chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Incorrect product storage (unknown if vaccine was administered); This case is considered invalid as it is unknown if any patient received the incorrectly stored vaccine, no specified event reported.   This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported that:  Patient characteristics: Patient: Unknown  Reaction(s)/Event(s): Reaction/event as reported by primary source: Excursion go from frozen to the core and we put in less then 30 minutes and then we put the vaccine back to the freezer  Drug(s) Information: Characterization of drug role: Suspect Proprietary medicinal product name: Covid-19 vaccine Batch/Lot number: Unknown Action(s) taken with drug: Unknown  Narrative case summary and further information: Case narrative: Submitted by Call Centre  Selected Report Type: Initial  Is the patient also the reporter? No  Reporter type: Pharmacist Reporter telephone: #  Primary / Prescribing Healthcare Professional Info HCP postal address:  Dates for Excursion go from frozen to the core and we put in less then 30 minutes and then we put the vaccine back to the freezer: (From: Unspecified To: Unspecified)  Is COVID 19 VACCINE a Pfizer product? Yes COVID 19 VACCINE manufacturer: Unspecified Dates for COVID 19 VACCINE: (Start: Unspecified Stop: Unspecified) NDC number of COVID 19 VACCINE: Unknown UPC number of COVID 19 VACCINE: Unknown  Reason for no lot number: of COVID 19 VACCINE: Caller unwilling to complete the report  Expiry Date of COVID 19 VACCINE: Unknown  Additional Context: Concern: Pharmacist stated "Yeah. I am calling to get some information about the Pfizer product excursion."  When asked that, Is the vaccine administered to anyone: Pharmacist stated, "Yes. So, this is Pfizer excursion go from frozen to the core and we put in less then 30 mins and then we put the vaccine back to the freezer so, what are we able to give that vaccine still."  LOT NO: Pharmacist stated "No. Thank you. I will call you back."  Pharmacist was informed about Pfizer Medical Information and telephone number was shared.  Product details (LOT#, Expiration Date, NDC# and UPC#) and Pharmacy details could not be probed as Pharmacist hung up the call abruptly. Hence further probing could not be done. Limited information available over the call.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.  Follow-up (07Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
pain to leg; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain to leg) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain to leg). At the time of the report, PAIN IN EXTREMITY (pain to leg) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
rash on left arm at injection site; itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash on left arm at injection site) and PRURITUS (itchy) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concomitant products included CHOLESTEROL for Cholesterol, VITAMINS NOS for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 27-Jan-2021, the patient experienced VACCINATION SITE RASH (rash on left arm at injection site) and PRURITUS (itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and CORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE RASH (rash on left arm at injection site) and PRURITUS (itchy) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Patient is currently taking Blood pressure medication.
102 F fever intermittent 24 hours, beginning 6 hours after injection. NSAIDs and antihistamines do not improve symptoms. Severe headache causing nausea, appetite loss, blurred vision, hypersensitivity to light - affecting ability to leave house, drive, work, lasting 8 days after injection so far and have not subsided. Severe fatigue lasting 8 days after injection and so far has not subsided.
PATIENT REPORTED HAVING SORENESS, REDNESS AND PAIN AT INJECTION SITE. SHE WAS ALSON UNABLE TO USE THE AFFECTED ARM FOR MORE THAN A WEAK. PATIENT WAS DIAGNOSED WITH SHINGLES OUTBREAK WITHIN DAYS FOLLOWING VACCINATION.
allergy; This case was reported by a physician via other manufacturer and described the occurrence of allergy in a patient who received Flu Seasonal TIV Dresden (Influenza vaccine unspecified 2011-12 season) for prophylaxis.   Co-suspect products included sumatriptan succinate (Imitrex) unknown for product used for unknown indication.   Concurrent medical conditions included adhesive tape allergy (Gets skin tear and itching with adhesive tapes), drug allergy (Bactrim allergy to severe heartburn, increased rash, shakes), drug allergy (Bees allergy to Hives) and drug allergy (Cleocin allergy to diarrhea, Flagyl allergy to diarrhea, Flexeril allergy to itching, Heparin allergy to PF4 And SRA Positive Dx, Imitrex allergy to makes want to crawl out of skin, Keflex allergy to itching, Lisinopril allergy to severe hypotension, Rifadin allergy to GI upset, Seroquel allergy to extreme sleepiness, Valium allergy to mental status change).   On an unknown date, the patient received Influenza vaccine unspecified 2011-12 season at an unknown dose and Imitrex at an unknown dose and frequency. On an unknown date, less than a year after receiving Influenza vaccine unspecified 2011-12 season and unknown after starting Imitrex, the patient experienced allergy. On an unknown date, the outcome of the allergy was unknown.   It was unknown if the reporter considered the allergy to be related to Influenza vaccine unspecified 2011-12 season and Imitrex.  Additional details were provided as follows: The age at vaccination was not reported. The reporter's contact information was available. The reporter was the prescribing healthcare professional.
DAYS AND WEEKS AFTER GETTING THE SHOT, I HAD INCREASING WEAKNESS AND FATIGUE.  MY FEET WERE FEELING AS IF MY ARCHES WERE FALLING.  MY ANKLE AND HIPS WERE WEAK AND UNCOORDINATED.  BACK PAIN AND PELVIC FLOOR PAIN. THIS CONTINUED DAILY FOR WEEKS.  I HAD SIGNIFICANT BALANCE ISSUES. THE WEEK BEFORE I WAS ADMITTED TO THE HOSPITAL IT WAS HARD FOR ME TO WALK AND LEGS WERE FEELING HEAVY.   WOKE UP ON OCTOBER 11, 2021 UNABLE TO WALK.
Suspected vaccination failure/got vaccinated for shingles, still got them; Still got them shingles/still have them/going on 5 months; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 22-Jul-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got vaccinated for shingles and still got them and still have them and going on 5 months. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
The patient states that she was fine at the time of immunization but started having pain in the shoulder area of the same arm where the immunizations were given about 2 hours after. The pain increased with time causing the patient to take ibuprofen and also to lose sleep. She was not better the next day so she went to her physician. She states that her doctor said the injections were very high and he was concerned that the vaccines may have entered the joint, ligament, or another part of the shoulder instead of the muscle. She was prescribed steroids, ibuprofen, and another "pain medicine".
She developed symptoms on 09/10/2021 and was admitted on 09/13/2021. She was moved from ICU to a regular room on 09/15/2021, but will be observed for 14 days due to the development of an irregular heartbeat.
Tachycardia; nitial information received on 16-Sep-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via Media Information (under reference 00772775).  This case involves a male patient (over 65years of age) who had tachycardia, after receiving QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK QIV).  The patient's past medical history included lung cancer (Lung neoplasm malignant), had a lung tumor removed (Pulmonary resection) with caller did not say when the tumor was removed and Tobacco user with had not smoked in twenty years.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  At the time of the event, the patient was suffering from COPD (Chronic obstructive pulmonary disease).  On an unknown date, the patient received a dose of suspect FLUBLOK QIV (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious tachycardia (unknown latency) following the administration of vaccine.  It was reported "he is concerned with his HCP wanting to administer FLUBLOCK; caller would rather have FLUZONE HIGH DOSE (522 - FLZ HD HV QIV) and would like to have an HCP agent give him some information regarding if he should ask for the FLUZONE HD caller states that he is trying to be cautious in his choice for a flu vaccine due to the current pandemic number levels and would like the vaccine that is best for his age group and health conditions; at time of call all agents were busy and caller agreed to a call back; caller states it is best to reach him until 12:00pm - 1:00pm. A consumer reporting that he tends to get side effects to allergy meds described as getting tachycardia; that the caller did report in passing that he received the Flublok last year and was told that this is a high dose; that his pharmacist confirmed that the Flublok was not the high dose."  No laboratory data were reported.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
Father returned with child the day after vaccines administered. Reports child woke up this AM with a red, swollen, itch, warm to touch area on (R) lateral Deltoid the size of a 50 cent piece. Child admitted he had been scratching area because it itched. Father stated area increased in size to the size of a baseball within 2 hours of awakening this AM - child denied pain in area only itching - reddened area noted on (R) arm that measured 3 inches x 3 inches warm and hard to touch. Advised dad to give child MOTRIN every 6 hrs, BENADRYL as needed for itching and keep cold compresses on area - Father called the Health Dept the next morning and reported area is the same size but "weeping" now and child has a fever, advised father to take child to Dr. this AM.
Pt developed a fever of 103 11 days after vaccination with a localized one inch area of papulovesicular red rash at site of vaccine.
Slept deeper than she has in 25 years; Feeling like she is in a vice is getting better since she had the vaccine; sleeping deeper and dreaming more; she was in REM sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left (Lot number: EW0169) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Spine and neck injury stenosis" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "hyper personality" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: VICODIN taken for stenosis, start date: 1992; CYCLOBENZAPRINE taken for fibromyalgia; MELOXICAM taken for fibromyalgia; SERTRALINE taken for personality disorder, start date: 2010; ATORVASTATIN taken for blood cholesterol increased; DICLOFENAC.  The following information was reported: SOMNOLENCE (non-serious) with onset 15Apr2021, outcome "not recovered", described as "Slept deeper than she has in 25 years"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 15Apr2021, outcome "not recovered", described as "Feeling like she is in a vice is getting better since she had the vaccine"; ABNORMAL DREAMS (non-serious) with onset 15Apr2021, outcome "not recovered", described as "sleeping deeper and dreaming more"; RAPID EYE MOVEMENT SLEEP BEHAVIOUR DISORDER (non-serious) with onset 15Apr2021, outcome "not recovered", described as "she was in REM sleep". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: She stated it was not an adverse event, but she wants to report a good symptom. After her first shot, she slept deeper than she has in 25 years. Since the first shot, she has been sleeping deeper and dreaming more. She believes this is because she was in REM sleep. Part of the Fibromyalgia is because you don't go into REM. She said it was 25 years worth of sleep. There is something in there that helps people with this. There was no prescriber. Her second dose is scheduled for 06May2021. She was still sleeping better, but not as good as that first night. She is still sleeping deeper and dreaming more. She wakes up every hour to 2 during the night. She said it doesn't keep her from waking up, but the sleep was deeper. That first night she woke up at 11:30pm and thought it was 6am. Her doctor recommended she had vaccine. Her husband has COPD and she got the vaccine because she did not want to catch the virus with him being there. The feeling like she is in a vice is getting better too since she had the vaccine. She was on Diclofenac before Meloxicam. They took it away and when the generic of Mobic, Meloxicam, came on the market, they switched her over. No further details provided. She got blood test a few hours after she had first vaccine and her cholesterol was great. No further details provided.  No follow-up attempts are possible. No further information is expected.
pt recv vax 1JUN95 & on 1NOV97 pt devel chickenpox;
itch around the neck, mouth, body & between the 2 legs; develops rash all over the body; eyes itch, swell, so does the part between the 2 legs;
Can't focus Right; Tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 24Sep2021 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Headache" (ongoing); "Sleeping Pills" (ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID] taken for headache (ongoing); NATROL MELATONIN SLEEP taken for sleep disorder (ongoing). The following information was reported: FATIGUE (non-serious) with onset Sep2021, outcome "not recovered", described as "Tiredness"; DISTURBANCE IN ATTENTION (non-serious) with onset Oct2021, outcome "not recovered", described as "Can't focus Right".  Additional information: The patient did not receive other vaccines within four weeks prior to COVID vaccine. Family Medical History Relevant to Adverse Events (AEs) Father died of Cancer. Concomitant medications included vitamins.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
They found her with her mouth just open, just dead; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "They found her with her mouth just open, just dead". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. ; Reported Cause(s) of Death: They found her with her mouth just open, just dead
High BP . CHECKED AT 6:55 AM 184/90 PULSE 80 CHECKED AT 7:00 AM 176/91 PULSE 76 CHECKED AT 7:11 AM 170/95 PULSE 71 Customer also complained of getting itchy around the chest and throat area, I administered 10 ml of liquid Benadryl at 6:57 am
Patient called 9/12/2020 and stated within hours of vaccine administration she experienced nausea and one episode of vomiting.  Patient stated still nauseated but no other symptoms as of 9/12/2020 afternoon.
positive for COVID 19/ no treatement/isolation at home for 5 days/symptoms - stuffy nose, cough
I have multiple sclerosis; Sickle cell; I am having problem with my throat like cold trying to come up; Drooling up from my mouth; My throat is bad and I keep drooling for no reason; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 29Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MULTIPLE SCLEROSIS (medically significant), outcome "unknown", described as "I have multiple sclerosis"; OROPHARYNGEAL DISCOMFORT (non-serious) with onset Nov2021, outcome "unknown", described as "I am having problem with my throat like cold trying to come up"; DROOLING (non-serious) with onset Nov2021, outcome "unknown", described as "Drooling up from my mouth; My throat is bad and I keep drooling for no reason"; SICKLE CELL DISEASE (non-serious), outcome "unknown", described as "Sickle cell".  Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
13SEP91 pt fainted & incurred injuries to the point that she was disabled; pt also exp a sore throat; at the time of the report, her symptoms persisted;
This spontaneous report as received from a Licensed Practical Nurse refers to 1 month old patient of unknown gender. No pertinent medical history or drug reactions/allergies were  reported. On 29-JUN-2013, the patient was vaccinated with the first dose of RECOMBIVAX HB (Lot #, dose, route and frequency not reported). On 30-JUL-2013, the patient was inadvertently administered on "adult dose of RECOMBIVAX HB (Lot #,  dose, route and frequency not reported)", instead of the pediatric dose. No adverse effect reported. Additional information has been requested.
had a breast ultrasound, abnormal lymph glands; Initial information received on 10-Nov-2021 regarding an unsolicited valid  non-serious case received from a consumer non health care professional under reference number: US-SA-SAC20211116001364.  This case involves an unknown age female patient who experienced had a breast ultrasound, abnormal lymph glands (Lymphadenopathy) after receiving vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  It was unknown if the patient had any concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious had a breast ultrasound, abnormal lymph glands (Lymphadenopathy) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/ event.  It was unknown if there were lab data/results available  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of the event was reported as unknown.
Lupus nephritis flare; This literature-non-study case was reported in a literature article and describes the occurrence of LUPUS NEPHRITIS (Lupus nephritis flare) in a 30-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 LUPUS NEPHRITIS (Lupus nephritis flare) (seriousness criterion medically significant). At the time of the report, LUPUS NEPHRITIS (Lupus nephritis flare) outcome was unknown.        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.   Treatment for the event was not reported.  Concomitant medication was not reported.  Company Comment: This literature non-study case concerns a 30-year-old male patient with no details on relevant medical history, who experienced the unexpected serious event of Lupus nephritis after mRNA- 1273 Moderna vaccine. The event occurred at an unknown date after dose of mRNA- 1273 vaccine, dose number unknown. Very limited information is available at this moment. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report   Reporter did not allow further contact; Sender's Comments: This literature non-study case concerns a 30-year-old male patient with no details on relevant medical history, who experienced the unexpected serious event of Lupus nephritis after mRNA- 1273 Moderna vaccine. The event occurred at an unknown date after dose of mRNA- 1273 vaccine, dose number unknown. Very limited information is available at this moment. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report