chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season (intramuscular) and Fluarix Tetra Pre-Filled Syringe Device. On 18th October 2021, less than a day after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: This case was reported by patient's wife. The age at vaccination was not reported. An elderly patient received dose Fluarix Quadrivalent vaccine and experienced arm pain which started the same day.  The reporter consented to follow up. This case has been linked with US2021222731 and US2021222783, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021222731:same reporter US-GLAXOSMITHKLINE-US2021222783:same reporter
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Cough, Fatigue, Pain in extremity
Clinical narrative: tired; Cough; Sinus drainage; Chills; Fever; Upset stomach; arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (many years prior to receiving the Shingrix vaccine) and shingles (many years prior to receiving the Shingrix vaccine).   On 22nd October 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 22nd October 2021, less than a day after receiving Shingrix, the patient experienced pain in arm. On 26th October 2021, the patient experienced tiredness, cough, nasal sinus discharge, chills, fever and upset stomach. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the tiredness, cough, nasal sinus discharge, chills, fever and upset stomach were unknown.   It was unknown if the reporter considered the pain in arm, tiredness, cough, nasal sinus discharge, chills, fever and upset stomach to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received dose of Shingrix vaccine in her left deltoid at her pharmacy and experienced arm pain after receiving the vaccine that lasted 3 days, and had since resolved in October 2021. Four days following her Shingrix vaccination, she felt tired, developed a cough, sinus drainage, chills, fever and upset stomach. The reporter stated that she was unsure that the symptoms she was experiencing this week were due to the Shingrix. The reporter could not provide the lot number and expiration date. The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Paranasal sinus hypersecretion, Pyrexia
Clinical narrative: tired; Cough; Sinus drainage; Chills; Fever; Upset stomach; arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (many years prior to receiving the Shingrix vaccine) and shingles (many years prior to receiving the Shingrix vaccine).   On 22nd October 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 22nd October 2021, less than a day after receiving Shingrix, the patient experienced pain in arm. On 26th October 2021, the patient experienced tiredness, cough, nasal sinus discharge, chills, fever and upset stomach. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the tiredness, cough, nasal sinus discharge, chills, fever and upset stomach were unknown.   It was unknown if the reporter considered the pain in arm, tiredness, cough, nasal sinus discharge, chills, fever and upset stomach to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received dose of Shingrix vaccine in her left deltoid at her pharmacy and experienced arm pain after receiving the vaccine that lasted 3 days, and had since resolved in October 2021. Four days following her Shingrix vaccination, she felt tired, developed a cough, sinus drainage, chills, fever and upset stomach. The reporter stated that she was unsure that the symptoms she was experiencing this week were due to the Shingrix. The reporter could not provide the lot number and expiration date. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia
Clinical narrative: no energy; This case was reported by a consumer via call center representative and described the occurrence of loss of energy in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   In October 2021, the patient received the 2nd dose of Shingrix. In October 2021, less than a week after receiving Shingrix, the patient experienced loss of energy. In October 2021, the outcome of the loss of energy was recovered/resolved.   It was unknown if the reporter considered the loss of energy to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received 2nd dose of Shingrix vaccine a week before the date of reporting. The patient had no energy for 3 days following vaccination but now had resolved. The reporter did not provide any additional information. The reporter did not consent to follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic shock, Guillain-Barre syndrome
Clinical narrative: ANAPHYLACTIC SHOCK; GUILLAIN BARRE; This spontaneous report received from a patient via social media via 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 not reported, batch number: Unknown) dose, 1 total, 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 anaphylactic shock, and guillain barre. The patient reported via social media that vaccine had caused anaphylactic shock and huge emergency room bill to the patient. Patient could not feel the feet but stated that arms, hands and fingers were mostly back to normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from guillain barre, and the outcome of anaphylactic shock was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211061612-covid-19 vaccine ad26.cov2.s-anaphylactic shock. This event(s) is considered unassessable. 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). 20211061612-covid-19 vaccine ad26.cov2.s-Guillain Barre. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Headache, Influenza like illness, Musculoskeletal stiffness, Nausea
Clinical narrative: Woke up with stiffness in head and neck; Arm is sore; Injection felt like it burned him; He feels like hes getting the flu; Slight headache; He is unsure if he is nauseous but he is not eating; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Woke up with stiffness in head and neck), PAIN IN EXTREMITY (Arm is sore), BURNING SENSATION (Injection felt like it burned him), INFLUENZA LIKE ILLNESS (He feels like hes getting the flu) and HEADACHE (Slight headache) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 291P21A, 044A21A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE in September 2021. Past adverse reactions to the above products included Whooping cough with INFLUENZA VACCINE.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Woke up with stiffness in head and neck), PAIN IN EXTREMITY (Arm is sore), BURNING SENSATION (Injection felt like it burned him), INFLUENZA LIKE ILLNESS (He feels like hes getting the flu), HEADACHE (Slight headache) and NAUSEA (He is unsure if he is nauseous but he is not eating). At the time of the report, MUSCULOSKELETAL STIFFNESS (Woke up with stiffness in head and neck), PAIN IN EXTREMITY (Arm is sore), BURNING SENSATION (Injection felt like it burned him), INFLUENZA LIKE ILLNESS (He feels like hes getting the flu), HEADACHE (Slight headache) and NAUSEA (He is unsure if he is nauseous but he is not eating) outcome was unknown.            Concomitant medication information was not reported. Treatment information was not reported.  Patient also reported that people who got Pfizer first shot, felt flu like symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Batch number for Dose 3 was updated.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Woke up with stiffness in head and neck; Arm is sore; Injection felt like it burned him; He feels like hes getting the flu; Slight headache; He is unsure if he is nauseous but he is not eating; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Woke up with stiffness in head and neck), PAIN IN EXTREMITY (Arm is sore), BURNING SENSATION (Injection felt like it burned him), INFLUENZA LIKE ILLNESS (He feels like hes getting the flu) and HEADACHE (Slight headache) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 291P21A, 044A21A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE in September 2021. Past adverse reactions to the above products included Whooping cough with INFLUENZA VACCINE.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Woke up with stiffness in head and neck), PAIN IN EXTREMITY (Arm is sore), BURNING SENSATION (Injection felt like it burned him), INFLUENZA LIKE ILLNESS (He feels like hes getting the flu), HEADACHE (Slight headache) and NAUSEA (He is unsure if he is nauseous but he is not eating). At the time of the report, MUSCULOSKELETAL STIFFNESS (Woke up with stiffness in head and neck), PAIN IN EXTREMITY (Arm is sore), BURNING SENSATION (Injection felt like it burned him), INFLUENZA LIKE ILLNESS (He feels like hes getting the flu), HEADACHE (Slight headache) and NAUSEA (He is unsure if he is nauseous but he is not eating) outcome was unknown.            Concomitant medication information was not reported. Treatment information was not reported.  Patient also reported that people who got Pfizer first shot, felt flu like symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Batch number for Dose 3 was updated.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Influenza like illness, Myalgia
Clinical narrative: she woke up at 3AM that night feeling sick; felt flu-like symptoms that lasted until 5pm; really bad body aches but no high fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (she woke up at 3AM that night feeling sick), INFLUENZA LIKE ILLNESS (felt flu-like symptoms that lasted until 5pm) and MYALGIA (really bad body aches but no high fever) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced ILLNESS (she woke up at 3AM that night feeling sick), INFLUENZA LIKE ILLNESS (felt flu-like symptoms that lasted until 5pm) and MYALGIA (really bad body aches but no high fever). On 20-Feb-2021, INFLUENZA LIKE ILLNESS (felt flu-like symptoms that lasted until 5pm) had resolved. At the time of the report, ILLNESS (she woke up at 3AM that night feeling sick) and MYALGIA (really bad body aches but no high fever) outcome was unknown.            No concomitant medications were reported.   Treatment information was not provided. After receiving second dose on 19-Feb-2021, patient woke up at 3 am at that night feeling sick, felt flu like symptoms which lasted until 5 pm and she also had really bad body aches but no high fever.   This case was linked to MOD-2021-363182 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Sore arm after the booster dose; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm after the booster dose) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 011M20A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (headache). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm after the booster dose). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm after the booster dose) and HEADACHE (headache) outcome was unknown.            No relevant concomitant medications were reported.  On 26-Oct-2021 at 02.00 A.M, the patient experienced headache.   This case was linked to MOD-2021-363881, MOD-2021-363885 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site movement impairment, Vaccination site pain
Clinical narrative: Cant use her left arm; extremely painful/Painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Cant use her left arm) and VACCINATION SITE PAIN (extremely painful/Painful) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045C21A, 027B21A and 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In October 2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Cant use her left arm) and VACCINATION SITE PAIN (extremely painful/Painful). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Cant use her left arm) and VACCINATION SITE PAIN (extremely painful/Painful) had not resolved.            Concomitant drugs were not reported. Treatment medications were not provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and PYREXIA (fever) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Hypertension and Hypercholesteremia. Concomitant products included METFORMIN for Diabetes, ATENOLOL for Hypertension, OMEPRAZOLE for an unknown indication.    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, the patient experienced HEADACHE (headache) and PYREXIA (fever). At the time of the report, HEADACHE (headache) and PYREXIA (fever) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medications were reported. Other concomitant medications included Blood thinner and Cholesterol pill.   This case was linked to MOD-2021-364084, MOD-2021-364085 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 500E21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   It was reported that 2 vials of the Moderna COVID-19 vaccine were left in the refrigerator past their use by date.   The vials expired on 08-Oct-2021 and were left in the refrigerator past that date.   No adverse reactions had been reported by the patient from the 3rd dose.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-364913 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: localized pain in the arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (localized pain in the arm) and HEADACHE (headache) 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 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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, received 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 PAIN IN EXTREMITY (localized pain in the arm) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (localized pain in the arm) and HEADACHE (headache) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: she went to the ER complaining of pain in head and was diagnosed with a sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (she went to the ER complaining of pain in head and was diagnosed with a sinus infection) 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 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced SINUSITIS (she went to the ER complaining of pain in head and was diagnosed with a sinus infection). The patient was treated with PREDNISOLONE for Adverse event, at a dose of 5 pills. At the time of the report, SINUSITIS (she went to the ER complaining of pain in head and was diagnosed with a sinus infection) outcome was unknown.            Patient had reported of visiting the ER, a week ago, complaining of pain in head and was diagnosed with a sinus infection and was treated with 5 pills of Prednisone Patient also wanted to know how long does she needs to wait for receiving her Booster dose of vaccine.  Concomitant product use was not provided by the reporter.   Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Depression
Clinical narrative: life has spiraled out of control with Anxiety/morning had a terrible anxiety attack'; life has spiraled out of control with Depression; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (life has spiraled out of control with Anxiety/morning had a terrible anxiety attack') and DEPRESSION (life has spiraled out of control with Depression) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 025L20A and 025L20A) for COVID-19 vaccination.     Previously administered products included for Depression: Prozac. Past adverse reactions to the above products included No adverse drug reaction with Prozac.   On 30-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. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANXIETY (life has spiraled out of control with Anxiety/morning had a terrible anxiety attack') and DEPRESSION (life has spiraled out of control with Depression). The patient was treated with DESVENLAFAXINE SUCCINATE MONOHYDRATE (PRISTIQ) (oral) for Adverse event, at a dose of 100 milligram once a day; MIRTAZAPINE (oral) for Adverse event, at a dose of 7.5 milligram once a day and CLONAZEPAM (oral) for Adverse event, at a dose of .5 milligram three times a day. At the time of the report, ANXIETY (life has spiraled out of control with Anxiety/morning had a terrible anxiety attack') and DEPRESSION (life has spiraled out of control with Depression) outcome was unknown.            Patient was reported to take the treatment medications previously but had stopped taking it.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Pharmacist states they gave full doses for boosters instead of half doses.; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Pharmacist states they gave full doses for boosters instead of half doses.) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 25-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (Pharmacist states they gave full doses for boosters instead of half doses.). At the time of the report, ACCIDENTAL OVERDOSE (Pharmacist states they gave full doses for boosters instead of half doses.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment informations were reported.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: COVID-19; Lack of Efficacy; After second dose patient said injection site was not as sore as with first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), DRUG INEFFECTIVE (Lack of Efficacy) and VACCINATION SITE PAIN (After second dose patient said injection site was not as sore as with first dose) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION SITE PAIN (After second dose patient said injection site was not as sore as with first dose). On 06-Oct-2021, the patient experienced COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of Efficacy). At the time of the report, COVID-19 (COVID-19), DRUG INEFFECTIVE (Lack of Efficacy) and VACCINATION SITE PAIN (After second dose patient said injection site was not as sore as with first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Oct-2021, SARS-CoV-2 test: positive (Positive) Result: Patient tested positive for COVID-19. On 08-Oct-2021, SARS-CoV-2 test: positive (Positive) Result: Patient tested positive for COVID-19.         Concomitant product use was not provided by the reporter.   Patient received MAB injection to treat COVID-19.  Company comment-This spontaneous report concerns a 71 year old male patient with no relevant medical history who experienced non-serious events of COVID-19 (unexpected) and vaccination site pain (expected). Lack of efficacy was considered as an additional event. The event COVID-19 occurred 8.5 months after the second dose and nearly 9.5 months after the first dose of mRNA-1273. The patient did not have any symptoms and was treated with MAB injection for COVID-19. The event vaccination site pain occurred after an unknown duration after the first dose of the mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-364478 (Patient Link).; Sender's Comments: This spontaneous report concerns a 71 year old male patient with no relevant medical history who experienced non-serious events of COVID-19 (unexpected) and vaccination site pain (expected). Lack of efficacy was considered as an additional event. The event COVID-19 occurred 8.5 months after the second dose and nearly 9.5 months after the first dose of mRNA-1273. The patient did not have any symptoms and was treated with MAB injection for COVID-19. The event vaccination site pain occurred after an unknown duration after the first dose of the mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Body ache; Headache; Joint ache; Chills; Extreme tiredness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body ache), HEADACHE (Headache), ARTHRALGIA (Joint ache), CHILLS (Chills) and FATIGUE (Extreme tiredness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced MYALGIA (Body ache), HEADACHE (Headache), ARTHRALGIA (Joint ache), CHILLS (Chills) and FATIGUE (Extreme tiredness). On 24-Oct-2021, MYALGIA (Body ache), HEADACHE (Headache), ARTHRALGIA (Joint ache), CHILLS (Chills) and FATIGUE (Extreme tiredness) had resolved.            No concomitant medications were reported. No treatment  medications were reported. Patient stated that she is not immunocompromised. Patient received the 1st dose in January, the 2nd in February and the 3rd dose on 22OCT2021. Patient stated that the dose she received was 0.5 mL 100 mcg.   This case was linked to MOD-2021-268326, MOD-2021-363244 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Eye movement disorder, Headache, Illness, Mobility decreased, Myalgia
Clinical narrative: burning smell that has continued; couldn't open eyes; couldn't move; very sick; severe body aches; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (burning smell that has continued), EYE MOVEMENT DISORDER (couldn't open eyes), MOBILITY DECREASED (couldn't move), ILLNESS (very sick) and MYALGIA (severe body aches) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 vaccination: Pfizer (Received Pfizer for both doses of primary series. After the second dose of Pfizer patient experienced same adverse reactions as of Moderna but it was less intense) from 20-Mar-2021 to 10-Apr-2021. Past adverse reactions to the above products included Vaccination adverse reaction with Pfizer.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced PAROSMIA (burning smell that has continued). October 2021, the patient experienced EYE MOVEMENT DISORDER (couldn't open eyes), MOBILITY DECREASED (couldn't move), ILLNESS (very sick), MYALGIA (severe body aches), HEADACHE (headache) and PYREXIA (fever). In October 2021, EYE MOVEMENT DISORDER (couldn't open eyes), MOBILITY DECREASED (couldn't move), ILLNESS (very sick), MYALGIA (severe body aches), HEADACHE (headache) and PYREXIA (fever) had resolved. At the time of the report, PAROSMIA (burning smell that has continued) had not resolved.            No concomitant medications were reported.  Treatment information was not provided. After 12 hours of Moderna booster dose patient became very sick with headache, fever, severe body aches, could not open her eyes and couldn't move. These symptoms lasted about 48 hours.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, Pyrexia
Clinical narrative: burning smell that has continued; couldn't open eyes; couldn't move; very sick; severe body aches; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (burning smell that has continued), EYE MOVEMENT DISORDER (couldn't open eyes), MOBILITY DECREASED (couldn't move), ILLNESS (very sick) and MYALGIA (severe body aches) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 vaccination: Pfizer (Received Pfizer for both doses of primary series. After the second dose of Pfizer patient experienced same adverse reactions as of Moderna but it was less intense) from 20-Mar-2021 to 10-Apr-2021. Past adverse reactions to the above products included Vaccination adverse reaction with Pfizer.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced PAROSMIA (burning smell that has continued). October 2021, the patient experienced EYE MOVEMENT DISORDER (couldn't open eyes), MOBILITY DECREASED (couldn't move), ILLNESS (very sick), MYALGIA (severe body aches), HEADACHE (headache) and PYREXIA (fever). In October 2021, EYE MOVEMENT DISORDER (couldn't open eyes), MOBILITY DECREASED (couldn't move), ILLNESS (very sick), MYALGIA (severe body aches), HEADACHE (headache) and PYREXIA (fever) had resolved. At the time of the report, PAROSMIA (burning smell that has continued) had not resolved.            No concomitant medications were reported.  Treatment information was not provided. After 12 hours of Moderna booster dose patient became very sick with headache, fever, severe body aches, could not open her eyes and couldn't move. These symptoms lasted about 48 hours.
Sex: U
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: 5 out of 100 patients have this rash; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (5 out of 100 patients have this rash) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE RASH (5 out of 100 patients have this rash). At the time of the report, INJECTION SITE RASH (5 out of 100 patients have this rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Started feeling low level of noise inside the head/referred it as tinnitus/It is constant at very low level; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Started feeling low level of noise inside the head/referred it as tinnitus/It is constant at very low level) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 039K20A) for COVID-19 vaccination.     Concomitant products included ATENOLOL and INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 06-Mar-2021, 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 TINNITUS (Started feeling low level of noise inside the head/referred it as tinnitus/It is constant at very low level). At the time of the report, TINNITUS (Started feeling low level of noise inside the head/referred it as tinnitus/It is constant at very low level) outcome was unknown.            No treatment information was provided by the reporter.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 500E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: Felt like she had the flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Felt like she had the flu) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016CZ1A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced INFLUENZA (Felt like she had the flu). At the time of the report, INFLUENZA (Felt like she had the flu) outcome was unknown.            No concomitant medications were provided. No treatment medications were reported.    This case was linked to MOD-2021-364501 (Patient Link).   Reporter did not allow further contact
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Influenza like illness, Lymph node pain, Pain
Clinical narrative: experienced the same side effects; achiness; flu like; slightly elevated temperature/feels feverish; joint pain; headache; lymph nodes feel sore all over; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (experienced the same side effects), PAIN (achiness), INFLUENZA LIKE ILLNESS (flu like), PYREXIA (slightly elevated temperature/feels feverish) and ARTHRALGIA (joint pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCTZ) and EMPAGLIFLOZIN (JARDIANCE) for an unknown indication.    On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (experienced the same side effects), PAIN (achiness), INFLUENZA LIKE ILLNESS (flu like), PYREXIA (slightly elevated temperature/feels feverish), ARTHRALGIA (joint pain), HEADACHE (headache) and LYMPH NODE PAIN (lymph nodes feel sore all over). The patient was treated with CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) in October 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (experienced the same side effects), PAIN (achiness), INFLUENZA LIKE ILLNESS (flu like), PYREXIA (slightly elevated temperature/feels feverish), ARTHRALGIA (joint pain), HEADACHE (headache) and LYMPH NODE PAIN (lymph nodes feel sore all over) was resolving.            After taking Excedrin, the patient felt some better.   This case was linked to MOD-2021-364147, MOD-2021-365066 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: experienced the same side effects; achiness; flu like; slightly elevated temperature/feels feverish; joint pain; headache; lymph nodes feel sore all over; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (experienced the same side effects), PAIN (achiness), INFLUENZA LIKE ILLNESS (flu like), PYREXIA (slightly elevated temperature/feels feverish) and ARTHRALGIA (joint pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCTZ) and EMPAGLIFLOZIN (JARDIANCE) for an unknown indication.    On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (experienced the same side effects), PAIN (achiness), INFLUENZA LIKE ILLNESS (flu like), PYREXIA (slightly elevated temperature/feels feverish), ARTHRALGIA (joint pain), HEADACHE (headache) and LYMPH NODE PAIN (lymph nodes feel sore all over). The patient was treated with CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) in October 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (experienced the same side effects), PAIN (achiness), INFLUENZA LIKE ILLNESS (flu like), PYREXIA (slightly elevated temperature/feels feverish), ARTHRALGIA (joint pain), HEADACHE (headache) and LYMPH NODE PAIN (lymph nodes feel sore all over) was resolving.            After taking Excedrin, the patient felt some better.   This case was linked to MOD-2021-364147, MOD-2021-365066 (Patient Link).
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Hyperacusis, Hypoacusis, Tinnitus
Clinical narrative: Sensitivity to high-pitched sounds/ He is sensitive to certain frequencies; He has really bad tinnitus/ The tinnitus comes and goes throughout the day; A daily fullness in his ears/ He feels pressure on the inside of his ears; Slight hearing loss/ muffled sound in his ears, like he is wearing headphones; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISCOMFORT (A daily fullness in his ears/ He feels pressure on the inside of his ears), HYPOACUSIS (Slight hearing loss/ muffled sound in his ears, like he is wearing headphones), HYPERACUSIS (Sensitivity to high-pitched sounds/ He is sensitive to certain frequencies) and TINNITUS (He has really bad tinnitus/ The tinnitus comes and goes throughout the day) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Oct-2021, the patient experienced EAR DISCOMFORT (A daily fullness in his ears/ He feels pressure on the inside of his ears) and HYPOACUSIS (Slight hearing loss/ muffled sound in his ears, like he is wearing headphones). On an unknown date, the patient experienced HYPERACUSIS (Sensitivity to high-pitched sounds/ He is sensitive to certain frequencies) and TINNITUS (He has really bad tinnitus/ The tinnitus comes and goes throughout the day). At the time of the report, EAR DISCOMFORT (A daily fullness in his ears/ He feels pressure on the inside of his ears), HYPOACUSIS (Slight hearing loss/ muffled sound in his ears, like he is wearing headphones), HYPERACUSIS (Sensitivity to high-pitched sounds/ He is sensitive to certain frequencies) and TINNITUS (He has really bad tinnitus/ The tinnitus comes and goes throughout the day) outcome was unknown.            No concomitant medications were reported. No treatment details were reported.  In October 2021, patient's doctor told him that the ear externally looks fine.   This case was linked to MOD-2021-365110 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M204, 022A21A and A11C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third 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 SITE PAIN (sore arm). At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-365207 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022A21A and 015M204) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.            Patient was reported to take the third/booster dose on 25-OCT-2021, lot no: A11C21A.  No concomitant medications were reported. No treatment details were provided.   This case was linked to MOD-2021-365201 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Vaccination site pain
Clinical narrative: Heart palpitations; Left arm was very sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitations) and VACCINATION SITE PAIN (Left arm was very sore at the injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021, the patient experienced PALPITATIONS (Heart palpitations) and VACCINATION SITE PAIN (Left arm was very sore at the injection site). At the time of the report, PALPITATIONS (Heart palpitations) and VACCINATION SITE PAIN (Left arm was very sore at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       She also takes blood pressure medication and thyroid medication.  No concomitants medication were provided.   This case was linked to MOD-2021-365231 (Patient Link).