chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired dose of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine). On 27-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not applicable   This case was linked to US-MODERNATX, INC.-MOD-2021-338616, US-MODERNATX, INC.-MOD-2021-338611, US-MODERNATX, INC.-MOD-2021-344166 (E2B Linked Report). This case was linked to MOD-2021-338604 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-344166:MOD21-148785 US-MODERNATX, INC.-MOD-2021-338611:Master case (same reporter) US-MODERNATX, INC.-MOD-2021-338616:Master case (same reporter)
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Erythema, Hyperhidrosis, Inflammation, Insomnia
Clinical narrative: massive sweats; not been able to sleep; intense dreams; Redness; very inflamed; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (massive sweats), INSOMNIA (not been able to sleep), ABNORMAL DREAMS (intense dreams), ERYTHEMA (Redness) and INFLAMMATION (very inflamed) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 046C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in June 2020 and Neurological symptoms NOS on 04-Jul-2020. Concurrent medical conditions included Type 1 diabetes mellitus (diabetic with major neuropathic reaction). Concomitant products included INSULIN for an unknown indication.   On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jul-2021, the patient experienced HYPERHIDROSIS (massive sweats), INSOMNIA (not been able to sleep), ABNORMAL DREAMS (intense dreams), ERYTHEMA (Redness) and INFLAMMATION (very inflamed). At the time of the report, HYPERHIDROSIS (massive sweats), INSOMNIA (not been able to sleep), ABNORMAL DREAMS (intense dreams), ERYTHEMA (Redness) and INFLAMMATION (very inflamed) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment details were reported.  Patient reports being on 2 types of insulin.  Patient reports after bug had sever rashes all over leg and arm left marks.   This case was linked to MOD-2021-337577 (Patient Link).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt tired) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, the patient experienced FATIGUE (Felt tired). On 01-Sep-2021, FATIGUE (Felt tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medication includes antidepressant.  No Treatment informations were reported.   This case was linked to MOD-2021-337689 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin irritation, Skin reaction, Vaccination site rash
Clinical narrative: Itches; more patient scratches it more it sores; sores; rash in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itches), SKIN IRRITATION (more patient scratches it more it sores), SKIN REACTION (sores) and VACCINATION SITE RASH (rash in the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 078C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Aug-2021, the patient experienced VACCINATION SITE RASH (rash in the injection site). On an unknown date, the patient experienced PRURITUS (Itches), SKIN IRRITATION (more patient scratches it more it sores) and SKIN REACTION (sores). At the time of the report, PRURITUS (Itches), SKIN IRRITATION (more patient scratches it more it sores), SKIN REACTION (sores) and VACCINATION SITE RASH (rash in the injection site) had not resolved.            No concomitant medications were reported. Patient applied creams and ointments given by dermatologist to treat symptoms
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-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 VACCINATION SITE PAIN (sore arm). At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-337525, MOD-2021-337582 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Headache, Neck pain, Pain in extremity, Periorbital swelling
Clinical narrative: right away she felt pain in neck; bagging in both eyes for about  a week; Left arm hurting now for almost a month; Left eye hurts but the pain went away in a few days/both eyes hurt; headaches; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (right away she felt pain in neck), PERIORBITAL SWELLING (bagging in both eyes for about  a week), PAIN IN EXTREMITY (Left arm hurting now for almost a month), EYE PAIN (Left eye hurts but the pain went away in a few days/both eyes hurt) and HEADACHE (headaches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN for an unknown indication.    On 05-Sep-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 NECK PAIN (right away she felt pain in neck), PERIORBITAL SWELLING (bagging in both eyes for about  a week), PAIN IN EXTREMITY (Left arm hurting now for almost a month), EYE PAIN (Left eye hurts but the pain went away in a few days/both eyes hurt) and HEADACHE (headaches). At the time of the report, NECK PAIN (right away she felt pain in neck), PERIORBITAL SWELLING (bagging in both eyes for about  a week), PAIN IN EXTREMITY (Left arm hurting now for almost a month) and HEADACHE (headaches) outcome was unknown and EYE PAIN (Left eye hurts but the pain went away in a few days/both eyes hurt) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.  It was reported that the patient experienced that her eyes felt better without the glasses and she was not sure if it was because of vaccine.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Dizziness, Dysstasia, Myalgia
Clinical narrative: I was not able to stand; dizzy spells; got Covid Just out of quarantine this Monday.; It attacked the muscles in my body and was in a lot of body pain; This spontaneous case was reported by a patient and describes the occurrence of DYSSTASIA (I was not able to stand), DIZZINESS (dizzy spells), COVID-19 (got Covid Just out of quarantine this Monday.) and MYALGIA (It attacked the muscles in my body and was in a lot of body pain) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSSTASIA (I was not able to stand), DIZZINESS (dizzy spells), COVID-19 (got Covid Just out of quarantine this Monday.) and MYALGIA (It attacked the muscles in my body and was in a lot of body pain). At the time of the report, DYSSTASIA (I was not able to stand), COVID-19 (got Covid Just out of quarantine this Monday.) and MYALGIA (It attacked the muscles in my body and was in a lot of body pain) outcome was unknown and DIZZINESS (dizzy spells) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. The patient had been treated with infusions, steroids, antibiotic, anti-inflammatory shot with nausea medicine in a IV.   This case was linked to MOD-2021-114938 (Patient Link).; Sender's Comments: This case concerns a patient of unknown age and gender with no relevant medical, who experienced the unexpected event of COVID-19. The event occurred on an unknown date after receiving the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: received a dose from a Moderna COVID-19 vaccine vial that had expired 2 days prior.; received dose from vial that was more than 30 days refrigerated; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose from a Moderna COVID-19 vaccine vial that had expired 2 days prior.) and PRODUCT STORAGE ERROR (received dose from vial that was more than 30 days refrigerated) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose from a Moderna COVID-19 vaccine vial that had expired 2 days prior.) and PRODUCT STORAGE ERROR (received dose from vial that was more than 30 days refrigerated). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a dose from a Moderna COVID-19 vaccine vial that had expired 2 days prior.) and PRODUCT STORAGE ERROR (received dose from vial that was more than 30 days refrigerated) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Follow up received on 05 oct 2021 contains non significant information .
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Was administered an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Was administered an expired vaccine) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Sep-2021, 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Was administered an expired vaccine). On 20-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Was administered an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: sore arm after the first dose; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm after the first dose) and HEADACHE (Headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     Concurrent medical conditions included Acid reflux (esophageal) and Headache. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), ASPIRIN;BUTALBITAL;CAFFEINE for Headache, MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (sore arm after the first dose) and HEADACHE (Headache). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Headache, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm after the first dose) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-337879 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site pain
Clinical narrative: hives few days later; vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives few days later) and VACCINATION SITE PAIN (vaccination site pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hives (mild hives before her first vaccination). Concurrent medical conditions included Penicillin allergy (reaction to Pennycillin). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and HYDROXYZINE for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives few days later) and VACCINATION SITE PAIN (vaccination site pain). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives few days later) and VACCINATION SITE PAIN (vaccination site pain) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient took Benadryl before she got the second vaccine to keep the hives down.  Treatment information for the event sore arm was not provided by the reporter.   This case was linked to MOD-2021-337946 (Patient Link).   Reporter did not allow further contact
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 12 year old patient was administered 1st dose of modern vaccine/12 year old received moderna vaccine/1st dose administered/Mistakenly administered moderna covid vaccine/error; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old patient was administered 1st dose of modern vaccine/12 year old received moderna vaccine/1st dose administered/Mistakenly administered moderna covid vaccine/error) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old patient was administered 1st dose of modern vaccine/12 year old received moderna vaccine/1st dose administered/Mistakenly administered moderna covid vaccine/error). On 29-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old patient was administered 1st dose of modern vaccine/12 year old received moderna vaccine/1st dose administered/Mistakenly administered moderna covid vaccine/error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Follow-up received contains additional Non-significant follow-up appended additional reporter details were added.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Urticaria
Clinical narrative: three days later she got hives, but it was not as bad as the first time.; first vaccine given on 10Feb2021 second vaccination on 23SEPT2021; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (three days later she got hives, but it was not as bad as the first time.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first vaccine given on 10Feb2021 second vaccination on 23SEPT2021) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Hives (before her first vaccination). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and HYDROXYZINE for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first vaccine given on 10Feb2021 second vaccination on 23SEPT2021). On 26-Sep-2021, the patient experienced URTICARIA (three days later she got hives, but it was not as bad as the first time.). On 23-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first vaccine given on 10Feb2021 second vaccination on 23SEPT2021) had resolved. At the time of the report, URTICARIA (three days later she got hives, but it was not as bad as the first time.) outcome was unknown.            Patient took Benadryl before the second vaccine to keep the hives down.   This case was linked to MOD-2021-337927 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Encephalitis autoimmune, Memory impairment
Clinical narrative: Auto-immune encephalitis; It effects your memory; This spontaneous case was reported by a consumer and describes the occurrence of ENCEPHALITIS AUTOIMMUNE (Auto-immune encephalitis) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant medical history was provided by the reporter.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-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 ENCEPHALITIS AUTOIMMUNE (Auto-immune encephalitis) (seriousness criteria hospitalization and medically significant) and MEMORY IMPAIRMENT (It effects your memory). The patient was hospitalized on sometime in March 2021 due to ENCEPHALITIS AUTOIMMUNE. At the time of the report, ENCEPHALITIS AUTOIMMUNE (Auto-immune encephalitis) and MEMORY IMPAIRMENT (It effects your memory) outcome was unknown.            Additional concomitant medication included unspecified hypertension medication.  Patient had the Moderna vaccine in January and February and ended up with auto immune disease. Patient was admitted to hospital in March for three weeks and was diagnosed with autoimmune encephalitis. Patient stated it affects the memory. Patient was on medical leave from work at the time of this report. Patient's neurologist recommended her to get the third dose. Patient declined to provide further medications due to having memory issue. Treatment medication was not provided by the reporter.  Company comment: This case concerns a 61-year-old, female patient with previous relevant medical history of hypertension, who experienced the unexpected event of encephalitis autoimmune. The event occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The medical history of hypertension remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-337939 (Patient Link).; Sender's Comments: This case concerns a 61-year-old, female patient with previous relevant medical history of hypertension, who experienced the unexpected event of encephalitis autoimmune. The event occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The medical history of hypertension remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Gait disturbance, Headache, Pyrexia
Clinical narrative: He started shaking.; He was walking crunched down by his back./He would walk really slow.; He had headaches.; He had chills.; He had fever around 104.; At midnight on same day, he was feeling hot.; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (At midnight on same day, he was feeling hot.), TREMOR (He started shaking.), GAIT DISTURBANCE (He was walking crunched down by his back./He would walk really slow.), HEADACHE (He had headaches.) and CHILLS (He had chills.) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient experienced FEELING HOT (At midnight on same day, he was feeling hot.). On an unknown date, the patient experienced TREMOR (He started shaking.), GAIT DISTURBANCE (He was walking crunched down by his back./He would walk really slow.), HEADACHE (He had headaches.), CHILLS (He had chills.) and PYREXIA (He had fever around 104.). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, FEELING HOT (At midnight on same day, he was feeling hot.), TREMOR (He started shaking.), GAIT DISTURBANCE (He was walking crunched down by his back./He would walk really slow.), HEADACHE (He had headaches.), CHILLS (He had chills.) and PYREXIA (He had fever around 104.) outcome was unknown.            Patient wants to know if there is any excuse note that can be provided to his work from moderna for not showing up to work and also wants to know if he should go to doctor if he has fever again.  No concomitant medication was reported.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: He started shaking.; He was walking crunched down by his back./He would walk really slow.; He had headaches.; He had chills.; He had fever around 104.; At midnight on same day, he was feeling hot.; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (At midnight on same day, he was feeling hot.), TREMOR (He started shaking.), GAIT DISTURBANCE (He was walking crunched down by his back./He would walk really slow.), HEADACHE (He had headaches.) and CHILLS (He had chills.) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient experienced FEELING HOT (At midnight on same day, he was feeling hot.). On an unknown date, the patient experienced TREMOR (He started shaking.), GAIT DISTURBANCE (He was walking crunched down by his back./He would walk really slow.), HEADACHE (He had headaches.), CHILLS (He had chills.) and PYREXIA (He had fever around 104.). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, FEELING HOT (At midnight on same day, he was feeling hot.), TREMOR (He started shaking.), GAIT DISTURBANCE (He was walking crunched down by his back./He would walk really slow.), HEADACHE (He had headaches.), CHILLS (He had chills.) and PYREXIA (He had fever around 104.) outcome was unknown.            Patient wants to know if there is any excuse note that can be provided to his work from moderna for not showing up to work and also wants to know if he should go to doctor if he has fever again.  No concomitant medication was reported.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired first dose of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired first dose of the Moderna vaccine) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired first dose of the Moderna vaccine). On 29-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired first dose of the Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment information was provided by reporter.   This case was linked to MOD-2021-338604 (Patient Link).
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received first expired dose of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received first expired dose of the Moderna vaccine) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received first expired dose of the Moderna vaccine). On 29-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received first expired dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-338604 (Patient Link).
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Product colour issue
Clinical narrative: when he received the vaccine, the liquid in the syringe was light blueish; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT COLOUR ISSUE (when he received the vaccine, the liquid in the syringe was light blueish) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04621A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced PRODUCT COLOUR ISSUE (when he received the vaccine, the liquid in the syringe was light blueish). On 16-Sep-2021, PRODUCT COLOUR ISSUE (when he received the vaccine, the liquid in the syringe was light blueish) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatement of medication was reported. Concomitant medication included supplements.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Myalgia
Clinical narrative: Stomach hurts; Arm is sore; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach hurts) and MYALGIA (Arm is sore) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Sep-2021, the patient experienced DIARRHOEA (Diarrhea). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach hurts) and MYALGIA (Arm is sore). At the time of the report, DIARRHOEA (Diarrhea) had not resolved and ABDOMINAL PAIN UPPER (Stomach hurts) and MYALGIA (Arm is sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment information was not reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired third dose of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired third dose of the Moderna vaccine) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired third dose of the Moderna vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired third dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not reported.  Treatment medications was not reported.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine beyond 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine beyond 30 days) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    In September 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In September 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine beyond 30 days). In September 2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine beyond 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The vials were in refrigerator for over 30 days. From 24-Aug-2021 the vials were stored in the refrigerator, which were administered on 27-Sep-2021 and 29-Sep-2021. It was stated that the vial did not undergo temperature excursions.  No concomitant medications were reported.  No treatment information was reported.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine beyond 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine beyond 30 days) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine beyond 30 days). On 27-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine beyond 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drug information was provided. no treatment information was provided. The vials were in refrigerator for over 30 days.   This case was linked to MOD-2021-338604 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: injection site was beet red a little painful; injection site was beet red a little painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site was beet red a little painful) and VACCINATION SITE PAIN (injection site was beet red a little painful) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     The patient's past medical history included Connective tissue disorder.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (injection site was beet red a little painful) and VACCINATION SITE PAIN (injection site was beet red a little painful). At the time of the report, VACCINATION SITE ERYTHEMA (injection site was beet red a little painful) and VACCINATION SITE PAIN (injection site was beet red a little painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient has a history of cancer twice but only received chemo once. Concomitant medication was not reported. Treatment information was not reported.   This case was linked to MOD-2021-338452 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vials stored in the refrigerator were exposed to temperatures below 36°F; vaccine that had experienced a temperature excursion was given as 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Vials stored in the refrigerator were exposed to temperatures below 36°F) and EXPIRED PRODUCT ADMINISTERED (vaccine that had experienced a temperature excursion was given as 2nd dose) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Sep-2021, the patient experienced PRODUCT STORAGE ERROR (Vials stored in the refrigerator were exposed to temperatures below 36°F) and EXPIRED PRODUCT ADMINISTERED (vaccine that had experienced a temperature excursion was given as 2nd dose). On 23-Sep-2021, PRODUCT STORAGE ERROR (Vials stored in the refrigerator were exposed to temperatures below 36°F) and EXPIRED PRODUCT ADMINISTERED (vaccine that had experienced a temperature excursion was given as 2nd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No Treatment medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.   Treatment information was not provided.   This case was linked to MOD-2021-338337 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We vaccinated 20 people with vaccine that was out of date since last Friday; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We vaccinated 20 people with vaccine that was out of date since last Friday) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 032B21A) for COVID-19 vaccination.     No Medical History information was reported.   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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We vaccinated 20 people with vaccine that was out of date since last Friday). On 29-Sep-2021, EXPIRED PRODUCT ADMINISTERED (We vaccinated 20 people with vaccine that was out of date since last Friday) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were not reported.  The 20 patients were vaccinated with the Moderna COVID-19 vaccine that expired on 24-Sep-2021. The vaccinations were administered over 3 days, starting on 27-Sep-2021 and ending on 29-Sep-2021 to all the patients.  No treatment medications were not provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Pain, Pain in extremity
Clinical narrative: Whole body hurts; Diarrhea; Sore arm,soreness in the arm; Tiredness, exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Whole body hurts), DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (Sore arm,soreness in the arm) and FATIGUE (Tiredness, exhaustion) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051E21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included METHYLPREDNISOLONE for an unknown indication.    On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Sep-2021, the patient experienced FATIGUE (Tiredness, exhaustion). On an unknown date, the patient experienced PAIN (Whole body hurts), DIARRHOEA (Diarrhea) and PAIN IN EXTREMITY (Sore arm,soreness in the arm). At the time of the report, PAIN (Whole body hurts), DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (Sore arm,soreness in the arm) and FATIGUE (Tiredness, exhaustion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment drugs were reported.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hot flush, Nausea, Vomiting
Clinical narrative: hot flashes; Nausea; vomiting; headaches; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (hot flashes), NAUSEA (Nausea), VOMITING (vomiting) and HEADACHE (headaches) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced HOT FLUSH (hot flashes), NAUSEA (Nausea), VOMITING (vomiting) and HEADACHE (headaches). At the time of the report, HOT FLUSH (hot flashes), NAUSEA (Nausea), VOMITING (vomiting) and HEADACHE (headaches) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-338526 (Patient Link).
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: tingling in right leg; pain in right leg; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in right leg) and PAIN IN EXTREMITY (pain in right leg) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced PARAESTHESIA (tingling in right leg) and PAIN IN EXTREMITY (pain in right leg). At the time of the report, PARAESTHESIA (tingling in right leg) and PAIN IN EXTREMITY (pain in right leg) outcome was unknown.            Concomitant medication of the patient was not reported.  On 30-Sep-2021, the patient woke up and started driving her son to school. She started having tingling and pain in her right leg. It hurt and tingles even when she was sitting still.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-338511 (Patient Link).
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; The vials were in the refrigerator for over 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (The vials were in the refrigerator for over 30 days) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (The vials were in the refrigerator for over 30 days). On 29-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (The vials were in the refrigerator for over 30 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.    This case was linked to MOD-2021-338604 (Patient Link).
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoacusis
Clinical narrative: had troubles hearing; This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS (had troubles hearing) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0A8BZ, 026L20A and 172267) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation. Concomitant products included RIVAROXABAN (XARELTO), ATORVASTATIN CALCIUM (LIPITOR), MIDODRINE, EICOSAPENTAENOIC ACID ETHYL ESTER (VASCEPA), TAMSULOSIN, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and MONTELUKAST for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Sep-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 HYPOACUSIS (had troubles hearing). At the time of the report, HYPOACUSIS (had troubles hearing) outcome was unknown.            Concomitant medication also includes Supplements. No treatment medication provided.  On 24-Sep-2021, patient had blood draw for blood tests, 14 vials of blood were taken due to that patient was worried it might effect the efficacy of the vaccine.  It was unknown if the patient was immunocompromised or not. patient took the third dose of the vaccine as his doctor told him to get it.  Patient had an unspecified coronary sugary 5 years ago for  atrial stimulation. Another unspecified coronary surgery was planned at the end of October. It was planed before prior to getting the vaccines.