chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: 19-year-old patient received an adult dose; 19-year-old patient received an adult dose; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 19-year-old female patient who received HBV (Engerix B adult) (batch number TB3KN, expiry date unknown) for prophylaxis.   On 4th April 2022, the patient received Engerix B adult. On 4th April 2022, unknown after receiving Engerix B adult, the patient experienced overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the overdose and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date: 05-Apr-2022 Reporter's comment: Nurse reported that a patient received an adult dose of Engerix-B, which led to overdose and inappropriate age of vaccine administration. The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Reconstitution with sterile water; Reconstitution with sterile water; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 05-Apr-2022 Reporter's comment: Registered pharmacist reported that one of their providers reconstituted Shingrix with sterile water for injection and administered it to patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter had no details regarding patient or product but agreed to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Diplopia
Clinical narrative: Double vision or diplopia; This case was reported by a consumer via call center representative and described the occurrence of diplopia in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 month after receiving Shingrix, the patient experienced diplopia. On an unknown date, the outcome of the diplopia was recovered/resolved.   It was unknown if the reporter considered the diplopia to be related to Shingrix.     Additional Information: GSK Receipt Date: 5-APR-2022 Reporter's Comment: The patient self-reported this case. The patient received first dose of Shingrix about a year ago from the date of reporting (exact date unknown) and about a month or so after, she stated she began experiencing double vision or diplopia. At the time she consulted her physician who advised her not to take dose 2 due to the side effect. She did not take dose 2 within the recommended interval of 2-6 months after dose first. Provided information per clinical trial data on PI (package insert). Referred to HCP (health care professional). Provided medical advice disclaimer. The reporter gave permission to contact HCP (health care professional). The reporter consented to follow-up.
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Blood pressure decreased, Blood pressure measurement, Immunisation reaction, Injection site haemorrhage, Injection site pain
Clinical narrative: PASSED OUT; VACCINATION ADVERSE REACTION; DROP IN BLOOD PRESSURE; INJECTION SITE BLEEDING; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 66 year old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: There was no reported medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) 1 in total, 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.  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 ulcerative colitis; and adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) (citrate free), dose, frequency, and therapy dates were not reported for moderate to severe ulcerative colitis.  No concomitant medications were reported.  On unspecified dates, the patient experienced covid-19 vaccine reaction, drop in blood pressure, passed out three times and injection pain and bleeding with previous presentation of Humira. On an unspecified date, covid-19 vaccine reaction, drop in blood pressure and passed out three times resolved. The patient had injection pain and bleeding with previous presentation of Humira before switching to citrate free Humira. Patient had a reaction to the covid-19 Johnson & Johnson vaccine. It was reported that it caused blood pressure to drop and patient passed out three times. Patient went to emergency room. The patient agreed to have physician contacted. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) Drop. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; treatment with adalimumab was withdrawn; and action taken with adalimumab was not reported. The patient recovered from passed out, vaccination adverse reaction, and drop in blood pressure, and had not recovered from injection site pain, and injection site bleeding. The reporter considered the causality between the covid-19 vaccine ad26.cov2.s, injection site pain, and injection site bleeding as not related. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20220402232-covid-19 vaccine ad26.cov2.s -Passed out. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Loss of consciousness
Clinical narrative: PASSED OUT; VACCINATION ADVERSE REACTION; DROP IN BLOOD PRESSURE; INJECTION SITE BLEEDING; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 66 year old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: There was no reported medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) 1 in total, 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.  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 ulcerative colitis; and adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) (citrate free), dose, frequency, and therapy dates were not reported for moderate to severe ulcerative colitis.  No concomitant medications were reported.  On unspecified dates, the patient experienced covid-19 vaccine reaction, drop in blood pressure, passed out three times and injection pain and bleeding with previous presentation of Humira. On an unspecified date, covid-19 vaccine reaction, drop in blood pressure and passed out three times resolved. The patient had injection pain and bleeding with previous presentation of Humira before switching to citrate free Humira. Patient had a reaction to the covid-19 Johnson & Johnson vaccine. It was reported that it caused blood pressure to drop and patient passed out three times. Patient went to emergency room. The patient agreed to have physician contacted. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) Drop. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; treatment with adalimumab was withdrawn; and action taken with adalimumab was not reported. The patient recovered from passed out, vaccination adverse reaction, and drop in blood pressure, and had not recovered from injection site pain, and injection site bleeding. The reporter considered the causality between the covid-19 vaccine ad26.cov2.s, injection site pain, and injection site bleeding as not related. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20220402232-covid-19 vaccine ad26.cov2.s -Passed out. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Myocarditis, Troponin
Clinical narrative: MILD MYOCARDITIS; This spontaneous report was received from literature:  Myopericarditis After Covid-19 Booster Dose Vaccination. This report concerned an adult female (age between 18-24 years). The objective of this study was to provide a more timely and complete case ascertainment of myopericarditis after Covid-19 booster vaccine in populations aged 18 to 39 years 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 (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total for prophylactic vaccination. The batch number was not reported and has been requested. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patient additionally received non-company suspect vaccine: Pfizer Biontech Covid-19 Vaccine (tozinameran, dose number in series 2) (form of admin, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. Interval between prime series to booster was 196 days. No concomitant medications were reported.  On an unspecified date, the patient experienced chest pain after four days of booster. The patient presented with mild myocarditis after a heterologous series of JNJ vaccine followed by a booster dose of Pfizer vaccine (dose number in series 2). The patient visited to emergency department. Laboratory data (dates unspecified) included: EKG (NR: not provided) ST elevation positive, Echocardiogram (NR: not provided) left-ventricular end-systolic function 60 to 65 percentage, and Troponin (Normal troponin range: less than or equal to 03 mcg/L) 0.04 mcg/L. The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The outcome of mild myocarditis was not reported. The authors discussed that myopericarditis occurs after booster doses and may be underreported by current surveillance methods. Completeness or high sensitivity of these case estimates are essential when modeling risk and benefit for wide-scale vaccine implementation and sequential COVID-19 vaccinations for the general population. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220402436-covid-19 vaccine ad26.cov2.s-mild myocarditis. 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: CONMEDS-OTHER SUSPECT DRUGS.(non-company suspect vaccine: Pfizer Biontech Covid-19 Vaccine). Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism
Clinical narrative: This spontaneous report received from a patient 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 not reported, batch number: unknown, expiry: unknown), dose was not reported, 1 total administered on an unspecified date for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced multiple deep vein thrombosis (DVT's) and multiple pulmonary embolisms (PE's) after receiving Johnson and Johnson vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the multiple deep vein thrombosis after receiving vaccine and multiple pulmonary embolisms after receiving vaccine was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220403496-COVID-19 VACCINE AD26.COV2.S-  Multiple Deep vein thrombosis after receiving vaccine ,Multiple Pulmonary embolisms after receiving vaccine The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age, race and ethnicity. Initial information processed with additional information received from reporter on 05-APR-2022. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) 1 total, dose was not reported, administered on 15-MAR-2021 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 was in hospital at the time of reporting with Covid-19 and was doing well. The patient was hospitalized (date and days unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from Covid-19. This report was serious (Hospitalization Caused / Prolonged). "This report was associated with product quality complaint: 90000224510. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed. Sender's Comments: V0: 20220405438-covid-19 vaccine ad26.cov2.s-Covid-19 . 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). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Increased tendency to bruise, Malaise, Rash vesicular
Clinical narrative: This spontaneous report received from a health care professional concerned a 62 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis, and other pre-existing medical conditions included: Patient was not pregnant. Patient was not being on Methotrexate. The patient previously received (dose number in series 1) (unspecified manufacturer) Covid-19 vaccine ad26. cov2. s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for prophylactic vaccination. It was unknown if the patient experienced any adverse events with Covid-19 vaccine ad26. cov2. s (dose number in series 1). The batch number was not reported and has been requested. Concomitant medications included golimumab in Oct-2017 for rheumatoid arthritis. On 04-APR-2022, the patient experienced extended period of feeling unwell, mild blister style rash without injury, did not feel good, not a headache, but her head felt different (all events with dose number in series 1). The patient received booster of Covid-19 vaccine ad26.cov2.s (dose number in series 2) (unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for prophylactic vaccination (dose number in series 2). It was unknown if the patient experienced any adverse event after vaccination with Covid-19 vaccine ad26.cov2.s (dose number in series 2). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the extended period, mild blister style rash without injury, did not feel well and head felt different was not reported. This report was non-serious. This case, involving the same patient is linked to 20100510627, 20040401101, 20210121863 and 20220409325.
Sex: U
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: MIGRAINE HEADACHE; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1, unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for prophylactic vaccination. It was unknown whether patient had any adverse event post primary vaccination (dose number in series 1). The patient received additional (booster) dose of covid-19 vaccine ad26.cov2.s (dose number in series 2, unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date 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 migraine headache after covid booster shot and was on Tylenol (paracetamol) oral suspension for pain, also patient said did not touch the pain (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain, and the outcome of migraine headache was not reported. This report was non-serious. This case, involving the same patient is linked to 20220146616.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Impaired work ability, Skin disorder
Clinical narrative: This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. 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, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced skin ended very badly, sick heart, and cannot even work, and patient was hospitalized (date unspecified). Number of days hospitalized was not reported. The patient reported that the vaccine almost killed the patient. The patient had 3 months sick heart and skin ended very badly. The patient cannot even work and did not leave hospitals. The patient said it was very bad decision to use the vaccine. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cannot even work, skin ended very badly, and sick heart. This report was serious (Hospitalization Caused / Prolonged). Sender's Comments: V0:20220407564-Covid-19 vaccine ad26.cov2.s-Sick heart, Skin ended very badly, Cannot even work. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: BODY ACHES; FEVERISH; This spontaneous report received from a patient via a 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 previously received covid-19 vaccine ad26. cov2.s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not report, 1 total administered for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1). The patient additionally received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered 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 body aches, and feverish (all events in dose number series 2). The patient took tylenol 8hr arthritis pain because it said pain reliever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feverish, and the outcome of body aches was not reported. This report was non-serious. This case, involving the same patient is linked to 20220150541.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: HEART FELT REALLY STRANGE; This spontaneous report received from a patient via a company representative concerned a 28 year old of unspecified sex. 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced heart felt really strange. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heart felt really strange. This report was non-serious.; Sender's Comments: V0:Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Cardiac monitoring, Cardiomegaly, Carditis, Computerised tomogram
Clinical narrative: HEART INFLAMED; ENLARGED HEART; This spontaneous report received from a consumer concerned a 53 year old female with unspecified race and ethnic origin. 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 (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on SEP-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported.  No adverse event reported after primary vaccination (dose number in series 1). The patient received additional non-company suspect vaccine Pfizer biontech covid 19 vaccine (tozinameran) (dose number in series 2)  ( form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered on 22-MAR-2022 for prophylactic vaccination.  On an unspecified date following vaccination with Pfizer biontech covid 19 vaccine, the patient experienced enlarged heart, and heart inflamed. The patient was put on a heart monitor. The patient underwent tons of tests, CT scans, bloodwork, EKGs (electrocardiogram), 14 tests that have came back (results unspecified). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The outcome of the enlarged heart and heart inflamed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220409107-covid-19 vaccine ad26.cov2.s-Heart inflamed. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram
Clinical narrative: HEART INFLAMED; ENLARGED HEART; This spontaneous report received from a consumer concerned a 53 year old female with unspecified race and ethnic origin. 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 (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on SEP-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported.  No adverse event reported after primary vaccination (dose number in series 1). The patient received additional non-company suspect vaccine Pfizer biontech covid 19 vaccine (tozinameran) (dose number in series 2)  ( form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered on 22-MAR-2022 for prophylactic vaccination.  On an unspecified date following vaccination with Pfizer biontech covid 19 vaccine, the patient experienced enlarged heart, and heart inflamed. The patient was put on a heart monitor. The patient underwent tons of tests, CT scans, bloodwork, EKGs (electrocardiogram), 14 tests that have came back (results unspecified). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The outcome of the enlarged heart and heart inflamed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220409107-covid-19 vaccine ad26.cov2.s-Heart inflamed. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation
Clinical narrative: WORSENING LEFT ARM BURNING SENSATION FROM ELBOW TO EAR; SHOULDER COMPLETELY LOCKED UP WITH EXCRUCIATING PAIN; This spontaneous report received from a patient 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 not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the patient experienced worsening left arm burning sensation from elbow to ear, and shoulder completely locked up with excruciating pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the worsening left arm burning sensation from elbow to ear and shoulder completely locked up with excruciating pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: ALLERGIC REACTION TO VACCINE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 allergic reaction to vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of allergic reaction to vaccine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthritis, Rash
Clinical narrative: ISSUES WITH ARTHRITIS/JOINTS; SKIN BREAKOUT; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis, and psoriatic arthritis. 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 numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled syringe, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis, and psoriatic arthritis. No concomitant medications were reported.  On an unspecified date, the patient experienced issues with arthritis/joints, and skin breakout. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient had not recovered from issues with arthritis/joints, and skin breakout. This report was non-serious.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood test, Chest pain, Dyspnoea, Ear discomfort
Clinical narrative: Burning pain in chest and head, blurry vision, pressure in head left side incl ear and eye, problems to breathe, muscle pain, pain in colon and stomach, extremely tired, strong headache since I got the booster.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gastrointestinal pain, Head discomfort, Headache, Myalgia
Clinical narrative: Burning pain in chest and head, blurry vision, pressure in head left side incl ear and eye, problems to breathe, muscle pain, pain in colon and stomach, extremely tired, strong headache since I got the booster.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular discomfort, Pain, Vision blurred
Clinical narrative: Burning pain in chest and head, blurry vision, pressure in head left side incl ear and eye, problems to breathe, muscle pain, pain in colon and stomach, extremely tired, strong headache since I got the booster.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Lymph gland infection, Lymphadenopathy, Pain, Skin warm
Clinical narrative: Swelling in lymph nodes resulted immediately day following the vaccine. The swelling in one specific lymph node did not go down, the lymph node behind the right ear became impacted and infected over the course of several days. Swollen, red, hot to the touch, and painful. Was prescribed antibiotics for infection at local urgent care center. Infection cleared within a week.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Glioblastoma
Clinical narrative: Diagnosed with brain tumor/Glioblastoma; This spontaneous case was reported by a nurse and describes the occurrence of GLIOBLASTOMA (Diagnosed with brain tumor/Glioblastoma) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third 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 and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GLIOBLASTOMA (Diagnosed with brain tumor/Glioblastoma) (seriousness criterion medically significant). At the time of the report, GLIOBLASTOMA (Diagnosed with brain tumor/Glioblastoma) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication information was reported.  No treatment medications were provided.  Reporter was enquiring whether they saw an increase of Brain tumors after receiving two shots plus booster vaccine. Reporter was wondering if doctors were reporting this and how would they determine if vaccine was cause or not. Reporter mentioned it was either a rare coincidence or suspicious.  Company Comment: This spontaneous case concerns a 67-year-old male patient with no medical history reported who experienced the unexpected serious event of Glioblastoma (Diagnosed with brain tumor/Glioblastoma) unspecified days after receiving a dose of mRNA-1273 vaccine administration. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 67-year-old male patient with no medical history reported who experienced the unexpected serious event of Glioblastoma (Diagnosed with brain tumor/Glioblastoma) unspecified days after receiving a dose of mRNA-1273 vaccine administration. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Disorientation, Feeling abnormal, Mental disorder
Clinical narrative: disorientated; significant depression; mental acuity; spaced out; This spontaneous case was reported by a physician and describes the occurrence of DISORIENTATION (disorientated), DEPRESSION (significant depression), MENTAL DISORDER (mental acuity) and FEELING ABNORMAL (spaced out) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 053E21A, 029K20A and 011J20A) for COVID-19 vaccination.     The patient's past medical history included Dementia. Previously administered products included for Product used for unknown indication: flu vaccine (She received a flu vaccine simultaneously with the 3rd dose of the vaccine.) on 20-Aug-2021. Past adverse reactions to the above products included No adverse event with flu vaccine.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Apr-2022, the patient experienced DISORIENTATION (disorientated), DEPRESSION (significant depression), MENTAL DISORDER (mental acuity) and FEELING ABNORMAL (spaced out). On 05-Apr-2022, DISORIENTATION (disorientated), DEPRESSION (significant depression), MENTAL DISORDER (mental acuity) and FEELING ABNORMAL (spaced out) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported. Patient stated that She was not pyretic.  No medications or treatments have been provided for her current symptoms.   This case was linked to MOD-2022-532755 (Patient Link).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: high frequency hearing loss; Developed a hissing in ears; This spontaneous case was reported by a physician and describes the occurrence of DEAFNESS (high frequency hearing loss) in a 72-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEAFNESS (high frequency hearing loss) (seriousness criterion medically significant) and TINNITUS (Developed a hissing in ears). At the time of the report, DEAFNESS (high frequency hearing loss) and TINNITUS (Developed a hissing in ears) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   It was stated that patient was double vaccinated and had booster. After the 2nd vaccine in February (unspecified year), developed a hissing in ears, and high frequency hearing loss. Patient saw an ENT. It was stated that patient made a decision about getting the 2nd booster dose the day after the date of report and said that data on booster was spotty. HCP asked if there was any MI on measuring immune memory or degree of cellular memory.  No concomitant product was provided. No treatment information was provided.  Company comment: This spontaneous case concerns a 72-year-old male patient with no medical history reported, who experienced the unexpected serious (medically significant) event Deafness, on an unspecified date after the second dose of mRNA-1273. The patient experienced high frequency hearing loss and hissing in the ears. The patient saw an ENT, but details not reported. At the time of reporting the event outcome was unknown. Elderly age of the patient could be a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-533147 (Patient Link).; Sender's Comments: This spontaneous case concerns a 72-year-old male patient with no medical history reported, who experienced the unexpected serious (medically significant) event Deafness, on an unspecified date after the second dose of mRNA-1273. The patient experienced high frequency hearing loss and hissing in the ears. The patient saw an ENT, but details not reported. At the time of reporting the event outcome was unknown. Elderly age of the patient could be a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received second dose 2 months after first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose 2 months after first dose) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose 2 months after first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose 2 months after first dose) outcome was unknown. No concomitant medications were reported. Treatment information was not provided. Reporter did not allow further contact
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Immunisation reaction
Clinical narrative: difficulty breathing; pretty severe reaction; chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing), VACCINATION COMPLICATION (pretty severe reaction) and CHILLS (chills) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013l20a and 039k20a) for COVID-19 vaccination.     Concurrent medical conditions included Reaction to preservatives.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2021, the patient experienced DYSPNOEA (difficulty breathing), VACCINATION COMPLICATION (pretty severe reaction) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (difficulty breathing), VACCINATION COMPLICATION (pretty severe reaction) and CHILLS (chills) outcome was unknown.            No concomitant medication was provided. Within 5 hours of receiving the 2nd dose patient started to experience a reaction.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Given a 0.25 mL dosage as their first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Given a 0.25 mL dosage as their first dose) in a 45-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 033K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .25 milliliter. On 05-Apr-2022, the patient experienced ACCIDENTAL UNDERDOSE (Given a 0.25 mL dosage as their first dose). At the time of the report, ACCIDENTAL UNDERDOSE (Given a 0.25 mL dosage as their first dose) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Reporter stated that the patient has not reported any symptoms. No additional doses or treatments had been administered to the patient till the time of report.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 12 year old received the Moderna COVID-19 vaccination; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received the Moderna COVID-19 vaccination) in a 12-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received the Moderna COVID-19 vaccination). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received the Moderna COVID-19 vaccination) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided.  The reporter thinks that is the patients gender and that it was the first COVID-19 vaccination.  No treatment medications was provided.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received expired doses of the Moderna COVID19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired doses of the Moderna COVID19 vaccine) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059h21a) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired doses of the Moderna COVID19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received expired doses of the Moderna COVID19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.  8 patients received expired doses of the Moderna COVID-19 vaccine.  Upon follow up, reporter provided the patient information for all patients, hence case became valid.  No treatment drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2022: Follow up received includes significant information, case became valid as patient details added with along with dose no. of suspect and product coding was updated.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, SARS-CoV-2 test
Clinical narrative: First shot make me tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (First shot make me tired) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     Patient had no allergies.  The patient's past medical history included Stent insertion NOS (3 Heart Stents). Concurrent medical conditions included Emphysema pulmonary (prior vaccination), Cholesterol and Breathing difficult. Concomitant products included THEOPHYLLINE for Breathing difficult, ATORVASTATIN for High cholesterol, METOPROLOL, DILTIAZEM, TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (First shot make me tired). At the time of the report, FATIGUE (First shot make me tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient did not register any change on her illness status post vaccination. Patient did not tested positive for COVID-19 and did not received any other vaccine within 1 month prior to Moderna's. Patient did not register any change on her illness status post vaccination. Patient confirm that received all the vaccines in her left deltoid and did not seek for medical care post vaccination. The patient did not experienced a similar event on the past. No treatment medications were reported by the reporter.   This case was linked to MOD-2022-533310, MOD-2022-533315, MOD-2022-533316 (Patient Link).