram.  Patient's lab data includes Abnormal EKG'S, had Echocardiogram, Cardiac MRI - Determined to have PAC, PVC arrhythmias.   This case was linked to MOD-2022-590374 (Patient Link).
Angioedema of lips; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on 10Feb2021 at 09:00 AM (at the age of 64 years old) at a single dose for COVID-19 immunisation.  Medical history reported as none. The patient has no known allergies. Concomitant medications included bupropion and vitamin D3.  The patient experienced angioedema of lips on 23Feb2021 at 08:00 AM. The patient did not receive treatment for the event. The patient did not receive other vaccine in four weeks. The patient did not have COVID prior to vaccination and not tested for COVID post vaccination. The patient is recovering from the event angioedema of lips.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of short angioedema of lips due to temporal relationship and current known drug safety profile.  Case will be re-assessed upon the additional information provided. Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of short of breath, throat tight and swallow difficulty due to temporal relationship and current known drug safety profile.  Case will be re-assessed upon the additional information provided.
DEATH; This spontaneous report received from a consumer concerned a 35 year old male of unspecified race and ethnicity. Initial information was processed along with the additional information received on 26-OCT-2021. The patient's height and weight were not reported. The patient was healthy as an Olympian before vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: L17021UA1 and 51737 and expiry: 28-FEB-2023 and 31-AUG-2023) dose, start therapy date were not reported,1 total administered for prophylactic vaccination. Concomitant medications included azathioprine, Inflectra, prednisone, caffeine, Neutrogena clear liquid lotion sunscreen SPF30/sunblock unspecified and Neutrogena ultra sheer mist sunscreen broad spectrum SPF70 5OZ for unspecified indication. It was reported that on an unspecified date, the patient was died days after the J and J (Johnson and Johnson ) shot. The cause of death was unknown. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of unknown cause. This report was serious (Death). This case, from the same reporter is linked to 20211049317 and 20211043304.; Sender's Comments: V0: 20211045102-covid-19 vaccine ad26.cov2.s -Death. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Beginning approximately one day after shot administration, I developed a red lesion at the injection site around 2 inches in diameter.  Around day 5, this went away.  Then, around day 8, the lesion returned, and is now about 3 inches in diameter. Both times, the lesion was red, itchy, burning, and painful to touch.  The lesion appears to be consistent with reports of "COVID Arm" seen in some instances after receiving the Moderna shot specifically.
This spontaneous report was received from a medical assistant referring to a unspecified number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an  unknown date, unspecified number of patients received an improperly stored dose of VARIVAX injection, subcutaneous route, (lot # M025865, expiration date: 24-MAY-2018), (lot # M008173, expiration date: 16-FEB-2018), (lot # M025869, expiration date: 24-MAY-2018), (lot # 024680, expiration date: 18-MAY-2018), (lot # M031969, expiration date: 30-JUN-2018) (strength and dose was not reported). The patient's concomitant medications were not reported. The temperature excursion with VARIVAX was 2 hours and 34 minutes (154 minutes) at 15.8 Fahrenheit degrees. The temperature excursions were detected by a data logger. No adverse effects were reported and no product quality complain was involved. Lot number M025869 has been verified to be a valid lot number for varicella virus vaccine live (Oka/Merck). Lot number 024680 is an invalid lot number for varicella virus vaccine live (Oka/Merck). Additional information has been requested.
Side effects; This case was reported by a pharmacist via call center representative and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. The pharmacist stated a coworker left a note at the pharmacy which outlined that the patient did not want to receive the 2nd dose of the Shingrix. The pharmacist believed that the patient experienced side effects from the 1st dose, but she was not sure what the patient experienced as the note did not specify further. The reporter consented to follow up. No further details provided during the call, but pharmacist granted permission for safety to follow up.