chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna dose administered 9 days after it expired/administered with an expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna dose administered 9 days after it expired/administered with an expired vaccine) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna dose administered 9 days after it expired/administered with an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna dose administered 9 days after it expired/administered with an expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. The patient received 2nd booster on 26-Apr-2022 and 1st booster on 31-Aug-2021. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2022: Added reporter information, batch lot number and vaccine expiration and administration date. On 26-Apr-2022: Added patient demographics, updated suspect product vaccine information.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: tested positive for COVID after three doses of Moderna; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for COVID after three doses of Moderna) 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2022, the patient experienced COVID-19 (tested positive for COVID after three doses of Moderna). At the time of the report, COVID-19 (tested positive for COVID after three doses of Moderna) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2022, SARS-CoV-2 antibody test: positive (Positive) Positive.         No concomitant medication information was provided. No treatment medication were provided. The patient asked when second booster shot could be administered.  Company Comment: This is a Spontaneous case concerning a patient of an unknown age and gender with no previous medical history reported, who experienced the non-serious unexpected AESI of COVID-19. The event occurred on an unknown date after the third dose of mRNA-1273. Vaccination doses dates were not reported. Clinical course with treatment details were not provided. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2022: Follow up contains no new information.; Sender's Comments: This is a Spontaneous case concerning a patient of an unknown age and gender with no previous medical history reported, who experienced the non-serious unexpected AESI of COVID-19. The event occurred on an unknown date after the third dose of mRNA-1273. Vaccination doses dates were not reported. Clinical course with treatment details were not provided. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: fever; pain and burning at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and VACCINATION SITE PAIN (pain and burning at the injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     Patient has never been diagnosed/tested positive for Covid-19. Patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Drug allergy, Arthritis (on her left wrist) and Raynaud's syndrome.    On 07-Apr-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 PYREXIA (fever) and VACCINATION SITE PAIN (pain and burning at the injection site). The patient was treated with TRAZODONE at a dose of Only as needed. At the time of the report, PYREXIA (fever) and VACCINATION SITE PAIN (pain and burning at the injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication information was provided.   This case was linked to MOD-2022-550368, MOD-2022-550270, MOD-2022-550346 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Tinnitus
Clinical narrative: Worsening of  decrease hearing in both ears after 2nd Booster; Worsening of Tinnitus in both ears after 2nd Booster; This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS (Worsening of  decrease hearing in both ears after 2nd Booster) and TINNITUS (Worsening of Tinnitus in both ears after 2nd Booster) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: J&J COVID-19 vaccine (1 Primary dose) on 05-Mar-2021. Past adverse reactions to the above products included No adverse event with J&J COVID-19 vaccine.   On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced HYPOACUSIS (Worsening of  decrease hearing in both ears after 2nd Booster) and TINNITUS (Worsening of Tinnitus in both ears after 2nd Booster). At the time of the report, HYPOACUSIS (Worsening of  decrease hearing in both ears after 2nd Booster) and TINNITUS (Worsening of Tinnitus in both ears after 2nd Booster) outcome was unknown.            No concomitant medications were reported. The patient did not call the doctor. No treatment  medications were reported.   This case was linked to MOD-2022-550259 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: received his last dose of the Moderna vaccine and he contracted COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (received his last dose of the Moderna vaccine and he contracted COVID-19) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (received his last dose of the Moderna vaccine and he contracted COVID-19). At the time of the report, COVID-19 (received his last dose of the Moderna vaccine and he contracted COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was reported.  The reporter stated that 'he received his last dose of the Moderna vaccine and that he contracted Covid-19'. No other adverse reactions were reported.  No treatment information was provided by the reporter.  Company Comment: This spontaneous case concerns a male patient, of unknown age, with no medical history reported, who experienced the unexpected, non-serious AESI of COVID-19 after receiving an unspecified dose of the mRNA-1273 vaccine on an unspecified date. The start date of the event was not provided. No further details were provided. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a male patient, of unknown age, with no medical history reported, who experienced the unexpected, non-serious AESI of COVID-19 after receiving an unspecified dose of the mRNA-1273 vaccine on an unspecified date. The start date of the event was not provided. No further details were provided. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Fever; Pain and burning at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and VACCINATION SITE PAIN (Pain and burning at the injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 031B21A) for COVID-19 vaccination.     Patient had never been diagnosed/tested positive for Covid-19. Patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Arthritis (on her left wrist), Raynaud's syndrome and Drug allergy (Sulfa Allergy). Concomitant products included TRAZODONE for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-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 PYREXIA (Fever) and VACCINATION SITE PAIN (Pain and burning at the injection site). At the time of the report, PYREXIA (Fever) and VACCINATION SITE PAIN (Pain and burning at the injection site) outcome was unknown.            Treatment details were not reported.    This case was linked to MOD-2022-550368, MOD-2022-550270, MOD-2022-550322 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: fever; pain and burning at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and VACCINATION SITE PAIN (pain and burning at the injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A, 004C21A and 031B21A) for COVID-19 vaccination.     The patient had never been tested positive or diagnosed with COVID-19. No other vaccine was given to the patient within 1 month prior to Moderna COVID-19 vaccination.  Concurrent medical conditions included Drug allergy (Sulfa allergy), Arthritis (Arthritis on left wrist) and Raynaud's syndrome.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever) and VACCINATION SITE PAIN (pain and burning at the injection site). The patient was treated with TRAZODONE at a dose of Only as needed. At the time of the report, PYREXIA (fever) had resolved and VACCINATION SITE PAIN (pain and burning at the injection site) had not resolved.            No concomitant medications were provided by the reporter.  On 22-Nov-2021, the patient received the first booster dose of Moderna vaccine.   This case was linked to MOD-2022-550270, MOD-2022-550322, MOD-2022-550346 (Patient Link).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria, Skin disorder
Clinical narrative: If she lightly touches or rubs her skin, skin gets red or breaks out Also happens with hotter temperature such as heat or shower makes it worse as it brings it out; Dermographia/Started developing itchy skin/Hives, Hives reaction; This spontaneous case was reported by a consumer and describes the occurrence of MECHANICAL URTICARIA (Dermographia/Started developing itchy skin/Hives, Hives reaction) and SKIN DISORDER (If she lightly touches or rubs her skin, skin gets red or breaks out Also happens with hotter temperature such as heat or shower makes it worse as it brings it out) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 046E21A) for COVID-19 vaccination.     Patient had no allergies in past.  Concomitant products included SERTRALINE for an unknown indication.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2022, the patient experienced MECHANICAL URTICARIA (Dermographia/Started developing itchy skin/Hives, Hives reaction). On an unknown date, the patient experienced SKIN DISORDER (If she lightly touches or rubs her skin, skin gets red or breaks out Also happens with hotter temperature such as heat or shower makes it worse as it brings it out). The patient was treated with PREDNISONE for Adverse event, at a dose of prednisone for 6 days. and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, MECHANICAL URTICARIA (Dermographia/Started developing itchy skin/Hives, Hives reaction) and SKIN DISORDER (If she lightly touches or rubs her skin, skin gets red or breaks out Also happens with hotter temperature such as heat or shower makes it worse as it brings it out) had not resolved.            The concomitant medication was Birth control medicine. Patient reported that she had Covid-19 in December2021(after the first 2 doses of Moderna Vaccine).  The patient stated that if she lightly touches or rubs her skin, skin gets red or breaks out and it also happened with hotter temperature such as heat or shower made it worse as it brings it out. The patient stated that she could not wear makeup or wear scented products and stated that she had a reaction to the booster dose.  The patient stated that she was taking Zyrtec daily and the doctor said it could take weeks to months to improve per the patient.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial's expiration date was 01-Apr-2022, and it was moved from the freezer to the fridge on 23-Apr-2022 and administered on 23-Apr-2022; The vial's expiration date was 01-Apr-2022 and it was administered on 23-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial's expiration date was 01-Apr-2022 and it was administered on 23-Apr-2022) and PRODUCT STORAGE ERROR (The vial's expiration date was 01-Apr-2022, and it was moved from the freezer to the fridge on 23-Apr-2022 and administered on 23-Apr-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 23-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial's expiration date was 01-Apr-2022 and it was administered on 23-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial's expiration date was 01-Apr-2022, and it was moved from the freezer to the fridge on 23-Apr-2022 and administered on 23-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vial's expiration date was 01-Apr-2022 and it was administered on 23-Apr-2022) and PRODUCT STORAGE ERROR (The vial's expiration date was 01-Apr-2022, and it was moved from the freezer to the fridge on 23-Apr-2022 and administered on 23-Apr-2022) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. It was reported that they had an excursion where Moderna product was administered past the expiration date. Expiration date of the vial was 01-Apr-2022. Product did not experience temperature excursions while stored in the freezer or fridge. The vial was moved from the freezer to the fridge on 23-Apr-2022 at approximately 10:00 am. Total amount of time the vial was exposed to room temperature before administration: Per Rph- approximately 15 minutes. No treatment medication details reported.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Type IV hypersensitivity reaction
Clinical narrative: very sore and painful for a few days; the last two doses she actually experience a delay type of hyper sensitive reaction.No seriousness to it, it resolve on its on; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (very sore and painful for a few days) and TYPE IV HYPERSENSITIVITY REACTION (the last two doses she actually experience a delay type of hyper sensitive reaction.No seriousness to it, it resolve on its on) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-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. In April 2022, the patient experienced PAIN (very sore and painful for a few days) and TYPE IV HYPERSENSITIVITY REACTION (the last two doses she actually experience a delay type of hyper sensitive reaction.No seriousness to it, it resolve on its on). In April 2022, PAIN (very sore and painful for a few days) and TYPE IV HYPERSENSITIVITY REACTION (the last two doses she actually experience a delay type of hyper sensitive reaction.No seriousness to it, it resolve on its on) had resolved.            No concomitant medication reported. No treatment information was provided.   This case was linked to MOD-2022-549689 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Rash
Clinical narrative: Did not feel good at all; Broke out in rash; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Did not feel good at all) and RASH (Broke out in rash) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Did not feel good at all) and RASH (Broke out in rash). At the time of the report, FEELING ABNORMAL (Did not feel good at all) and RASH (Broke out in rash) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2022-550751, MOD-2022-550427 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Impaired work ability, Tremor
Clinical narrative: woke up   got a severe headache  /feel like her headache, is  hurting, and stuffy,; had to stop working; 5 hours later started to feel extremely fatigue; during the night  ended up shaken , not cold but like shivering like when someone is cold, during the night  ended up shaken, not cold but like shivering like when someone is cold. This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED WORK ABILITY (had to stop working), TREMOR (during the night  ended up shaken , not cold but like shivering like when someone is cold,), FATIGUE (5 hours later started to feel extremely fatigue), CHILLS (during the night  ended up shaken, not cold but like shivering like when someone is cold,) and HEADACHE (woke up got a severe headache  /feel like her headache, is  hurting, and stuffy,) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21a) for COVID-19 vaccination.     Patient has never tested positive for COVID-19.  Previously administered products included for Product used for unknown indication: Pfizer Biontech Covid-19 vaccine. Past adverse reactions to the above products included No adverse event with Pfizer Biontech Covid-19 vaccine.    On 25-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced TREMOR (during the night  ended up shaken , not cold but like shivering like when someone is cold,) and CHILLS (during the night  ended up shaken , not cold but like shivering like when someone is cold,). On 25-Apr-2022, the patient experienced IMPAIRED WORK ABILITY (had to stop working) and FATIGUE (5 hours later started to feel extremely fatigue). On 26-Apr-2022, the patient experienced HEADACHE (woke up   got a severe headache  /feel like her headache, is  hurting, and stuffy,). The patient was treated with NAPROXEN SODIUM (ALEVE) for Headache, at an unspecified dose and frequency. At the time of the report, IMPAIRED WORK ABILITY (had to stop working), TREMOR (during the night  ended up shaken , not cold but like shivering like when someone is cold,), FATIGUE (5 hours later started to feel extremely fatigue), CHILLS (during the night  ended up shaken , not cold but like shivering like when someone is cold,) and HEADACHE (woke up   got a severe headache  /feel like her headache, is  hurting, and stuffy,) outcome was unknown.            No concomitant medication was provided.  It was reported that 5 hours later started to felt extremely fatigue, had to stop working, and then during the night ended up shaken, not cold but like shivering when someone was cold, and continue all night. On 26-Apr-2022 got a severe headache, had to change their plans because did not know if there were going to have another event. The headache was hurting, and stuffy, even with taken medication.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Urticaria; This spontaneous case was reported by a nurse and describes the occurrence of URTICARIA (Urticaria) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal. Concomitant products included PROPRANOLOL HYDROCHLORIDE (INDERAL) for Blood pressure abnormal.   In January 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (Urticaria). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, URTICARIA (Urticaria) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient had been experiencing an itchy rash, and the itchiness still had not gone away. It was a big purple rash, with urticaria. Dermatologist had looked at it and did not know what to do. Patient was still experiencing the itchiness and it was bothering her.   This case was linked to MOD-2022-550703 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 5-Mar-2022, expired on 08-Apr-2022 and administrated to the patient on 14-Apr-2022; Vial was initially stored in the refrigerator on 5-Mar-2022, expired on 08-Apr-2022 and administrated to the patient on 14-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial was initially stored in the refrigerator on 5-Mar-2022, expired on 08-Apr-2022 and administrated to the patient on 14-Apr-2022) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 5-Mar-2022, expired on 08-Apr-2022 and administrated to the patient on 14-Apr-2022) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial was initially stored in the refrigerator on 5-Mar-2022, expired on 08-Apr-2022 and administrated to the patient on 14-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 5-Mar-2022, expired on 08-Apr-2022 and administrated to the patient on 14-Apr-2022). On 14-Apr-2022, EXPIRED PRODUCT ADMINISTERED (Vial was initially stored in the refrigerator on 5-Mar-2022, expired on 08-Apr-2022 and administrated to the patient on 14-Apr-2022) outcome was unknown. At the time of the report, PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 5-Mar-2022, expired on 08-Apr-2022 and administrated to the patient on 14-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was reported that on the 14 Apr 2022 a 6 days old vaccine that expired on the 08 Apr 2022 was given to patient who was receiving their first booster of the Moderna covid19 vaccine.  Date the vial was initially stored in the refrigerator was 05 Mar 2022 and they stayed in the refrigerator until the 14 Apr 2022.  It was reported that the patient had never had COVID positive test nor diagnosis.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2022: Patient's demographics details and new event added.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Immunisation reaction
Clinical narrative: From the 2nd dose, she said it was not too bad.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (From the 2nd dose, she said it was not too bad.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine, CLL and Immunocompromised (immunocompromised with CLL, a type of leukemia.). Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) for Migraine, ESTRADIOL for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (From the 2nd dose, she said it was not too bad.). At the time of the report, VACCINATION COMPLICATION (From the 2nd dose, she said it was not too bad.) outcome was unknown.      No treatment medication were reported.   This case was linked to MOD-2022-550721, MOD-2022-550747, MOD-2022-550751 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Body temperature, Fatigue, Pyrexia, Rash
Clinical narrative: From the 2nd dose, she said it was not too bad.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (From the 2nd dose, she said it was not too bad.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine, CLL and Immunocompromised (immunocompromised with CLL, a type of leukemia.). Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) for Migraine, ESTRADIOL for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (From the 2nd dose, she said it was not too bad.). At the time of the report, VACCINATION COMPLICATION (From the 2nd dose, she said it was not too bad.) outcome was unknown.      No treatment medication were reported.   This case was linked to MOD-2022-550721, MOD-2022-550747, MOD-2022-550751 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chills, Erythema, Fatigue, Headache, Insomnia
Clinical narrative: From the 2nd dose, she said it was not too bad.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (From the 2nd dose, she said it was not too bad.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine, CLL and Immunocompromised (immunocompromised with CLL, a type of leukemia.). Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) for Migraine, ESTRADIOL for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (From the 2nd dose, she said it was not too bad.). At the time of the report, VACCINATION COMPLICATION (From the 2nd dose, she said it was not too bad.) outcome was unknown.      No treatment medication were reported.   This case was linked to MOD-2022-550721, MOD-2022-550747, MOD-2022-550751 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pruritus, Sensitive skin, Skin reaction, Somnolence
Clinical narrative: From the 2nd dose, she said it was not too bad.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (From the 2nd dose, she said it was not too bad.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine, CLL and Immunocompromised (immunocompromised with CLL, a type of leukemia.). Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) for Migraine, ESTRADIOL for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (From the 2nd dose, she said it was not too bad.). At the time of the report, VACCINATION COMPLICATION (From the 2nd dose, she said it was not too bad.) outcome was unknown.      No treatment medication were reported.   This case was linked to MOD-2022-550721, MOD-2022-550747, MOD-2022-550751 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Accidental underdose, Somnolence
Clinical narrative: From the 2nd dose, she said it was not too bad.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (From the 2nd dose, she said it was not too bad.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine, CLL and Immunocompromised (immunocompromised with CLL, a type of leukemia.). Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) for Migraine, ESTRADIOL for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (From the 2nd dose, she said it was not too bad.). At the time of the report, VACCINATION COMPLICATION (From the 2nd dose, she said it was not too bad.) outcome was unknown.      No treatment medication were reported.   This case was linked to MOD-2022-550721, MOD-2022-550747, MOD-2022-550751 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Immunisation reaction
Clinical narrative: slept for 2 days; feeling itchy; skin sensitive to the touch; She reports no hives, but it is kind of red. could not sleep; chills on and off; tired/extra tired/felt very tired; delayed reaction; mild headache; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (slept for 2 days), PRURITUS (feeling itchy), SENSITIVE SKIN (skin sensitive to the touch), ERYTHEMA (She reports no hives, but it is kind of red.) and INSOMNIA (could not sleep) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001M21A, 001C21A, 003A21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine, Immunocompromised and CLL (CLL, a type of leukemia). Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) for Migraine, ESTRADIOL for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced SOMNOLENCE (slept for 2 days), PRURITUS (feeling itchy), SENSITIVE SKIN (skin sensitive to the touch), ERYTHEMA (She reports no hives, but it is kind of red.), INSOMNIA (could not sleep), CHILLS (chills on and off), FATIGUE (tired/extra tired/felt very tired), SKIN REACTION (delayed reaction) and HEADACHE (mild headache). In April 2022, SOMNOLENCE (slept for 2 days) had resolved. At the time of the report, PRURITUS (feeling itchy), SENSITIVE SKIN (skin sensitive to the touch), ERYTHEMA (She reports no hives, but it is kind of red.), INSOMNIA (could not sleep), FATIGUE (tired/extra tired/felt very tired), SKIN REACTION (delayed reaction) and HEADACHE (mild headache) outcome was unknown and CHILLS (chills on and off) had not resolved.            She was a very active person.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-550721, MOD-2022-550746, MOD-2022-550747, MOD-2022-550512 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Body temperature, Fatigue, Pyrexia, Rash
Clinical narrative: slept for 2 days; feeling itchy; skin sensitive to the touch; She reports no hives, but it is kind of red. could not sleep; chills on and off; tired/extra tired/felt very tired; delayed reaction; mild headache; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (slept for 2 days), PRURITUS (feeling itchy), SENSITIVE SKIN (skin sensitive to the touch), ERYTHEMA (She reports no hives, but it is kind of red.) and INSOMNIA (could not sleep) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001M21A, 001C21A, 003A21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine, Immunocompromised and CLL (CLL, a type of leukemia). Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) for Migraine, ESTRADIOL for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced SOMNOLENCE (slept for 2 days), PRURITUS (feeling itchy), SENSITIVE SKIN (skin sensitive to the touch), ERYTHEMA (She reports no hives, but it is kind of red.), INSOMNIA (could not sleep), CHILLS (chills on and off), FATIGUE (tired/extra tired/felt very tired), SKIN REACTION (delayed reaction) and HEADACHE (mild headache). In April 2022, SOMNOLENCE (slept for 2 days) had resolved. At the time of the report, PRURITUS (feeling itchy), SENSITIVE SKIN (skin sensitive to the touch), ERYTHEMA (She reports no hives, but it is kind of red.), INSOMNIA (could not sleep), FATIGUE (tired/extra tired/felt very tired), SKIN REACTION (delayed reaction) and HEADACHE (mild headache) outcome was unknown and CHILLS (chills on and off) had not resolved.            She was a very active person.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-550721, MOD-2022-550746, MOD-2022-550747, MOD-2022-550512 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chills, Erythema, Fatigue, Headache, Insomnia
Clinical narrative: slept for 2 days; feeling itchy; skin sensitive to the touch; She reports no hives, but it is kind of red. could not sleep; chills on and off; tired/extra tired/felt very tired; delayed reaction; mild headache; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (slept for 2 days), PRURITUS (feeling itchy), SENSITIVE SKIN (skin sensitive to the touch), ERYTHEMA (She reports no hives, but it is kind of red.) and INSOMNIA (could not sleep) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001M21A, 001C21A, 003A21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine, Immunocompromised and CLL (CLL, a type of leukemia). Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) for Migraine, ESTRADIOL for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced SOMNOLENCE (slept for 2 days), PRURITUS (feeling itchy), SENSITIVE SKIN (skin sensitive to the touch), ERYTHEMA (She reports no hives, but it is kind of red.), INSOMNIA (could not sleep), CHILLS (chills on and off), FATIGUE (tired/extra tired/felt very tired), SKIN REACTION (delayed reaction) and HEADACHE (mild headache). In April 2022, SOMNOLENCE (slept for 2 days) had resolved. At the time of the report, PRURITUS (feeling itchy), SENSITIVE SKIN (skin sensitive to the touch), ERYTHEMA (She reports no hives, but it is kind of red.), INSOMNIA (could not sleep), FATIGUE (tired/extra tired/felt very tired), SKIN REACTION (delayed reaction) and HEADACHE (mild headache) outcome was unknown and CHILLS (chills on and off) had not resolved.            She was a very active person.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-550721, MOD-2022-550746, MOD-2022-550747, MOD-2022-550512 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pruritus, Sensitive skin, Skin reaction, Somnolence
Clinical narrative: slept for 2 days; feeling itchy; skin sensitive to the touch; She reports no hives, but it is kind of red. could not sleep; chills on and off; tired/extra tired/felt very tired; delayed reaction; mild headache; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (slept for 2 days), PRURITUS (feeling itchy), SENSITIVE SKIN (skin sensitive to the touch), ERYTHEMA (She reports no hives, but it is kind of red.) and INSOMNIA (could not sleep) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001M21A, 001C21A, 003A21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine, Immunocompromised and CLL (CLL, a type of leukemia). Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) for Migraine, ESTRADIOL for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced SOMNOLENCE (slept for 2 days), PRURITUS (feeling itchy), SENSITIVE SKIN (skin sensitive to the touch), ERYTHEMA (She reports no hives, but it is kind of red.), INSOMNIA (could not sleep), CHILLS (chills on and off), FATIGUE (tired/extra tired/felt very tired), SKIN REACTION (delayed reaction) and HEADACHE (mild headache). In April 2022, SOMNOLENCE (slept for 2 days) had resolved. At the time of the report, PRURITUS (feeling itchy), SENSITIVE SKIN (skin sensitive to the touch), ERYTHEMA (She reports no hives, but it is kind of red.), INSOMNIA (could not sleep), FATIGUE (tired/extra tired/felt very tired), SKIN REACTION (delayed reaction) and HEADACHE (mild headache) outcome was unknown and CHILLS (chills on and off) had not resolved.            She was a very active person.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-550721, MOD-2022-550746, MOD-2022-550747, MOD-2022-550512 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Accidental underdose, Somnolence
Clinical narrative: slept for 2 days; feeling itchy; skin sensitive to the touch; She reports no hives, but it is kind of red. could not sleep; chills on and off; tired/extra tired/felt very tired; delayed reaction; mild headache; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (slept for 2 days), PRURITUS (feeling itchy), SENSITIVE SKIN (skin sensitive to the touch), ERYTHEMA (She reports no hives, but it is kind of red.) and INSOMNIA (could not sleep) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001M21A, 001C21A, 003A21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine, Immunocompromised and CLL (CLL, a type of leukemia). Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) for Migraine, ESTRADIOL for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced SOMNOLENCE (slept for 2 days), PRURITUS (feeling itchy), SENSITIVE SKIN (skin sensitive to the touch), ERYTHEMA (She reports no hives, but it is kind of red.), INSOMNIA (could not sleep), CHILLS (chills on and off), FATIGUE (tired/extra tired/felt very tired), SKIN REACTION (delayed reaction) and HEADACHE (mild headache). In April 2022, SOMNOLENCE (slept for 2 days) had resolved. At the time of the report, PRURITUS (feeling itchy), SENSITIVE SKIN (skin sensitive to the touch), ERYTHEMA (She reports no hives, but it is kind of red.), INSOMNIA (could not sleep), FATIGUE (tired/extra tired/felt very tired), SKIN REACTION (delayed reaction) and HEADACHE (mild headache) outcome was unknown and CHILLS (chills on and off) had not resolved.            She was a very active person.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-550721, MOD-2022-550746, MOD-2022-550747, MOD-2022-550512 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Immunisation reaction
Clinical narrative: she reports she just slept. Patient took 1st booster dose instead 3rd primary dose; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (she reports she just slept.) and ACCIDENTAL UNDERDOSE (Patient took 1st booster dose instead 3rd primary dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     Concurrent medical conditions included CLL (She is immunocompromised with CLL, a type of leukemia.). Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) for Migraine NOS, ESTRADIOL for an unknown indication.    On 27-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, the patient experienced ACCIDENTAL UNDERDOSE (Patient took 1st booster dose instead 3rd primary dose). On an unknown date, the patient experienced SOMNOLENCE (she reports she just slept.). At the time of the report, SOMNOLENCE (she reports she just slept.) had resolved and ACCIDENTAL UNDERDOSE (Patient took 1st booster dose instead 3rd primary dose) outcome was unknown.            No treatment medications were reported   This case was linked to MOD-2022-550721, MOD-2022-550746, MOD-2022-550751 (Patient Link).