chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Balance disorder, Feeling abnormal, Muscle spasms, Pain
Clinical narrative: chronic spasms in her jaw; achy; pain in the back; unstable; almost lost her balance; skin on both her arms hurt/ached for hours; feverish; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (chronic spasms in her jaw), PAIN (achy), BACK PAIN (pain in the back), FEELING ABNORMAL (unstable) and BALANCE DISORDER (almost lost her balance) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Back surgery (have some lasting things from the surgery). Previously administered products included for Product used for unknown indication: J and J (Dose no : 1st dose) in March 2020. Past adverse reactions to the above products included No adverse event with J and J. Concurrent medical conditions included Drug allergy (compazine), Drug allergy (codeine), Drug allergy (morphine), Milk allergy (milk and some dairy), Hypertension, High cholesterol, Cystitis interstitial, Depression (depression with anxiety), Anxiety (depression with anxiety) and Plantar fasciitis. Concomitant products included METOPROLOL, ATORVASTATIN, MIRABEGRON (MYRBETRIQ) and GABAPENTIN for an unknown indication.    On 25-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jul-2022, the patient experienced MUSCLE SPASMS (chronic spasms in her jaw), PAIN (achy), BACK PAIN (pain in the back), FEELING ABNORMAL (unstable), BALANCE DISORDER (almost lost her balance), PAIN IN EXTREMITY (skin on both her arms hurt/ached for hours) and PYREXIA (feverish). The patient was treated with BACLOFEN at an unspecified dose and frequency; CLONAZEPAM at an unspecified dose and frequency and HYDROCODONE at an unspecified dose and frequency. In July 2022, MUSCLE SPASMS (chronic spasms in her jaw), PAIN (achy), BACK PAIN (pain in the back), FEELING ABNORMAL (unstable), BALANCE DISORDER (almost lost her balance), PAIN IN EXTREMITY (skin on both her arms hurt/ached for hours) and PYREXIA (feverish) had resolved.            Relevant medical history includes patient had received shingles vaccine 2 weeks ago from the time of the call. Patient had taken 1st booster dose at around 12noon. Patient felt better at 2:00am and was able to sleep and woke up at around 8:30. Other treatment were includes heat pads.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: chronic spasms in her jaw; achy; pain in the back; unstable; almost lost her balance; skin on both her arms hurt/ached for hours; feverish; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (chronic spasms in her jaw), PAIN (achy), BACK PAIN (pain in the back), FEELING ABNORMAL (unstable) and BALANCE DISORDER (almost lost her balance) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Back surgery (have some lasting things from the surgery). Previously administered products included for Product used for unknown indication: J and J (Dose no : 1st dose) in March 2020. Past adverse reactions to the above products included No adverse event with J and J. Concurrent medical conditions included Drug allergy (compazine), Drug allergy (codeine), Drug allergy (morphine), Milk allergy (milk and some dairy), Hypertension, High cholesterol, Cystitis interstitial, Depression (depression with anxiety), Anxiety (depression with anxiety) and Plantar fasciitis. Concomitant products included METOPROLOL, ATORVASTATIN, MIRABEGRON (MYRBETRIQ) and GABAPENTIN for an unknown indication.    On 25-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jul-2022, the patient experienced MUSCLE SPASMS (chronic spasms in her jaw), PAIN (achy), BACK PAIN (pain in the back), FEELING ABNORMAL (unstable), BALANCE DISORDER (almost lost her balance), PAIN IN EXTREMITY (skin on both her arms hurt/ached for hours) and PYREXIA (feverish). The patient was treated with BACLOFEN at an unspecified dose and frequency; CLONAZEPAM at an unspecified dose and frequency and HYDROCODONE at an unspecified dose and frequency. In July 2022, MUSCLE SPASMS (chronic spasms in her jaw), PAIN (achy), BACK PAIN (pain in the back), FEELING ABNORMAL (unstable), BALANCE DISORDER (almost lost her balance), PAIN IN EXTREMITY (skin on both her arms hurt/ached for hours) and PYREXIA (feverish) had resolved.            Relevant medical history includes patient had received shingles vaccine 2 weeks ago from the time of the call. Patient had taken 1st booster dose at around 12noon. Patient felt better at 2:00am and was able to sleep and woke up at around 8:30. Other treatment were includes heat pads.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Adverse drug reaction, Chills, Headache, Insomnia, Muscle spasms
Clinical narrative: chronic spasms in her jaw; achy; pain in the back; unstable; almost lost her balance; skin on both her arms hurt/ached for hours; feverish; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (chronic spasms in her jaw), PAIN (achy), BACK PAIN (pain in the back), FEELING ABNORMAL (unstable) and BALANCE DISORDER (almost lost her balance) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Back surgery (have some lasting things from the surgery). Previously administered products included for Product used for unknown indication: J and J (Dose no : 1st dose) in March 2020. Past adverse reactions to the above products included No adverse event with J and J. Concurrent medical conditions included Drug allergy (compazine), Drug allergy (codeine), Drug allergy (morphine), Milk allergy (milk and some dairy), Hypertension, High cholesterol, Cystitis interstitial, Depression (depression with anxiety), Anxiety (depression with anxiety) and Plantar fasciitis. Concomitant products included METOPROLOL, ATORVASTATIN, MIRABEGRON (MYRBETRIQ) and GABAPENTIN for an unknown indication.    On 25-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jul-2022, the patient experienced MUSCLE SPASMS (chronic spasms in her jaw), PAIN (achy), BACK PAIN (pain in the back), FEELING ABNORMAL (unstable), BALANCE DISORDER (almost lost her balance), PAIN IN EXTREMITY (skin on both her arms hurt/ached for hours) and PYREXIA (feverish). The patient was treated with BACLOFEN at an unspecified dose and frequency; CLONAZEPAM at an unspecified dose and frequency and HYDROCODONE at an unspecified dose and frequency. In July 2022, MUSCLE SPASMS (chronic spasms in her jaw), PAIN (achy), BACK PAIN (pain in the back), FEELING ABNORMAL (unstable), BALANCE DISORDER (almost lost her balance), PAIN IN EXTREMITY (skin on both her arms hurt/ached for hours) and PYREXIA (feverish) had resolved.            Relevant medical history includes patient had received shingles vaccine 2 weeks ago from the time of the call. Patient had taken 1st booster dose at around 12noon. Patient felt better at 2:00am and was able to sleep and woke up at around 8:30. Other treatment were includes heat pads.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain of skin, Pyrexia
Clinical narrative: chronic spasms in her jaw; achy; pain in the back; unstable; almost lost her balance; skin on both her arms hurt/ached for hours; feverish; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (chronic spasms in her jaw), PAIN (achy), BACK PAIN (pain in the back), FEELING ABNORMAL (unstable) and BALANCE DISORDER (almost lost her balance) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Back surgery (have some lasting things from the surgery). Previously administered products included for Product used for unknown indication: J and J (Dose no : 1st dose) in March 2020. Past adverse reactions to the above products included No adverse event with J and J. Concurrent medical conditions included Drug allergy (compazine), Drug allergy (codeine), Drug allergy (morphine), Milk allergy (milk and some dairy), Hypertension, High cholesterol, Cystitis interstitial, Depression (depression with anxiety), Anxiety (depression with anxiety) and Plantar fasciitis. Concomitant products included METOPROLOL, ATORVASTATIN, MIRABEGRON (MYRBETRIQ) and GABAPENTIN for an unknown indication.    On 25-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jul-2022, the patient experienced MUSCLE SPASMS (chronic spasms in her jaw), PAIN (achy), BACK PAIN (pain in the back), FEELING ABNORMAL (unstable), BALANCE DISORDER (almost lost her balance), PAIN IN EXTREMITY (skin on both her arms hurt/ached for hours) and PYREXIA (feverish). The patient was treated with BACLOFEN at an unspecified dose and frequency; CLONAZEPAM at an unspecified dose and frequency and HYDROCODONE at an unspecified dose and frequency. In July 2022, MUSCLE SPASMS (chronic spasms in her jaw), PAIN (achy), BACK PAIN (pain in the back), FEELING ABNORMAL (unstable), BALANCE DISORDER (almost lost her balance), PAIN IN EXTREMITY (skin on both her arms hurt/ached for hours) and PYREXIA (feverish) had resolved.            Relevant medical history includes patient had received shingles vaccine 2 weeks ago from the time of the call. Patient had taken 1st booster dose at around 12noon. Patient felt better at 2:00am and was able to sleep and woke up at around 8:30. Other treatment were includes heat pads.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial expired on 13-Jul-2022, vial was initially stored in refrigerator on 21-Jul-2022 and the vaccine was administered on 22-Jul-2022; Patient received expired Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (The vial expired on 13-Jul-2022, vial was initially stored in refrigerator on 21-Jul-2022 and the vaccine was administered on 22-Jul-2022) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 012A21A and 027B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 13-Jul-2022, vial was initially stored in refrigerator on 21-Jul-2022 and the vaccine was administered on 22-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (The vial expired on 13-Jul-2022, vial was initially stored in refrigerator on 21-Jul-2022 and the vaccine was administered on 22-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Number of doses or vials includes 4 doses.  On 29-Mar, the patient received vaccine (unspecified) (unknown route), batch number was reported as 016B21A (expiration date was 13-Sep-2021). The patient received vaccine in right arm.  On 21-Jul-2022, the vial was initially stored in the refrigerator.  The vial did not undergo any temperature excursions.  No treatment medication was reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: administered a dose after improper storage and handling; Dose administered more than 12(US) post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12(US) post puncture) and PRODUCT STORAGE ERROR (administered a dose after improper storage and handling) in a 74-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 011B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Jul-2022 at 9:00 AM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12(US) post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administered a dose after improper storage and handling). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12(US) post puncture) and PRODUCT STORAGE ERROR (administered a dose after improper storage and handling) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant were reported. The number of doses in the vial was 3 doses. The vial was never in the fridge. They moved the vial from the freezer to room temperature 25-Jul-2022. The date and time the vial was first punctured was on 25-Jul-2022 around 10 AM. The vial stored post puncture at room temperature. Total amount of time the vial was exposed to room temperature range was 23 hours. The vial did not underwent any temperature excursions. No treatment were reported.
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Imunocompromised patient received a booster dose instead of a 3rd full dose; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Imunocompromised patient received a booster dose instead of a 3rd full dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer and Immunocompromised.   In November 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. In November 2021, the patient experienced UNDERDOSE (Immunocompromised patient received a booster dose instead of a 3rd full dose). At the time of the report, UNDERDOSE (Immunocompromised patient received a booster dose instead of a 3rd full dose) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient has to receive now the 2nd booster dose and HCP was wondering if this patient can get the 3rd full dose for immunocompromised patients that had not received before. No further information could be gathered. No treatment information was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after 30 day beyond use date/administered an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day beyond use date/administered an expired vaccine) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 045L21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension, Nervous system disorder NOS (Nerve condition) and Drug allergy (Aspirin). Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (HYZAAR) for Hypertension, GABAPENTIN for Nervous system disorder NOS.    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 EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day beyond use date/administered an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day beyond use date/administered an expired vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Height and weight was unknown. It was reported that they put on the ready to use sticker and had to go back from 01-Jul-2022 through 05-Jul-2022 and found one more patient to add to their case apart from the initial 2 patients. Treatment information was not provided.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy tongue, Burning mouth syndrome, Speech disorder, Tongue discolouration, Tongue ulceration
Clinical narrative: burning mouth Syndrome, got worst after the booster; 3 ulcers on his tongue after the booster; Speech has been affected after the booster/"I speaks like a person whom had a stroke." after booster; The Back of the tongue is black/ dark; This spontaneous case was reported by a patient and describes the occurrence of BURNING MOUTH SYNDROME (burning mouth Syndrome, got worst after the booster), TONGUE ULCERATION (3 ulcers on his tongue after the booster), SPEECH DISORDER (Speech has been affected after the booster/"I speaks like a person whom had a stroke." after booster) and TONGUE DISCOLOURATION (The Back of the tongue is black/ dark) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2022, the patient experienced BURNING MOUTH SYNDROME (burning mouth Syndrome, got worst after the booster), TONGUE ULCERATION (3 ulcers on his tongue after the booster), SPEECH DISORDER (Speech has been affected after the booster/"I speaks like a person whom had a stroke." after booster) and TONGUE DISCOLOURATION (The Back of the tongue is black/ dark). At the time of the report, BURNING MOUTH SYNDROME (burning mouth Syndrome, got worst after the booster) had not resolved, TONGUE ULCERATION (3 ulcers on his tongue after the booster) and TONGUE DISCOLOURATION (The Back of the tongue is black/ dark) was resolving and SPEECH DISORDER (Speech has been affected after the booster/"I speaks like a person whom had a stroke." after booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy tongue: did not find anything.         No concomitant medications were reported. In Mar-2022, patient had received the booster dose. The patient had 3 blisters on tongue and the doctor did biopsy of tongue blisters but they did not find anything. The tongue still burned all the time, he had dry mouth.  Treatment included Magic mouthwash (twice with different formulas).   This case was linked to MOD-2022-614412 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: I think my Dr gave my child the wrong vaccine. I don't believe them.; This spontaneous case was reported by a patient and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (I think my Dr gave my child the wrong vaccine. I don't believe them.) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 26-Jul-2022, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (I think my Dr gave my child the wrong vaccine. I don't believe them.). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (I think my Dr gave my child the wrong vaccine. I don't believe them.) outcome was unknown.            Concomitant medication was not provided.  It was unknown patient ever had COVID positive test or diagnosis.It was unknown other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  It was reported that they think doctor gave his/her child the wrong vaccine and they don't believe them. It was unknown that AE cause patient to seek medical care. The patient experienced a similar event in the past and symptoms improved was unknown.  Treatment information was not provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: administered a dose after improper storage and handling/ Vial was never in the fridge, the vial was moved from the freezer to room temperature; Dose administered greater than 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture) and PRODUCT STORAGE ERROR (administered a dose after improper storage and handling/ Vial was never in the fridge, the vial was moved from the freezer to room temperature) in a 77-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 011B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Jul-2022 at 9:00 AM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administered a dose after improper storage and handling/ Vial was never in the fridge, the vial was moved from the freezer to room temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture) and PRODUCT STORAGE ERROR (administered a dose after improper storage and handling/ Vial was never in the fridge, the vial was moved from the freezer to room temperature) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was reported.  The vial was first punctured on 25-Jul-2022 around 10 AM and then it was left unattended and kept at room temperature range (8 to 25 degree Celsius/46 to 77 degree Fahrenheit) for 23 hours. The vial did not undergo any temperature excursion.  It was reported that the vial was never in the fridge and it was moved from the freezer to room temperature directly on 25-Jul-2022.  No treatment medication details was reported.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: expiration date 13Jul2022, vial was initially stored in the refrigerator on 21Jul2022, administration of vaccine on 22Jul2022; patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (expiration date 13Jul2022, vial was initially stored in the refrigerator on 21Jul2022, administration of vaccine on 22Jul2022) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 051F21A, 031A21A and 013M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (expiration date 13Jul2022, vial was initially stored in the refrigerator on 21Jul2022, administration of vaccine on 22Jul2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (expiration date 13Jul2022, vial was initially stored in the refrigerator on 21Jul2022, administration of vaccine on 22Jul2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. It was reported they gave outdated Moderna Covid-19 vaccine to four patients on 22-Jul-2022 and number of doses was 4. The vial did not undergo any temperature excursions. No other adverse reaction and side effect reported.Treatment medications were not reported.
Age: 1.75
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received Pfizer as the second dose instead of Moderna; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Pfizer as the second dose instead of Moderna) in a 21-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS141413) for COVID-19 vaccination.     The patient had no known allergies. The patient never had COVID positive test or diagnosis.  Previously administered products included for Drug use for unknown indication: Hepatitis A on 20-May-2022. Past adverse reactions to the above products included No adverse event with Hepatitis A. Family history included Drug allergy (family allergy to codeine) since an unknown date.    On 27-Jun-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jul-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Pfizer as the second dose instead of Moderna). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Pfizer as the second dose instead of Moderna) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient received first dose of the Moderna vaccine at one facility and was referred to another facility for the second dose, where the patient was given Pfizer as the second dose on 25-JUL-2022 (batch no. FT9142). The reporter contacted medical doctor for opinion. No treatment medications were reported.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination complication
Clinical narrative: two other friends said that taking the vaccine was like having the disease; pain in the arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION COMPLICATION (two other friends said that taking the vaccine was like having the disease) and PAIN IN EXTREMITY (pain in the arm) in a 45-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (two other friends said that taking the vaccine was like having the disease) and PAIN IN EXTREMITY (pain in the arm). At the time of the report, VACCINATION COMPLICATION (two other friends said that taking the vaccine was like having the disease) and PAIN IN EXTREMITY (pain in the arm) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. No treatment drugs were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-614664 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-614664:Master case (Friend with eczema)
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Dry throat, Fatigue, Insomnia
Clinical narrative: Could not sleep; Dry throat; Cough; Arm pain like never experience in life, could not lean on it/the pain was so exurban; Chills; Fever; Extreme fatigue; This spontaneous case was reported by a patient and describes the occurrence of INSOMNIA (Could not sleep), DRY THROAT (Dry throat), COUGH (Cough), PAIN IN EXTREMITY (Arm pain like never experience in life, could not lean on it/the pain was so exurban) and CHILLS (Chills) in a 70-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient did not had any allergies to medications, food and other products. The patient did not had any medical history relating to mentioned adverse event and both acute and chronic illnesses at the time of vaccination. The patient did not had any other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included COVID-19 in January 2022. Concomitant products included TRAMADOL for Pain.    On 20-Jul-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In July 2022, the patient experienced INSOMNIA (Could not sleep), DRY THROAT (Dry throat), COUGH (Cough), PAIN IN EXTREMITY (Arm pain like never experience in life, could not lean on it/the pain was so exurban), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Extreme fatigue). In July 2022, INSOMNIA (Could not sleep), DRY THROAT (Dry throat), COUGH (Cough), PAIN IN EXTREMITY (Arm pain like never experience in life, could not lean on it/the pain was so exurban), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Extreme fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 test: (Positive) Positive - Yes.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       It was reported that the pain was so exurban it was like patient was having covid all over again. The patient was angry and thinking of suing because patient lost 5 day of quality of life that patient would never get back. The patient would never get vaccinated. The patient went to hospital for observation. The patient did not experienced a similar event in the past. It was reported that the symptoms were stabilizing. No treatment information was reported.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: Could not sleep; Dry throat; Cough; Arm pain like never experience in life, could not lean on it/the pain was so exurban; Chills; Fever; Extreme fatigue; This spontaneous case was reported by a patient and describes the occurrence of INSOMNIA (Could not sleep), DRY THROAT (Dry throat), COUGH (Cough), PAIN IN EXTREMITY (Arm pain like never experience in life, could not lean on it/the pain was so exurban) and CHILLS (Chills) in a 70-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient did not had any allergies to medications, food and other products. The patient did not had any medical history relating to mentioned adverse event and both acute and chronic illnesses at the time of vaccination. The patient did not had any other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included COVID-19 in January 2022. Concomitant products included TRAMADOL for Pain.    On 20-Jul-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In July 2022, the patient experienced INSOMNIA (Could not sleep), DRY THROAT (Dry throat), COUGH (Cough), PAIN IN EXTREMITY (Arm pain like never experience in life, could not lean on it/the pain was so exurban), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Extreme fatigue). In July 2022, INSOMNIA (Could not sleep), DRY THROAT (Dry throat), COUGH (Cough), PAIN IN EXTREMITY (Arm pain like never experience in life, could not lean on it/the pain was so exurban), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Extreme fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 test: (Positive) Positive - Yes.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       It was reported that the pain was so exurban it was like patient was having covid all over again. The patient was angry and thinking of suing because patient lost 5 day of quality of life that patient would never get back. The patient would never get vaccinated. The patient went to hospital for observation. The patient did not experienced a similar event in the past. It was reported that the symptoms were stabilizing. No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Rash, Skin reaction
Clinical narrative: increased cough; severe skin reaction in his groin area; Face and feet were also affected by rash; This spontaneous case was reported by an other health care professional and describes the occurrence of COUGH (increased cough), SKIN REACTION (severe skin reaction in his groin area) and RASH (Face and feet were also affected by rash) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Asthma (Severe persistent asthma, Uncomplicated) and Bronchiectasis. Concomitant products included OMALIZUMAB (XOLAIR), VITAMIN D [VITAMIN D NOS], ZINC, VITAMIN C [ASCORBIC ACID], AMLODIPINE BESYLATE, ASPIRIN [ACETYLSALICYLIC ACID], OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), METOPROLOL SUCCINATE (TOPROL), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (WIXELA INHUB), EPINEPHRINE, BENZONATATE (TESSALON PERLE), SALBUTAMOL SULFATE (PROAIR HFA) and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (increased cough), SKIN REACTION (severe skin reaction in his groin area) and RASH (Face and feet were also affected by rash). At the time of the report, COUGH (increased cough), SKIN REACTION (severe skin reaction in his groin area) and RASH (Face and feet were also affected by rash) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concurrent condition included chronic cough. Concomitant medication included probiotic ultra flora plus. No treatment medication was reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Multiple sclerosis exacerbation. Concurrent medical conditions included Dementia, Weight gain, Wheeze worsened, Memory impaired, Difficulty in walking and Aspiration pneumonia. Concomitant products included OCRELIZUMAB (OCREVUS) and ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced COVID-19 (COVID) (seriousness criterion hospitalization). The patient was hospitalized from sometime in 2022 to sometime in 2022 due to COVID-19. In 2022, COVID-19 (COVID) had resolved.            Patient's concomitant medication included monoclonal antibodies.  On 20-Apr-2021, patient started therapy with MODERNA COVID-19 VACCINE for Prevention of Covid. She was never tested for any antibody production after she received her COVID-19 vaccinations. patient was hospitalized for COVID, about 4 months ago in 2022.  No treatment information was provided.  Company comment: This spontaneous case concerns a 63 year old female patient with no relevant medical history, who experienced the unexpected serious (hospitalization) AESI of COVID 19 , unknown days after receiving the third dose (first booster)of mRNA-1273 vaccine. Patient received the primary series of vaccination with mRNA-1273 vaccine in accordance with the recommended schedule. No further information on detailed clinical course, investigations and treatment details of the event was available in the report. The COVID 19 pandemic could be a confounder for the event COVID 19. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-610564 (Patient Link).; Sender's Comments: This spontaneous case concerns a 63 year old female patient with no relevant medical history, who experienced the unexpected serious (hospitalization) AESI of COVID 19 , unknown days after receiving the third dose (first booster)of mRNA-1273 vaccine. Patient received the primary series of vaccination with mRNA-1273 vaccine in accordance with the recommended schedule. No further information on detailed clinical course, investigations and treatment details of the event was available in the report. The COVID 19 pandemic could be a confounder for the event COVID 19. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Vaccination site nodule
Clinical narrative: raised pink circle that bumped up about the size of a grape; aching joints; headache; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE NODULE (raised pink circle that bumped up about the size of a grape), ARTHRALGIA (aching joints) and HEADACHE (headache) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced VACCINATION SITE NODULE (raised pink circle that bumped up about the size of a grape), ARTHRALGIA (aching joints) and HEADACHE (headache). At the time of the report, VACCINATION SITE NODULE (raised pink circle that bumped up about the size of a grape), ARTHRALGIA (aching joints) and HEADACHE (headache) outcome was unknown.            Concomitant medication of the patient was not reported.  After receiving the second dose, the patient again had a reaction at the injection site again.  No treatment information was provided by the reporter.  The reporter reported that he had not got COVID-19 and he was very thankful for that and also reported that this was because he received the Moderna COVID-19 vaccine.   This case was linked to MOD-2022-614709, MOD-2022-614959 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: little dizziness in the Morning/slight dizziness/starts in the morning and weans out, slight dizziness, not staggering, dizzy feeling; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (little dizziness in the Morning/slight dizziness/starts in the morning and weans out, slight dizziness, not staggering, dizzy feeling) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concomitant products included EXEMESTANE, LISINOPRIL and AMLODIPINE for an unknown indication.  On 25-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2022, the patient experienced DIZZINESS (little dizziness in the Morning/slight dizziness/starts in the morning and weans out, slight dizziness, not staggering, dizzy feeling). At the time of the report, DIZZINESS (little dizziness in the Morning/slight dizziness/starts in the morning and weans out, slight dizziness, not staggering, dizzy feeling) outcome was unknown.      No medical history was reported.  The patient received the second Moderna booster dose on 25-Jul-2022.  The  patient reported that Moderna vaccine was the only thing that was new that patient had. The patient did not took any medication for the dizziness.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 21-Jun2022 and administered on 27-Jul-2022; Administer a vaccine to a patient after the after 30 day use day; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer a vaccine to a patient after the after 30 day use day) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 21-Jun2022 and administered on 27-Jul-2022) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis. No Medical History information was reported. On 27-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer a vaccine to a patient after the after 30 day use day). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 21-Jun2022 and administered on 27-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer a vaccine to a patient after the after 30 day use day) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 21-Jun2022 and administered on 27-Jul-2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient did not experienced a similar event in the past. No concomitant product use was provided. Dose administered after 30-day Use by Date or after manufacturer date of expiry. The vial was initially stored in the refrigerator on 21Jun2022. The AE does not cause patient to seek medical care. The vial did not undergo any temperature excursions. The symptoms have improved. No treatment medication was provided.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Feels dizzy; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DIZZINESS (Feels dizzy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (Feels dizzy). At the time of the report, DIZZINESS (Feels dizzy) had not resolved.     No concomitant medications were provided. Patient received half a dose. The patient was referred to HCP No treatment medications were reported.   Reporter did not allow further contact
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Less than 4 months in between 1st and second booster doses of the Moderna Covid-19 vaccine; This spontaneous case was reported by a medical assistant and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 4 months in between 1st and second booster doses of the Moderna Covid-19 vaccine) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044C22A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 4 months in between 1st and second booster doses of the Moderna Covid-19 vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 4 months in between 1st and second booster doses of the Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. The dose patient received on 31-Mar-2022 and 27-Jul-2022 was first and second booster doses respectively.  The arm that the patient received the first dose, second dose and first booster dose was not known. The patient did not experienced any adverse reactions with first dose, second dose and first booster dose . Treatment information was not reported.
Sex: M
Vaccine: MEN
Symptoms: Death
Clinical narrative: my son passed on 20Oct2020 after getting the men B vaccine; This case was reported by a consumer and described the occurrence of unknown cause of death in a male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   In October 2020, the patient received Meningococcal B vaccine. On 20th October 2020, 4 days after receiving Meningococcal B vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The patient died on 20th October 2020. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death to be related to Meningococcal B vaccine.     Additional Information: GSK Receipt Date: 27-JUL-2022 Reporter's Comment: This case was reported by a patient's parent via interactive digital media. The reporter's son passed 4 days after getting the Meningococcal B vaccine. Additional Supportive Information: The follow up would not possible as no contact details were available.; Reported Cause(s) of Death: Unknown cause of death