chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No Adverse event; 12 year old siblings who received the Moderna's Bivalent booster instead of the Pfizer's Bivalent booster; 12 year old siblings who received the Moderna's Bivalent booster instead of the Pfizer's Bivalent booster; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old siblings who received the Moderna's Bivalent booster instead of the Pfizer's Bivalent booster), WRONG PRODUCT ADMINISTERED (12 year old siblings who received the Moderna's Bivalent booster instead of the Pfizer's Bivalent booster) and NO ADVERSE EVENT (No Adverse event) in a 12-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Sep-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old siblings who received the Moderna's Bivalent booster instead of the Pfizer's Bivalent booster) and WRONG PRODUCT ADMINISTERED (12 year old siblings who received the Moderna's Bivalent booster instead of the Pfizer's Bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old siblings who received the Moderna's Bivalent booster instead of the Pfizer's Bivalent booster), WRONG PRODUCT ADMINISTERED (12 year old siblings who received the Moderna's Bivalent booster instead of the Pfizer's Bivalent booster) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old siblings who received the Moderna's Bivalent booster instead of the Pfizer's Bivalent booster) and WRONG PRODUCT ADMINISTERED (12 year old siblings who received the Moderna's Bivalent booster instead of the Pfizer's Bivalent booster).    Concomitant medication was not provided.  The dose administered was booster.  Treatment information was not provided.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Frustration tolerance decreased, Wrong product administered
Clinical narrative: Husband received the monovalent vaccine/Husband received Monovalent as 3rd booster dose; We are frustrated; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FRUSTRATION TOLERANCE DECREASED (We are frustrated) and WRONG PRODUCT ADMINISTERED (Husband received the monovalent vaccine/Husband received Monovalent as 3rd booster dose) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Husband received the monovalent vaccine/Husband received Monovalent as 3rd booster dose). In September 2022, the patient experienced FRUSTRATION TOLERANCE DECREASED (We are frustrated). At the time of the report, FRUSTRATION TOLERANCE DECREASED (We are frustrated) and WRONG PRODUCT ADMINISTERED (Husband received the monovalent vaccine/Husband received Monovalent as 3rd booster dose) outcome was unknown.            No concomitant medications were reported.  Patient received third Moderna booster.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-647556 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2022: Follow up received and patient details, additional event and narrative update.; Sender's Comments: US-MODERNATX, INC.-MOD-2022-647556:same reporter.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Nasal congestion, Oropharyngeal pain
Clinical narrative: She also had congestion in nasal passages, and sore throat on and off after all vaccinations; She also had congestion in nasal passages, and sore throat on and off after all vaccinations; This spontaneous case was reported by a patient and describes the occurrence of NASAL CONGESTION (She also had congestion in nasal passages, and sore throat on and off after all vaccinations) and OROPHARYNGEAL PAIN (She also had congestion in nasal passages, and sore throat on and off after all vaccinations) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Lupus erythematosus (Lupus in 1975 secondary to Tetracycline (Went away by d/c of tetracycline)) in 1975. Previously administered products included for Drug use for unknown indication: Tetracycline in 1975. Past adverse reactions to the above products included Lupus erythematosus with Tetracycline. Concurrent medical conditions included Lyme disease since 2013 and Hypothyroidism. Concomitant products included THYROID (ARMOUR THYROID) for Hypothyroidism.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced NASAL CONGESTION (She also had congestion in nasal passages, and sore throat on and off after all vaccinations) and OROPHARYNGEAL PAIN (She also had congestion in nasal passages, and sore throat on and off after all vaccinations). At the time of the report, NASAL CONGESTION (She also had congestion in nasal passages, and sore throat on and off after all vaccinations) and OROPHARYNGEAL PAIN (She also had congestion in nasal passages, and sore throat on and off after all vaccinations) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: had 2 Negative Lyme Disease tests before and after vaccination.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that she had congestion in nasal passages, and sore throat on and off after all vaccinations and in between. She thinks she has Mold around her home that may be causing it. She states that this issue did not exist prior to Pandemic and vaccinations. No treatment medications were reported.   This case was linked to MOD-2022-647550 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Lyme disease, Nasal congestion, Oropharyngeal pain
Clinical narrative: She also had congestion in nasal passages, and sore throat on and off after all vaccinations; She also had congestion in nasal passages, and sore throat on and off after all vaccinations; This spontaneous case was reported by a patient and describes the occurrence of NASAL CONGESTION (She also had congestion in nasal passages, and sore throat on and off after all vaccinations) and OROPHARYNGEAL PAIN (She also had congestion in nasal passages, and sore throat on and off after all vaccinations) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Lupus erythematosus (Lupus in 1975 secondary to Tetracycline (Went away by d/c of tetracycline)) in 1975. Previously administered products included for Drug use for unknown indication: Tetracycline in 1975. Past adverse reactions to the above products included Lupus erythematosus with Tetracycline. Concurrent medical conditions included Lyme disease since 2013 and Hypothyroidism. Concomitant products included THYROID (ARMOUR THYROID) for Hypothyroidism.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced NASAL CONGESTION (She also had congestion in nasal passages, and sore throat on and off after all vaccinations) and OROPHARYNGEAL PAIN (She also had congestion in nasal passages, and sore throat on and off after all vaccinations). At the time of the report, NASAL CONGESTION (She also had congestion in nasal passages, and sore throat on and off after all vaccinations) and OROPHARYNGEAL PAIN (She also had congestion in nasal passages, and sore throat on and off after all vaccinations) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: had 2 Negative Lyme Disease tests before and after vaccination.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that she had congestion in nasal passages, and sore throat on and off after all vaccinations and in between. She thinks she has Mold around her home that may be causing it. She states that this issue did not exist prior to Pandemic and vaccinations. No treatment medications were reported.   This case was linked to MOD-2022-647550 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort
Clinical narrative: I experienced discomfort in the arm in which I received the shot.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE DISCOMFORT (I experienced discomfort in the arm in which I received the shot.) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005M21A, 037F21A, 023M20A and 032L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high since 2018. Concomitant products included DILTIAZEM for Blood pressure high.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-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 VACCINATION SITE DISCOMFORT (I experienced discomfort in the arm in which I received the shot.). At the time of the report, VACCINATION SITE DISCOMFORT (I experienced discomfort in the arm in which I received the shot.) outcome was unknown.            No acute illnesses at the time of vaccination. Patient was never diagnosed or tested positive for COVID-19.  After both the boosters patient experienced discomfort in the arm in which she received the shot. No treatment medication were reported.   This case was linked to MOD-2022-644263, MOD-2021-024267 (Patient Link).
Sex: M
Vaccine: COVID19-2
Symptoms: Malaise, Pyrexia
Clinical narrative: patient didn't feel very well; patient was experiencing high temperature; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (patient didn't feel very well) and PYREXIA (patient was experiencing high temperature) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Sep-2022, the patient experienced MALAISE (patient didn't feel very well) and PYREXIA (patient was experiencing high temperature). At the time of the report, MALAISE (patient didn't feel very well) and PYREXIA (patient was experiencing high temperature) outcome was unknown.            No concomitant medication was reported.    On an unknown date the patient received first dose with unknown lot number. On an unknown date the patient received second dose unknown lot number. On an unknown date the patient received first Moderna booster vaccine with unknown lot number. On an unknown date the patient received second Moderna booster vaccine with unknown lot number. Patient mentioned that with previous booster of Moderna COVID-19 Vaccine a few months ago, he didn't experience any side effects.  No treatment information was reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Adult patient received 2 child shots instead of Bivalent adult shot.; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (Adult patient received 2 child shots instead of Bivalent adult shot.) and NO ADVERSE EVENT (No adverse event) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Adult patient received 2 child shots instead of Bivalent adult shot.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Adult patient received 2 child shots instead of Bivalent adult shot.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            The patient was taking concomitant medication but did not specified on which medication exactly.  The patient had no allergies.   When the patient got the shot, the person that gave the shot made a mistake and gave the juvenile dosage and so on same day they gave patient a second shot of the MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) with batch no. AS7145B. The patient went there to get the BA5. The patient did not know what patient got so patient got two shots.   Reporter stated that the pharmacist said gave the patient received wrong shot, they gave patient the juvenile shot. The patient wanted to know if 2 shots of the Moderna Covid-19 vaccine bivalent are equivalent to 1 adult dose of the bivalent vaccine.  The patient was not tested positive for COVID-19.  No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2022: Live follow-up received. Updated narrative.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; administered 1 dose of Moderna COVID-19 Vaccine to a patient on 19Sep2022 after expiry date (15Sep2022); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 1 dose of Moderna COVID-19 Vaccine to a patient on 19Sep2022 after expiry date (15Sep2022)) and NO ADVERSE EVENT (No adverse event) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M21A) for COVID-19 vaccination.     Relevant medical history reported as No Allergies (medications, food and other products). It was unknown if patient ever had COVID positive test or diagnosis. It was unknown if patient had Acute and Chronic illnesses at the time of vaccination. No Other vaccines given within 1 month prior to Moderna COVID-19 vaccine.     On 19-Sep-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 1 dose of Moderna COVID-19 Vaccine to a patient on 19Sep2022 after expiry date (15Sep2022)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 1 dose of Moderna COVID-19 Vaccine to a patient on 19Sep2022 after expiry date (15Sep2022)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered 1 dose of Moderna COVID-19 Vaccine to a patient on 19Sep2022 after expiry date (15Sep2022)).    Reporter did not know if patient was under any concomitant or regular medication.  Patient received unknown 1st dose of vaccine with unknown Lot number and Expiration date. No AEs were reported. It was unknown when the vaccine vial was initially stored in the refrigerator. The Vial did not undergo any temperature excursion.  Reporter did not know if any treatment was given
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (her arm hurt like a sun of a gun/She had pain in the arm and it was sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. In May 2022, 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. On an unknown date, the patient experienced PAIN IN EXTREMITY (her arm hurt like a sun of a gun/She had pain in the arm and it was sore). At the time of the report, PAIN IN EXTREMITY (her arm hurt like a sun of a gun/She had pain in the arm and it was sore) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication information was not provided by the reporter. On an unknown date, the patient received first booster dose and received second booster dose on May-2022. On an unknown date, the pain went away. Treatment information was not provided by the reporter. Reporter did not allow further contact.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was iniially stored in refrigerator on 10-Aug-2022 expired on 10-Sep-2022 and was administered on 19-Sep-2022; No adverse event; Patient received expired doses of the Moderna Vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired doses of the Moderna Vaccine), PRODUCT STORAGE ERROR (The vial was iniially stored in refrigerator on 10-Aug-2022 expired on 10-Sep-2022 and was administered on 19-Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 24-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 001M21A) for COVID-19 prophylaxis.     Patient has no Allergies.  It was unknown whether patient ever had COVID positive test or diagnosis.     On 19-Sep-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 19-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired doses of the Moderna Vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was iniially stored in refrigerator on 10-Aug-2022 expired on 10-Sep-2022 and was administered on 19-Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired doses of the Moderna Vaccine), PRODUCT STORAGE ERROR (The vial was iniially stored in refrigerator on 10-Aug-2022 expired on 10-Sep-2022 and was administered on 19-Sep-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired doses of the Moderna Vaccine) and PRODUCT STORAGE ERROR (The vial was iniially stored in refrigerator on 10-Aug-2022 expired on 10-Sep-2022 and was administered on 19-Sep-2022).    No concomitant medications were reported. Patient not received other vaccines within 1 month prior to Moderna COVID-19 vaccine It was in the original box, but it was the last vial left.  The vial size was 5.5 ml. The vial was initially stored in the refrigerator on 10-Aug-2022. The vial did not undergo any temperature excursions. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-648029 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2022: Follow-up received contains no new information; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-648029:Second patient case
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: on 10Aug2022 vial was initially stored in the refrigerator, Expired on 10Sep2022, administered on 19Sep2022; no adverse event; patient received expired doses of the Moderna Vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired doses of the Moderna Vaccine), PRODUCT STORAGE ERROR (on 10Aug2022 vial was initially stored in the refrigerator, Expired on 10Sep2022, administered on 19Sep2022) and NO ADVERSE EVENT (no adverse event) in a 27-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 001M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Sep-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 19-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired doses of the Moderna Vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (on 10Aug2022 vial was initially stored in the refrigerator, Expired on 10Sep2022, administered on 19Sep2022) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received expired doses of the Moderna Vaccine), PRODUCT STORAGE ERROR (on 10Aug2022 vial was initially stored in the refrigerator, Expired on 10Sep2022, administered on 19Sep2022) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient received expired doses of the Moderna Vaccine) and PRODUCT STORAGE ERROR (on 10Aug2022 vial was initially stored in the refrigerator, Expired on 10Sep2022, administered on 19Sep2022).    No concomitant medications were reported. Patient not received other vaccines within 1 month prior to Moderna COVID-19 vaccine It was in the original box, but it was the last vial left.  The vial size was 5.5 ml. The vial was initially stored in the refrigerator on 10-Aug-2022. The vial did not undergo any temperature excursions. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-648026 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2022: Follow-up received contains no new information; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-648026:First patient case
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Fatigue, Illness, Lethargy, Pain in extremity
Clinical narrative: More than 28 days in between doses of the Moderna Covid-19 vaccine,did not come back for their second dose until today; very sick; lethargic; tired/Very tired and run down; sore left arm; This spontaneous case was reported by a pharmacist and describes the occurrence of ILLNESS (very sick), LETHARGY (lethargic), FATIGUE (tired/Very tired and run down), PAIN IN EXTREMITY (sore left arm) and PRODUCT ADMINISTRATION INTERRUPTED (More than 28 days in between doses of the Moderna Covid-19 vaccine,did not come back for their second dose until today) in a 29-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 058A22A) for COVID-19 vaccination.     Concurrent medical conditions included Hemoglobin low.    On 14-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Jun-2022, the patient experienced ILLNESS (very sick), LETHARGY (lethargic), FATIGUE (tired/Very tired and run down) and PAIN IN EXTREMITY (sore left arm). On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (More than 28 days in between doses of the Moderna Covid-19 vaccine,did not come back for their second dose until today). At the time of the report, ILLNESS (very sick), LETHARGY (lethargic), FATIGUE (tired/Very tired and run down), PAIN IN EXTREMITY (sore left arm) and PRODUCT ADMINISTRATION INTERRUPTED (More than 28 days in between doses of the Moderna Covid-19 vaccine,did not come back for their second dose until today) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2022, Blood test: low hemoglobin.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Patient height and weight were unknown. No concomitant medications was reported. Patient went for a blood test and her iron test and had a low hemoglobin. No treatment medications was reported.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration interrupted
Clinical narrative: More than 28 days in between doses of the Moderna Covid-19 vaccine,did not come back for their second dose until today; very sick; lethargic; tired/Very tired and run down; sore left arm; This spontaneous case was reported by a pharmacist and describes the occurrence of ILLNESS (very sick), LETHARGY (lethargic), FATIGUE (tired/Very tired and run down), PAIN IN EXTREMITY (sore left arm) and PRODUCT ADMINISTRATION INTERRUPTED (More than 28 days in between doses of the Moderna Covid-19 vaccine,did not come back for their second dose until today) in a 29-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 058A22A) for COVID-19 vaccination.     Concurrent medical conditions included Hemoglobin low.    On 14-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Jun-2022, the patient experienced ILLNESS (very sick), LETHARGY (lethargic), FATIGUE (tired/Very tired and run down) and PAIN IN EXTREMITY (sore left arm). On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (More than 28 days in between doses of the Moderna Covid-19 vaccine,did not come back for their second dose until today). At the time of the report, ILLNESS (very sick), LETHARGY (lethargic), FATIGUE (tired/Very tired and run down), PAIN IN EXTREMITY (sore left arm) and PRODUCT ADMINISTRATION INTERRUPTED (More than 28 days in between doses of the Moderna Covid-19 vaccine,did not come back for their second dose until today) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2022, Blood test: low hemoglobin.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Patient height and weight were unknown. No concomitant medications was reported. Patient went for a blood test and her iron test and had a low hemoglobin. No treatment medications was reported.
Age: 0.58
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial initially stored in the refrigerator on 18-Aug-2022 and then administered on 19-Sep-2022; No adverse event; Patient received Moderna Covid 19 vaccine 2 days after the 30 day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid 19 vaccine 2 days after the 30 day use by date), PRODUCT STORAGE ERROR (Vial initially stored in the refrigerator on 18-Aug-2022 and then administered on 19-Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 7-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination.     It was reported that patient had no allergies. Patient had never tested positive for COVID-19.     On 19-Sep-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid 19 vaccine 2 days after the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored in the refrigerator on 18-Aug-2022 and then administered on 19-Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid 19 vaccine 2 days after the 30 day use by date), PRODUCT STORAGE ERROR (Vial initially stored in the refrigerator on 18-Aug-2022 and then administered on 19-Sep-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid 19 vaccine 2 days after the 30 day use by date) and PRODUCT STORAGE ERROR (Vial initially stored in the refrigerator on 18-Aug-2022 and then administered on 19-Sep-2022).    No concomitant medication given.  The monovalent vial was of 2.5 ml size. The vial did not undergo any temperature excursion.  Treatment medications were not provided.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: patient never returned for their second dose; No adverse event; This spontaneous case was reported by an other health professional and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (patient never returned for their second dose) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-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 PRODUCT ADMINISTRATION INTERRUPTED (patient never returned for their second dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (patient never returned for their second dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (patient never returned for their second dose).    It was reported that, reporter was a student pharmacist. No concomitant products were reported. It was reported that, patient now interested in completing the series. No treatment information were reported
Age: 42.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Fatigue, Hypoaesthesia, Myalgia, Paraesthesia
Clinical narrative: Numbness / Numbness in the left hand, described it as decrease sensation in left hand; Paresthesia of left hand, thumb, and index finger; Pain on the injection site (Left Deltoid) after bivalent booster; Chills; Fatigue; Muscle Pain; This spontaneous case was reported by a physician and describes the occurrence of HYPOAESTHESIA (Numbness / Numbness in the left hand, described it as decrease sensation in left hand), PARAESTHESIA (Paresthesia of left hand, thumb, and index finger), VACCINATION SITE PAIN (Pain on the injection site (Left Deltoid) after bivalent booster), CHILLS (Chills) and FATIGUE (Fatigue) in a 42-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 07-Sep-2022, the patient experienced HYPOAESTHESIA (Numbness / Numbness in the left hand, described it as decrease sensation in left hand), PARAESTHESIA (Paresthesia of left hand, thumb, and index finger), VACCINATION SITE PAIN (Pain on the injection site (Left Deltoid) after bivalent booster), CHILLS (Chills), FATIGUE (Fatigue) and MYALGIA (Muscle Pain). At the time of the report, HYPOAESTHESIA (Numbness / Numbness in the left hand, described it as decrease sensation in left hand), PARAESTHESIA (Paresthesia of left hand, thumb, and index finger), VACCINATION SITE PAIN (Pain on the injection site (Left Deltoid) after bivalent booster), CHILLS (Chills), FATIGUE (Fatigue) and MYALGIA (Muscle Pain) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. On SEP-2021, Patient received first Moderna COVID-19 Monovalent Booster dose of unknown lot number and expiry date. It was reported that all of the patient's previous shots were also Moderna COVID-19 vaccine but did not have the lot number and exact dates. Patient did not report side effects after previous Moderna COVID-19 shots. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-648147, US-MODERNATX, INC.-MOD-2022-648133 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-648147:MOD22-024161 (same reporter) US-MODERNATX, INC.-MOD-2022-648133:MOD22-024156 (crosslinked case with same reporter)
Age: 42.0
Sex: F
Vaccine: COVID19-2
Symptoms: Vaccination site pain
Clinical narrative: Numbness / Numbness in the left hand, described it as decrease sensation in left hand; Paresthesia of left hand, thumb, and index finger; Pain on the injection site (Left Deltoid) after bivalent booster; Chills; Fatigue; Muscle Pain; This spontaneous case was reported by a physician and describes the occurrence of HYPOAESTHESIA (Numbness / Numbness in the left hand, described it as decrease sensation in left hand), PARAESTHESIA (Paresthesia of left hand, thumb, and index finger), VACCINATION SITE PAIN (Pain on the injection site (Left Deltoid) after bivalent booster), CHILLS (Chills) and FATIGUE (Fatigue) in a 42-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 07-Sep-2022, the patient experienced HYPOAESTHESIA (Numbness / Numbness in the left hand, described it as decrease sensation in left hand), PARAESTHESIA (Paresthesia of left hand, thumb, and index finger), VACCINATION SITE PAIN (Pain on the injection site (Left Deltoid) after bivalent booster), CHILLS (Chills), FATIGUE (Fatigue) and MYALGIA (Muscle Pain). At the time of the report, HYPOAESTHESIA (Numbness / Numbness in the left hand, described it as decrease sensation in left hand), PARAESTHESIA (Paresthesia of left hand, thumb, and index finger), VACCINATION SITE PAIN (Pain on the injection site (Left Deltoid) after bivalent booster), CHILLS (Chills), FATIGUE (Fatigue) and MYALGIA (Muscle Pain) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. On SEP-2021, Patient received first Moderna COVID-19 Monovalent Booster dose of unknown lot number and expiry date. It was reported that all of the patient's previous shots were also Moderna COVID-19 vaccine but did not have the lot number and exact dates. Patient did not report side effects after previous Moderna COVID-19 shots. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-648147, US-MODERNATX, INC.-MOD-2022-648133 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-648147:MOD22-024161 (same reporter) US-MODERNATX, INC.-MOD-2022-648133:MOD22-024156 (crosslinked case with same reporter)
Sex: M
Vaccine: COVID19-2
Symptoms: Fatigue, Feeling abnormal, Headache, Hypersensitivity
Clinical narrative: Patient felt a little out of it; Patient head was hurting; Patient felt really tired; Patient reported an allergic reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (Patient felt a little out of it), HYPERSENSITIVITY (Patient reported an allergic reaction), HEADACHE (Patient head was hurting) and FATIGUE (Patient felt really tired) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination. No Medical History information was reported. On 19-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In September 2022, the patient experienced HYPERSENSITIVITY (Patient reported an allergic reaction). On 19-Sep-2022, the patient experienced FEELING ABNORMAL (Patient felt a little out of it), HEADACHE (Patient head was hurting) and FATIGUE (Patient felt really tired). At the time of the report, FEELING ABNORMAL (Patient felt a little out of it), HYPERSENSITIVITY (Patient reported an allergic reaction), HEADACHE (Patient head was hurting) and FATIGUE (Patient felt really tired) outcome was unknown. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments. Reporters degree was reported as PA (Physician assistant). No concomitant medication information was provided.  No treatment medication was provided.   This case was linked to MOD-2021-297516, MOD-2021-297590, MOD-2021-297591 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Patient experienced paraesthesia; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Patient experienced paraesthesia) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Patient experienced paraesthesia). At the time of the report, PARAESTHESIA (Patient experienced paraesthesia) outcome was unknown.      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: The vial was initially stored in the refrigerator on 20-Aug-2022 and was administered on 19-Sep-2022; The vial undergo 1st temperature excursion; No adverse event; Administered with vaccine stored in the fridge for 32 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with vaccine stored in the fridge for 32 days), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 20-Aug-2022 and was administered on 19-Sep-2022), PRODUCT TEMPERATURE EXCURSION ISSUE (The vial undergo 1st temperature excursion) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 053B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Sep-2022 at 3:00 PM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Sep-2022 at 3:00 PM,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with vaccine stored in the fridge for 32 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 20-Aug-2022 and was administered on 19-Sep-2022), PRODUCT TEMPERATURE EXCURSION ISSUE (The vial undergo 1st temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with vaccine stored in the fridge for 32 days), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 20-Aug-2022 and was administered on 19-Sep-2022), PRODUCT TEMPERATURE EXCURSION ISSUE (The vial undergo 1st temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered with vaccine stored in the fridge for 32 days), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 20-Aug-2022 and was administered on 19-Sep-2022) and PRODUCT TEMPERATURE EXCURSION ISSUE (The vial undergo 1st temperature excursion).    No concomitant product use was provided.  Patient was administered one dose of the Moderna monovalent vaccine which had been in the refrigerator for 32 days and administrated on 19-Sep-2022 at 3:00 PM.   The vial size was 5.5ml. The vial was initially stored in the refrigerator on 20-Aug-2022. The vial undergo 1st temperature excursion.  No treatment medication was provided.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Neck was numb after 1st booster; This spontaneous case was reported by a patient and describes the occurrence of HYPOAESTHESIA (Neck was numb after 1st booster) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060H21A, 019B21A and 014M20A) for COVID-19 vaccination.     Patient never had COVID positive test or diagnosis.  The patient's past medical history included Neuropathy (feet and legs, from kneed down) in 2012. Concurrent medical conditions included Drug allergy (Aspirin) and Type II diabetes mellitus. Concomitant products included GABAPENTIN and INSULIN ASPART (NOVOLOG) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced HYPOAESTHESIA (Neck was numb after 1st booster). At the time of the report, HYPOAESTHESIA (Neck was numb after 1st booster) had not resolved.      Other concomitant medication included Mylan 26 Units (1 a day). It was reported that, the 1 week after receiving the vaccine, neck was numb after 1st booster.  No treatment medication was reported.  This case was linked to MOD-2022-648121 (Patient Link).
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, SARS-CoV-2 test
Clinical narrative: Neck was numb after 1st booster; This spontaneous case was reported by a patient and describes the occurrence of HYPOAESTHESIA (Neck was numb after 1st booster) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060H21A, 019B21A and 014M20A) for COVID-19 vaccination.     Patient never had COVID positive test or diagnosis.  The patient's past medical history included Neuropathy (feet and legs, from kneed down) in 2012. Concurrent medical conditions included Drug allergy (Aspirin) and Type II diabetes mellitus. Concomitant products included GABAPENTIN and INSULIN ASPART (NOVOLOG) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced HYPOAESTHESIA (Neck was numb after 1st booster). At the time of the report, HYPOAESTHESIA (Neck was numb after 1st booster) had not resolved.      Other concomitant medication included Mylan 26 Units (1 a day). It was reported that, the 1 week after receiving the vaccine, neck was numb after 1st booster.  No treatment medication was reported.  This case was linked to MOD-2022-648121 (Patient Link).
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia
Clinical narrative: this time both arms and hands are numb,started dropping things; This spontaneous case was reported by a patient and describes the occurrence of HYPOAESTHESIA (this time both arms and hands are numb,started dropping things) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M21A, 060H21A, 019B21A and 014M20A) for COVID-19 vaccination.     The patient's past medical history included Neuropathy (Neuropathy feet and legs, from kneed down) in 2012. Concurrent medical conditions included Drug allergy (Aspirin) and Type II diabetes mellitus. Concomitant products included GABAPENTIN and INSULIN ASPART (NOVOLOG) for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (this time both arms and hands are numb,started dropping things). At the time of the report, HYPOAESTHESIA (this time both arms and hands are numb,started dropping things) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) Negative.         Patient received Mylan 26 Units once a day. It was reported that patient wanted to inform that  his pneumonia shot the same day as the booster shot, but in opposite arms. Symptoms were slowly Worsened. No treatment drug were reported.   This case was linked to MOD-2022-648104 (Patient Link).