chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unspecified date in 2015, the patient was vaccinated with a dose of ZOSTAVAX for prophylaxis (strength, dose, route, lot # and expiration date were not reported). Concomitant therapies included sterile diluent. On 26-SEP-2017 the patient was vaccinated with another dose of ZOSTAVAX (inappropriate schedule of drug administration) 19400 Plaque-forming unit, lot # N014018 with expiration date 04-JUL-2018, for prophylaxis (route was not reported). No adverse effects were reported.
pt recv vax;5jul95 devel T of 101 which progressed to 104 in early am hr of 6jun95;MD notified; to take apap & alcohol rub down; 6jun daytime fever dec to 102 & abated in friday 7jul95;
Received the 1st of Moderna vaccine under 18 years of age; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the 1st of Moderna vaccine under 18 years of age) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant product use was not provided by the reporter.   On 05-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the 1st of Moderna vaccine under 18 years of age). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the 1st of Moderna vaccine under 18 years of age) outcome was unknown.      Action taken with mRNA-1273 in response to the event was not applicable.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-068225 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068225:Same reporter
Last vaccine date was 3-3-2021.  April 12th I woke up with a tomato red face. lasted all day and pretty much resolved the next day. May 5th I woke up with a tomato red face and developed an under the skin rash (very itchy), that lasted 10 days. June 10th I woke again with a tomato red, hot and swollen face. It got a little better today the next day. It seems to be aggravated by heat. Slight itching on arms and legs so far. I took a photo this last time.
Muscle and bone pain over one week in duration, Joint pain over one week in duration, episodic flushing, hot flashes w/o fever, and episodic vision changes.
About 6 hours after receiving my second dose of Shingrix by Glaxosmithkline, I had fever of about 100 degrees, chills, body aches,  and fatigue.  My symptoms lasted approximately 16  hours and then I was completely better.  The same thing happened in January 2020 after my first dose, although I didn?t report it.  My bad!
It started out with itching and redness at the injection site on the morning of the 14th. And this morning its not as red or itchy but the armpit area is sore. This morning I took three Advil.  Also the redness is warm to the touch.
This spontaneous report as received from a registered nurse refers to a 12 year old patient (unspecified gender). On 17-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route were not provided) (lot # K008931 exp. 04-MAR-2017; lot K009482 exp. 06-MAR-2017) which was exposed to below 36F for 361.82 hours. The nurse was requesting assistance in determining revaccination. In addition, excursion below 32F (31.2F) started on 13-JUL-2015. No adverse effects were reported. This is one of several reports received form the same reporter. Additional information has been requested.
ADULT CLIENT COMPLETED PEDIATRIC CONSENT. ACCORDING TO PRE-STAMPED LOT AND DOSE, RECEIVED A PEDIATRIC LOT# AND DOSE INSTEAD OF APPROPRIATE ADULT LOT AND DOSE.
Fifteen minutes after receiving injection, on 6/14/21,  a mild headache developed, lasting for three hours.  At 3:00 AM day of injection right arm began to hurt; area was hot with severe pain, no swelling, lasting 72 hours.  On June 22, 2021, at noon, injection site developed extreme heat, pain, and swelling, symptoms have worsened through out the day.  By 8:00 PM area was size of a lemon.  This AM, 6/23/21, injection site is size of a softball and certain areas have the texture of lemon rind.  A headache also started today, 6/23/21, and was present upon awaking, headache pain has stayed the same throughout the day. Described as dull ache with squeezing feeling that starts at bridge of nose, going over forehead and extending along top of head.  Has taken Ibuprofen 800 mg three times (last night and today) without relief.  Called her :PMD to call in rx. for topical steroid; has been using cold gel pack on arm every hour for 10 minutes.  States cold makes it feel good but has not improved site. Encouraged client to go to ER due to c/o headache. States she will not go now but will monitor her symptoms and if symptoms worsen, she feels fever, heartbeat in headache, or symptoms worsen she will go to the ER and will call an ambulance for transportation.
Felt swollen throat, chest pain and anxiety was sent to hospital where I was told it was anxiety but I have never had that before. I lost 20 pounds no appetite for 3 months after the vaccination. Felt like everything was a blur for 3 months I was not myself. It got better after the 3 months but I still have moments where my chest hurts and anxiety happens.
Hive reaction centered around right arm. Hives on face. BENADRYL Allergy, inj (50m/1ml) 0.5 ml IM. MENACTRA Sanofi Pasteur (L) U3906AA.
Starting within 12 hours, moderate muscle soreness in center of upper left arm (not near injection site). Within 24 hours pain became severe and constant. Treated with ice and OTC NSAIDs with little relief. Xray taken 9/23 to rule out broken bone. Office visit 9/27 - received prescriptions for antibiotic and percoset and order for MRI. MRI is scheduled for 10/2 (today is 9/30).
Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the Health Agency that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility local authority. The CDC website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
Parent states that @ 9pm on 11/23/09 child started with hives on chin @ first then to face legs, back, and trunk of the childs body. Child also had mild swelling to eyelids resolved < 1hr. Parent indicated that child had french fries for the first 1 1/2 hr prior to onset of the hives. Child referred to allergy clinic.
The vial was moved from the freezer to place in the refrigerator the day before it was used; No adverse event; Patient was administered with expired Moderna Covid-19 vaccine (Monovalent); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with expired Moderna Covid-19 vaccine (Monovalent)), PRODUCT STORAGE ERROR (The vial was moved from the freezer to place in the refrigerator the day before it was used) and NO ADVERSE EVENT (No adverse event) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-2022 at 10:07 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Aug-2022 at 10:07 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with expired Moderna Covid-19 vaccine (Monovalent)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was moved from the freezer to place in the refrigerator the day before it was used) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with expired Moderna Covid-19 vaccine (Monovalent)), PRODUCT STORAGE ERROR (The vial was moved from the freezer to place in the refrigerator the day before it was used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered with expired Moderna Covid-19 vaccine (Monovalent)) and PRODUCT STORAGE ERROR (The vial was moved from the freezer to place in the refrigerator the day before it was used).    No concomitant medication were reported. The patient had received 2 covid doses plus one booster dose. Only one vial was removed from the freezer to place in the refrigerator the day before it was used i.e on 15-Aug-2022  the vial was removed from the freezer and placed in the refrigerator. The vial was initially stored in the freezer on 18-Apr-2022. The size of the vial was reported as 5.5ml. The vial had not undergone any temperature excursions. No treatment medication were reported.
tested positive for covid-19 on 12Feb2021; This is a spontaneous report from a Pfizer-sponsored program COVAX US SUPPORT. A non-contactable consumer (patient) reported that female patient of unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 04Feb2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient reported, she had her first dose of the covid-19 vaccine on 04Feb2021, tested positive for covid-19 on 12Feb2021, questioning if should receive second dose on 25Feb2021. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt had vaccine done at a pharmacy, I do not have the lot number information. After receiving first vaccine, she had blurry vision on 5/30/2021, and received shot on 5/24/2021. After receiving her booster vaccine on 1/21/2022, she had an outbreak of shingles in march of 2022.
Four days after receiving second dose of the Pfizer vaccine I began having headaches, which continuously became more violent to the point of continuously vomiting and being bedridden for greater than a week. I went to urgent care where they gave me medication for nausea (Zofran), and Ibuprofen (800mg) for the headaches. To this day I am still continuously having headaches. I have had an MRI and will be seeing a neurologist for further examination.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. In December 2013, the patient received their first dose of GARDASIL (dose, route, lot# and expiration date were not provided). On 04-OCT-2015, the patient received their second dose of GARDASIL (dose, route, lot# and expiration date were not provided). No adverse effect was reported. Additional information has been requested.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: Pt came back to store on 3/6/21 with a redness/ rash on the injection site with swelling in the area, no pain was mentioned. When she got the first 2/26/21 symtoms started on 3/5/21 a week later. PT advised my RPH to follow up MD
09/08/2018  Woke with left arm pain and large red spot about 4" X 6". Felt feverish and weak. Had difficulty falling asleep at night due to the arm pain. 09/09/2018 got out of bed at 4:00 a.m. to get an ice pack for the painful arm. Passed out on the kitchen floor. Came to and went back to the bedroom. Later that morning I had a large goose egg on the upper back right side of my head where I must have hit when I fainted. Continued to have pain and redness in the arm for a week. The red spot faded to pink and remained for another 2 weeks.
wheals, redness, intense itching to trunk and all extremities. Benadryl was prescribed to control symptoms
Within 5 min. tingling injection site, right arm, spread to entire arm, red area above wrist. Tingle and tightness spread to head, arms, legs.
pt stated within a couple of minutes after rcvg vax that she got nauseated.  She said she felt like it went straight to her stomach.  She has diarrhea and feels like she has the flu.  Pt stated she had a virtual appt w/ PCP and was told to FU if her symptoms didn't subside.
Information has been received from a health professional concerning a 7 yr old female with no known medical history or allergies who on 30Aug99 was vaccinated in the left thigh with a 0.5mL dose varicella virus vaccine live (lot631167/0709J). There was no concurrent medication. The pt developed herpes zoster 25Jan06. On 25Jan06 the pt had a temp of 104F. The pt was seen a day or two ago, on 28Jan06 or 29Jan06, with severe shingles. She was admitted to the hospital. The pt's herpes zoster was described as left S1-S2 distribution, plus scattered discrete vesicles (<20) on the trunk and face. The pt's pain was described as an 8, requiring morphine for 24 hrs, then acetaminophen (+) codeine phosphate (Tylenol with codeine). A specimen was taken for one of the pt's lesions, on 25Jan06 results were not reported. Subsequently, the pt recovered. The pt had no history of chickenpox. It was noted that the pt was exposed to primary varicella zoster virus from her siblings (2) when she was 3 wk of age. There was no known illness during the month following exposure. A rash did not occur at the site of injection or elsewhere within 42 days of the vaccine. There was no recent exposure to varicella or shingles. There was no product quality complaint involved. Additional information is not expected. Follow up information has been received that indicated the specimen was wild type VZV.
RIGHT AFTER PATIENT RECEIVED HER VACCINE AT 9:45 AM, SHE REPORTED HERSELF DIZZY. WE IMMEDIATELY WENT OUT THE PHARMACY TO ASSIST HER. WE WERE ABLE TO BREAK HER FALL WHEN SHE STARTS FAINTING AND SLOWLY LIE HER DOWN THE FLOOR. I IMMEDIATELY ASK MY OTHER TECHNICIAN TO CALL 911. PATIENT STARTED SITTING UP AND REQUESTED SONE COLD WATER WHICH WE GAVE. WE WAITED FOR HER TO FEEL BETTER BEFORE WE ASKED HER TO STAND UP SO SHE CAN SIT PROPERLY WHILE WE WAIT FOR THE PARAMEDIC.
Information has been received from a pharmacist concerning a patient who was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wister RA 27/3). On approximately 07-APR-2006, the patient had a negative titer to mumps. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Information has been received from a physician who was told that a female patient of another physician in the same practice, was vaccinated on 16-OCT-2008 with a dose of GARDASIL 0.5 mL IM.  Subsequently, the patient fainted while in the office.  The patient was unconscious for 20 minutes and was transported by ambulance to the Emergency Room.  It was not known yet if the patient was admitted to the hospital or what treatment was given.  Additional information has been requested.
18 hrs. after vaccination awoke at 3 AM w/ bright, red arm; swollen to triple size betw. shoulder & elbow; severe pain; arm hot to touch; fever to 103 degrees F; dizzy; hurt from head to toe; "could hardly breathe"; could not get out of bed; slight cough; did not seek medical care; treated w/ pain med, fluids & rest; has improved each day; still has hot/sore arm w/ occasional shooting pains and tired. 9/23/10 Re-called patient - she is feeling much better today.
No other AE; patient administered RECOMBIVAX HB during a temperature excursion; This spontaneous report was received from a nurse concerning a newborn male of unknown age. The patient's concurrent condition, medical history and concomitant therapy were not reported.    On 17-FEB-2021, the patient was vaccinated with hepatitis B vaccine (recombinant) (RECOMBIVAX HB) (thimerosal free) at the dose of 0.5 ml (lot # T004378, expiration date 01-NOV-2022, route was not reported) during a temperature excursion (product storage error) as prophylaxis. The temperature was 45.5 F. The time frame was 10 hours. There was no previous temperature excursion. The call was because of data logger. No other adverse event (AE) was reported.
Fever, shakes, headache and inflammation under my armpit with pain. Took some Tylenol and the fever, shakes and headache calmed down, but the inflammation prolonged for almost three days.
No additional adverse events reported; Improper storage of product in use; This spontaneous report as received from a nurse referring to a 4 years old patient. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.    On 10-SEP-2021, the patient was vaccinated with a improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # U015682that has been verified to be valid for varicella virus vaccine live (oka/merck)  expiration date 18-MAY-2023 for prophylaxis, 1 dosage form (frequency, strength, and route of administration, were not reported). The vaccine was expose to a temperature of 4 Celsius degrees for 20 minutes during the transport in two occasions and also a previously temperature excursion of -10 to 8 Celsius degrees (4C) for  7 hours and 30 minutes  (product storage error). No additional adverse events were reported.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2109USA005628: US-009507513-2109USA005910: US-009507513-2109USA005648: US-009507513-2109USA005742: US-009507513-2109USA005964: US-009507513-2109USA005891: US-009507513-2109USA005795: US-009507513-2109USA005662: US-009507513-2109USA005651: US-009507513-2109USA005648: US-009507513-2109USA005641: US-009507513-2109USA005639: US-009507513-2109USA005632: US-009507513-2109USA005628: US-009507513-2109USA005618:
Is feeling cold.; lots of pain in the legs; lots of pain in the hips; lots of pain in the neck; cannot move the arm where they got the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (lots of pain in the legs), MUSCULOSKELETAL DISCOMFORT (lots of pain in the hips), NECK PAIN (lots of pain in the neck), VACCINATION SITE MOVEMENT IMPAIRMENT (cannot move the arm where they got the vaccine) and NASOPHARYNGITIS (Is feeling cold.) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (lots of pain in the legs), MUSCULOSKELETAL DISCOMFORT (lots of pain in the hips), NECK PAIN (lots of pain in the neck) and VACCINATION SITE MOVEMENT IMPAIRMENT (cannot move the arm where they got the vaccine). On an unknown date, the patient experienced NASOPHARYNGITIS (Is feeling cold.). At the time of the report, PAIN IN EXTREMITY (lots of pain in the legs), MUSCULOSKELETAL DISCOMFORT (lots of pain in the hips), NECK PAIN (lots of pain in the neck), VACCINATION SITE MOVEMENT IMPAIRMENT (cannot move the arm where they got the vaccine) and NASOPHARYNGITIS (Is feeling cold.) had not resolved. Not Provided  No treatment information was reported.   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.
This spontaneous report received from a patient through other manufacturer (Pfizer) concerned a patient of unspecified age, sex, race and ethnicity. Initial information was processed along with the additional information received on 05-AUG-2022. The patient's weight, height, and medical history were not reported.- The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of administration, batch number were not reported, expiry: unknown) dose was not reported, 1 in total was administered on 12-MAR-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). No concomitant medications were reported. The patient additionally received non-company suspect vaccine Moderna Covid-19 vaccine (elasomeran) (dose number in series 2) (form of administration, route of administration, batch number were not reported, expiry: unknown), dose was not reported, administered on 14-OCT-2021 for covid-19 prophylaxis. On 15-JUL-2022, the patient was treated with non-company suspect drug Paxlovid (route of administration, batch number and expiry were not reported) dose and frequency were not reported for covid-19 treatment and last administered on 20-JUL-2022. On 26-JUL-2022, 11 days after (on day 12) non company suspect drug Paxlovid treatment (for covid-19) the patient experienced suspected covid-19 infection (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable and and with Paxlovid was drug discontinued on 20-JUL-2022. The patient had not recovered from suspected covid-19 infection. This report was non-serious. This case was associated with a product quality complaint: 90000245309. Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Diarrhea for a month; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea for a month) in a male patient of an unknown age 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea for a month). At the time of the report, DIARRHOEA (Diarrhea for a month) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: event verbatim updated to diarrhea (earlier was 'side effect'), also reporter's email ID added