chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician assistant and refers to a 4-year-old child. The patient's concurrent condition, medical history and concomitant therapies were not reported. On 11-JUN-2018, the patient was inadvertently vaccinated with VARIVAX injection, for prophylaxis. On the same day, the patient was also vaccinated with PROQUAD for prophylaxis. Expiration dates and lot# for both vaccines were unknown. No adverse effect was reported.
Lose sense of taste; experienced lethargy; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Lose sense of taste) and LETHARGY (experienced lethargy) in a 78-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (Lose sense of taste) and LETHARGY (experienced lethargy). At the time of the report, AGEUSIA (Lose sense of taste) and LETHARGY (experienced lethargy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No medical history was provided. No concomitant and treatment medication was provided. This is a spontaneous case concerning a 78-year-old male patient with no relevant medical history reported, who experienced non serious, AESI, unexpected event of Ageusia. The event occurred unknown days after a dose of mRNA-1273. Rechallenge is not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 78-year-old male patient with no relevant medical history reported, who experienced non serious, AESI, unexpected event of Ageusia. The event occurred unknown days after a dose of mRNA-1273. Rechallenge is not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Local reaction 3 days after inj. Redness, hive like swelling, itchiness, burning, tenderness, rash, h/a.
Patient reported with swollen, erythematous, painful, hot to the touch skin at injection site.  Began after injection
no adverse event; administered vaccine after the 30 day beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered vaccine after the 30 day beyond use date) and NO ADVERSE EVENT (no adverse event) in a child patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jan-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Jan-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered vaccine after the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered vaccine after the 30 day beyond use date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.   This case was linked to MODERNATX, INC.-MOD-2023-704453, MODERNATX, INC.-MOD-2023-704462, MODERNATX, INC.-MOD-2023-704474 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-704453:2nd child MODERNATX, INC.-MOD-2023-704474:4th child MODERNATX, INC.-MOD-2023-704462:3rd child
This spontaneous report was received from a physician via a company representative. The physician heard about this shingles case study which was presented during a meeting, referring a male patient of an unknown age. The patient was considered "immunosuppressed" and he had a transplant surgery in an unspecified date for an unspecified cause/reason. Information regarding drug reactions, allergies or concomitant medications was not mentioned. In an unspecified date in 2012, the patient was vaccinated with ZOSTAVAX (dose, anatomical location and patient route of administration, lot # and expiration date were not reported). On an unmentioned date, after getting vaccinated the patient experienced disseminated shingles virus. It was unknown which the outcome of shingles was. Furthermore, on an unspecified date due to an unspecified cause the patient died. It was not known if an autopsy was performed. The causal relationship between shingles and death, with vaccination with ZOSTAVAX was not reported. Upon internal review, the event Herpes zoster disseminated was considered to be medically significant.; Reported Cause(s) of Death: died due to an unspecified cause.
12 days after primary smallpox vaccine (3 jabs to left deltoid) patient returns to vaccination clinic complaining of pus filled vesicles on body.  Duration of 5 days, no itching, asymptomatic lesions.  No other complaints.  Was involved in MVA a few days ago and is taking hydrocodone.  No other medications.  Lesions on the occipital scalp described as acneiform papules, similar lesions on posterior neck, 8-10 lesions on back, left shoulder with mild erythema surrounding the scabbed over SP eschar.  No lesions to face, upper extremities, chest or abdomen.
Severe chills; Fever 99.5; Severe headache; Skin hurt; Dehydration; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Apr2021 at 11:45 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy (sulfa type antibiotics) and penicillin allergy (PCN antibiotic). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Apr2021 at 02:00, 14 hours after 2nd dose, the patient experienced severe chills, fever 99.5, severe headache, skin hurt and dehydration. On the same day, the patient underwent a body temperature test and the result was 99.5 (UNSPECIFIED UNITS). The events did not result in doctor or other healthcare professional office/clinic visits, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe chills, fever 99.5, severe headache, skin hurt and dehydration was recovered on 24Apr2021 at 17:00, after the duration of 15 hours.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
PATIENT DEVELOPED STABBING RIGHT ARM PAIN AFTER THE SECOND DOSE OF MODERNA PRIMARY SERIES VACCINE.  THE PAIN IS CONSTANT AND IS DESCRIBED AS STABBING, ACHINESS THAT LIMITS USE OF THE ARM.  IT HAS BEEN THERE SINCE THE 2ND VACCINE DATE AND HAS NOT WENT AWAY.  HAS NOT SEEN A MEDICAL PROFESSIONAL AS OF TODAY BUT IS MAKING AN APPOINTMENT WITH HIS PRIMARY CARE PHYSICIAN IN THE NEAR FUTURE.
Systemic: Tachycardia-Medium, Additional Details: told her to go to hospital immediately for observation and evaluation. I told her son she shouldn't be driving and if he was unable to bring her to call for an ambulance immediately.
At the time, I noticed a swelling (1 inch) under his left arm and it was slightly red. It seemed to be sore to him (he is non-verbal) but I could that he was uncomfortable to press on. I noticed a week later that it still swollen and I took him to see the doctor, who said to monitor it. A month later, the lump was still there. By the November appointment, he still had the lump.
Death Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH,allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. No notes detailing the circumstances the death of the patient. Patient had issues controlling his blood pressure in the prior 6  months with an average BP of 150/68 and systolic blood pressure readings >200 at times, Other comorbidities include anemia, DM2, Afib on pradaxa, cardiac pacemaker, and HLD.
Patient reports muscle spasms along LT rear deltoid same arm vaccine was administered. Symptoms have lasted a month with consistent occurrence throughout day.
This case was reported by a other health professional via sales rep and described the occurrence of allergic skin reaction in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced allergic skin reaction, swelling arm, general body pain and blister. On an unknown date, the outcome of the allergic skin reaction, swelling arm, general body pain and blister were unknown. It was unknown if the reporter considered the allergic skin reaction, swelling arm, general body pain and blister to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a Physician assistant. The age at vaccination was not reported. The patient experienced an epidermal allergic reaction which consisted of arm swelling and blisters forming around the elbow; additionally the patient experienced intense body aches.
Pt. c/o LUE "dead arm" sensation since the vaccination 10/11/17. Reaching upwards today, Pt experienced sharp pain ever injection site. Pt c/o (L) hand/wrist joint edema-radiating pain from deltoid to thumb. M/S and Neuro exams area all normal. "Dead arm" resolved after ice application. Given Ibuprofen 400 mg PO q 6-8 hours PRN. PMD follow-up.
Pain in the upper left arm - not muscular pain like a flu shot, but more like mottling of redness and pain on the skin  itself . The skin itself was hot and mottled redness in a palm-sized area.  Extremely sensitive from the lower part of the shoulder to the lower upper arm. Extremely lethargic  and ?clammy? for about 12 hrs.
SWELLING, ERYTHEMA TO UPPER LEFT ARM, 10 CM, WARM TO TOUCH. 10 FLUID FILLED VESTICLES AT LOWER AREA OF SWELLING. ERYTHEMIA STARTED AFTER 24 HOURS, VESTICLES NOTICED APPROXIMATELY 36 HOURS LATER. NO GENERALIZED FEVER, NO ITCHING AT TIME OF REPORT. MOTHER STATES CHILD EXHIBITING USUAL ACTIVE BEHAVIOR. NO DISTRESS OR MALAISE. REFERRED TO CHILDS PHYSICIAN.
This spontaneous report was received from a physician concerning a 12 year old female patient. The patient's medical history, historical drug, concurrent condition and concomitant therapy details were not reported. On an unknown date, the patient was vaccinated with GARDASIL lot # H021861 expiration date: 09-OCT-2015 (dose, frequency, route and anatomical location were not provided) for prophylaxis. On an unknown date, post vaccination the patient had fever up to 103 Fahrenheit and dizziness. The patient was given with TYLENOL for fever. After 3 days, the patient was afebrile and considered to be recovered. No product quality complaint was reported. Causality assessment was not provided by the reporter.
Patient started having fever and joint pain on 7/5/19, redness to left upper arm in the area of the injection.  on 7/8/19 she developed a rash. Labs were drawn and she was found to have acute ITP, neutropenia, and trhombocytopenia.
Systemic: Fainting / Unresponsive-Medium, Systemic: Vomiting-Mild, Additional Details: Immediately after administration the patient indicated they were not feeling good. Her mother was holding her hand in support and noticed she was fainting. She alterted the pharmacist as she had turned around to get the next vaccine ready (a COVID booster). Patient fell back from the chair to the ground, hit her head on the privacy screen. Her eyes were rolled back and she was not breathing. Pharmacist immediately called EMS. Her mom helped the patient back up and paramedics checked on her.
A non-serious spontaneous report of pneumonia manifested by fever, achy, shaking and shortness of breath, finger tips and toes were numb and dizzy has been received from a consumer concerning a 14-year-old male, subsequent to FLUMIST. Neither relevant past medical history nor concomitant medications had been reported for this patient. On 26-Sep-2011, the patient received FLUMIST. Within four hours of receiving FLUMIST on 26-Sep-2011, the patient had full blown flu symptoms. The patient was taken to the hospital but not admitted. He had a fever of 104 degrees F and was diagnosed with pneumonia. The patient was given amoxicillin. The fever broke by the time he reached the hospital. The patient consistently had a high fever for ten days before going to the emergency room. The patient was taken to the hospital when the fever rose to 104 degrees F. The strep test was negative. The patient missed three weeks of his school. The outcome for the events of pneumonia manifested by fever, shaking and shortness of breath, finger tips and toes were numb and dizzy was unknown.
Body aches all night and next morning, Jan 8 - 9, 2021.  Slight fever and cough and congestion all day Jan 9, 2021.  Better on Jan 10.  Noticed redness around vaccine on morning of Jan 11, 2021.  Stomach pain after eating on Monday, Jan 11; Tues, Jan 12.
Nauseous all day 5/2 and 5/3 Arm very sore, could not lift over my head until 5/3 Back pain just on left side started the afternoon of 5/2 and continued until the afternoon of 5/3, difficult to sleep because of discomfort in the mid back to side 5/3 injection site slightly itchy started in the evening and onset of headache
This is in follow-up to report(s) previously submitted on 2/14/2007; 4/6/2007. Information has been received from a physician concerning a female patient with NKDA or preexisting medical conditions who on 22-DEC-2006, at 1:15 PM, the patient was vaccinated in the right arm with a 0.5 ml dose of GARDASIL (lot # 654389/0961F). Subsequently, several hours after the vaccination, she experienced localized right arm pain, developed a rash which was described as hives or her chin. Subsequently, on an unspecified date, the patient recovered from the events without treatment. The patient sought unspecified medical attention. Additional information is not expected.   Additional information has been requested
Pt is complaining  that his right arm still hurts a month after injection.  Pt did contact MD but MD just said to talk to the place that administered the shot.
This spontaneous report has been received from a pharmacist and refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent conditions, and concomitant therapies were not reported. On 11-MAY-2017, the patient was vaccinated with a dose of M-M-R II (strength, dose, frequency, route of administration, lot number and expiration date were not reported) and a dose of PROQUAD (strength, dose, frequency, route of administration, lot number and expiration date were not reported); both for prophylaxis. No adverse effects and no product quality complaints were reported. Additional information has been requested.
After 12 hours, swollen and ache. After 24 hours slight hardness and reddening of the injection site.  Ache persisted/increased and red area kept on spreading with passing days. Itching developed. After 7 days, the redness spread over approximately 4.5 inches diameter that kept on itching. Currently there is no redness but occasional itching, and scaling off at several spots around the injection site.
Information has been received from a certified medical assistant concerning a female who was vaccinated with a second dose of GARDASIL.  "Recently" the patient was found out that she had papilloma viral infection.  At the time of this report, the outcome was unknown.  Additional information has been requested.
This spontaneous report as received from a registered nurse refers to numerous unspecified patients. It was reported that in 2013, numerous unspecified patients received (Merck) VARIVAX that might have been exposed to temperatures outside the range of the recommended storage temperatures. No lot# was reported. This occurred over a period of 2 months. No adverse effect reported. Additional information has been requested.
PATIENT RECEIVED VACCINES ON 3/19/14 THEN TWO DAYS (3/21/14) LATER PRESENTED TO OFFICE C/O OF  PAPULAR RASH AT VACCINE SITES- BOTH THIGHS.  PARENTS WERE ADVISED TO USE EUCERIN CREAM TO AFFECTED AREA.
Swelling of her lymph nodes in her neck; Swelling in face; arm was Sore; This case was reported by a consumer via call center representative and described the occurrence of enlargement of lymph nodes in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 9 months after receiving Shingrix and an unknown time after starting ibuprofen, the patient experienced enlargement of lymph nodes, facial swelling and pain in arm. The patient was treated with ibuprofen. On an unknown date, the outcome of the enlargement of lymph nodes, facial swelling and pain in arm were recovered/resolved.   It was unknown if the reporter considered the enlargement of lymph nodes, facial swelling and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right deltoid. The age at vaccination was not reported. After receiving Shingrix, the patient experienced swelling of her lymph nodes in her neck, swelling in face and her right arm was sore. The patient took Ibuprofen and symptoms disappeared after second day.  For the tolerance of 2nd dose, refer linked case US2020189744. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020189744:same patient, 2nd dose
This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. On unspecified dates, the patients were vaccinated with PROQUAD which was exposed to unknown temperatures out of the recommended range for an unknown period of time (dose, route, lot number and expiration date unknown). No adverse effect had been reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received form a physician and a licensed practical nurse (LPN) regarding a 4 year old (also reported as age 5, units not provided) female patient (child). On 07-APR-2014 at 4:00 pm, the patient might have been immunized with a dose of PROQUAD lot number J015596, expiration date 05-JUN-2015, in the right thigh (dose number, route and dose were not reported) which was not stored at the appropriate temperature (not further specified). Concomitant medications were not specified. The outcome of the event was reported as unknown. This is one of several reports received from the same source. Additional information is not expected because follow up has been obtained.
Information has been received from a physician concerning a female patient with no pertinent medical history or drug reactions or allergies, who on an unspecified date was vaccinated with the first 0.5 ml dose of GARDASIL (Lot # and route not reported) and on 06-JAN-2011 was vaccinated with the second dose of GARDASIL (Lot # and route not reported). There was no concomitant medication. The physician reported that the patient complained of pain at the injection site after receiving the first dose. The pain lasted approximately two weeks and each day the pain diminished. When the patient received the second dose reported that the pain level was minimal. The physician reported that on 06-JAN-2011 the patient had recovered. No laboratory tests were performed. The patient sought unspecified medical attention. No further information is available.
Low titer; This case was reported by a other health professional via call center representative and described the occurrence of therapeutic response decreased in a 19-year-old male patient who received Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown.  Additional details were provided as follows: The reporter reported that a 19 year old patient needed a booster dose of Engerix-B due to a low titer. The reporter could not identify what previous vaccination series for Hepatitis consisted of.  The reporter consented to follow up.  No specific data given when asked by the agent during the call.
Patient started experiencing nausea, vomiting, diplopia, numbness in lower extremities on November 4. Also weakness in LE Then on Nov 8 she was admitted to hospital for symptoms, worked up and diagnosed with Guillain-Barre Miller Fisher variant Hospital stay Nov 8 - 29th Patient had a lengthy hospital stay. While being diagnosed with Guillain Barre she developed severe hyponatremia and orthostatic hypotension due to Guillain Barre. Patient improved with IVIG. Following with specialists.
FELT LIKE TRUCK HIT ME; FLU- LIKE SYMPTOMS; EXTREME MUSCLE DISCOMFORT AND SENSITIVE HIPS AND IN LOWER BACK TO SIDE; SORE ARM; FATIGUE; FEVER; This spontaneous report received from a consumer concerned a 52 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 01-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-MAY-2021, the subject experienced felt like truck hit me. On 02-MAY-2021, the subject experienced flu- like symptoms. On 02-MAY-2021, the subject experienced extreme muscle discomfort and sensitive hips and in lower back to side. On 02-MAY-2021, the subject experienced sore arm. On 02-MAY-2021, the subject experienced fatigue. On 02-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu- like symptoms, and fever on 03-MAY-2021, was recovering from felt like truck hit me, and had not recovered from extreme muscle discomfort and sensitive hips and in lower back to side, sore arm, and fatigue. This report was non-serious.
pt. recvd 1st dose of hepatitis B vac & exp. flu synd. recvd 2nd dose & developed rash w/ pruritis.
1 1/2 weeks after injection developed itching and swelling to site which has progressed to cover most of left upper arm with reddened, swollen area