chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administration of PROQUAD following a temperature excursion; No other AE; This spontaneous report was received from a health business professional (also reported as administrator) referring to a patient of unspecified age and gender. Information regarding the patient's medical history, concurrent conditions, and concomitant therapies was not reported.   On an unspecified date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) as prophylaxis (dose, route of administration, anatomical site of vaccination, lot number and expiration date were not reported) (product storage error).  No additional events were reported (no adverse event).
shingles; Information has been received regarding a case in litigation from a lawyer concerning a female patient of unknown age. Her medical history, concurrent conditions and concomitant medications were not reported.     On an unspecified date in 2016, the pt was vaccinated with a dose of zoster vaccine live(ZOSTAVAX) by a healthcare provider at a medical office for the long-term prevention of shingles and zoster-related conditions (Strength, dose, route of administration, lot # and expiration date were not reported).        Subsequently to Plaintiff's zoster vaccine live(ZOSTAVAX) inoculation, Plaintiff was treated by a healthcare provider for shingles for which the pt was hospitalized (No dates reported). As a direct and proximate result of Plaintiff's use of the zoster vaccine live(ZOSTAVAX), Plaintiff had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.   The outcome of shingles was reported as not recovered.    The reporter considered shingles to be related to Zoster Vaccine Live(ZOSTAVAX).
An onset of swelling and hives across the body (head, shoulders, neck, arms, legs, feet, armpits, buttocks, scrotum, by eyes), as well as swollen lips. Locations would change throughout the day and week.  After onset January 23, a shot of steroids January 24, a course of prednisone 50mg/day January 25-29, and many antihistamines, symptoms have subsided to dermotagraphia and frequent rashes.
During the 10 minute observation period, patient developed tightness in chest as if she was having an asthma attack.  Assisted to stretcher where  she used her albuterol inhaler.  Her SaO2 was  99% RA.  After 10-15 minutes, she began to feel better.
Event:  Nausea, chills, profuse sweating, headache Treatment:  Tylenol Time: 4-6 hours
Breakthrough case admission after 5 vaccines Moderna 3/5/21 Lot# 010A21A;  Moderna 4/7/21 Lot# 017B21A;  Moderna 10/28/21 Lot# 939904;  Moderna 5/10/22 Lot# 056A22A;  Pfizer 9/18/22 Lot# GJ5342
ANY QUESTIONS PLEASE CALL MYSELF AT THE PHARMACY AS THIS IS WHERE THE VACCINE WAS GIVEN AND I AM THE VACCINATOR WHO THE REACTION WAS REPORTED TOO.  PATIENT WAS ASSESSED AT TIME OF REPORT (TODAY). PATIENT HAS RASH ON RIGHT ARM WHERE FLU SHOT WAS GIVEN. LUNGS CLEAR TO AUSCULTATION. PT REOPRTS NO SHORTNESS OF BREATH OR DIFFICULTY BREATHING. TEMP WNL. VITALS STABLE. PATIENT WAS ADVISED TO TAKE BENADRYL PO 50MG AS NEEDED PER PHARMACEUDICAL DIRECTIONS AND APPLY HYDROCORTISONE CREAM TO THE RASHED AREA. CONTINUE TO MONITOR AND SEE PCM AS NEEDED OR GO TO ER OR URGENT CARE IF RASH BECOMES WORSE. ANY SOB OR DIFFICULTY BREATHING REPORT TO ER IMMEDIATELY. PATIENT WAS ADVISED TO FOLLOW DOCTORS ORDERS AS TO WHETHER OR NOT GET FLU VACCINE IN FUTURE.  PATIENT ALSO GOT PREVNAR SHOT IN LEFT ARM ON THE SAME DAY . NO NOTED RASH OR REDNESS TO LEFT ARM/DELTOID. THANK YOU
Extremely high resting heart rate, chronic pain in leg muscles, chronic fatigue, chronic chest pain (even 8 months later), chronic headaches, chronic nausea
Got shot 8/6/2021 @ 1:45pm.   At 2:30pm started itching- knew I was having an allergic reaction.  by 3:40pm called the pharmacy to report- itching was severe (worse) no hives.  was told to take 2 Benadryl. Took Benadryl- didn't work!   6 pm same day- ate some soup and took more Benadryl- was itching all over in my head and throughout my body to bottom of feet. 6:10 pm itching started calming down, then lower back right side started hurting, eyelids started twitching, face itching, and keep feeling like wanted to have diareha- had 2 BM's since having shot.  6:45pm - pain in right arm started at injection site, had dull muscle pain. Then left arm started aching.  8:30pm-  itching started back stronger and moderate stomach ache.  Did not sleep that night.  Sat. overall- still itching, not as severe, Right shot arm really hurting- did arm exercises and got better. stomach issues still there and itching.  itching FINALLY went away by Monday morning.  Sunday- by mid-late afternoon, I was really feeling unwell- started to go to hospital or urgent care- it was rough.  Prayed and toughed it out until could speak to my doctor on Monday- still unable to reach my Primary doctor- will see Allergy doctor  tomorrow- tues 8/10/21
Body ache; Chills; Fatigue; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache), CHILLS (Chills), FATIGUE (Fatigue) and HEADACHE (Headaches) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D11M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN (Body ache), CHILLS (Chills), FATIGUE (Fatigue) and HEADACHE (Headaches). At the time of the report, PAIN (Body ache), CHILLS (Chills), FATIGUE (Fatigue) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No corrective treatment was provided.
This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received KINRIX (batch number 99A7M, expiry date 3rd September 2016). On an unknown date, the patient received KINRIX .5 ml. On an unknown date, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. This case is one of the 2 cases reported by the same reporter for the same vaccine.
ED visit for closed fracture of nasal bone - treated and released. ED to hospital admission for Febrile illness and chronic cough in setting of refractory pancytopenia secondary to MDS. Treated with IV antibiotics and will complete 3 additional days of doxycycline. ED visits and hospital admission within 6 weeks of receiving the COVID vaccine.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 6 (booster), single (Lot number: GJ5342) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.   Additional information: The patient was treated with anti-viral for COVID 19 from 03May2023 to 08May2023.
ACHES; BALLOON HEAD; CHILLS; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced aches, balloon head, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, aches and balloon head was not reported. This report was non-serious.
This spontaneous prospective pregnancy report as received from a Certified Medical Assistant refers to a 17 year old female patient with no pertinent medical history and no drug reactions or allergies. On 26-APR-2013 the patient was vaccinated intramuscularly with a 0.5 ml dose of GARDASIL (lot #: H021346, exp. date: 01-OCT-2015) for HPV prevention. There was no concomitant medication. The healthcare worker reported that GARDASIL was administered to a pregnant patient on 26-APR-2013. The healthcare worker reported blood was drawn for testing on 26-APR-2013 and HCG level results were received on 29-APR-2013 indicating a pregnancy of 5 weeks gestation. There were lab diagnostics studies performed without results, including: complete blood count (CBC), comprehensive lipid panel and urinalysis. The patient became pregnant with LMP of 22-MAR-2013 and EDD of 27-DEC-2013. Initial exposure to GARDASIL was at 5 week(s). The healthcare worker reported that the patient had not been notified of the pregnancy. No adverse experience symptoms reported. Additional information has been requested.
My sister and brother called me and tole me they were COVID positive and we had been together so I went to pharmacy and got tested and it was positive.
Myocarditis side effect.  Approximately 2-3 days after receiving my second vaccination( April 28th ), I started experiencing extreme chest pain and a chest pressure that was also causing an instant dizziness spell that would last 4-5 seconds.  The episodes were happening a few times a day then proceeded to get worse over the next 5 days until I called the urgent care on May 3rd and was told to come in immediately.  They proceeded to run an EKG, TSH, along with running blood tests and performing chest x-rays.  They hooked me up to a heart monitor and told me to press the button when the episode happened again.  They found out that I was having heart PVC's that were causing the chest pressure and dizzy spells.  They told me they did not know what this was caused by ( I mentioned to them multiple times that I had just recently had my second vaccination, and that I had caught COVID last year ), and that these heart PVC's are "  relatively normal ". I asked if the chest pressure, pain, and dizzy spells are normal as well, and they said not normally.  They proceeded to set me up an appointment with cardiology a few days later to get fitted for a cardiac holter monitor in which I would wear it for 3 days and then get the results back.  I was told to wear it 24/7 and press the button and record the times and what I was doing when the episodes happened. When the results came in, I guess I was not important enough for a cardiologist to call me, so I was told that I would be having a call with my PCP. He informed me that during the episodes that I recorded, sometimes it was because of a PVC, and sometimes when I pressed the button and timestamped the chest pressure and dizzy spells, there was not a current PVC that was happening.  At the time of our phone visit( around May 12th), the episodes had subsided.  I should let you know that in total, the episodes lasted roughly 2 weeks.  He told me that he did not have any other information as to why or what it could be, and that if things continued or the episodes came back, to go to Urgent care or contact him.
Fatigue; chills; pain at injection site; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 20Apr2021 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history and past drug. The patient received unspecified medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021 the patient experienced fatigue, chills and pain at injection site. The clinical outcome of the event fatigue, chills and pain at injection site was resolved on unknown date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
no adverse event; Expired vaccine used; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant medications were not reported.  On 23-MAR-2022, the patient was vaccinated with and expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T030761 (rHA), expiration date 08-MAR-2022, 0.5 milliliter (route and anatomical location were not reported) for prophylaxis. No adverse event reported.
EXTREME DIZZINESS UPON EXERTION; LOSS OF APPETITE; HEADACHE; FEVER; FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age. 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: Q07AQ1A expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 13:00  for prophylactic vaccination. No concomitant medications were reported. On 04-MAY-2021, the subject experienced fatigue. On 05-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.1 F. On 07-MAY-2021, the subject experienced extreme dizziness upon exertion. On 07-MAY-2021, the subject experienced loss of appetite. On 07-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and had not recovered from fatigue, headache, loss of appetite, and extreme dizziness upon exertion. This report was non-serious.
Body aches, fatigue, rapid heart beat, high blood pressure, right eyelid pain. Slowly started and became critical at end of August. Diagnosed with Graves? disease sept 3, 2021. Put on methimazole 10 mg  for four weeks, slightly better symptoms. Then 15 mg for 3 1/2 weeks.   fatigue, under jaw pain, head pain, feeling of unwell.  Diagnosed with low white blood count, 2.1.  Observed in emergency room for  several hours, all viruses, etc. stopped taking methimazole oct 31.  White blood count up to  3.9 on  nov 2.  Left ear redness and fluid still present 11/2. Still severe head congestion, pain., feeling of unwell.  Thyroidism apparent out 31. No thyroid bloodwork done since 10/31.  Feeling incrementally better each day. Taking Tylenol and Sudafed for symptoms.  Awaiting more bloodwork to check all levels, thyroid, liver, blood count.
Couldn't walk; Muscle really tight; Excruciating pain; Couldn't lay down; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Jul-2021 and was forwarded to Moderna on 02-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (Couldn't walk), MUSCLE TIGHTNESS (Muscle really tight), PAIN (Excruciating pain) and MOBILITY DECREASED (Couldn't lay down) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     Concurrent medical conditions included Liver disorder (on dialysis 3 days per week with stage 5 liver disease).   On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jun-2021, the patient experienced GAIT INABILITY (Couldn't walk), MUSCLE TIGHTNESS (Muscle really tight), PAIN (Excruciating pain) and MOBILITY DECREASED (Couldn't lay down). At the time of the report, GAIT INABILITY (Couldn't walk), MUSCLE TIGHTNESS (Muscle really tight), PAIN (Excruciating pain) and MOBILITY DECREASED (Couldn't lay down) outcome was unknown.            No concomitant medications were reported.  Treatment medications included muscle relaxer, unspecified.
Red welts appeared on her arm at the injection site. Started breaking out in hives in different places also in her face. Welts on her forearm turn into a black  and blue bruise. Left side of face became swollen and hives became worse all over her body. She stated her face had been changing constantly everyday it was different. One side of her face is bigger than the other. (left side). Heart palpitations, weakness and headaches. Elevated blood pressure
This initial spontaneous case, was received from a Pharmacist on 20-Oct-2017, concerns a pregnant female patient of an unknown age. On 25-Oct-2017, the patient was administered with FLUCELVAX QIV (dose, route of administration, anatomical location: not reported, batch no: 195242 and expiry date: Jun-2018). FLUCELVAX QIV was administered to pregnant patient (explicitly coded as: vaccine exposure during pregnancy). The reporter assessed this report as non-serious.
Developed Covid-19 disease; This case was reported by a other health professional via call center representative and described the occurrence of covid-19 in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th August 2020, the patient received the 1st dose of Shingrix. On 1st December 2020, 113 days after receiving Shingrix, the patient experienced covid-19. On an unknown date, the outcome of the covid-19 was resolved with sequelae.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient developed Covid-19 disease after vaccination with 1st dose. Till the time of reporting patient was not feeling the best and healthcare professional wanted to postpone, probably, the 2nd dose until patient fully recovers from the Covid-19. The reporter was asked for information regarding the probable late 2nd dose of the Shingrix for a patient. The agent did not consider this an adverse event since Covid-19 case was several months after first dose and healthcare professional focused on the probable late 2nd dose and not on the Covid-19. For tolerance with 2nd dose refer case US2021AMR024456. No consent for follow-up was collected by the agent . ; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR024456:same reporter
severe diarrhea; Two urinary track infections; severe vomiting; Second dose was given more than 36 days apart from first dose; Minerals were very low; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (severe diarrhea), URINARY TRACT INFECTION (Two urinary track infections), MINERAL DEFICIENCY (Minerals were very low) and VOMITING (severe vomiting) in a 91-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.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced DIARRHOEA (severe diarrhea) (seriousness criterion hospitalization), URINARY TRACT INFECTION (Two urinary track infections) (seriousness criterion hospitalization), MINERAL DEFICIENCY (Minerals were very low) (seriousness criterion hospitalization) and VOMITING (severe vomiting) (seriousness criterion hospitalization). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose was given more than 36 days apart from first dose). The patient was hospitalized on 19-Mar-2021 due to DIARRHOEA, URINARY TRACT INFECTION and VOMITING. The patient was treated with Rehabilitation therapy for Diarrhoea; Rehabilitation therapy for Urinary tract infection; Rehabilitation therapy for Mineral deficiency and Rehabilitation therapy for Vomiting. At the time of the report, DIARRHOEA (severe diarrhea), URINARY TRACT INFECTION (Two urinary track infections), MINERAL DEFICIENCY (Minerals were very low), VOMITING (severe vomiting) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose was given more than 36 days apart from first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood electrolytes: severely (Low) severely.         Patient called in to report an adverse event on behalf of her mother. Mother received the Moderna COVID 19 vaccine 2 dose series on 6 February and 18 March (left arm). On March 19 patient suffered from severe vomiting and diarrhea which led her to have 2 different urinary tract infections. Additionally, her minerals and electrolytes were very low. Patient was hospitalized as a result of this on March 19th. She was currently in rehabilitation. Patient has gone through IV antibiotics, oral antibiotics, and IV electrolyte supplements.  Treatment medications included: IV antibiotics, oral antibiotics, and IV electrolyte supplements.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
I had nausea, vomiting, migraines, dizziness, lack of energy, diarrhea, and I slept a lot. I called my doctor and set up an appointment to see if I can get some blood work did. My blood pressure and blood sugar has been high, and my oxygen levels has been low. I had some acid reflux as well so I took some MYLANTA.
Patient has been having severe pain in left arm after receiving Flublok. Describes sharp pain that radiates from left arm to neck. States this pain has been ongoing  since the day after receiving the vaccine in September 2020. She has had an X-ray done and has been doing physical therapy as well as using pain patches.