chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: patient also stated that he experienced sore arm with all the shots; fever; chills; tiredness; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (patient also stated that he experienced sore arm with all the shots), PYREXIA (fever), CHILLS (chills) and FATIGUE (tiredness) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 028L20A) for COVID-19 vaccination.     It was unknown that patient has allergies to (medications, food and other products). Patient never had COVID positive test or diagnosis.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 30-Mar-2021, the patient experienced PYREXIA (fever), CHILLS (chills) and FATIGUE (tiredness). On an unknown date, the patient experienced PAIN IN EXTREMITY (patient also stated that he experienced sore arm with all the shots). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 2 doses. On 30-Mar-2021, PYREXIA (fever), CHILLS (chills) and FATIGUE (tiredness) had resolved. At the time of the report, PAIN IN EXTREMITY (patient also stated that he experienced sore arm with all the shots) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  No other vaccines was given 1 month prior to vaccine.  It was reported that patient has received 4 doses of the Moderna COVID-19 vaccine so far, with side effects getting progressively longer lasting and worse with each dose.  Patient experienced fever, chills and tiredness for 6 hours. Patient also stated that patient experienced sore arm with all the shots. Patient mentioned that lost 45 pounds between 1st dose and 3rd dose of the Moderna COVID-19 vaccine. The patient started losing weight about a year and a half ago. Reported the side effects were significantly increased with each shot of the Moderna vaccine. He was now looking to get the Moderna bivalent vaccine but was not sure if that wasthe right thing to do based on his prior experiences. He wonders if he has a high level of antibodies with all the previous Moderna doses and that was why he has reacted more strongly with each dose.  Adverse events did not cause patient to seek medical care. The patient did not experience a similar event in the past.   This case was linked to MOD-2021-045065, MOD-2022-575425, MOD-2022-672853 (Patient Link).
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, Vaccination site pain
Clinical narrative: sore arm; Administration error: only half dose given of bivalent vaccine; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (sore arm) and ACCIDENTAL UNDERDOSE (Administration error: only half dose given of bivalent vaccine) in a 76-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 prophylaxis.     Concurrent medical conditions included Coronary artery disease, Hypertension, Sleep apnea and Drug allergy (ophthalmic drops for pupils dilatation). Concomitant products included APIXABAN (ELIQUIS), LATANOPROST, SPIRONOLACTONE, LOSARTAN POTASSIUM, CHLORTALIDONE (CHLORTHALIDONE) and ATORVASTATIN for an unknown indication.    On 12-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 12-Sep-2022, the patient experienced VACCINATION SITE PAIN (sore arm) and ACCIDENTAL UNDERDOSE (Administration error: only half dose given of bivalent vaccine). On 12-Sep-2022, VACCINATION SITE PAIN (sore arm) had resolved. At the time of the report, ACCIDENTAL UNDERDOSE (Administration error: only half dose given of bivalent vaccine) outcome was unknown.            No treatment medication was reported. The patient received the 1st dose of Moderna vaccine on 02-Mar-2021, second dose of vaccine on 30-Mar-2021, first booster dose on 25-Oct-2021, second booster dose on 01-Apr-2022 with batch numbers 12A21A, 021B21A, 27C21A and 002M21A respectively.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; Recieved 0.5 cc as dose 3; This spontaneous case was reported by a patient and describes the occurrence of INCORRECT DOSE ADMINISTERED (Recieved 0.5 cc as dose 3) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069FZ1A, 026L20A and 017B21A) for COVID-19 prophylaxis.     Patient has not diagnosed or tested positive for COVID-19. Patient has no acute illness at the time of vaccination and up to one month before.  Concurrent medical conditions included Sulfonamide allergy, Allergic rhinitis since 1990, Osteoarthritis since 2000 and Hypothyroidism since 1995. Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXIN) from 01-Jan-1995 to an unknown date for Hypothyroidism, VITAMIN D NOS from 01-Jan-2020 to an unknown date for Vitamin D low, VITAMIN C [ASCORBIC ACID] from 01-Jan-2021 to an unknown date for an unknown indication.   On 04-Mar-2021 at 10:42 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 01-Apr-2021 at 10:35 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 23-Nov-2021 at 11:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 23-Nov-2021 at 11:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INCORRECT DOSE ADMINISTERED (Received 0.5 cc as dose 3). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Received 0.5 cc as dose 3) 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 INCORRECT DOSE ADMINISTERED (Received 0.5 cc as dose 3).    Patient's weight was reported as 145 units not specified. Patient had not received other vaccine on same day as Moderna COVID-19 vaccine or within one month prior to any Moderna dose.  Patient received 0.25 ml dose 4 of Moderna (batch number 005M21A) on 01-Apr-2022 at 09:30 am. Patient received dose 5 of Moderna on 26-Sep-2022 at 09:00 am and experienced adverse events which were treated with Tylenol and Meloxicam.   This case was linked to MOD-2022-662826 (Patient Link).
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccines were stored in the fridge since 13-Oct-2022 and administered on 14-Nov-2022; No adverse event; Administration error: 4 patients administered with Moderna bivalent beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration error: 4 patients administered with Moderna bivalent beyond use date), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge since 13-Oct-2022 and administered on 14-Nov-2022) and NO ADVERSE EVENT (No adverse event) in an 80-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 050D22A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 14-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration error: 4 patients administered with Moderna bivalent beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored in the fridge since 13-Oct-2022 and administered on 14-Nov-2022) and NO ADVERSE EVENT (No adverse event). On 14-Nov-2022, EXPIRED PRODUCT ADMINISTERED (Administration error: 4 patients administered with Moderna bivalent beyond use date) outcome was unknown. At the time of the report, PRODUCT STORAGE ERROR (Vaccines were stored in the fridge since 13-Oct-2022 and administered on 14-Nov-2022) 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 EXPIRED PRODUCT ADMINISTERED (Administration error: 4 patients administered with Moderna bivalent beyond use date) and PRODUCT STORAGE ERROR (Vaccines were stored in the fridge since 13-Oct-2022 and administered on 14-Nov-2022).    Concomitant product use was not provided by the reporter.  It was reported that, vial size was 2.5ml.  Vial was initially stored in refrigerator on 13-Oct-2022. The vial had not undergone temperature excursion. No AEs were reported.  No treatment medications were reported.  This case contains information for one patient out of 4 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-673345, US-MODERNATX, INC.-MOD-2022-673344, US-MODERNATX, INC.-MOD-2022-673303 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-673344:Same reporter US-MODERNATX, INC.-MOD-2022-673345:Same reporter US-MODERNATX, INC.-MOD-2022-673303:Same reporter
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vial was initially stored in the refrigerator on 03Oct2022 and administered on 07Nov2022; No adverse event; received doses after its beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received doses after its beyond use date), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 03Oct2022 and administered on 07Nov2022) and NO ADVERSE EVENT (No adverse event) 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)) (batch no. 030g22b) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Nov-2022, the patient received fourth 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-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received doses after its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 03Oct2022 and administered on 07Nov2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received doses after its beyond use date), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 03Oct2022 and administered on 07Nov2022) 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 EXPIRED PRODUCT ADMINISTERED (received doses after its beyond use date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 03Oct2022 and administered on 07Nov2022).    No concomitant medications were reported.  Individual vials or unbroken cartons: in the box. Vial size was 2.5ml. Vial did not undergo any temperature excursions.   Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-673091, US-MODERNATX, INC.-MOD-2022-673093 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2022: Live Follow-up: Significant information accepted: Patient information updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-673093:Same reporter case US-MODERNATX, INC.-MOD-2022-673091:Same reporter case
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vial was initially stored in the refrigerator on 03Oct2022 and administered on 10Nov2022; No adverse event; received doses after its beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received doses after its beyond use date), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 03Oct2022 and administered on 10Nov2022) and NO ADVERSE EVENT (No adverse event) in a 79-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030g22b) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-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 10-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received doses after its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 03Oct2022 and administered on 10Nov2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received doses after its beyond use date), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 03Oct2022 and administered on 10Nov2022) 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 EXPIRED PRODUCT ADMINISTERED (received doses after its beyond use date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 03Oct2022 and administered on 10Nov2022).    No concomitant medication information was provided. It was reported that Individual vials or unbroken cartons was in the box, Vial size was 2.5ml Date the vial was initially stored in the refrigerator was 03Oct2022. Vial did not undergo any temperature excursions. No treatment medications were provided   This case was linked to US-MODERNATX, INC.-MOD-2022-672844, US-MODERNATX, INC.-MOD-2022-673082, US-MODERNATX, INC.-MOD-2022-673093 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2022: Live Follow-up  Significant information accepted: Patient information updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-672844:Same reporter case US-MODERNATX, INC.-MOD-2022-673082:Same reporter case US-MODERNATX, INC.-MOD-2022-673093:Same reporter case
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Illness, Myalgia, Pain
Clinical narrative: Sick after the second Moderna/ got quite sick after that shot; weakness; aches and pain; Chills; Fever; Muscle pain; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Sick after the second Moderna/ got quite sick after that shot), ASTHENIA (weakness), PAIN (aches and pain), CHILLS (Chills) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 029L20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Omeprazole allergy), Drug allergy (Novocaine allergy), Sulfonamide allergy (Sulfas allergy), Iodine allergy, Shellfish allergy and Food allergy (some other foods).   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick after the second Moderna/ got quite sick after that shot), ASTHENIA (weakness), PAIN (aches and pain), CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Muscle pain). At the time of the report, ILLNESS (Sick after the second Moderna/ got quite sick after that shot), ASTHENIA (weakness), PAIN (aches and pain), CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Muscle pain) had resolved.            Concomitant product use was not provided by the reporter.   It was reported that after the second shot with Moderna patient had chills, fever, muscle pain, weakness for 5 days. It was almost as if patient had the infection and wanted to knowif that could be due to an allergic reaction and patient was referred to HCP for information about the potential allergic reaction to the Moderna vaccine. Patient also asked if the booster was strong as the first two doses and mentioned that patient heard that, there were some differences between ingredients of the original vaccine and the new booster. Patient never got a booster after patient's first 2 shots. Both first and second dose were from Moderna, and patient had allergies to medications. Patient stated that didn't seem like an allergic reaction and was just sick and hours of operation from  8am to 7pm EST prior to transfer. Treatment medication was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Sick after the second Moderna/ got quite sick after that shot; weakness; aches and pain; Chills; Fever; Muscle pain; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Sick after the second Moderna/ got quite sick after that shot), ASTHENIA (weakness), PAIN (aches and pain), CHILLS (Chills) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 029L20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Omeprazole allergy), Drug allergy (Novocaine allergy), Sulfonamide allergy (Sulfas allergy), Iodine allergy, Shellfish allergy and Food allergy (some other foods).   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick after the second Moderna/ got quite sick after that shot), ASTHENIA (weakness), PAIN (aches and pain), CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Muscle pain). At the time of the report, ILLNESS (Sick after the second Moderna/ got quite sick after that shot), ASTHENIA (weakness), PAIN (aches and pain), CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Muscle pain) had resolved.            Concomitant product use was not provided by the reporter.   It was reported that after the second shot with Moderna patient had chills, fever, muscle pain, weakness for 5 days. It was almost as if patient had the infection and wanted to knowif that could be due to an allergic reaction and patient was referred to HCP for information about the potential allergic reaction to the Moderna vaccine. Patient also asked if the booster was strong as the first two doses and mentioned that patient heard that, there were some differences between ingredients of the original vaccine and the new booster. Patient never got a booster after patient's first 2 shots. Both first and second dose were from Moderna, and patient had allergies to medications. Patient stated that didn't seem like an allergic reaction and was just sick and hours of operation from  8am to 7pm EST prior to transfer. Treatment medication was not provided.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 03Oct2022 and administered on 14-Nov-2022; No adverse event; Dose administered after 30-day Use By Date or after manufacturer date of expiry/received doses after its beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry/received doses after its beyond use date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 03Oct2022 and administered on 14-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a 61-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030g22b) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry/received doses after its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 03Oct2022 and administered on 14-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry/received doses after its beyond use date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 03Oct2022 and administered on 14-Nov-2022) 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 EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry/received doses after its beyond use date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 03Oct2022 and administered on 14-Nov-2022).    Concomitant medication was not provided.  It was reported that, vial size was 2.5ml and it was initially stored in refrigerator on 03-OCT-2022.  The vial had not undergone temperature excursion.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-673091, US-MODERNATX, INC.-MOD-2022-672844, US-MODERNATX, INC.-MOD-2022-673082  (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2022: Follow-up received and updated patient identifiers.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-673091:Same reporter case US-MODERNATX, INC.-MOD-2022-672844:Same reporter case US-MODERNATX, INC.-MOD-2022-673082:Same reporter case
Age: 12.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 12-Oct-2022 and administered on 14-Nov-2022; No adverse event; Received expired Bivalent Booster  after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired Bivalent Booster  after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 12-Oct-2022 and administered on 14-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a 12-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Nov-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 14-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired Bivalent Booster  after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 12-Oct-2022 and administered on 14-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired Bivalent Booster  after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 12-Oct-2022 and administered on 14-Nov-2022) 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 EXPIRED PRODUCT ADMINISTERED (Received expired Bivalent Booster  after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 12-Oct-2022 and administered on 14-Nov-2022).    No concomitant medication details was reported. It was reported that individual vial from an open Box was used. Vial size was reported as 2.5 ml. The vial was initially stored in the refrigerator on 12-OCT-2022. Beyond use date was 11-NOV-2022. The vial did not undergo any temperature excursions. No treatment medication details was reported.
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted, Product availability issue
Clinical narrative: not receiving second dose on time; he was unable to find stock of the vaccine for his second dose; no adverse event; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (not receiving second dose on time), PRODUCT AVAILABILITY ISSUE (he was unable to find stock of the vaccine for his second dose) and NO ADVERSE EVENT (no adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (not receiving second dose on time), PRODUCT AVAILABILITY ISSUE (he was unable to find stock of the vaccine for his second dose) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (not receiving second dose on time), PRODUCT AVAILABILITY ISSUE (he was unable to find stock of the vaccine for his second dose) and NO ADVERSE EVENT (no adverse event) outcome was unknown.      No concomitant medications were reported. Patient only received 1 dose of the Moderna COVID19 vaccine because he was unable to find stock of the vaccine for his second dose and that happened two months ago. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 12-OCT-2022, the vaccine was administered on 14-Nov-2022; No adverse event; patients 6-11-year group received expired Bivalent Moderna COVID-19 vaccine after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients 6-11-year group received expired Bivalent Moderna COVID-19 vaccine after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 12-OCT-2022, the vaccine was administered on 14-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination. No Medical History information was reported. On 14-Nov-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 14-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients 6-11-year group received expired Bivalent Moderna COVID-19 vaccine after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 12-OCT-2022, the vaccine was administered on 14-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients 6-11-year group received expired Bivalent Moderna COVID-19 vaccine after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 12-OCT-2022, the vaccine was administered on 14-Nov-2022) 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 EXPIRED PRODUCT ADMINISTERED (patients 6-11-year group received expired Bivalent Moderna COVID-19 vaccine after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 12-OCT-2022, the vaccine was administered on 14-Nov-2022).    Concomitant product use was not provided by the reporter. The vial size was reported as 2.5 ml. It was initially stored in the refrigerator on 12-Oct-2022 and beyond use date was 11-Nov-2022. The vial did not undergo any temperature excursions. Treatment information was not provided.  This case contains information for the first of the 2 patients of 6 to 11 year old group described by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 12-OCT-2022, the vaccine was administered on 14-Nov-2022; No adverse event; Patient received expired Bivalent Moderna COVID-19 vaccine after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Bivalent Moderna COVID-19 vaccine after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 12-OCT-2022, the vaccine was administered on 14-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Nov-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 14-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Bivalent Moderna COVID-19 vaccine after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 12-OCT-2022, the vaccine was administered on 14-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Bivalent Moderna COVID-19 vaccine after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 12-OCT-2022, the vaccine was administered on 14-Nov-2022) 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 EXPIRED PRODUCT ADMINISTERED (Patient received expired Bivalent Moderna COVID-19 vaccine after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 12-OCT-2022, the vaccine was administered on 14-Nov-2022).    Concomitant product use was not provided by the reporter.  The vial size was reported as 2.5 ml. It was initially stored in the refrigerator on 12-Oct-2022 and beyond use date was 11-Nov-2022. The vial did not undergo any temperature excursions.  Treatment information was not provided.  This case contains information for the second of the 2 patients of 6 to 11 year old group described by the reporter.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: breakthrough after fifth vaccine  injection/rebound of symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (breakthrough after fifth vaccine  injection/rebound of symptoms) in a 73-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19.    Concurrent medical conditions included Asthma, Blood pressure high and Overweight. Concomitant products included HYDRALAZINE from 13-Nov-2022 to an unknown date, METOPROLOL SUCCINATE from 16-Aug-2022 to an unknown date, LOVASTATIN from 12-Jul-2022 to 13-Nov-2022 and TELMISARTAN from 24-Aug-2022 to an unknown date for an unknown indication.   In September 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 13-Nov-2022, NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) dosage was changed to 20 milligram once a day. On an unknown date, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) 10 milligram twice a day. On an unknown date, the patient experienced COVID-19 (breakthrough after fifth vaccine  injection/rebound of symptoms). At the time of the report, COVID-19 (breakthrough after fifth vaccine  injection/rebound of symptoms) had resolved.            Patient physician advised high risk of COVID-19.  No treatment medication was reported.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccines were stored in the fridge since 13Oct2022 and administered on 14Nov2022; No adverse event; Administration error: patient was administered with Moderna bivalent beyond use date on 14Nov2022. Vaccines were stored in fridge since 13Oct2022.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration error: patient was administered with Moderna bivalent beyond use date on 14Nov2022. Vaccines were stored in fridge since 13Oct2022.), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge since 13Oct2022 and administered on 14Nov2022) and NO ADVERSE EVENT (No adverse event) in a 90-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 050D22A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 14-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration error: patient was administered with Moderna bivalent beyond use date on 14Nov2022. Vaccines were stored in fridge since 13Oct2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored in the fridge since 13Oct2022 and administered on 14Nov2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration error: patient was administered with Moderna bivalent beyond use date on 14Nov2022. Vaccines were stored in fridge since 13Oct2022.), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge since 13Oct2022 and administered on 14Nov2022) 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 EXPIRED PRODUCT ADMINISTERED (Administration error: patient was administered with Moderna bivalent beyond use date on 14Nov2022. Vaccines were stored in fridge since 13Oct2022.) and PRODUCT STORAGE ERROR (Vaccines were stored in the fridge since 13Oct2022 and administered on 14Nov2022).    Concomitant product use was not provided by the reporter.   It was reported that, vial size was 2.5ml and it was initially stored in refrigerator on 13-Oct-2022.The vial had not undergone temperature excursion.  Treatment information was not reported.  This case contains information of second patient out of 4 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-673303, US-MODERNATX, INC.-MOD-2022-673035, US-MODERNATX, INC.-MOD-2022-673345 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-673303:Same reporter US-MODERNATX, INC.-MOD-2022-673035:Same reporter US-MODERNATX, INC.-MOD-2022-673345:Same reporter
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccines were stored in the fridge since 13Oct2022 and administered on 14Nov2022; No adverse event; Administration error: 4 patients administered with Moderna bivalent beyond use date on 14Nov2022. Vaccines were stored in fridge since 13Oct2022.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration error: 4 patients administered with Moderna bivalent beyond use date on 14Nov2022. Vaccines were stored in fridge since 13Oct2022.), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge since 13Oct2022 and administered on 14Nov2022) and NO ADVERSE EVENT (No adverse event) in a 78-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 050D22A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 14-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration error: 4 patients administered with Moderna bivalent beyond use date on 14Nov2022. Vaccines were stored in fridge since 13Oct2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored in the fridge since 13Oct2022 and administered on 14Nov2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration error: 4 patients administered with Moderna bivalent beyond use date on 14Nov2022. Vaccines were stored in fridge since 13Oct2022.), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge since 13Oct2022 and administered on 14Nov2022) 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 EXPIRED PRODUCT ADMINISTERED (Administration error: 4 patients administered with Moderna bivalent beyond use date on 14Nov2022. Vaccines were stored in fridge since 13Oct2022.) and PRODUCT STORAGE ERROR (Vaccines were stored in the fridge since 13Oct2022 and administered on 14Nov2022).    Concomitant medication was not provided.  The vials were individual vials, vial size was 2.5ml and it was initially stored in refrigerator on 13-OCT-2022.The vial had not undergone temperature excursion.  Treatment information was not reported.  This case contains information of third patient of 4 patients described by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-673035, US-MODERNATX, INC.-MOD-2022-673303, US-MODERNATX, INC.-MOD-2022-673344 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-673035:Same Reporter US-MODERNATX, INC.-MOD-2022-673303:Same Reporter US-MODERNATX, INC.-MOD-2022-673344:Same reporter
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; possible administration of Moderna monovalent booster instead of bivalent booster; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (possible administration of Moderna monovalent booster instead of bivalent booster) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (possible administration of Moderna monovalent booster instead of bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (possible administration of Moderna monovalent booster instead of bivalent booster) 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 WRONG PRODUCT ADMINISTERED (possible administration of Moderna monovalent booster instead of bivalent booster).    No concomitant medication was provided.  It was reported that patient had received a Moderna COVID-19 booster on 5 Sep 2022. However, it was incorrectly recorded as a Pfizer booster on her vaccination card by the provider.  Treatment medication was not provided by the reporter.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: contracted covid post-vaccination; contracted covid post-vaccination; This is a spontaneous report received from contactable reporter (Pharmacist).  A 16-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Sep2021 as dose 1, single (batch/lot number: unknown) and in Oct2021 as dose 2, single (batch/lot number: unknown) at the age of 15 years for covid-19 immunisation. The patient had no relevant medical history, notes: no known allergies, no other medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "contracted covid post-vaccination". The patient underwent the following laboratory tests and procedures: Covid-19 test: positive, notes: post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events drug ineffective, COVID-19 and the use of suspect product cannot be fully excluded.,Linked Report(s) : US-PFIZER INC-202201300297 same reporter, different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Asthenia, Dyspnoea
Clinical narrative: low energy; It took 3 months to get her voice back; she had breathing problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 77-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: ASTHENIA (non-serious), outcome "unknown", described as "low energy"; APHONIA (non-serious), outcome "recovered", described as "It took 3 months to get her voice back"; DYSPNOEA (non-serious), outcome "unknown", described as "she had breathing problems".  Additional information: Caller was asking what was the difference between the bivalent ba1 vs ba4/5. She had a very bad case of corona virus in June, it took 3 months to get her voice back, she had breathing problems and low energy. Caller stated she got covid on the plane when traveling. Caller also stated she had all her prior covid vaccinations from Pfizer and had either 4 or 5 doses (unsure). Caller stated she will be coming back in December and trying to decide which would be best for her to receive.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201296087 same patient; different event;
Sex: F
Vaccine: PNC13
Symptoms: Allergy to vaccine, Drug ineffective, Hypersensitivity, Peripheral swelling, Pneumonia
Clinical narrative: Patient has pneumonia; Patient has pneumonia; Allergic reaction to Prevnar 13 / Arm swelling, big time, like a lot; Allergic reaction to Prevnar 13 / Arm swelling, big time, like a lot; This is a spontaneous report received from a contactable reporter (Pharmacist), Program ID: (004756). A female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALLERGY TO VACCINE (medically significant), PERIPHERAL SWELLING (medically significant), outcome "unknown" and all described as "Allergic reaction to Prevnar 13 / Arm swelling, big time, like a lot"; PNEUMONIA (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Patient has pneumonia". The event "allergic reaction to prevnar 13 / arm swelling, big time, like a lot" required physician office visit. Clinical course: it was reported that a while before, 8, 9, or maybe 10 years before patient had allergic reaction to Prevnar 13. Arm swelling, big time, like a lot. Had to go back to doctor and got a Diphenhydramine shot. Clarifies a Diphenhydramine shot, like Benadryl allergic reaction shot. Patient had pneumonia, was interested in getting Prevnar 20. The reporter want to know if it was possible for patient to receive Prevnar 20 even though had allergic reaction to Prevnar 13.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is subject to many factors. The association between the event lack of effect (pneumonia) with PREVNAR13 can not be fully excluded. There is a reasonable possibility that the events peripheral swelling and allergy to vaccine were related to PREVNAR13 based on known drug safety profile.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.