chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoacusis, SARS-CoV-2 test, Tinnitus
Clinical narrative: A profoundly loud Tinnitus in my left ear and minor tinnitus in my right ear, it has grown in intensity; Now the ringing noise is almost deafening; 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), administered in arm left, administration date 21Aug2021 11:00 (Lot number: AFA7485) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: in February, testing positive on 11Feb and 20Feb. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FA7485, Location of injection: Arm Left, Vaccine Administration Time: 12:30 AM), administration date: 31Jul2021, when the patient was 56 years old, for Covid-19 immunization, reaction(s): "sore in my left arm", "fatigued", "pain radiated across my shoulder blades toward my right shoulder", "a profoundly loud Tinnitus in his left ear and minor tinnitus in his right ear", "sick", "muscle or tendon connecting to the left arm across his shoulders had not returned to normal". The following information was reported: TINNITUS (disability) with onset 2021, outcome "not recovered", described as "A profoundly loud Tinnitus in my left ear and minor tinnitus in my right ear, it has grown in intensity"; HYPOACUSIS (disability) with onset 2021, outcome "not recovered", described as "Now the ringing noise is almost deafening". The events "a profoundly loud tinnitus in my left ear and minor tinnitus in my right ear, it has grown in intensity" and "now the ringing noise is almost deafening" were evaluated at the physician office visit. Clinical course: patient had a profoundly loud Tinnitus in his left ear and minor tinnitus in his right ear. Patient first noticed it in mid August just and it has grown in intensity. Patient had never experienced Tinnitus before and it took awhile for him to understand what was going on. Now the ringing noise was almost deafening. Since the vaccination, the patient had been tested for COVID-19. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (unspecified date) positive, notes: on 11Feb; (unspecified date) positive, notes: on 20Feb; (06Sep2021) negative.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101698205 Same reporter/SD, Different AE/dose
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Rheumatoid arthritis
Clinical narrative: developing autoimmune diseases/ diagnosed with Rheumatoid Arthritis; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101698326 (Pfizer).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: Jan2021, for COVID-19 immunization; Bnt162b2 (Dose 2), administration date: Feb2021, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset Oct2021, outcome "unknown", described as "booster"; RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "developing autoimmune diseases/ diagnosed with Rheumatoid Arthritis". Clinical course: Developing autoimmune diseases after receiving the Pfizer COVID-19 vaccines and boosters. The patient had since been diagnosed with Rheumatoid Arthritis. There very well could be a correlation considering the effects of the vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Dizziness, Presyncope
Clinical narrative: fluttering in her chest; felt like she was going to pass out; Dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101698105 (Pfizer).  A 66 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:1, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: CARDIAC FLUTTER (medically significant), outcome "recovered", described as "fluttering in her chest"; PRESYNCOPE (non-serious), outcome "recovered", described as "felt like she was going to pass out"; DIZZINESS (non-serious), outcome "recovered", described as "Dizzy". Clinical course: Caller stated she had some kind of reaction after her second vaccine and she was wanting to know if it was safe for her to have the booster. After the second shot of the vaccine, clarified about 10 days after the second shot, she developed fluttering in her chest and the sensation went instantly to her head where she got dizzy and she felt like she was going to pass out. It was random and it was intense. She stated it tapered off after about 3 months.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Gait disturbance, Hypoaesthesia, Magnetic resonance imaging, Mobility decreased
Clinical narrative: Numbness of right side from stomach all the way down to right foot; nerve squeezing/nerve pain; itching at stomach; Gait and Mobility loss on right side; Gait and Mobility loss on right side; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 11Feb2021 (Lot number: EL9664) at the age of 34 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Contact Dermatitis ylang-ylang" (unspecified if ongoing), notes: Known allergies: Contact Dermatitis ylang-ylang; "Contact Dermatitis" (unspecified if ongoing); "Known allergies: decyl glucoside, thiuram mix, thioreas" (unspecified if ongoing), notes: Known allergies: decyl glucoside, thiuram mix, thioreas; "Breast cancer survivor (2 year survivor at time of Vaccine)" (unspecified if ongoing), notes: Other medical history: Breast cancer survivor (2 year survivor at time of Vaccine); "have BRCA2" (unspecified if ongoing), notes: Other medical history: have BRCA2. Concomitant medication(s) included: CLARITINE; LETROZOLE; VITAMIN C [ASCORBIC ACID]; VITAMIN D3; ZOLADEX. Past drug history included: Thimerosal, reaction(s): "allergies", notes: Known allergies: thimerosal. no other vaccine in four weeks. No Covid prior vaccination. Vaccination history included: Bnt162b2 (lot number: EL3302, administration date: 21Jan2021, dose number: 1, Vaccine location: Right arm), administration date: 21Jan2021, when the patient was 34 years old, for COVID-19 Immunization. The following information was reported: HYPOAESTHESIA (disability) with onset 26Mar2021, outcome "not recovered", described as "Numbness of right side from stomach all the way down to right foot"; NEURALGIA (disability) with onset 26Mar2021, outcome "not recovered", described as "nerve squeezing/nerve pain"; PRURITUS (disability) with onset 26Mar2021, outcome "not recovered", described as "itching at stomach"; GAIT DISTURBANCE (disability), MOBILITY DECREASED (disability) all with onset 26Mar2021, outcome "not recovered" and all described as "Gait and Mobility loss on right side". The events "numbness of right side from stomach all the way down to right foot", "nerve squeezing/nerve pain", "itching at stomach", "gait and mobility loss on right side" and "gait and mobility loss on right side" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: (2021) unknown results; magnetic resonance imaging: (2021) unknown results; sars-cov-2 test: (2021) negative. Therapeutic measures were taken as a result of hypoaesthesia, neuralgia, pruritus, gait disturbance, mobility decreased.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Pruritus, SARS-CoV-2 test
Clinical narrative: Numbness of right side from stomach all the way down to right foot; nerve squeezing/nerve pain; itching at stomach; Gait and Mobility loss on right side; Gait and Mobility loss on right side; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 11Feb2021 (Lot number: EL9664) at the age of 34 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Contact Dermatitis ylang-ylang" (unspecified if ongoing), notes: Known allergies: Contact Dermatitis ylang-ylang; "Contact Dermatitis" (unspecified if ongoing); "Known allergies: decyl glucoside, thiuram mix, thioreas" (unspecified if ongoing), notes: Known allergies: decyl glucoside, thiuram mix, thioreas; "Breast cancer survivor (2 year survivor at time of Vaccine)" (unspecified if ongoing), notes: Other medical history: Breast cancer survivor (2 year survivor at time of Vaccine); "have BRCA2" (unspecified if ongoing), notes: Other medical history: have BRCA2. Concomitant medication(s) included: CLARITINE; LETROZOLE; VITAMIN C [ASCORBIC ACID]; VITAMIN D3; ZOLADEX. Past drug history included: Thimerosal, reaction(s): "allergies", notes: Known allergies: thimerosal. no other vaccine in four weeks. No Covid prior vaccination. Vaccination history included: Bnt162b2 (lot number: EL3302, administration date: 21Jan2021, dose number: 1, Vaccine location: Right arm), administration date: 21Jan2021, when the patient was 34 years old, for COVID-19 Immunization. The following information was reported: HYPOAESTHESIA (disability) with onset 26Mar2021, outcome "not recovered", described as "Numbness of right side from stomach all the way down to right foot"; NEURALGIA (disability) with onset 26Mar2021, outcome "not recovered", described as "nerve squeezing/nerve pain"; PRURITUS (disability) with onset 26Mar2021, outcome "not recovered", described as "itching at stomach"; GAIT DISTURBANCE (disability), MOBILITY DECREASED (disability) all with onset 26Mar2021, outcome "not recovered" and all described as "Gait and Mobility loss on right side". The events "numbness of right side from stomach all the way down to right foot", "nerve squeezing/nerve pain", "itching at stomach", "gait and mobility loss on right side" and "gait and mobility loss on right side" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: (2021) unknown results; magnetic resonance imaging: (2021) unknown results; sars-cov-2 test: (2021) negative. Therapeutic measures were taken as a result of hypoaesthesia, neuralgia, pruritus, gait disturbance, mobility decreased.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fall, Immunisation, Limb discomfort, Pain
Clinical narrative: I have lost strength; have pain radiating from my right leg nonstop. It also goes completely straight not bending; have pain radiating from my right leg nonstop. It also goes completely straight not bending; I lose complete strength in it causing me to fall over.; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Aug2021 (Lot number: ew0198) at the age of 24 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Pollen" (unspecified if ongoing); "Known allergies: sutures" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Adderall, reaction(s): "Known allergies: Adderall"; Ritalin, reaction(s): "Known allergies: Ritalin". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ew0186, Location of injection: Arm Right), administration date: 28May2021, when the patient was 24 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ew0164, Location of injection: Arm Right), administration date: 24Apr2021, when the patient was 24 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (disability) with onset 24Aug2021, outcome "unknown", described as "booster"; ASTHENIA (disability) with onset 25Aug2021, outcome "unknown", described as "I have lost strength"; PAIN (disability), LIMB DISCOMFORT (disability) all with onset 25Aug2021, outcome "unknown" and all described as "have pain radiating from my right leg nonstop. It also goes completely straight not bending"; FALL (disability) with onset 25Aug2021, outcome "unknown", described as "I lose complete strength in it causing me to fall over.". The events "booster", "i have lost strength", "have pain radiating from my right leg nonstop. it also goes completely straight not bending", "have pain radiating from my right leg nonstop. it also goes completely straight not bending" and "i lose complete strength in it causing me to fall over." were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of immunisation, asthenia, pain, limb discomfort, fall and included treatment with medications (tried) and in physical therapy. Clinical course: There was no other vaccine in four weeks. Patient did not have covid tested post vaccination.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site infection, Product administered at inappropriate site
Clinical narrative: After each dose the patient had an infection from the injection site to the knee that lasted 3 weeks; Patient had redness in both legs; she received the MODERNA shot on her side; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INFECTION (After each dose the patient had an infection from the injection site to the knee that lasted 3 weeks), ERYTHEMA (Patient had redness in both legs) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (she received the MODERNA shot on her side) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal (Blood pressure), Blood cholesterol abnormal (Cholesteol), Disorder sleep (Trouble sleeping), Panic attacks and Panic disorder (panic disorders). Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) for Anticoagulant therapy, SIMVASTATIN (ZOCOR) for Blood cholesterol abnormal, LISINOPRIL and METOPROLOL for Blood pressure abnormal, MELATONIN for Disorder sleep, FUROSEMIDE (LASIX M) for Diuretic therapy, BIFIDOBACTERIUM LONGUM, LACTOBACILLUS ACIDOPHILUS (SENEX 3) for Panic attacks, ALPRAZOLAM for Panic disorder, COLECALCIFEROL (VITAMIN D3), VITAMIN B12 [VITAMIN B12 NOS] and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (she received the MODERNA shot on her side). On an unknown date, the patient experienced INJECTION SITE INFECTION (After each dose the patient had an infection from the injection site to the knee that lasted 3 weeks) and ERYTHEMA (Patient had redness in both legs). On 08-Feb-2021, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (she received the MODERNA shot on her side) had resolved. At the time of the report, INJECTION SITE INFECTION (After each dose the patient had an infection from the injection site to the knee that lasted 3 weeks) had resolved and ERYTHEMA (Patient had redness in both legs) outcome was unknown.            Patient stated that a time ago she took another vaccine (pneumonia) and she had an adverse reaction who disabled from being vaccinated again in the arm.  After receiving each dose, she had an infection from the injection site to the knee that lasted 3 weeks, and redness in both legs. She went to the Hospital and she received like 50 antibiotics (she doesn't remember the names of the antibiotics). 50 unknown antibiotics to treat the infection.   This case was linked to MOD-2021-404978 (Patient Link).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the vaccine, it gave shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female 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 and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient's siblings for his brother. The age at vaccination was not reported. The patient got the Shingle vaccine and it gave them shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This case is linked with US2021AMR252703, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR252703:same reporter, other patient
Sex: U
Vaccine: VARZOS
Symptoms: Cough, Nasopharyngitis, Pain, Pyrexia
Clinical narrative: fever; bad cold / full blown cold; body aches; cough; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 4th December 2021, the patient received Shingles vaccine. On 6th December 2021, 2 days after receiving Shingles vaccine, the patient experienced general body pain and cough. On 8th December 2021, the patient experienced fever and cold. On an unknown date, the outcome of the general body pain and cough were recovered/resolved and the outcome of the fever and cold were not recovered/not resolved.   It was unknown if the reporter considered the general body pain, cough, fever and cold to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient reported that he/she had the shingles vaccine on Saturday afternoon (from the day of reporting) felt fine on Sunday but developed body aches and a cough on Monday and Tuesday. Woke up today (on the day of reporting) had a fever and a full blown cold. The patient wanted to know if it was normal 4 days after vaccination. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included fall (before shingles appeared the patient had a fall). Concurrent medical conditions included cancer. 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. The patient was treated with acyclovir. 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 Shingles vaccine. Additional details were provided are as follows: The patient self-reported this case. The age at vaccination was not reported. It was reported that year ago the patient was told that shingles appear when the body had a traumatic experience and before shingles appeared he/she had a fall days before. The patient has had cancer as concurrent condition. The patient took Shingles vaccine because they appeared during treatment for cancer. The patient stated he/she had the vaccine a long time ago. The patient was taking acyclovir 400mg tablet, 1 in morning and 1 at night. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had shingles 4x. Had the shots in between /Suspected vaccination failure; shingles 4x; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient 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 Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had shingles 4 times and had the Shingles shots in between too. The patient enquired how about those vaccines and asked if they worked. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. In January 2021, the patient received the 2nd dose of Shingles vaccine. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine and 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 and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got both the Shingles vaccine doses and still got shingles. The patient stated that he/she never had shingles, and last week from reporting date it resulted in it on his/her left side. The patient enquired if the vaccine did not work. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the detail regarding laboratory test confirming shingles was unknown at the time of reporting.
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female of unspecified age, race and ethic origin. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 in AUG-2020. The patient received covid-19 vaccine ad26.cov2.s (Dose Number in Series: 1, suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, after the vaccination, the patient was sick for 5 days and experienced suspected covid-19 infection (suspected clinical vaccination failure). The patient also reported that her covid was clinically confirmed by her physician. (Dose Number in Series: 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint and reference number requested.; Sender's Comments: :20211225283-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Malaise, Psoriasis
Clinical narrative: HEART PROBLEMS; PSORIASIS; SO SICK; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced heart problems, psoriasis, and so sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from psoriasis, and the outcome of so sick and heart problems was not reported. This report was non-serious.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Vaccination failure
Clinical narrative: COVID PNEUMONIA; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via social media through company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown expiry: unknown) dose was not reported, 1 total, administered on 01-JUN-2021 for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced COVID (Coronavirus disease) pneumonia, and was hospitalized with it on 27-NOV-21 (number of days unspecified) (suspected clinical vaccination failure). Patient fought a huge battle with COVID.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the COVID pneumonia and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This report was associated with product quality complaint: 90000206657.; Sender's Comments: V0:20211227883-COVID-19 VACCINE AD26.COV2.S-Covid pneumonia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20211227883-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Psoriasis
Clinical narrative: FLU-LIKE SYMPTOMS; FATIGUE; PLAQUE PSORIASIS FLARE-UP; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On OCT-2021, the patient experienced plaque psoriasis flare-up. On an unspecified date, the patient experienced flu-like symptoms, and fatigue. Treatment medications (dates unspecified) included: calcipotriol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from flu-like symptoms, and fatigue, and had not recovered from plaque psoriasis flare-up. This report was non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, SARS-CoV-2 test
Clinical narrative: BODY ACHES; FEELING SUPER TIRED; HEADACHE; This spontaneous report received from a patient concerned a 35 year old female. The patient's weight was 165 pounds, and height was 66 inches. The patient's concurrent conditions included: hypothyroidism, no alcohol use, and non smoker, and other pre-existing medical conditions included: The patient was not pregnant at the time reporting. The patient had no other medical conditions or medications. The patient had no known allergies/ had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855791, and expiry: UNKNOWN) dose was not reported, administered on 12-DEC-2021 for prophylactic vaccination. Concomitant medications included levothyroxine for hypothyroidism. On 13-DEC-2021, the patient experienced body aches. On 13-DEC-2021, the patient experienced feeling super tired. On 13-DEC-2021, the patient experienced headache. Laboratory data included: COVID-19 virus test (NR: not provided) negative. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feeling super tired, had not recovered from headache, and the outcome of body aches was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: DEVELOP COVID AFTER VACCINE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 30-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 04-DEC-2021, the patient experienced develop covid after vaccine. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of develop covid after vaccine was not reported. This report was non-serious.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site infection, Product administered at inappropriate site
Clinical narrative: After each dose the patient had an infection from the injection site to the knee that lasted 3 weeks; Patient had redness in both legs; she received the MODERNA shot on her side; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INFECTION (After each dose the patient had an infection from the injection site to the knee that lasted 3 weeks), ERYTHEMA (Patient had redness in both legs) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (she received the MODERNA shot on her side) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) for Anticoagulant therapy, LISINOPRIL and METOPROLOL for Blood pressure, SIMVASTATIN (ZOCOR) for Cholesterol, MELATONIN for Difficulty sleeping, FUROSEMIDE (LASIX [FUROSEMIDE]) for Diuretic therapy, SECNIDAZOLE (SENEX [SECNIDAZOLE]) for Panic attacks, ALPRAZOLAM for Panic disorder, COLECALCIFEROL (VITAMIN D3), VITAMIN B12 [VITAMIN B12 NOS] and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2021, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (she received the MODERNA shot on her side). On an unknown date, the patient experienced INJECTION SITE INFECTION (After each dose the patient had an infection from the injection site to the knee that lasted 3 weeks) and ERYTHEMA (Patient had redness in both legs). At the time of the report, INJECTION SITE INFECTION (After each dose the patient had an infection from the injection site to the knee that lasted 3 weeks), ERYTHEMA (Patient had redness in both legs) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (she received the MODERNA shot on her side) had resolved.        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.   Patient had 50 unknown antibiotics to treat the infection.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pemphigus
Clinical narrative: pemphigus vulgaris; This literature-non-study case was reported in a literature article and describes the occurrence of PEMPHIGUS (pemphigus vulgaris) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE:(Redacted)     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PEMPHIGUS (pemphigus vulgaris) (seriousness criterion medically significant). At the time of the report, PEMPHIGUS (pemphigus vulgaris) outcome was unknown. Not Related      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PEMPHIGUS (pemphigus vulgaris) to be related.    Company comment: This is a literature case concerning a 60 year-old, male patient with no reported medical history, who experienced the serious (due to medically significant) unexpected, according, event of Pemphigus. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. Very limited information regarding clinical course of event was provided. The rechallenge was not applicable, as the event was reported exclusively after the second dose and no information on additional dosing is available. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a literature case concerning a 60 year-old, male patient with no reported medical history, who experienced the serious (due to medically significant) unexpected, according, event of Pemphigus. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. Very limited information regarding clinical course of event was provided. The rechallenge was not applicable, as the event was reported exclusively after the second dose and no information on additional dosing is available. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: a little girl that has bad reaction to shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (a little girl that has bad reaction to shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Previously administered products included for Drug use for unknown indication: A and B shots (she has done A and B shots and both wipe her out.). Past adverse reactions to the above products included Adverse event with A and B shots. Concurrent medical conditions included Drug allergy.    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 VACCINATION COMPLICATION (a little girl that has bad reaction to shot). At the time of the report, VACCINATION COMPLICATION (a little girl that has bad reaction to shot) outcome was unknown.            Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter.   This case was linked to MOD-2021-409294, MOD-2021-408510 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Liver function test increased, Nasopharyngitis, SARS-CoV-2 antibody test, Vaccination complication
Clinical narrative: Vague symptoms; Cold type symptoms; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Vague symptoms) and NASOPHARYNGITIS (Cold type symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vague symptoms) and NASOPHARYNGITIS (Cold type symptoms). At the time of the report, VACCINATION COMPLICATION (Vague symptoms) and NASOPHARYNGITIS (Cold type symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Liver function test increased: other (High) increased liver function tests. On an unknown date, SARS-CoV-2 antibody test: positive (Positive) IgG was positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Nausea, Vaccination site pain
Clinical narrative: feeling uneasy; a little pain when being injected; feel a little bit uneasy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling uneasy), VACCINATION SITE PAIN (a little pain when being injected) and NAUSEA (feel a little bit uneasy) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID -19 Vaccination: Janssen.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced FEELING ABNORMAL (feeling uneasy), VACCINATION SITE PAIN (a little pain when being injected) and NAUSEA (feel a little bit uneasy). On 23-Nov-2021, FEELING ABNORMAL (feeling uneasy), VACCINATION SITE PAIN (a little pain when being injected) and NAUSEA (feel a little bit uneasy) had resolved.            Concomitant medication was not reported. Treatment information was not reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: pain after Moderna Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (pain after Moderna Booster) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (pain after Moderna Booster). At the time of the report, PAIN (pain after Moderna Booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment medication was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effects from booster; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (Side effects from booster) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects from booster). At the time of the report, VACCINATION COMPLICATION (Side effects from booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter. Patient enquired about, to get a double dosage on booster if immunocompromised.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 11 YO girl who received the Moderna Covid-19 vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (11 YO girl who received the Moderna Covid-19 vaccine.) in an 11-year-old female 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (11 YO girl who received the Moderna Covid-19 vaccine.). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (11 YO girl who received the Moderna Covid-19 vaccine.) had resolved.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Skin discolouration
Clinical narrative: Also noticed brown spot on her right middle finger; Developed a big brownish blotch spot on her right arm above wrist, underneath her arm, and around her arm.; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Developed a big brownish blotch spot on her right arm above wrist, underneath her arm, and around her arm.) and SKIN DISCOLOURATION (Also noticed brown spot on her right middle finger) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Dec-2021, the patient experienced RASH MACULAR (Developed a big brownish blotch spot on her right arm above wrist, underneath her arm, and around her arm.). On an unknown date, the patient experienced SKIN DISCOLOURATION (Also noticed brown spot on her right middle finger). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH MACULAR (Developed a big brownish blotch spot on her right arm above wrist, underneath her arm, and around her arm.) and SKIN DISCOLOURATION (Also noticed brown spot on her right middle finger) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was reported.    This case was linked to MOD-2021-052941 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medications were reported. No Treatment medication reported.   This case was linked to MOD-2021-409881 (Patient Link).