chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Heart rate, Heart rate increased, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 56-year-old male patient received BNT162b2 (BNT162B2), on 17Feb2022 at 14:00 as dose 4 (booster), single (Lot number: FK9729) at the age of 55 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sarcoidosis pulmonary" (ongoing); "Cholesterol" (unspecified if ongoing); "high BP" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN oral taken for blood cholesterol (ongoing); DULERA taken for sarcoidosis (ongoing); LOSARTAN HCT oral taken for hypertension (ongoing). Vaccination history included: BNT162b2 (Dose-1, Time: 16:30, Anatomical Site of injection: Left Arm, Route of administration: Intramuscular, Batch Lot number: EL3247), administration date: 21Jan2021, when the patient was 54-year-old, for Covid-19 immunization, reaction(s): "Vaccination failure", "Treatment of COVID-19"; BNT162b2 (Dose-2, Time: 16:00, Site and Route of injection, Anatomical Site of injection: Left Arm, Route of administration: Intramuscular, Batch/Lot number: EM9809), administration date: 11Feb2021, when the patient was 54-year-old, for Covid-19 immunization, reaction(s): "Vaccination failure", "Treatment of COVID-19"; BNT162b2 (Dose-3, Time: 09:00, Site and Route of injection, Anatomical Site of injection: Left Arm, Route of administration: Intramuscular, Batch/Lot number: EW0187), administration date: 17Aug2021, when the patient was 55-year-old, for Covid-19 immunization, reaction(s): "Vaccination failure", "Treatment of COVID-19". The following information was reported: HEART RATE INCREASED (non-serious), outcome "unknown", described as "rapid heart rate". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious covid-19 complications). Booster dose due to a weakened immune system: Use of medication that suppress the immune system (e.g., high-dose of corticosteroids, cyclosporine, methotrexate, azathioprine, and biological therapies like rituximab and etanercept). No prior vaccinations (within 4 weeks). Post recovery from symptoms and after negative antigen test, patient experienced rapid heart rate greater 115 BPM on multiple occasions for duration of 15-25mins.; Sender's Comments: Linked Report(s) : PFIZER INC-202201054994 Same patient/drug, different dose/event;
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Chills, Diarrhoea, Hyperaesthesia, Vomiting
Clinical narrative: Fri.Aug.05.2022: I ate lunch at 3pm with a friend same food (no food poisoning), Pfizer vaccine at 5pm, Then at 11:45pm severe diarrhea, head and body aches, dizziness and confusion. Sat.Aug.06 thru Tue.Aug.09 more diarrhea and vomiting, everything I ate or drank felt horrible. I could not stand odors and flavors: chicken soup, Gatorade, Pedialyte, bath soap, tooth paste, cleaning products. Every one told me those are the "vaccine immune reaction" . Symptoms kept getting worse: Tue.Aug.09 in the evening I could not sleep or rest, my skin was sensitive, could not stand clothes or textures. Next morning I was having abdominal pain so a relative took me to the emergency room. The first sodium blood test they read to me was 108, crams in my legs etc. They took me to the ICU.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: Fri.Aug.05.2022: I ate lunch at 3pm with a friend same food (no food poisoning), Pfizer vaccine at 5pm, Then at 11:45pm severe diarrhea, head and body aches, dizziness and confusion. Sat.Aug.06 thru Tue.Aug.09 more diarrhea and vomiting, everything I ate or drank felt horrible. I could not stand odors and flavors: chicken soup, Gatorade, Pedialyte, bath soap, tooth paste, cleaning products. Every one told me those are the "vaccine immune reaction" . Symptoms kept getting worse: Tue.Aug.09 in the evening I could not sleep or rest, my skin was sensitive, could not stand clothes or textures. Next morning I was having abdominal pain so a relative took me to the emergency room. The first sodium blood test they read to me was 108, crams in my legs etc. They took me to the ICU.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Blood sodium decreased, Confusional state, Diarrhoea, Dizziness
Clinical narrative: Fri.Aug.05.2022: I ate lunch at 3pm with a friend same food (no food poisoning), Pfizer vaccine at 5pm, Then at 11:45pm severe diarrhea, head and body aches, dizziness and confusion. Sat.Aug.06 thru Tue.Aug.09 more diarrhea and vomiting, everything I ate or drank felt horrible. I could not stand odors and flavors: chicken soup, Gatorade, Pedialyte, bath soap, tooth paste, cleaning products. Every one told me those are the "vaccine immune reaction" . Symptoms kept getting worse: Tue.Aug.09 in the evening I could not sleep or rest, my skin was sensitive, could not stand clothes or textures. Next morning I was having abdominal pain so a relative took me to the emergency room. The first sodium blood test they read to me was 108, crams in my legs etc. They took me to the ICU.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Headache, Immunisation reaction, Intensive care, Muscle spasms
Clinical narrative: Fri.Aug.05.2022: I ate lunch at 3pm with a friend same food (no food poisoning), Pfizer vaccine at 5pm, Then at 11:45pm severe diarrhea, head and body aches, dizziness and confusion. Sat.Aug.06 thru Tue.Aug.09 more diarrhea and vomiting, everything I ate or drank felt horrible. I could not stand odors and flavors: chicken soup, Gatorade, Pedialyte, bath soap, tooth paste, cleaning products. Every one told me those are the "vaccine immune reaction" . Symptoms kept getting worse: Tue.Aug.09 in the evening I could not sleep or rest, my skin was sensitive, could not stand clothes or textures. Next morning I was having abdominal pain so a relative took me to the emergency room. The first sodium blood test they read to me was 108, crams in my legs etc. They took me to the ICU.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Perfume sensitivity, Restlessness, Sensitive skin, Sleep disorder
Clinical narrative: Fri.Aug.05.2022: I ate lunch at 3pm with a friend same food (no food poisoning), Pfizer vaccine at 5pm, Then at 11:45pm severe diarrhea, head and body aches, dizziness and confusion. Sat.Aug.06 thru Tue.Aug.09 more diarrhea and vomiting, everything I ate or drank felt horrible. I could not stand odors and flavors: chicken soup, Gatorade, Pedialyte, bath soap, tooth paste, cleaning products. Every one told me those are the "vaccine immune reaction" . Symptoms kept getting worse: Tue.Aug.09 in the evening I could not sleep or rest, my skin was sensitive, could not stand clothes or textures. Next morning I was having abdominal pain so a relative took me to the emergency room. The first sodium blood test they read to me was 108, crams in my legs etc. They took me to the ICU.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Taste disorder, Vomiting
Clinical narrative: Fri.Aug.05.2022: I ate lunch at 3pm with a friend same food (no food poisoning), Pfizer vaccine at 5pm, Then at 11:45pm severe diarrhea, head and body aches, dizziness and confusion. Sat.Aug.06 thru Tue.Aug.09 more diarrhea and vomiting, everything I ate or drank felt horrible. I could not stand odors and flavors: chicken soup, Gatorade, Pedialyte, bath soap, tooth paste, cleaning products. Every one told me those are the "vaccine immune reaction" . Symptoms kept getting worse: Tue.Aug.09 in the evening I could not sleep or rest, my skin was sensitive, could not stand clothes or textures. Next morning I was having abdominal pain so a relative took me to the emergency room. The first sodium blood test they read to me was 108, crams in my legs etc. They took me to the ICU.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Magnetic resonance imaging, Muscle spasms, Paraesthesia
Clinical narrative: BOTH HANDS STARTED SWELLING; ARTHRITIS IN THE NECK; LEFT HEAD AND HAND STARTED TO HAVE ELECTRIC JOLT LIKE HAVING A STROKE; COULDN'T GET OUT OF BED; RECALLED VACCINE ADMINISTERED; TINGLING; SIDE OF THE HEAD (EAR TO MY JAWLINE) ON FIRE; SWELLING OF ENTIRE FACE; BALANCE OFF; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: back surgery, and cyst at the tail bone, and concurrent conditions included: penicillin allergy, and other pre-existing medical conditions included: patient was completely healthy before vaccination, other than having a back surgery and that since 3 years now. She has to wear a back brace and be careful when she bends over. patient is an health care professional (pharmacy technician). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 55 years old. No concomitant medications were reported. On 2021, the patient experienced side of the head (ear to my jawline) on fire, swelling of entire face, balance off, and tingling. On 05-APR-2021, the patient experienced recalled vaccine administered. On 06-APR-2021, the patient experienced couldn't get out of bed. On 07-APR-2021, the patient experienced left head and hand started to have electric jolt like having a stroke. On JUL-2021, the patient experienced both hands started swelling, and arthritis in the neck. Laboratory data (dates unspecified) included: CAT scan normal, Nerve stimulation tests NOS no sign of any nerve damage, and X-ray normal, disc was fine. Treatment medications (dates unspecified) included: prednisone, and gabapentin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the couldn't get out of bed, left head and hand started to have electric jolt like having a stroke, both hands started swelling, swelling of entire face, side of the head (ear to my jawline) on fire, tingling, balance off, arthritis in the neck and recalled vaccine administered was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000247523 The suspected product quality complaint has been confirmed to be voided, this record indicates medical adverse events for the patient. there is no product quality issue described in the information reported. based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20220848257 and 20220846180.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Bedridden, Burning sensation, Computerised tomogram, Electric shock sensation
Clinical narrative: BOTH HANDS STARTED SWELLING; ARTHRITIS IN THE NECK; LEFT HEAD AND HAND STARTED TO HAVE ELECTRIC JOLT LIKE HAVING A STROKE; COULDN'T GET OUT OF BED; RECALLED VACCINE ADMINISTERED; TINGLING; SIDE OF THE HEAD (EAR TO MY JAWLINE) ON FIRE; SWELLING OF ENTIRE FACE; BALANCE OFF; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: back surgery, and cyst at the tail bone, and concurrent conditions included: penicillin allergy, and other pre-existing medical conditions included: patient was completely healthy before vaccination, other than having a back surgery and that since 3 years now. She has to wear a back brace and be careful when she bends over. patient is an health care professional (pharmacy technician). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 55 years old. No concomitant medications were reported. On 2021, the patient experienced side of the head (ear to my jawline) on fire, swelling of entire face, balance off, and tingling. On 05-APR-2021, the patient experienced recalled vaccine administered. On 06-APR-2021, the patient experienced couldn't get out of bed. On 07-APR-2021, the patient experienced left head and hand started to have electric jolt like having a stroke. On JUL-2021, the patient experienced both hands started swelling, and arthritis in the neck. Laboratory data (dates unspecified) included: CAT scan normal, Nerve stimulation tests NOS no sign of any nerve damage, and X-ray normal, disc was fine. Treatment medications (dates unspecified) included: prednisone, and gabapentin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the couldn't get out of bed, left head and hand started to have electric jolt like having a stroke, both hands started swelling, swelling of entire face, side of the head (ear to my jawline) on fire, tingling, balance off, arthritis in the neck and recalled vaccine administered was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000247523 The suspected product quality complaint has been confirmed to be voided, this record indicates medical adverse events for the patient. there is no product quality issue described in the information reported. based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20220848257 and 20220846180.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nerve stimulation test, Paraesthesia, Peripheral swelling, Recalled product administered, Spondylitis
Clinical narrative: BOTH HANDS STARTED SWELLING; ARTHRITIS IN THE NECK; LEFT HEAD AND HAND STARTED TO HAVE ELECTRIC JOLT LIKE HAVING A STROKE; COULDN'T GET OUT OF BED; RECALLED VACCINE ADMINISTERED; TINGLING; SIDE OF THE HEAD (EAR TO MY JAWLINE) ON FIRE; SWELLING OF ENTIRE FACE; BALANCE OFF; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: back surgery, and cyst at the tail bone, and concurrent conditions included: penicillin allergy, and other pre-existing medical conditions included: patient was completely healthy before vaccination, other than having a back surgery and that since 3 years now. She has to wear a back brace and be careful when she bends over. patient is an health care professional (pharmacy technician). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 55 years old. No concomitant medications were reported. On 2021, the patient experienced side of the head (ear to my jawline) on fire, swelling of entire face, balance off, and tingling. On 05-APR-2021, the patient experienced recalled vaccine administered. On 06-APR-2021, the patient experienced couldn't get out of bed. On 07-APR-2021, the patient experienced left head and hand started to have electric jolt like having a stroke. On JUL-2021, the patient experienced both hands started swelling, and arthritis in the neck. Laboratory data (dates unspecified) included: CAT scan normal, Nerve stimulation tests NOS no sign of any nerve damage, and X-ray normal, disc was fine. Treatment medications (dates unspecified) included: prednisone, and gabapentin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the couldn't get out of bed, left head and hand started to have electric jolt like having a stroke, both hands started swelling, swelling of entire face, side of the head (ear to my jawline) on fire, tingling, balance off, arthritis in the neck and recalled vaccine administered was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000247523 The suspected product quality complaint has been confirmed to be voided, this record indicates medical adverse events for the patient. there is no product quality issue described in the information reported. based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20220848257 and 20220846180.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face, X-ray
Clinical narrative: BOTH HANDS STARTED SWELLING; ARTHRITIS IN THE NECK; LEFT HEAD AND HAND STARTED TO HAVE ELECTRIC JOLT LIKE HAVING A STROKE; COULDN'T GET OUT OF BED; RECALLED VACCINE ADMINISTERED; TINGLING; SIDE OF THE HEAD (EAR TO MY JAWLINE) ON FIRE; SWELLING OF ENTIRE FACE; BALANCE OFF; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: back surgery, and cyst at the tail bone, and concurrent conditions included: penicillin allergy, and other pre-existing medical conditions included: patient was completely healthy before vaccination, other than having a back surgery and that since 3 years now. She has to wear a back brace and be careful when she bends over. patient is an health care professional (pharmacy technician). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 55 years old. No concomitant medications were reported. On 2021, the patient experienced side of the head (ear to my jawline) on fire, swelling of entire face, balance off, and tingling. On 05-APR-2021, the patient experienced recalled vaccine administered. On 06-APR-2021, the patient experienced couldn't get out of bed. On 07-APR-2021, the patient experienced left head and hand started to have electric jolt like having a stroke. On JUL-2021, the patient experienced both hands started swelling, and arthritis in the neck. Laboratory data (dates unspecified) included: CAT scan normal, Nerve stimulation tests NOS no sign of any nerve damage, and X-ray normal, disc was fine. Treatment medications (dates unspecified) included: prednisone, and gabapentin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the couldn't get out of bed, left head and hand started to have electric jolt like having a stroke, both hands started swelling, swelling of entire face, side of the head (ear to my jawline) on fire, tingling, balance off, arthritis in the neck and recalled vaccine administered was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000247523 The suspected product quality complaint has been confirmed to be voided, this record indicates medical adverse events for the patient. there is no product quality issue described in the information reported. based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20220848257 and 20220846180.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Joint range of motion decreased, Magnetic resonance imaging, Pain in extremity, X-ray
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 08Aug2021 as dose 1, 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "start having pain in right arm"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "can't rise my arm over my head". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: It was reported that yes as patient received the shot on 08Aug2021 and second on 24Aug2021. Patient start having pain in the right arm; could not rise the arm over the head; it hurt when patient reach for things; it pain when patient get out of bed shoulder to elbow. Patient had not worked in 5 months so it was probably not job related. One Doc (physician) gave patient a x-ray (captured as x-ray) and a MRI (magnetic resonance imaging); he had changed his insurance policy. Patient really need some assistance. Patient was out on a medical leave; look like patient would be going back late September were early October; need to no what is the next step. The lot number for BNT162b2 was not provided and will be requested during follow up. Sender's Comments: Linked Report(s): UM-PFIZER INC-PV202200051491.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Mobility decreased, Pain in extremity, X-ray
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 08Aug2021 as dose 1, 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "start having pain in right arm"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "can't rise my arm over my head". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: It was reported that yes as patient received the shot on 08Aug2021 and second on 24Aug2021. Patient start having pain in the right arm; could not rise the arm over the head; it hurt when patient reach for things; it pain when patient get out of bed shoulder to elbow. Patient had not worked in 5 months so it was probably not job related. One Doc (physician) gave patient a x-ray (captured as x-ray) and a MRI (magnetic resonance imaging); he had changed his insurance policy. Patient really need some assistance. Patient was out on a medical leave; look like patient would be going back late September were early October; need to no what is the next step. The lot number for BNT162b2 was not provided and will be requested during follow up. Sender's Comments: Linked Report(s): UM-PFIZER INC-PV202200051491.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular, Thrombosis, Ultrasound scan normal
Clinical narrative: I got first and second dose of vaccines of Pfizer, First dose november 14, and second dose December 05, 2021.  On December 2021 after two days of my vaccines I got my period, it was spotting for 4 days, After  that, In January, I dont have period at all, by February I only got spotting for 9 days, Its was weird because for many years I always have period. By March for some reason I got heaviest period in my life, I feel the blood its like pee, it last for 15 days, because I took advil to help it decreased.  By end of April my period start again, but at first I got spotting at like 3 to 4 days before actual period start April 24 to May 10, its like 17 days bleeding, I know it was not normal at all Im taken advil for this also to help me stop the bleeding. In May I went to have check up the doctor advice me to get a transvaginal ultrasound,  and I'm glad it went, normal result. That time, the doctor prescribed me a traxenemic acid. In June, It seem it was lighter and I have 9 days period but in the 7th day, I took traxenemic and stop in 9 days.  So I thought,  and hoping by July will go back to normal  but it wasnt.  In July I got my period again start July 04 to July 18, its 15 days bleeding,  before the period start, I had spotting again by 4 days before start, this time my period, has a lot of clots and there are some days i'ts lighter and for some reason the next day it will be heavier. I took the traxenemic and advil, I only allowed 5 days for traxenemic so when its end after a day, I took advil. So  in August I got my period.I didnt spotting but my period start August 17 but stop for 2 days. And then August 20 start again, its lighter some days, and next days it heavier its been like 12 days up to now it didnt stop. For many years I never experienced this before I got the vaccine. I have only like 4 days of period and like 28  days of cycle before. I'm hoping that one day it will go back to normal,  i'ts been like almost 6 months, and I still dealing with it. I dont have any cramps, but I do have like more clotty period,  and heavier some days, some days lighter, and for some reason I feel it won't stop unless I took some medication.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Cardiac monitoring
Clinical narrative: Unclassified arrhythmia on mobile app all day on the 24th continues today on and off.  Wore a monitor for 3 days in July.
Age: 62.0
Sex: F
Vaccine: DTAP
Symptoms: Contusion, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Dark purple bruise, 1.5?x2.5?, and swelling appeared about 1 hour after vaccination 6? below injection site. Red, diffuse rash  appeared above and beside bruise 2 days later.  Bruise and rash still present at day 4.
Sex: M
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: TACHYCARDIA; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (TACHYCARDIA) in an adult male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 18-Aug-2018, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. In May 2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. In June 2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. In February 2022, received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. In February 2022, the patient experienced TACHYCARDIA (TACHYCARDIA). At the time of the report, TACHYCARDIA (TACHYCARDIA) had resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant product use was reported.  In March-2022, the patient had another episode of Tachycardia which was recovered on an unknown date.  No treatment information was provided.  The reporter's causality for the events of tachycardia onset in February-2022, tachycardia onset in March-2022 Humira 40MG/0.8ML (Adalimumab) was no reasonable possibility.   This case was linked to MOD-2022-636538.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Immunisation reaction
Clinical narrative: Reaction to covid-19 vaccine; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Reaction to covid-19 vaccine) and FATIGUE (Tiredness) in an adult male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 18-Aug-2018, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. In May 2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. In June 2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. In February 2022, received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. In June 2022, received fourth dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. In June 2022, the patient experienced IMMUNISATION REACTION (Reaction to covid-19 vaccine) and FATIGUE (Tiredness). At the time of the report, IMMUNISATION REACTION (Reaction to covid-19 vaccine) outcome was unknown and FATIGUE (Tiredness) had not resolved.            Concomitant product use was not provided by the reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the packaging was discarded. The reporter's causality for the event of tiredness with humira 40mg/0.8ml(adalimumab) was no reasonable possibility. Treatment information was not provided.   This case was linked to MOD-2022-636537.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: I have not noticed any adverse effects at this time; misread the label when pulling MMR out of the freezer, believed at the time of pulling the vaccine that MMR was in the freezer with VARIVAX, the vaccine in the freezer was actually  Proquad; varivax and proquad administered the same day misread the label when pulling MMR out of the freezer, believed at the time of pulling the vaccine that MMR was in the freezer with VARIVAX, the vaccine in the freezer was actually  Proquad; did not double checked the vial on the vaccine to make sure it was the right medication; This spontaneous report has been received from a registered nurse concerning a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.  On 01-AUG-2022 at 13:45, the patient was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck)(VARIVAX) in the right arm for prophylaxis, lot #U015689, expiration date was not provided, however, upon internal validation was confirmed to be 18-MAY-2023 (strength, dose, frequency and route of administration were not provided). On the same date,  the registered nurse administered in error a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneously in the left arm also for prophylaxis lot #U009261, expiration date was not provided, however, upon internal validation was confirmed to be 19-SEP-2022 (strength, dose and frequency were not reported) asat the time of pulling the vaccine out from the freezer he took the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) instead of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR-II) vaccine. The registered nurse reported that the patietn was scheduled to receive five vaccines which included hib vaccine conj (tet tox) (ACT-HIB), pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) and hepatitis a vaccine inact (HEP A IN VAC).   On the same date, the registered nurse notified the vaccination error to the patient's mother, she inquired regarding the possible adverse effects that double vaccination with varicella vaccine, however, the patient's mother informed that the patient had no experienced any adverse effect from the vaccines.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: a patient received an extra dose of GARDASIL 9; no adverse event; This spontaneous report was received from a physician via company Representative and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient started vaccination with 9-valent Human Papillomavirus (types 16, 18, 31, 33, 45, 52, 58, 6 and 11) recombinant vaccine (GARDASIL 9) (dosage regimen, route of administration, lot #, and expiry date were not reported) as prophylaxis.  On an unknown date, the patient received an extra dose of 9-valent Human Papillomavirus (types 16, 18, 31, 33, 45, 52, 58, 6 and 11) recombinant vaccine (GARDASIL 9) (dosage regimen, route of administration, lot #, and expiry date were not reported) as prophylaxis.(Extra dose administered). No adverse event was reported.  This is a non-valid case due to lack of patient's identifiers.  Follow-up information has been received from a vaccine provider, on 19-AUG-2022.  The patient's demographics were updated. On 28-JUL-2022 the patient was shown to need a pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccine but was in adversely given a fourth dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (conflicting information, also reported as hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) [GARDASIL 9]) vaccine inactivated, intramuscular, right deltoid (not valid lot number 4019412 [expiration date 30-OCT-2023]) as soon as the incident was noticed the vaccine manufacturer was notified.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; a dose of PROQUAD was administered to the patient on 11AUG2022 after experiencing a temperautre excursion.; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and previous drug reactions and allergies were not provided.   On 11-AUG-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), for prophylaxis, with a dose of 0.5 milliliters (ml) (lot number U031560 had been verified as a valid number, and expiration date reported and established as: 06-APR-2023) (vaccination scheme, route of administration, and anatomical site of injection were not reported). The administered dose of the vaccine was stored at a temperature of 18.6 degrees Fahrenheit (F) during a time frame of 30 minutes. There was a previous temperature excursion reported as: 9.8 F for 30 minutes. There was no adverse effect reported.; Sender's Comments:  US-009507513-2208USA005443:MSD US-009507513-2208USA005325:MSD US-009507513-2208USA004963:MSD US-009507513-2208USA005272:MSD
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: no known adverse side effects; an improperly stored dose of GARDASIL 9 was administered to a patient; This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On 10-AUG-2022, the patient was vaccinated with an improperly stored 0.5 mL dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # U034200 exp date 21-OCT-2023) intramuscularly. The temperature of excursion was 49.4 F for a time frame of 72 hours. There was a previous temperature excursion of 34.5 F for 7 hours on 03-MAY-2022. The patient had no known side effects.
Age: 0.42
Sex: U
Vaccine: HIBV, RV1
Symptoms: Incorrect route of product administration, No adverse event, Product preparation error
Clinical narrative: The patient has had no adverse side effects at this time.; Medical Assistant called stating that a dose of PEDVAX HIB was drawn out of the vial into a plastic syringe and accidentally reconstituted with ROTARIX instead of the recommended ROTARIX diluent.; Given to a 5 month old patient orally instead of intramuscularly today.; This spontaneous report was received from a medical assistant regarding a 5-month-old patient of an unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 12-AUG-2022, the patient was accidentally vaccinated with a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 milliliter x 1 dose, lot #U029145, expiration date: 30-MAR-2024, (strength was not provided) as prophylaxis, which was used as diluent of rotavirus vaccine live oral 1v (ROTARIX), 1 milliliter x dose, expiration date: 29-JUN-2023 (strength, formulation, lot #, and indication were not provided), instead of the recommended diluent (Product preparation error) and it was given to the patient orally instead of intramuscularly (Incorrect route of product administration). At the time of reporting, the patient had no adverse side effects. The reporter stated that they were able to get in touch with poison control who stated there should be no issues or adverse side effects with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) taken orally an they could vaccinate the patient via the appropriate route.
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse event; patient received the GARDASIL 9 three-dose series at 60 years old; This spontaneous report was received from a consumer refers to a 60 year old female patient. On 10-MAR-2021, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route and lot # not provided) (Product administered to patient of inappropriate age). On 11-MAY-2021, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route and lot # not provided) and on 13-SEP-2021, the patient received the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route and lot # not provided). The patient stated that her doctor and her insurance company both told her that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was approved for 60-year old women, but after receiving the series her insurance company then said it was only approved up to age 45.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQCs reported; temperature excursion for VARIVAX/ temperature: 9 degrees C to 25 degrees C (14.5C) for 2 hours/ product was administered; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided.  On 26-MAY-2022, the varicella virus vaccine live (oka/merck) (VARIVAX), lot # T027305, expiry date reported as 31-AUG-2022, but upon internal validation established as 12-AUG-2022, experienced a temperature excursion of 9 degrees C to 25 degrees C (14.5 degrees C) for 2 hours. It was also stored in -14 degrees C up to -10 degrees C (-11.49 degrees C) for 2 hours.  On 27-MAY-2022 the patient was vaccinated with 1 dose of above mentioned improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (exact dose, route and site of administration were not reported) for prophylaxis (product storage error). No additional adverse events (AEs) or product quality complaints (PQCs) were reported (no adverse event).   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA006055:
Sex: U
Vaccine: HEPA, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; Caller is an office manager reporting that an improperly stored dose of M-M-R II and VAQTA were administered to the patient on 27MAY2022 after experiencing a temperautre excursion.; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 27-MAY-2022, the patient was vaccinated with improperly storage hepatitis a vaccine, inactivated (VAQTA) (valid lot #U033212, upon internal review expiration date was 07-NOV-2022 [also reported as 28-OCT-2022]) (strength, anatomical location and route of administration were not provided); and  measles, mumps, and rubella (WISTAR RA 27-3) virus vaccine, live (M-M-R II) (valid lot #T033814, expiration date: 05-OCT-2022) (strength, and route of administration were not provided) both administered for prophylaxis. Temperature excursion was at 54.5 Fahrenheit (F) for 11 hours. No additional information or adverse event was reported. ; Sender's Comments:  US-009507513-2208USA006720: US-009507513-2208USA006883: US-009507513-2208USA006520: US-009507513-2208USA006700:
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional AE; Caller explained a patient started the GARDASIL 9 vaccination series at the age of 17 years old on 08JUN2020. Caller stated the patient did not receive his second vaccination until JULY 2022.; This spontaneous report has been received from a nurse referring to a male patient of unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitants therapies were not mentioned.  On 08-JUN-2020, the patient started his vaccination series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dosage, vaccination scheme, route of administration, anatomical site of injection, lot number and expiration date were not provided). However, did not received his second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) until unspecified date in July 2022 (inappropriate schedule of vaccine administered).
Age: 59.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional AE or PQC reported; Caller explained a 59 year old patient was administered GARDASIL 9 in error; patient was administered GARDASIL 9 in error; This spontaneous report was received from a registered nurse and refers to a 59-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 16-AUG-2022, the patient was vaccinated in an error with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)pre-filled syringe injection, lot #U037063 was confirmed to be valid, expiration date: 21-OCT-2023, administered for prophylaxis (dose, anatomical location and route of administration were not provided)(Inappropriate age at vaccine administration and wrong product administered). No additional adverse event was reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; Improperly stored vaccine was administered; This spontaneous report was received from a nurse referring to a patient of unspecified age and gender. Information regarding the patient's medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.   On 18-AUG-2022, the patient was administered an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (dose, route of administration, and anatomical site of vaccination were not reported; lot number 1775811 has been verified to be valid, expiration date reported and established as 07-DEC-2023) (product storage error). No additional adverse event was reported (no adverse event).   This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2208USA008089: US-009507513-2208USA008439:
Sex: U
Vaccine: VARCEL, MMR
Symptoms: Incorrect route of product administration, No adverse event, Product storage error
Clinical narrative: No additional AEs; vaccines administered after temperature excursion.; the vaccines were administered IM (instead of SQ).; This spontaneous report was received from a medical assistant referring to a patient of unspecified age and gender. Information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant therapies was not provided.   On 17-AUG-2022, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) as prophylaxis (lot number U028164 has been verified to be valid, expiration date reported and established as 09-SEP-2023) 0.5 milliliters (ml) administered intramuscularly (IM) instead of subcutaneously (incorrect route of product administration).   In addition, it was reported that the vaccine was improperly stored at 32.9 degrees Fahrenheit during a time frame of 28 hours and 39 minutes. Moreover, the vaccine was exposed to a previous temperature excursion of a maximum temperature of 20.7 degrees Fahrenheit for 32 hours and 10 minutes (product storage error).  No additional adverse events were reported (no adverse event). The patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) administered intramuscularly instead of subcutaneously (case # 2208USA010122).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA008668: US-009507513-2208USA010122: US-009507513-2208USA009718: US-009507513-2208USA008497: US-009507513-2208USA008503: US-009507513-2208USA008699:
Sex: U
Vaccine: VARCEL, MMR
Symptoms: Incorrect route of product administration, Product storage error
Clinical narrative: No additional AEs; vaccines administered after temperature excursion.; the vaccines were administered IM (instead of SQ).; This spontaneous report was received from a medical assistant referring to a patient of unspecified age and gender. Information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant therapies was not provided.   On 17-AUG-2022, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) as prophylaxis (lot number U028164 has been verified to be valid, expiration date reported and established as 09-SEP-2023) 0.5 milliliters (ml) administered intramuscularly (IM) instead of subcutaneously (incorrect route of product administration).   In addition, it was reported that the vaccine was improperly stored at 32.9 degrees Fahrenheit during a time frame of 28 hours and 39 minutes. Moreover, the vaccine was exposed to a previous temperature excursion of a maximum temperature of 20.7 degrees Fahrenheit for 32 hours and 10 minutes (product storage error).  No additional adverse events were reported (no adverse event). The patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) administered intramuscularly instead of subcutaneously (case # 2208USA010122).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA008668: US-009507513-2208USA010122: US-009507513-2208USA009718: US-009507513-2208USA008497: US-009507513-2208USA008503: US-009507513-2208USA008699:
Sex: U
Vaccine: VARCEL, MMR
Symptoms: Incorrect route of product administration, No adverse event, Product storage error
Clinical narrative: No additional AEs; the vaccines were administered IM (instead of SQ).; This spontaneous report was received from a medical assistant referring to a patient of unspecified age and gender. Information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant therapies was not provided.   On 17-AUG-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) as prophylaxis (lot number U006596 has been verified to be valid, expiration date reported and established as 01-MAR-2023) 0.5 milliliters (ml) administered intramuscularly (IM) instead of subcutaneously (incorrect route of product administration).   It was reported that measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) was stored within recommended temperature range. No additional adverse events were reported (no adverse event). The patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (case # 2208USA008558).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA008668: US-009507513-2208USA009718: US-009507513-2208USA008558: US-009507513-2208USA008497: US-009507513-2208USA008503: US-009507513-2208USA008699: