chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Illness, Immunisation reaction
Clinical narrative: Got COVID after having the first two doses; Hit him pretty hard; Pretty sick; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got COVID after having the first two doses), VACCINATION COMPLICATION (Hit him pretty hard) and ILLNESS (Pretty sick) in a male 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, the patient experienced COVID-19 (Got COVID after having the first two doses), VACCINATION COMPLICATION (Hit him pretty hard) and ILLNESS (Pretty sick). At the time of the report, COVID-19 (Got COVID after having the first two doses), VACCINATION COMPLICATION (Hit him pretty hard) and ILLNESS (Pretty sick) outcome was unknown.        mRNA-1273 (Spikevax) (Unknown) was withdrawn on an unknown date.       Concomitant and treatment medication of the patient was not reported.  The patient reported that about 5 months ago (from the date of reporting), his car got broken into and his wallet was stolen with vaccination card. The patient also reported that, he was not going to get the booster.  Company comments:This case concerns a male patient of unknown age, with no reported medical history, who experienced the unexpected, non-serious, AESI event of COVID-19, on an unknown date after receiving two doses of mRNA-1273.  The dates of both doses were unknown.   Clinical course and treatment were not reported in this case.  Additionally, patient reported unspecified non-serious side effects after both doses. At the time of the report, the outcome of the event of COVID-19 was unknown.  The benefit-risk relationship of mRNA-1273 is not affected by this report   This case was linked to MOD-2022-522464 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2022: Follow-up information contains addition of reporter's phone number.; Sender's Comments: This case concerns a male patient of unknown age, with no reported medical history, who experienced the unexpected, non-serious, AESI event of COVID-19, on an unknown date after receiving two doses of mRNA-1273.  The dates of both doses were unknown.   Clinical course and treatment were not reported in this case.  Additionally, patient reported unspecified non-serious side effects after both doses. At the time of the report, the outcome of the event of COVID-19 was unknown.  The benefit-risk relationship of mRNA-1273 is not affected by this report
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: a moderately to severely immunocompromised patient received a half dose booster dose instead of full 3rd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (a moderately to severely immunocompromised patient received a half dose booster dose instead of full 3rd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    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 ACCIDENTAL UNDERDOSE (a moderately to severely immunocompromised patient received a half dose booster dose instead of full 3rd dose). At the time of the report, ACCIDENTAL UNDERDOSE (a moderately to severely immunocompromised patient received a half dose booster dose instead of full 3rd 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. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Immunocompromised patient received 0.25 mL as a 3rd dose instead of 0.5mL full dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised patient received 0.25 mL as a 3rd dose instead of 0.5mL 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 Immunocompromised.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised patient received 0.25 mL as a 3rd dose instead of 0.5mL full dose). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised patient received 0.25 mL as a 3rd dose instead of 0.5mL full dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided. No treatment medication was provided.  The patient wants the 4th dose because they are immunocompromised.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): 25 hours and 34 minutes; Patient received expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and PRODUCT STORAGE ERROR (Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): 25 hours and 34 minutes) in a 50-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 066K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2022 at 12:10 PM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 24-Mar-2022 at 12:10 PM, after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): 25 hours and 34 minutes). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and PRODUCT STORAGE ERROR (Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): 25 hours and 34 minutes) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported On 13-Mar-2022, the vial was initially stored in the refrigerator. On 23-Mar-2022 at 10:36 AM, the vial was first punctured. Vial was stored in room temperature post puncture and no  previous temperature excursion. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was 25 hours and 34 minutes. The vaccine bottle expired on 23-Mar-2022 at 10:36 PM. No treatment drugs were reported.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dehydration, Tremor
Clinical narrative: Dehydrated; Shaking; chills; This spontaneous case was reported by a consumer and describes the occurrence of DEHYDRATION (Dehydrated), TREMOR (Shaking) and CHILLS (chills) in a male 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 DEHYDRATION (Dehydrated), TREMOR (Shaking) and CHILLS (chills). At the time of the report, DEHYDRATION (Dehydrated), TREMOR (Shaking) and CHILLS (chills) outcome was unknown.            No concomitant medications were reported.  No treatment details were reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Sore vaccination arm; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore vaccination arm) and PYREXIA (Fever) in a 60-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore vaccination arm) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (Sore vaccination arm) and PYREXIA (Fever) outcome was unknown.            No concomitant medication was provided  Treatment information was not provided.   This case was linked to MOD-2022-522832 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort
Clinical narrative: like somebody punched them in the arm/felt the same thing; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (like somebody punched them in the arm/felt the same thing) 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 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCOMFORT (like somebody punched them in the arm/felt the same thing). At the time of the report, VACCINATION SITE DISCOMFORT (like somebody punched them in the arm/felt the same thing) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. The first two doses were given on 13FEB2021 and 15MAR2021 both given in left arm. Caller says wife complained about for a day or so and he did the same with the first two, was like somebody punched them in the arm for 2,3,4 days. After the booster they felt the same thing and hers cleared up in 3-4 days but his did not.  No treatment medications were reported.   This case was linked to MOD-2022-523033, MOD-2022-523034 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Myalgia
Clinical narrative: slight headache and body ache after the first 2 doses; slight headache and body ache after the first 2 doses; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (slight headache and body ache after the first 2 doses) and MYALGIA (slight headache and body ache after the first 2 doses) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LAMOTRIGINE (LAMICTAL) and GABAPENTIN for an unknown indication.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (slight headache and body ache after the first 2 doses) and MYALGIA (slight headache and body ache after the first 2 doses). At the time of the report, HEADACHE (slight headache and body ache after the first 2 doses) and MYALGIA (slight headache and body ache after the first 2 doses) outcome was unknown.            Treatment information was not provided by the reporter.   This case was linked to MOD-2022-522878, MOD-2022-522960 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Myalgia
Clinical narrative: slight headache; body ache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (slight headache) and MYALGIA (body ache) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LAMOTRIGINE (LAMICTAL) and GABAPENTIN for an unknown indication.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced HEADACHE (slight headache) and MYALGIA (body ache). At the time of the report, HEADACHE (slight headache) and MYALGIA (body ache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment information was not reported.  The patient had received the primary series and booster dose of Moderna vaccine 7.5 months ago and had visited 2 neurologists and a neurosurgeon. The patient had no fever or experienced anything else after the first dose.   This case was linked to MOD-2022-522955, MOD-2022-522878 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Non immunocompromised patient has received 2 booster doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Non immunocompromised patient has received 2 booster doses) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus.   In October 2021, the patient 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 received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced EXTRA DOSE ADMINISTERED (Non immunocompromised patient has received 2 booster doses). At the time of the report, EXTRA DOSE ADMINISTERED (Non immunocompromised patient has received 2 booster doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. No treatment medication was reported by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort
Clinical narrative: Like somebody punched them in the arm/felt the same thing; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (Like somebody punched them in the arm/felt the same thing) 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 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE DISCOMFORT (Like somebody punched them in the arm/felt the same thing). In 2021, VACCINATION SITE DISCOMFORT (Like somebody punched them in the arm/felt the same thing) had resolved.            No Concomitant information was reported. No Treatment information was reported. Patient has complained about hers for a day was like somebody punched her in the arm for 2,3,4 days.   This case was linked to MOD-2022-522811, MOD-2022-522804, MOD-2022-522968, MOD-2022-523034 (Patient Link).
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Three doses were given outside the 12-hour window; dose was given outside the 12-hour window; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was given outside the 12-hour window) and PRODUCT STORAGE ERROR (Three doses were given outside the 12-hour window) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was given outside the 12-hour window). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Three doses were given outside the 12-hour window). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose was given outside the 12-hour window) and PRODUCT STORAGE ERROR (Three doses were given outside the 12-hour window) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.  It was reported that the vaccine was stored in the fridge at night of 22-Mar-2022 and left in the fridge for overnight. It was also reported that the vial was first punctured on 23-Mar-2022 around 10:15 am and was administered on 24-Mar-2022.  The vial did not underwent any temperature excursions and was exposed to room temperature for maybe 5 minutes.   This case was linked to MOD-2022-523279, MOD-2022-523314 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Three doses were given outside the 12-hour window; Three doses were given outside the 12-hour window; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Three doses were given outside the 12-hour window) and PRODUCT STORAGE ERROR (Three doses were given outside the 12-hour window) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K212A, 047B21A and 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Three doses were given outside the 12-hour window). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Three doses were given outside the 12-hour window). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Three doses were given outside the 12-hour window) and PRODUCT STORAGE ERROR (Three doses were given outside the 12-hour window) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had received booster shot. No concomitant information was reported. The vial was initially stored in the refrigerator at night of 22 Mar 2022 and the vial was first punctured on 23 Mar 2022 around 10.15 AM. Vaccine that were left in the fridge overnight.The vial did not undergone any temperature excursions. Time the vial was exposed to room temperature range only for drawing up the doses, maybe 5 minutes. No treatment information was reported.   This case was linked to MOD-2022-523240, MOD-2022-523314 (Patient Link).
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: dose was given outside the 12-hour window; dose was given outside the 12-hour window; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was given outside the 12-hour window) and PRODUCT STORAGE ERROR (dose was given outside the 12-hour window) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-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 24-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was given outside the 12-hour window). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (dose was given outside the 12-hour window). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose was given outside the 12-hour window) and PRODUCT STORAGE ERROR (dose was given outside the 12-hour window) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided. It was reported that number of doses/vials is 4 doses.  On night of 22-MAR-2022 vial was initially stored in the refrigerator.  On 23-MAR-2022 around 10:15 AM vial was first punctured.  The doses were drawn out and stored in the fridge.  Vial did not undergone any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) is only for drawing up the doses, maybe 5 minutes.   This case was linked to MOD-2022-523240, MOD-2022-523279 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: After the second shot, her hair started to fall out; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (After the second shot, her hair started to fall out) in a 78-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 040B21A and 032B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. 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 ALOPECIA (After the second shot, her hair started to fall out). At the time of the report, ALOPECIA (After the second shot, her hair started to fall out) outcome was unknown.            The patient weight reported as 192. The patient had no past medical history. Patient did not disclose medication, concomitant drugs were not reported. Patient did not receive treatment.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old received first dose; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received first dose) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received first dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received first dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.   On 09-Feb-2022, received second dose of vaccine (lot number: 022J21A).  Treatment medications were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: She did not feel like herself; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (She did not feel like herself) 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 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (She did not feel like herself). At the time of the report, FEELING ABNORMAL (She did not feel like herself) outcome was unknown.            No concomitant medications were provided. No treatment medications were reported. The patient stated that she did not felt like herself after the first and the second dose of the Moderna Covid-19 vaccine. The patient got fully vaccinated with her first two Moderna Covid-19 vaccinations. The patient has not yet received her Moderna Covid-19 booster dose.   This case was linked to MOD-2022-523616 (Patient Link).   Reporter did not allow further contact
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding
Clinical narrative: dose administered to a patient who is breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (dose administered to a patient who is breastfeeding) in a 26-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 25-Mar-2022, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (dose administered to a patient who is breastfeeding). On 25-Mar-2022, MATERNAL EXPOSURE DURING BREAST FEEDING (dose administered to a patient who is breastfeeding) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: immunocompromised patient given 0.25ml as 3rd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (immunocompromised patient given 0.25ml as 3rd 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 Immunocompromised.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (immunocompromised patient given 0.25ml as 3rd dose). At the time of the report, UNDERDOSE (immunocompromised patient given 0.25ml as 3rd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient was on high dose of immunocompromising medication before the vaccine.  The patient was then in the facility to get the booster dose as 4th dose. HCP was asking whether they should give an additional 0.25ml or give a full dose 0.5ml.  No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Immunocompromised patient received the booster instead of the 3rd dose; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised patient received the booster instead of the 3rd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised patient received the booster instead of the 3rd dose). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised patient received the booster instead of the 3rd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medications was reported.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Product was placed in refrigerator on 19Feb2022; One of our locations give a dose of Moderna Covid-19 vaccine 2 days beyond the 30 day beyond use date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (One of our locations give a dose of Moderna Covid-19 vaccine 2 days beyond the 30 day beyond use date.) and PRODUCT STORAGE ERROR (Product was placed in refrigerator on 19Feb2022) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 21-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (One of our locations give a dose of Moderna Covid-19 vaccine 2 days beyond the 30 day beyond use date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product was placed in refrigerator on 19Feb2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (One of our locations give a dose of Moderna Covid-19 vaccine 2 days beyond the 30 day beyond use date.) and PRODUCT STORAGE ERROR (Product was placed in refrigerator on 19Feb2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Product was placed in refrigerator on 19-Feb-2022 and Use by date was 19-Mar-2022. Reporter reported that at one of our locations give a dose of Moderna Covid-19 vaccine 2 days beyond the 30 day beyond use date.  No concomitant drug information was provided. No treatment drug information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2022: Follow-up received contains no new information
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Morphoea, Pruritus, Skin discomfort
Clinical narrative: Skin morphing; Skin grew under her skin; the skin grew under her skin and is itchy, red and is circular; the skin grew under her skin and is itchy, red and is circular; This spontaneous case was reported by a consumer and describes the occurrence of MORPHOEA (Skin morphing), SKIN DISCOMFORT (Skin grew under her skin), ERYTHEMA (the skin grew under her skin and is itchy, red and is circular) and PRURITUS (the skin grew under her skin and is itchy, red and is circular) 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 MORPHOEA (Skin morphing), SKIN DISCOMFORT (Skin grew under her skin), ERYTHEMA (the skin grew under her skin and is itchy, red and is circular) and PRURITUS (the skin grew under her skin and is itchy, red and is circular). At the time of the report, MORPHOEA (Skin morphing), SKIN DISCOMFORT (Skin grew under her skin), ERYTHEMA (the skin grew under her skin and is itchy, red and is circular) and PRURITUS (the skin grew under her skin and is itchy, red and is circular) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: A immunocompromised patient on his 3rd dose received only 0.25mL.; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (A immunocompromised patient on his 3rd dose received only 0.25mL.) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 30-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, the patient experienced UNDERDOSE (A immunocompromised patient on his 3rd dose received only 0.25mL.). At the time of the report, UNDERDOSE (A immunocompromised patient on his 3rd dose received only 0.25mL.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No information on concomitant medication was reported. The patient received 3 Covid-19 vaccine doses. He was coming in for his fourth dose.  No information on treatment medications were reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2022: Follow-up information received includes no newmedically significant information.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: 17 strokes in vaccinated persons; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (17 strokes in vaccinated persons) 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 CEREBROVASCULAR ACCIDENT (17 strokes in vaccinated persons) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (17 strokes in vaccinated persons) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant product use was provided by the reporter. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2022: Live Significant follow-up. Reporter's causality updated.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised patient received half booster dose as 3rd dose) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A, 002A21A and 007M20A) for COVID-19 vaccination. Concurrent medical conditions included Cancer. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 27-Oct-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised patient received half booster dose as 3rd dose). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised patient received half booster dose as 3rd dose) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications reported included unspecified cancer treatment medications. Patient did not report any adverse reactions to the 3 doses. Treatment information was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (fever) 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 PYREXIA (fever). At the time of the report, PYREXIA (fever) 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.   No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered the Moderna Covid-19 vaccine which was beyond the 6 month expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered the Moderna Covid-19 vaccine which was beyond the 6 month expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2022 at 1:20 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered the Moderna Covid-19 vaccine which was beyond the 6 month expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered the Moderna Covid-19 vaccine which was beyond the 6 month expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment information was provided by the reporter.  It was the patient's booster dose. Manufacturing date of Moderna Covid-19 vaccine  was reported as 24-Aug-2021
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Chills, Epistaxis, Headache, Insomnia
Clinical narrative: Nose congestion; Soreness in shoulder at injection site; Fever/Chills; Inability to sleep the first night; Lingering headache (3 days); Backache (upper and lower); Sore neck; Nose bleed; Fever/Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: NASAL CONGESTION (non-serious) with onset Apr2021, outcome "unknown", described as "Nose congestion"; VACCINATION SITE PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "Soreness in shoulder at injection site"; CHILLS (non-serious), PYREXIA (non-serious) all with onset Apr2021, outcome "unknown" and all described as "Fever/Chills"; INSOMNIA (non-serious) with onset Apr2021, outcome "unknown", described as "Inability to sleep the first night"; HEADACHE (non-serious) with onset Apr2021, outcome "unknown", described as "Lingering headache (3 days)"; BACK PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "Backache (upper and lower)"; NECK PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "Sore neck"; EPISTAXIS (non-serious) with onset Apr2021, outcome "unknown", described as "Nose bleed".  Additional information: Patient did not take any medications and was generally good health. It was mentioned that the patient tested positive for COVID post 2 doses of Covid vaccine and Comirnaty doses conclude on 25Apr2021.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Nasal congestion, Neck pain, Pyrexia, Vaccination site pain
Clinical narrative: Nose congestion; Soreness in shoulder at injection site; Fever/Chills; Inability to sleep the first night; Lingering headache (3 days); Backache (upper and lower); Sore neck; Nose bleed; Fever/Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: NASAL CONGESTION (non-serious) with onset Apr2021, outcome "unknown", described as "Nose congestion"; VACCINATION SITE PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "Soreness in shoulder at injection site"; CHILLS (non-serious), PYREXIA (non-serious) all with onset Apr2021, outcome "unknown" and all described as "Fever/Chills"; INSOMNIA (non-serious) with onset Apr2021, outcome "unknown", described as "Inability to sleep the first night"; HEADACHE (non-serious) with onset Apr2021, outcome "unknown", described as "Lingering headache (3 days)"; BACK PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "Backache (upper and lower)"; NECK PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "Sore neck"; EPISTAXIS (non-serious) with onset Apr2021, outcome "unknown", described as "Nose bleed".  Additional information: Patient did not take any medications and was generally good health. It was mentioned that the patient tested positive for COVID post 2 doses of Covid vaccine and Comirnaty doses conclude on 25Apr2021.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: my hair started falling out; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANFACTURER: UNKNOWN, DOSE 1, SINGLE), for COVID-19 immunization; Covid-19 vaccine (MANUFACTURER: UNKNOWN, DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "my hair started falling out".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (07Mar2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Cervicobrachial syndrome, Muscle spasms, Neck pain
Clinical narrative: left shoulder sometimes it feels like he walked into a spider web and it catches his neck and left chest and shoulder area; spotty spasm feeling in that general area [neck, left chest and shoulder area]; Pain in the left shoulder; Pain on the left side of the neck; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster) single for covid-19 immunisation. Relevant medical history included: "Leukaemia" (ongoing), notes: Verbatim: Leukemia. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Lot: Unknown), administration date: Apr2021, when the patient was 65 years old, for COVID-19 immunization; Bnt162b2 (Dose: 2, Lot: Unknown), administration date: 2021, when the patient was 65 years old, for COVID-19 immunization. The following information was reported: CERVICOBRACHIAL SYNDROME (non-serious), outcome "not recovered", described as "left shoulder sometimes it feels like he walked into a spider web and it catches his neck and left chest and shoulder area"; MUSCLE SPASMS (non-serious), outcome "not recovered", described as "spotty spasm feeling in that general area [neck, left chest and shoulder area]"; ARTHRALGIA (non-serious), outcome "recovered", described as "Pain in the left shoulder"; NECK PAIN (non-serious), outcome "recovered", described as "Pain on the left side of the neck". The events "left shoulder sometimes it feels like he walked into a spider web and it catches his neck and left chest and shoulder area", "spotty spasm feeling in that general area [neck, left chest and shoulder area]", "pain in the left shoulder" and "pain on the left side of the neck" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of cervicobrachial syndrome, muscle spasms, arthralgia, neck pain.  Additional information: Caller states this started 4-5 days after his booster dose of the vaccine. It was reported that the patient stated it started with pain in his left shoulder that started the day after the booster dose. He also had pain on the left side of his neck starting the day after the booster dose. All those resolved 10 days after the shot. The patient stated that his side effects alternate between the spider web feeling and the spasm feeling. The patient did not had any prior vaccinations within 4 weeks. The patient did not had any family medical history relevant to AEs and relevant tests.   Follow-up attempts completed. No further information is expected.