chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Vaccination site pain
Clinical narrative: Soreness around the injection site; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness around the injection site), CHILLS (Chills) and HEADACHE (Headache) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced VACCINATION SITE PAIN (Soreness around the injection site), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, VACCINATION SITE PAIN (Soreness around the injection site), CHILLS (Chills) and HEADACHE (Headache) 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-2022-560043, MOD-2022-560044 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2022: Follow-up information contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Rash
Clinical narrative: Rash after a dose of vaccine; Muscle Ache after a dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash after a dose of vaccine) and MYALGIA (Muscle Ache after a dose of vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash after a dose of vaccine) and MYALGIA (Muscle Ache after a dose of vaccine). At the time of the report, RASH (Rash after a dose of vaccine) and MYALGIA (Muscle Ache after a dose of vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: arm pain after previous doses; second dose >36 days after first dose; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose >36 days after first dose) and PAIN IN EXTREMITY (arm pain after previous doses) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cancer (25 to 30 years ago). Concurrent medical conditions included High cholesterol, Allergy to chemicals (nitrates) and Allergy (MSG).   On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose >36 days after first dose). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain after previous doses). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose >36 days after first dose) outcome was unknown and PAIN IN EXTREMITY (arm pain after previous doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient had concomitant medications daily for high cholesterol and blood pressure. It was reported that patient was not immunocompromised. Patient neither diagnosed with COVID-19 nor tested positive. Treatment medications were not reported.   This case was linked to MOD-2022-559342, MOD-2022-559594, MOD-2022-559608 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: they may have given a dose of the Moderna Covid-19 Vaccine from a vial that was punctured 32; they may have given a dose of the Moderna Covid-19 Vaccine from a vial that was punctured 32 hours previously and was also stored at room temperature for 32 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they may have given a dose of the Moderna Covid-19 Vaccine from a vial that was punctured 32 hours previously and was also stored at room temperature for 32 hours) and PRODUCT STORAGE ERROR (they may have given a dose of the Moderna Covid-19 Vaccine from a vial that was punctured 32) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 049L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2022 at 5:00 PM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-May-2022 at 5:00 PM,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (they may have given a dose of the Moderna Covid-19 Vaccine from a vial that was punctured 32 hours previously and was also stored at room temperature for 32 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (they may have given a dose of the Moderna Covid-19 Vaccine from a vial that was punctured 32). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they may have given a dose of the Moderna Covid-19 Vaccine from a vial that was punctured 32 hours previously and was also stored at room temperature for 32 hours) and PRODUCT STORAGE ERROR (they may have given a dose of the Moderna Covid-19 Vaccine from a vial that was punctured 32) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   Pharmacist stated that they might have given a dose of the Moderna COVID-19 Vaccine from a vial that was punctured 32 hours previously and was also stored at room temperature for 32 hours.   The number of doses/vial reported as one dose/one vial.  Dose administered more than 12 hours post puncture and after exposure to room temperature for more than 24 hours. The vial was initially stored in the refrigerator on 28Apr2022. Vial was first punctured on 03-May-2022 at 9 am. Vaccine was administered on 04-May-2022 at 5 pm. The vial was stored in room temperature post punctured. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was 32 hours.  No treatment drug was reported.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: no wonder your vaccine almost killed me; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (no wonder your vaccine almost killed me) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     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 IMMUNISATION REACTION (no wonder your vaccine almost killed me). At the time of the report, IMMUNISATION REACTION (no wonder your vaccine almost killed me) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were provided by the reporter. It was reported that no wonder your vaccine almost killed. No treatment information was provided by the reporter.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, SARS-CoV-2 test
Clinical narrative: felt tired; chills; some joint pain; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt tired), CHILLS (chills) and ARTHRALGIA (some joint pain) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included Cancer (NOS) (No Change reported for this condition whether it was improved of worsening) and Polyp removal (No Change reported for this condition whether it was improved of worsening). Concurrent medical conditions included Seasonal allergy, Fruit allergy (multiple allergies including grapes,) and Drug allergy (colonoscopy "Prep" medication.). Concomitant products included VITAMINS NOS, VITAMIN D NOS and CYANOCOBALAMIN (VITAMIN B-12) for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Apr-2021, the patient experienced FATIGUE (felt tired), CHILLS (chills) and ARTHRALGIA (some joint pain). At the time of the report, FATIGUE (felt tired), CHILLS (chills) and ARTHRALGIA (some joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, SARS-CoV-2 test: negative (Negative) Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment medications was provided by the reporter.   This case was linked to MOD-2022-559985, MOD-2022-559987, MOD-2022-559986 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, SARS-CoV-2 test
Clinical narrative: felt tired (2nd dose); chills (2nd dose); a little more pain in joints (2nd dose); This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt tired (2nd dose)), CHILLS (chills (2nd dose)) and ARTHRALGIA (a little more pain in joints (2nd dose)) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included Cancer (NOS) (Cancer Survivor-No recent change in status such as improvement or worsening) and Cancer surgery (Precancerous polyps removed-No recent change in status like improvement or worsening). Concurrent medical conditions included Seasonal allergy, Fruit allergy (Multiple allergies including grapes) and Drug allergy (Allergic to the colonoscopy "Prep" medication). Concomitant products included VITAMINS NOS, VITAMIN D NOS and CYANOCOBALAMIN (VITAMIN B-12) for an unknown indication.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 18-May-2021, the patient experienced FATIGUE (felt tired (2nd dose)), CHILLS (chills (2nd dose)) and ARTHRALGIA (a little more pain in joints (2nd dose)). At the time of the report, FATIGUE (felt tired (2nd dose)), CHILLS (chills (2nd dose)) and ARTHRALGIA (a little more pain in joints (2nd dose)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, SARS-CoV-2 test: negative (Negative) Tested negative in September 2021 she thinks..         Lot number of dose 1 was said to be illegible, caller reported it as 039B2?D Treatment information was not provided.   This case was linked to MOD-2022-559967, MOD-2022-559987, MOD-2022-559986 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, SARS-CoV-2 test
Clinical narrative: she couldn't walk  (1st booster); so much pain in her hips (1st booster); This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (she couldn't walk  (1st booster)) and ARTHRALGIA (so much pain in her hips (1st booster)) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013P2M, 004C21A and 039B2?D) for COVID-19 vaccination.     The patient's past medical history included Cancer (NOS) (Cancer Survivor. No change reported) and Polyp removal (Precancerous polyps removed. No change reported). Concurrent medical conditions included Seasonal allergy, Fruit allergy (Multiple allergies including grapes) and Drug allergy (Allergic to the colonoscopy "Prep" medication). Concomitant products included VITAMINS NOS, VITAMIN D [VITAMIN D NOS] and CYANOCOBALAMIN (VITAMIN B-12) for an unknown indication.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 01-Dec-2021, the patient experienced GAIT DISTURBANCE (she couldn't walk  (1st booster)) and ARTHRALGIA (so much pain in her hips (1st booster)). At the time of the report, GAIT DISTURBANCE (she couldn't walk  (1st booster)) and ARTHRALGIA (so much pain in her hips (1st booster)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, SARS-CoV-2 test: negative (Negative) Negative.         It was reported that lot number for dose 1 and 1st booster dose was illegible. No treatment medications were provided.   This case was linked to MOD-2022-559967, MOD-2022-559967 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Somnambulism
Clinical narrative: Sleep walking/drove while I was sleeping; This spontaneous case was reported by a patient and describes the occurrence of SOMNAMBULISM (Sleep walking/drove while I was sleeping) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNAMBULISM (Sleep walking/drove while I was sleeping). At the time of the report, SOMNAMBULISM (Sleep walking/drove while I was sleeping) outcome was unknown.            No concomitant drug reported.  Patient received, 1st booster shot.   No treatment information was provided by the reporter.   This case was linked to MOD-2022-560020 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Somnambulism
Clinical narrative: Sleep walking/drove while I was sleeping; This spontaneous case was reported by a patient and describes the occurrence of SOMNAMBULISM (Sleep walking/drove while I was sleeping) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNAMBULISM (Sleep walking/drove while I was sleeping). At the time of the report, SOMNAMBULISM (Sleep walking/drove while I was sleeping) outcome was unknown.            No concomitant drug reported.  Patient received, 1st booster shot.   No treatment information was provided by the reporter.   This case was linked to MOD-2022-560020 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Somnambulism
Clinical narrative: sleep walk; I wasn't able to go outside with the second one; This spontaneous case was reported by a consumer and describes the occurrence of SOMNAMBULISM (sleep walk) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I wasn't able to go outside with the second one) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNAMBULISM (sleep walk) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I wasn't able to go outside with the second one). At the time of the report, SOMNAMBULISM (sleep walk) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I wasn't able to go outside with the second one) outcome was unknown.            No concomitant medication information was provided.  It was reported that patient received 2nd booster shots.  Patient stated that patient was able to do a change in how the patient sleep and dump. It was reported that the patient was just in her house, but it affected the patient that patient had done a lot of stuff while being awake.  No treatment medication were provided.   This case was linked to MOD-2022-560019 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Somnambulism
Clinical narrative: sleep walk; I wasn't able to go outside with the second one; This spontaneous case was reported by a consumer and describes the occurrence of SOMNAMBULISM (sleep walk) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I wasn't able to go outside with the second one) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNAMBULISM (sleep walk) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I wasn't able to go outside with the second one). At the time of the report, SOMNAMBULISM (sleep walk) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I wasn't able to go outside with the second one) outcome was unknown.            No concomitant medication information was provided.  It was reported that patient received 2nd booster shots.  Patient stated that patient was able to do a change in how the patient sleep and dump. It was reported that the patient was just in her house, but it affected the patient that patient had done a lot of stuff while being awake.  No treatment medication were provided.   This case was linked to MOD-2022-560019 (Patient Link).
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022B21A and 002C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown.            No concomitant medications were reported. No treatment information was reported.   This case was linked to MOD-2022-559357, MOD-2022-560044 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2022: Follow-up contains no new information.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling cold
Clinical narrative: Patient felt cold; Patient has chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Patient felt cold) and CHILLS (Patient has chills) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007321-2A, 022B21A and 002C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2022, the patient experienced FEELING COLD (Patient felt cold) and CHILLS (Patient has chills). At the time of the report, FEELING COLD (Patient felt cold) and CHILLS (Patient has chills) outcome was unknown.            No concomitant medication were reported. It was reported that the patient received his booster shot in his left arm shoulder deltoid muscle. No treatment medication were reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2022: Follow up received contains non significant information.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Opioids (rash)), Drug allergy (Tamiflu) and Controlled hypertension (High Blood Pressure (controlled). No change reported; controlled.).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced DYSPNOEA (shortness of breath). At the time of the report, DYSPNOEA (shortness of breath) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient experienced Shortness of breath over a year ago with unknown start date. It was reported that patient concomitant medications include Unknown medications and Same medications for a long time. No treatment medications were provided.   This case was linked to MOD-2022-560263, MOD-2022-560264 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Fatigue, Pain, Pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Opioids (rash)), Drug allergy (Tamiflu) and Controlled hypertension (High Blood Pressure (controlled). No change reported; controlled.).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced DYSPNOEA (shortness of breath). At the time of the report, DYSPNOEA (shortness of breath) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient experienced Shortness of breath over a year ago with unknown start date. It was reported that patient concomitant medications include Unknown medications and Same medications for a long time. No treatment medications were provided.   This case was linked to MOD-2022-560263, MOD-2022-560264 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea
Clinical narrative: experienced shortness of breath started that same day; itchiness; aches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (experienced shortness of breath started that same day), PRURITUS (itchiness), PAIN (aches) and FATIGUE (fatigue) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001M21A, 939903, 001A21A and 041L20A) for COVID-19 vaccination.     Patient had no food allergies. It was unknown other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included COVID-19 in May 2020. Concurrent medical conditions included Drug allergy (Rash caused due to opioids), Drug allergy (Patient had Tamiflu allergy) and Controlled hypertension (started years ago and no change in the condition).   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 20-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 30-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 30-Apr-2022, the patient experienced DYSPNOEA (experienced shortness of breath started that same day), PRURITUS (itchiness), PAIN (aches) and FATIGUE (fatigue). On 01-May-2022, PRURITUS (itchiness), PAIN (aches) and FATIGUE (fatigue) had resolved. At the time of the report, DYSPNOEA (experienced shortness of breath started that same day) had not resolved.      Concomitant medications were unknown but was using same medications for a long time. Shortness of breath started over a year ago and worsened now. Patient stated it had been months had been dealing with shortness of breath and it was still pretty bad. She had seen a doctor about the events and was prescribed an unknown oral inhaler. The inhaler did nothing. Patient reported a pulmonologist determined there was no lung scaring present and she was experiencing shortness of breath even when tying shoes. The patient mentioned that so far, doctor had not determined the cause of the shortness of breath.  Patient did not seek medical care for fatigue, itchiness, and aches.   This case was linked to MOD-2022-560051, MOD-2022-560263 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Fatigue, Pain, Pruritus
Clinical narrative: experienced shortness of breath started that same day; itchiness; aches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (experienced shortness of breath started that same day), PRURITUS (itchiness), PAIN (aches) and FATIGUE (fatigue) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001M21A, 939903, 001A21A and 041L20A) for COVID-19 vaccination.     Patient had no food allergies. It was unknown other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included COVID-19 in May 2020. Concurrent medical conditions included Drug allergy (Rash caused due to opioids), Drug allergy (Patient had Tamiflu allergy) and Controlled hypertension (started years ago and no change in the condition).   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 20-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 30-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 30-Apr-2022, the patient experienced DYSPNOEA (experienced shortness of breath started that same day), PRURITUS (itchiness), PAIN (aches) and FATIGUE (fatigue). On 01-May-2022, PRURITUS (itchiness), PAIN (aches) and FATIGUE (fatigue) had resolved. At the time of the report, DYSPNOEA (experienced shortness of breath started that same day) had not resolved.      Concomitant medications were unknown but was using same medications for a long time. Shortness of breath started over a year ago and worsened now. Patient stated it had been months had been dealing with shortness of breath and it was still pretty bad. She had seen a doctor about the events and was prescribed an unknown oral inhaler. The inhaler did nothing. Patient reported a pulmonologist determined there was no lung scaring present and she was experiencing shortness of breath even when tying shoes. The patient mentioned that so far, doctor had not determined the cause of the shortness of breath.  Patient did not seek medical care for fatigue, itchiness, and aches.   This case was linked to MOD-2022-560051, MOD-2022-560263 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Having some issues from the vaccine/ Side effects; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Having some issues from the vaccine/ Side effects) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Having some issues from the vaccine/ Side effects). At the time of the report, IMMUNISATION REACTION (Having some issues from the vaccine/ Side effects) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications was provided by the reporter.  No treatment medications was provided by the reporter.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Suffered from side effects with the primary series; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Suffered from side effects with the primary series) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Suffered from side effects with the primary series). At the time of the report, IMMUNISATION REACTION (Suffered from side effects with the primary series) outcome was unknown.            Patient was taking Excedrin.   This case was linked to MOD-2022-560254 (Patient Link).   Reporter did not allow further contact
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired vaccine was stored in the refrigerator; Patient received expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and PRODUCT STORAGE ERROR (Expired vaccine was stored in the refrigerator) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A, 069H21A, 017C21A and 026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-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 04-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was stored in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and PRODUCT STORAGE ERROR (Expired vaccine was stored in the refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  The patient had no side effects or adverse events with first, second and third dose of Moderna COVID-19 vaccine.  Date the vial was initially stored in the refrigerator was on 4MAY2022 and 5MAY2022.   The vial did not undergone any temperature excursions.  No treatment medications were reported.   This case was linked to MOD-2022-560259, MOD-2022-561462 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2022: Follow-up received included no new information.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath gradually started to get better but after receiving the first and second booster it has worsened again/ Intermittent shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath gradually started to get better but after receiving the first and second booster it has worsened again/ Intermittent shortness of breath) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 041L20A and 001A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in May 2020. Concurrent medical conditions included Drug allergy (Opioids (rash)), Drug allergy (Tamiflu) and Blood pressure high (Started years ago. No change reported. Controlled.).   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 20-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 20-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPNOEA (Shortness of breath gradually started to get better but after receiving the first and second booster it has worsened again/ Intermittent shortness of breath). At the time of the report, DYSPNOEA (Shortness of breath gradually started to get better but after receiving the first and second booster it has worsened again/ Intermittent shortness of breath) had not resolved.            Concomitant medications included some unspecified same medications for a long time.  The shortness of breath started over a year ago, may have been around the time of receiving the first Moderna COVID-19 dose and it gradually started to get better but after receiving the first and second booster it had worsened again.  Patient stated that she had seen a doctor and was prescribed an unknown oral inhaler. She stated the inhaler does nothing. She reported a pulmonologist determined there is no lung scaring present. She reported she is experiencing shortness of breath even when tying her shoes.  Treatment included unknown oral inhaler.   This case was linked to MOD-2022-560051, MOD-2022-560264.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: soreness in his left arm; tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in his left arm) and FATIGUE (tired) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A, 044B21A and 032F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE PAIN (soreness in his left arm) and FATIGUE (tired). At the time of the report, VACCINATION SITE PAIN (soreness in his left arm) and FATIGUE (tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment  medications were reported. The patient experienced no side effects or adverse reactions to the second shot. No Adverse reactions or side effects were reported after the booster dose.   This case was linked to MOD-2022-560498.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Administered half dose (0.25ml red cap vial)  for the 2nd primary dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Administered half dose (0.25ml red cap vial)  for the 2nd primary dose) in a 28-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 05-May-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .25 milliliter. On 05-May-2022,  after starting mRNA-1273 (Spikevax), the patient experienced ACCIDENTAL UNDERDOSE (Administered half dose (0.25ml red cap vial)  for the 2nd primary dose). At the time of the report, ACCIDENTAL UNDERDOSE (Administered half dose (0.25ml red cap vial)  for the 2nd primary dose) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter.  Patient administered half dose (0.25ml red cap vial) instead of full dose by mistake.  Treatment information was not provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash erythematous
Clinical narrative: red rash that appeared. It looks like a birthmark. It is reddish; lot of pain on my arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash that appeared. It looks like a birthmark. It is reddish) and PAIN IN EXTREMITY (lot of pain on my arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 037C21A, 018B21A and 030M20A) for COVID-19 vaccination.   Concurrent medical conditions included Hypertension and Hypercholesterolemia.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (red rash that appeared. It looks like a birthmark. It is reddish) and PAIN IN EXTREMITY (lot of pain on my arm). At the time of the report, RASH ERYTHEMATOUS (red rash that appeared. It looks like a birthmark. It is reddish) and PAIN IN EXTREMITY (lot of pain on my arm) outcome was unknown.            No known allergies were reported. Patient was never been diagnosed with COVID.  High cholesterol medication and high blood pressure medication as concomitant medication.  The patient never had this before. patient was sore for many days.  No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: patient received expired vaccine; Product Storage error; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired vaccine) and PRODUCT STORAGE ERROR (Product Storage error) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired vaccine) and PRODUCT STORAGE ERROR (Product Storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received expired vaccine) and PRODUCT STORAGE ERROR (Product Storage error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Product moved from freezer to fridge on 06-MAY-2022. Treatment details was not reported by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Pain
Clinical narrative: Achy; Hot at injection site; Went to bed he covered himself with blankets and when he woke up all sweaty; Really bad headache; Fatigued; Hot at inject site and red color; Cold chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), VACCINATION SITE WARMTH (Hot at injection site), HYPERHIDROSIS (Went to bed he covered himself with blankets and when he woke up all sweaty), HEADACHE (Really bad headache) and FATIGUE (Fatigued) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 046A21A and 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient experienced PAIN (Achy), VACCINATION SITE WARMTH (Hot at injection site), HYPERHIDROSIS (Went to bed he covered himself with blankets and when he woke up all sweaty), HEADACHE (Really bad headache), FATIGUE (Fatigued), VACCINATION SITE ERYTHEMA (Hot at inject site and red color), CHILLS (Cold chills) and PYREXIA (Fever). At the time of the report, PAIN (Achy), VACCINATION SITE WARMTH (Hot at injection site), HYPERHIDROSIS (Went to bed he covered himself with blankets and when he woke up all sweaty), HEADACHE (Really bad headache), FATIGUE (Fatigued), VACCINATION SITE ERYTHEMA (Hot at inject site and red color), CHILLS (Cold chills) and PYREXIA (Fever) outcome was unknown.            No concomitant drug was reported. No treatment drug was reported.   This case was linked to MOD-2022-560588 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Achy; Hot at injection site; Went to bed he covered himself with blankets and when he woke up all sweaty; Really bad headache; Fatigued; Hot at inject site and red color; Cold chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), VACCINATION SITE WARMTH (Hot at injection site), HYPERHIDROSIS (Went to bed he covered himself with blankets and when he woke up all sweaty), HEADACHE (Really bad headache) and FATIGUE (Fatigued) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 046A21A and 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient experienced PAIN (Achy), VACCINATION SITE WARMTH (Hot at injection site), HYPERHIDROSIS (Went to bed he covered himself with blankets and when he woke up all sweaty), HEADACHE (Really bad headache), FATIGUE (Fatigued), VACCINATION SITE ERYTHEMA (Hot at inject site and red color), CHILLS (Cold chills) and PYREXIA (Fever). At the time of the report, PAIN (Achy), VACCINATION SITE WARMTH (Hot at injection site), HYPERHIDROSIS (Went to bed he covered himself with blankets and when he woke up all sweaty), HEADACHE (Really bad headache), FATIGUE (Fatigued), VACCINATION SITE ERYTHEMA (Hot at inject site and red color), CHILLS (Cold chills) and PYREXIA (Fever) outcome was unknown.            No concomitant drug was reported. No treatment drug was reported.   This case was linked to MOD-2022-560588 (Patient Link).   Reporter did not allow further contact
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm//had very mild side effects from the first vaccine; Mild fatigue/had very mild side effects from the first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm//had very mild side effects from the first vaccine) and FATIGUE (Mild fatigue/had very mild side effects from the first vaccine) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Patient never have tested or diagnosed positive for COVID. Patient not had any Acute and Chronic /long standing health conditions at the time or up to 1 month before vaccination. Patient did not receive any vaccine on the same day of moderna vaccination. Patient never had any side effects from any other vaccines.  Concurrent medical conditions included Penicillin allergy. Concomitant products included CALCIUM for Calcium supplementation, VITAMIN D3 for Vitamin D supplementation, MULTIVITAMIN [VITAMINS NOS] for Vitamin supplementation.    On 22-Mar-2021 at 12:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Mar-2021 at 6:00 PM, the patient experienced PAIN IN EXTREMITY (Sore arm//had very mild side effects from the first vaccine) and FATIGUE (Mild fatigue/had very mild side effects from the first vaccine). On 23-Mar-2021, PAIN IN EXTREMITY (Sore arm//had very mild side effects from the first vaccine) and FATIGUE (Mild fatigue/had very mild side effects from the first vaccine) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       There were no other potential causes for adverse events.  Patient was concerned about the long-term effects and consequences of having received a full dose instead of half dose as a healthy person. Patient did not seek medical care.  No treatment medication were provided.   This case was linked to MOD-2021-405083 (Patient Link).