chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist via a field representative referring to a female patient of unknown age. Information of concomitant therapy, historical condition and current condition was unknown. On 01-OCT-2018 the patient was vaccinated with PNEUMOVAX 23 (lot number, expiration date, strength, dose, frequency and route unknown) for prophylaxis (reported as "prevention of pneumonia"). In October 2018 (reported as "an unspecified amount of time later"), the patient had pain at injection site and trouble breathing. On an unspecified date in October 2018, the patient went to the emergency room at an unspecified location. The patient was not admitted to the hospital and discharged from emergency room on an unspecified date. It was unknown if treatment was given or if lab diagnostics or studies were performed for the events. The patient had sought medical attention. The outcome of the events was unknown. The causality assessment was not provided by the reporter.
covid pfizer bivalent vaccine was administered less than 48 hrs after beyond use date. NO known adverse reaction occured.
Localized reaction with injection area become red, hot, tender.  No constitutional symptoms.  Lasted 5-7 days.
This spontaneous report as received from a pharmacy technician refers to a 39 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 28-FEB-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Information has been received from a Registered Pharmacist concerning a current 61 year old patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# unknown). The pharmacist reported that on an unspecified date, the patient experienced injection site reactions. At the time of the report, the outcome of the patient was unknown. It was unknown if the patient sought medical attention. This is one of several reports from the same source. Additional information is not expected.
About 15 hours after receiving shot number two, I woke up to severe chills.; hot flashes; feeling feverish; muscle ache; skin hurt to touch; lack of energy; exhausted with chills; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736), via an unspecified route of administration on 29Apr2021(at the age of 34-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient's past drug history included shellfish and sulfamethoxazole, trimethoprim (BACTRIM) for an unknown indication and also the patient previously took first dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735), via an unspecified route of administration on 08Apr2021(at the age of 34-year-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Apr2021 at 03:00 fifteen hours after vaccination, the patient experienced chills and were off and on for the next day. On an unknown date in 2021, the patient experienced hot flashes when the chills subsided, felt feverish, muscle aches, skin hurt to be touched and felt better the following day later onto the evening. On an unknown date in 2021 the next day, the patient experienced  lack of energy and exhausted with chills coming on once in a great while. The clinical outcome of the event chills, hot flashes, feverish, muscle ache, skin hurt to touch, lack of energy, exhausted with chills were recovering at the time of this report.       .   No follow-up attempts are needed. No further information is expected.
5:05 patient in general observation area. C/O roof of mouth and gums being numb. Is flushed. Transported to private observation area via w/c to outside area. Accompanied by Dr. and EMT on site. 5:13 BP 190/120 taken per Dr.. HR 112; O2 97% on room air. Patient accompanied by mother. Mother is driving personal vehicle. Patient speaking to Dr. without SOB noted. Flushing in face subsiding. States cool air helps. Admits to having some anxiety issues.  5:14 Per Dr. directions, Benadryl liquid 50 mg (20 mL) given PO followed with water. No difficulty swallowing.  o5:20 BP 160/110 HR 101 O2 98%  r/a - no SOB noted Color now pink. Patient states numbness sensation is decreasing  5:23 BP 150/100; HR 97; O2 sat 98% on r/a. Continues to experience decreasing numbness in mouth/lips  5:25 Patient states numbness gone.  Patient released per Dr. with directions for patient to contact physician and f/u with BP. Patient states she is able to monitor own BP and that her mother is an RN. Dr. instructed patient to call 911 or go to ED if BP problems persist, develops any other symptoms, or if numbness returns. Patient taken via w/c to personal vehicle, accompanied by her mother.
Information has been received from a licensed nurse practitioner (LPN) regarding two patients of unknown ages and genders. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients received an unspecified dose of GARDASIL 9 lot # L043214,, expiration date 30-AUG-2017, intramuscular for prophylaxis (dose number was not reported). The LPN reported a possible quality issue regarding the appearance of the vaccine in vials of GARDASIL 9. A product quality complaint has been filled. Additional information has been requested.
Left arm, swollen and red on 11/25/10. MOC gave IBUPROFEN and ice. Symptoms have resolved.
few days later after the shot at 2am my wife woke up with chills headache and no fever. 1/14 no symptoms. 1/15 My wife woke up with chills and sever headaches.
Dr had given orders for the MA to give vaccines. Which was done, but two were given incorrectly. Employee had noticed mistake after vaccines were administrated. I did let Dr know and he will be in contact with Mom.
runny nose; cough; congestion; This is a spontaneous report from a contactable consumer (Patient, self-reported).   A 70-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced runny nose, cough and congestion. The clinical outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
02/20/2021-COVID vaccine injected high into the upper shoulder causing redness/soreness immediately at the site, ct felt neck swell 'like a balloon', monitored x 30 min, RNs at clinic determined not an anaphylactic reaction. PHN at site recommended after 24hrs to take antinflammatory  and warm pack on site. Neck sensation continued x couple of days, referred to PCP for evaluation.
body aches; chills; slight fever; This is a spontaneous report from a contactable consumer (patient) based on the information received (LRN: LRN4264059). A patient of unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date the patient experienced body aches, chills, slight fever. The outcome of the events was unknown.  No follow up attempts are possible. Information about lot/batch number cannot be obtained.
Lethargy; Discomfort; wrist pain; This spontaneous case was reported by a physician and describes the occurrence of LETHARGY (Lethargy), DISCOMFORT (Discomfort) and ARTHRALGIA (wrist pain) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis and Psoriasis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (unknown route) 1 dosage form. On an unknown date, the patient experienced LETHARGY (Lethargy), DISCOMFORT (Discomfort) and ARTHRALGIA (wrist pain). At the time of the report, LETHARGY (Lethargy), DISCOMFORT (Discomfort) and ARTHRALGIA (wrist pain) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Received 0.3 ml of the total 0.5 ml volume due to a syringe malfunction.
Hair falling out on head; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair falling out on head) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included NORTRIPTYLINE, LEVOTHYROXINE, TOPIRAMATE and VITAMINS NOS (DAILY VITAMINS) for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (Hair falling out on head). At the time of the report, ALOPECIA (Hair falling out on head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: NNI; 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.
Suspected vaccination failure; developed shingles; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patients received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patients experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The lot number and expiry date for Shingrix was not reported. It was reported that there were several patients who experienced shingles after receiving both the doses of Shingrix. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirmation for shingles were unknown. The reporter consented to follow-up.
The day of the vaccine,  I have the  normal regular arm pain. The following day, I had minor body aches and a lot of joint pain in my knees and legs. Those symptoms lasted a few days and resolved.  My doctor prescribed a new medication called Cymbalta  for my depression on 5/3/2021. I took the medication and developed tinnitus on 5/8/2021 and thought the tinnitus from the medication and stopped the medication. I called my doctor who advised that Cymbalta does not cause that reaction. The tinnitus went away and I was not taking Cymbalta.  Around mid June, I developed tinnitus again.  I consulted my doctor and was prescribed Dramamine. I did not take the medication since the tinnitus have resolve. I had only those 2 episodes of tinnitus and haven't had any other episode.   I am going to follow up with a specialist ENT doctor.
pt recvd vax & exp unconsolable crying 1 hr p/ vax;cry was not high pitched;seen in ofc same pm; not eating,afebrile;tx w/ advil;improving following am;
This spontaneous report was received from a nurse practitioner (midwife) regarding a female patient of unknown age. Current condition and Medical history were not provided. On an unknown date, the patient started therapy with GARDASIL 9 (dose, route of administration and lot# were not provided). Concomitant medications were not reported. On an unknown date, the patient developed lymphadenopathy and itching of the eyes and face a week after receiving her 2nd dose of GARDASIL 9. Patient went to an urgent care clinic where she was prescribed an unspecified antibiotics (manufacturer unknown). The nurse reported that the unspecified antibiotic caused a yeast infection on an unknown date. Nurse prescribed VISTARIL as treatment for itching. Outcome of the events were not reported. Causality was not reported. Additional information has been requested.
thought I was going to die; breathing hasn't subsided; chest pain; everything was coming up, could not hold nothing, nothing stays in my body; left arm redness/red circle was worse than after 2nd dose; left arm had swelling/arm got big and swollen; a lot of pain in left arm; baseball-size bump or ball under left arm, against breast; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (thought I was going to die), RESPIRATORY RATE INCREASED (breathing hasn't subsided), CHEST PAIN (chest pain), VOMITING (everything was coming up, could not hold nothing, nothing stays in my body) and VACCINATION SITE ERYTHEMA (left arm redness/red circle was worse than after 2nd dose) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (thought I was going to die), RESPIRATORY RATE INCREASED (breathing hasn't subsided), CHEST PAIN (chest pain), VOMITING (everything was coming up, could not hold nothing, nothing stays in my body), VACCINATION SITE ERYTHEMA (left arm redness/red circle was worse than after 2nd dose), VACCINATION SITE SWELLING (left arm had swelling/arm got big and swollen), VACCINATION SITE PAIN (a lot of pain in left arm) and LYMPHADENOPATHY (baseball-size bump or ball under left arm, against breast). At the time of the report, FEELING ABNORMAL (thought I was going to die), RESPIRATORY RATE INCREASED (breathing hasn't subsided), CHEST PAIN (chest pain), VOMITING (everything was coming up, could not hold nothing, nothing stays in my body), VACCINATION SITE ERYTHEMA (left arm redness/red circle was worse than after 2nd dose), VACCINATION SITE SWELLING (left arm had swelling/arm got big and swollen), VACCINATION SITE PAIN (a lot of pain in left arm) and LYMPHADENOPATHY (baseball-size bump or ball under left arm, against breast) outcome was unknown.            .Concomitant product usage include steroids. Treatment medications was not reported.   This case was linked to MOD-2021-314562, MOD-2021-314597 (Patient Link).
muscle pain; This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was unknown.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The batch number was not reported. The reporter consented to follow up. The reporter was calling from home and did not have other details about the product or patient details at the time of the initial report. For tolerances of 2nd dose of Shingrix, refer case US2019177117.
Developed 6x7 cm area of induration and erythema, lasted 4 days.
Upper Abdominal Pain/ cramping; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Upper Abdominal Pain/ cramping) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Upper Abdominal Pain/ cramping). At the time of the report, ABDOMINAL PAIN UPPER (Upper Abdominal Pain/ cramping) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Severe arm pain myalgia and burning in feet 2nd day after vaccine. I reported to v safe could not go to work for few days. Slowly improved. Neck and left arm pain reduced . Then in March pain returned slowly, lifted patient and left shoulder pain sharp returned. After that continued to work. Pain was building left arm shoulder upper back. In June pain was worse . Severe generalized fatigue . Saw occ med. left hand arm is weak.in September burning and pain in hand and feet started . Now pain is both arms left >>>> right . I got 2 steroid injections in left shoulder. The pain is less still present . Weakness is there. Taking gabapentin/ Tylenol / norco/naproxen.I?m working modified duty since June .left arm shoulder is weak and painful. Other burning and pain in feet . Seeing neurology/ ID/Occ med/PT / Chiropractor/Acupuncture to improve .
Clinic is embedded in congregate care setting. Pt. presented to vaccine clinic for Moderna vaccine. Approximately 20 minutes after administration of vaccine, pt developed hives and experienced tingling in  her throat.
Patient could not raise his right arm 4-5 hours after receiving the vaccination. Recommended cold compress and pain relievers/anti-inflammatory meds as needed and to contact MD if symptoms didn't resolve by the following morning. Patient will contact his PCP if needed.
Pt developed body aches, redness and cellulitis at the injection site. Also, had flu-like symptoms.
patient stated she received the Moderna COVID-19 Vaccine Bivalent without receiving the primary series.; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient stated she received the Moderna COVID-19 Vaccine Bivalent without receiving the primary series.) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19.     On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (patient stated she received the Moderna COVID-19 Vaccine Bivalent without receiving the primary series.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient stated she received the Moderna COVID-19 Vaccine Bivalent without receiving the primary series.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patient stated she received the Moderna COVID-19 Vaccine Bivalent without receiving the primary series.).    No concomitant medications were reported. patient stated she received the Moderna COVID-19 Vaccine Bivalent without receiving the primary series.  No treatment medications were reported.   Reporter did not allow further contact
flu; Initial information received on 14-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp via interactive digital media.  This case involves an unknown age and gender patient who experienced flu ,while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (unknown dose, formulation, via unknown route in unknown administration site) as prophylactic vaccination.  On an unknown date, the patient developed a non-serious event "flu" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported"I get the flu shot I get the flu."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
pt brought to clinic for #3 hepB; mom stated pt had hives on face p/#2 hepB; MD contacted; 3# hepB not given
Shortness of Breath  ? Sinus Problem  ? Generalized Body Aches ? Weakness, Fatigue, Diarrhea, leukopenia
Admitted to hospital COVID PCR + on 4/20/22.  Up to date with COVID vaccination.
Patient received SHINGRIX on 10/20/21 that expired on 10/1/21. I have not heard from the patient regarding any adverse reactions.
"Patient with J+J COVID vaccine who admitted to hospital with COVID detected PCR.  Provider d/c note:  Patient is a 79 YO male history of diabetes, atrial fibrillation presents after being found unresponsive.  He was reported to be severely hypoglycemic on arrival.  He was incidentally found to be COVID-19 positive as well. He was subsequently admitted to the hospital for evaluation and management of acute metabolic encephalopathy due to hypo glycemia.   During his stay, he received half the dose of his long-acting insulin with out any further hypoglycemic episode.  His mentation has returned to baseline.  He stayed in the hospital longer despite being medically stable due to COVID clearance requirements for nursing home placement.  Strict return precautions given.
8/22/07-Fever of 102-103 deg-started at 11pm Fever continued of 101-102 through 8/26/07 8/24/07-Hives over 90% of body at 7am Saw physician-Still has hives on 8/27