chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Vaccination site movement impairment
Clinical narrative: Can't move her arm; nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Can't move her arm), NAUSEA (nausea) and CHILLS (Chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Can't move her arm), NAUSEA (nausea) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Can't move her arm), NAUSEA (nausea) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea
Clinical narrative: shortness of breath; Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath) and CHEST PAIN (Chest pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (shortness of breath) and CHEST PAIN (Chest pain).  At the time of the report, DYSPNOEA (shortness of breath) and CHEST PAIN (Chest pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal behaviour, Body temperature, Pyrexia, Vaccination complication
Clinical narrative: Wicked couple of months; Diagnosed with a medical problem; Fever between 100F -102F that was fluctuating after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of ABNORMAL BEHAVIOUR (Wicked couple of months), VACCINATION COMPLICATION (Diagnosed with a medical problem) and PYREXIA (Fever between 100F -102F that was fluctuating after 2nd dose) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 003C21A) for COVID-19 vaccination.     The patient's past medical history included Colonoscopy (A medical procedure (colonoscopy) was done for an internal infection after the first dose down the throat to diagnose for the internal infection and stated that now everything is normal regarding that infection.The patient had hiccups for 10 days before the procedure hence the colonoscopy procedure was done.). Concurrent medical conditions included Blood pressure high. Concomitant products included LISINOPRIL for Blood pressure high.   On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jul-2021, the patient experienced PYREXIA (Fever between 100F -102F that was fluctuating after 2nd dose). On an unknown date, the patient experienced ABNORMAL BEHAVIOUR (Wicked couple of months) and VACCINATION COMPLICATION (Diagnosed with a medical problem). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, ABNORMAL BEHAVIOUR (Wicked couple of months) and VACCINATION COMPLICATION (Diagnosed with a medical problem) outcome was unknown and PYREXIA (Fever between 100F -102F that was fluctuating after 2nd dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jul-2021, Body temperature: high (High) High( 100-102 degree Fahrenheit).     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient experienced Ran fever for 2 months (102*)  and it was treated with antibiotics.   This case was linked to MOD-2021-231193.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow-up received contains significant information. The patient initials were updated. The event was updated. On 12-Oct-2021: Follow up received  included Patient height, weight and race information, Start date of event Fever, outcome and Treatment was updated.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Joint injury, Product administered at inappropriate site, Product administration error
Clinical narrative: She was in rehab for 6 weeks after twisting her ankle; Received second dose in the bone instead of the muscle; Technician who was administering the vaccine did not give her an alcohol swab, band-aid, or anything; This spontaneous case was reported by a consumer and describes the occurrence of JOINT INJURY (She was in rehab for 6 weeks after twisting her ankle), PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Received second dose in the bone instead of the muscle) and PRODUCT ADMINISTRATION ERROR (Technician who was administering the vaccine did not give her an alcohol swab, band-aid, or anything) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for Hashimoto's disease.   On 22-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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, the patient experienced JOINT INJURY (She was in rehab for 6 weeks after twisting her ankle), PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Received second dose in the bone instead of the muscle) and PRODUCT ADMINISTRATION ERROR (Technician who was administering the vaccine did not give her an  alcohol swab, band-aid, or anything). At the time of the report, JOINT INJURY (She was in rehab for 6 weeks after twisting her ankle) outcome was unknown and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Received second dose in the bone instead of the muscle) and PRODUCT ADMINISTRATION ERROR (Technician who was administering the vaccine did not give her an  alcohol swab, band-aid, or anything) had resolved.            Patient reported that she didn't get a prescription for prednisone and that her symptoms were from when she was taken off of prednisone.  No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: Follow-up received non-significant On 23-Aug-2021: Follow up document received on 23AUG2021 contains no new information.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Feeling abnormal, Illness, Impaired work ability, Malaise
Clinical narrative: Started feeling so sick; He Is sick on the stomach/Is still sick; he could not go to work and has not gone to work; It got so bad last night; He is still sick; Nauseated/Nausea/felt like throwing up; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Started feeling so sick), ABDOMINAL DISCOMFORT (He Is sick on the stomach/Is still sick), IMPAIRED WORK ABILITY (he could not go to work and has not gone to work), FEELING ABNORMAL (It got so bad last night) and ILLNESS (He is still sick) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  Concurrent medical conditions included Diabetes. Concomitant products included INSULIN GLARGINE (LANTUS), DULAGLUTIDE (TRULICITY), INSULIN HUMAN (NOVOLIN R), MORNIFLUMATE (FLOMAX [MORNIFLUMATE]), GABAPENTIN, TIZANIDINE, OMEPRAZOLE and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (Started feeling so sick), ABDOMINAL DISCOMFORT (He Is sick on the stomach/Is still sick), IMPAIRED WORK ABILITY (he could not go to work and has not gone to work), FEELING ABNORMAL (It got so bad last night), ILLNESS (He is still sick) and NAUSEA (Nauseated/Nausea/felt like throwing up). The patient was treated with ONDANSETRON (ZOFRAN MELT) for Nausea, at an unspecified dose and frequency. At the time of the report, MALAISE (Started feeling so sick), ABDOMINAL DISCOMFORT (He Is sick on the stomach/Is still sick), IMPAIRED WORK ABILITY (he could not go to work and has not gone to work), FEELING ABNORMAL (It got so bad last night), ILLNESS (He is still sick) and NAUSEA (Nauseated/Nausea/felt like throwing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated that he takes lots of medications and reported taking "sugar" medicine.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Started feeling so sick; He Is sick on the stomach/Is still sick; he could not go to work and has not gone to work; It got so bad last night; He is still sick; Nauseated/Nausea/felt like throwing up; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Started feeling so sick), ABDOMINAL DISCOMFORT (He Is sick on the stomach/Is still sick), IMPAIRED WORK ABILITY (he could not go to work and has not gone to work), FEELING ABNORMAL (It got so bad last night) and ILLNESS (He is still sick) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  Concurrent medical conditions included Diabetes. Concomitant products included INSULIN GLARGINE (LANTUS), DULAGLUTIDE (TRULICITY), INSULIN HUMAN (NOVOLIN R), MORNIFLUMATE (FLOMAX [MORNIFLUMATE]), GABAPENTIN, TIZANIDINE, OMEPRAZOLE and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (Started feeling so sick), ABDOMINAL DISCOMFORT (He Is sick on the stomach/Is still sick), IMPAIRED WORK ABILITY (he could not go to work and has not gone to work), FEELING ABNORMAL (It got so bad last night), ILLNESS (He is still sick) and NAUSEA (Nauseated/Nausea/felt like throwing up). The patient was treated with ONDANSETRON (ZOFRAN MELT) for Nausea, at an unspecified dose and frequency. At the time of the report, MALAISE (Started feeling so sick), ABDOMINAL DISCOMFORT (He Is sick on the stomach/Is still sick), IMPAIRED WORK ABILITY (he could not go to work and has not gone to work), FEELING ABNORMAL (It got so bad last night), ILLNESS (He is still sick) and NAUSEA (Nauseated/Nausea/felt like throwing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated that he takes lots of medications and reported taking "sugar" medicine.
Age: 81.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: received a vaccine which was more than 30 days in the refrigerator; vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021).; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021).) in an 81-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jul-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 1. On 07-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021).). On 07-Jul-2021, EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021).) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported  No treatment medication was reported   This case was linked to MOD21-126929 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Illness, SARS-CoV-2 test
Clinical narrative: when I had my shots I was sick 3days both times; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (when I had my shots I was sick 3days both times) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (when I had my shots I was sick 3days both times). At the time of the report, ILLNESS (when I had my shots I was sick 3days both times) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-286336 (Patient Link).   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: I know at least 3 people that got COVID even having the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I know at least 3 people that got COVID even having the vaccine) 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 specified medical history has been 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 COVID-19 (I know at least 3 people that got COVID even having the vaccine). At the time of the report, COVID-19 (I know at least 3 people that got COVID even having the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: chest pain; Med Info Agent: Staff The caller reported that saw online reports of chest pain
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A, 042L20A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021 at 9:32 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021 at 9:16 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: pass 34 days he has been having headaches daily; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (pass 34 days he has been having headaches daily) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (pass 34 days he has been having headaches daily). At the time of the report, HEADACHE (pass 34 days he has been having headaches daily) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported.  Treatment information was not reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Decreased appetite, Dizziness
Clinical narrative: Pillow was soaking wet/swetted it out/Night sweats; left arm was killing me; No energy; Joints hurt; Exhausted; chills; Couldn't eat/no appetite; Very, very ill; Couldn't wake up; Dizzy; Slept for 34 hours; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Couldn't eat/no appetite), ILLNESS (Very, very ill), SOMNOLENCE (Couldn't wake up), DIZZINESS (Dizzy) and SOMNOLENCE (Slept for 34 hours) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A, 013L20A and 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Immunocompromised. Concomitant products included GLIPIZIDE, METFORMIN, SIMVASTATIN, LISINOPRIL and LEVOTHYROXINE for an unknown indication. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Oct-2021, the patient experienced SOMNOLENCE (Slept for 34 hours). On 10-Oct-2021, the patient experienced DECREASED APPETITE (Couldn't eat/no appetite), ILLNESS (Very, very ill), SOMNOLENCE (Couldn't wake up), DIZZINESS (Dizzy), FATIGUE (Exhausted) and CHILLS (chills). On 11-Oct-2021, the patient experienced ASTHENIA (No energy), PAIN IN EXTREMITY (left arm was killing me) and ARTHRALGIA (Joints hurt). On 12-Oct-2021, the patient experienced NIGHT SWEATS (Pillow was soaking wet/swetted it out/Night sweats). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (Couldn't eat/no appetite) had not resolved and ILLNESS (Very, very ill), SOMNOLENCE (Couldn't wake up), DIZZINESS (Dizzy), SOMNOLENCE (Slept for 34 hours), ASTHENIA (No energy), NIGHT SWEATS (Pillow was soaking wet/swetted it out/Night sweats), PAIN IN EXTREMITY (left arm was killing me), FATIGUE (Exhausted), CHILLS (chills) and ARTHRALGIA (Joints hurt) outcome was unknown.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case was linked to MOD-2021-349585 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Patient decline for the nervousness event.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness, Night sweats, Pain in extremity, Somnolence
Clinical narrative: Pillow was soaking wet/swetted it out/Night sweats; left arm was killing me; No energy; Joints hurt; Exhausted; chills; Couldn't eat/no appetite; Very, very ill; Couldn't wake up; Dizzy; Slept for 34 hours; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Couldn't eat/no appetite), ILLNESS (Very, very ill), SOMNOLENCE (Couldn't wake up), DIZZINESS (Dizzy) and SOMNOLENCE (Slept for 34 hours) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A, 013L20A and 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Immunocompromised. Concomitant products included GLIPIZIDE, METFORMIN, SIMVASTATIN, LISINOPRIL and LEVOTHYROXINE for an unknown indication. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Oct-2021, the patient experienced SOMNOLENCE (Slept for 34 hours). On 10-Oct-2021, the patient experienced DECREASED APPETITE (Couldn't eat/no appetite), ILLNESS (Very, very ill), SOMNOLENCE (Couldn't wake up), DIZZINESS (Dizzy), FATIGUE (Exhausted) and CHILLS (chills). On 11-Oct-2021, the patient experienced ASTHENIA (No energy), PAIN IN EXTREMITY (left arm was killing me) and ARTHRALGIA (Joints hurt). On 12-Oct-2021, the patient experienced NIGHT SWEATS (Pillow was soaking wet/swetted it out/Night sweats). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (Couldn't eat/no appetite) had not resolved and ILLNESS (Very, very ill), SOMNOLENCE (Couldn't wake up), DIZZINESS (Dizzy), SOMNOLENCE (Slept for 34 hours), ASTHENIA (No energy), NIGHT SWEATS (Pillow was soaking wet/swetted it out/Night sweats), PAIN IN EXTREMITY (left arm was killing me), FATIGUE (Exhausted), CHILLS (chills) and ARTHRALGIA (Joints hurt) outcome was unknown.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case was linked to MOD-2021-349585 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Patient decline for the nervousness event.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: More than 35 days between does 1 and dose 2; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between does 1 and dose 2) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised. Concomitant products included GLIPIZIDE, METFORMIN, SIMVASTATIN, LISINOPRIL and LEVOTHYROXINE for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between does 1 and dose 2). On 28-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between does 1 and dose 2) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Caller reported that she have had the first two doses (Moderna) and experienced no problem.   This case was linked to MOD-2021-349550.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for covid-19 after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for covid-19 after vaccination) and FEELING ABNORMAL (felt badly) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, the patient experienced COVID-19 (tested positive for covid-19 after vaccination). On an unknown date, the patient experienced FEELING ABNORMAL (felt badly). The patient was treated with MONOCLONAL ANTIBODIES, GRANULOCYTE for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (tested positive for covid-19 after vaccination) outcome was unknown and FEELING ABNORMAL (felt badly) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication were reported.; Sender's Comments: This report concerns a male patient of unknown age with no relevant medical history who experienced a serious unexpected event of COVID-19. The event occurred approximately 7 months after the second dose of mRNA-1273. The report states that patient had a mild disease and was in hospital. The patient was treated with monoclonal antibodies. Re-challenge was not applicable as the event happened after the second dose, and no additional dosing will be given. There is no information about the first dose. Outcome of the event COVID-19 was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 52.0
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue, Vaccination site bruising, Vaccination site erythema
Clinical narrative: (Arm) had a pretty big  bruise (at injection site) for 5 to 6 weeks; Arm was red (at injection site) for 5 to 6 weeks; I decided not to get second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING ((Arm) had a pretty big  bruise (at injection site) for 5 to 6 weeks), VACCINATION SITE ERYTHEMA (Arm was red (at injection site) for 5 to 6 weeks) and PRODUCT DOSE OMISSION ISSUE (I decided not to get second dose) in a 52-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    In May 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 BRUISING ((Arm) had a pretty big  bruise (at injection site) for 5 to 6 weeks), VACCINATION SITE ERYTHEMA (Arm was red (at injection site) for 5 to 6 weeks) and PRODUCT DOSE OMISSION ISSUE (I decided not to get second dose). At the time of the report, VACCINATION SITE BRUISING ((Arm) had a pretty big  bruise (at injection site) for 5 to 6 weeks), VACCINATION SITE ERYTHEMA (Arm was red (at injection site) for 5 to 6 weeks) and PRODUCT DOSE OMISSION ISSUE (I decided not to get second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant history was not reported. The treatment history was not provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Illness, Migraine
Clinical narrative: He starts to get sick in the middle afternoon; Migraine; chills and fever on and off has happened 4 times in total by 7 pm he has fever 101 fever all night; 3 pm starts chills by 5 pm  he has chills; headache this morning; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (He starts to get sick in the middle afternoon), MIGRAINE (Migraine), PYREXIA (chills and fever on and off has happened 4 times in total by 7 pm he has fever 101 fever all night), CHILLS (3 pm starts chills by 5 pm  he has chills) and HEADACHE (headache this morning) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A, 041LC0A and 045C21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included Adverse event with Flu shot.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-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 ILLNESS (He starts to get sick in the middle afternoon), MIGRAINE (Migraine), PYREXIA (chills and fever on and off has happened 4 times in total by 7 pm he has fever 101 fever all night), CHILLS (3 pm starts chills by 5 pm  he has chills) and HEADACHE (headache this morning). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] (oral) for Migraine, at an unspecified dose and frequency. At the time of the report, ILLNESS (He starts to get sick in the middle afternoon), MIGRAINE (Migraine), PYREXIA (chills and fever on and off has happened 4 times in total by 7 pm he has fever 101 fever all night), CHILLS (3 pm starts chills by 5 pm  he has chills) and HEADACHE (headache this morning) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) 101 fever.         No concomitant medications were reported. Patient had no actual side effects from the vaccines themselves and reported he took lots of medications daily but unspecified and stated he took the 3rd dose and he mentioned he wasn't supposed to.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: He starts to get sick in the middle afternoon; Migraine; chills and fever on and off has happened 4 times in total by 7 pm he has fever 101 fever all night; 3 pm starts chills by 5 pm  he has chills; headache this morning; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (He starts to get sick in the middle afternoon), MIGRAINE (Migraine), PYREXIA (chills and fever on and off has happened 4 times in total by 7 pm he has fever 101 fever all night), CHILLS (3 pm starts chills by 5 pm  he has chills) and HEADACHE (headache this morning) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A, 041LC0A and 045C21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included Adverse event with Flu shot.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-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 ILLNESS (He starts to get sick in the middle afternoon), MIGRAINE (Migraine), PYREXIA (chills and fever on and off has happened 4 times in total by 7 pm he has fever 101 fever all night), CHILLS (3 pm starts chills by 5 pm  he has chills) and HEADACHE (headache this morning). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] (oral) for Migraine, at an unspecified dose and frequency. At the time of the report, ILLNESS (He starts to get sick in the middle afternoon), MIGRAINE (Migraine), PYREXIA (chills and fever on and off has happened 4 times in total by 7 pm he has fever 101 fever all night), CHILLS (3 pm starts chills by 5 pm  he has chills) and HEADACHE (headache this morning) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) 101 fever.         No concomitant medications were reported. Patient had no actual side effects from the vaccines themselves and reported he took lots of medications daily but unspecified and stated he took the 3rd dose and he mentioned he wasn't supposed to.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: there was general malaise; feeling a little sick; fever with booster; sore arm; pain in arm; I did get a headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (there was general malaise), MALAISE (feeling a little sick), PAIN IN EXTREMITY (pain in arm), HEADACHE (I did get a headache) and PYREXIA (fever with booster) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lymphoma (The patient had a history of lymphoma for which she is on a maintenance infusion.). Concomitant products included PRAVASTATIN, PANTOPRAZOLE, DEXAMETHASONE, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), PARACETAMOL (TYLENOL), RITUXIMAB (TRUXIMA [RITUXIMAB]), COLECALCIFEROL (VITAMIN D3), CALCIUM, ACETYLSALICYLIC ACID (ASPIRIN), MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE] and ONDANSETRON for an unknown indication.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Sep-2021, the patient experienced PAIN IN EXTREMITY (pain in arm), HEADACHE (I did get a headache) and MYALGIA (sore arm). On 14-Sep-2021, the patient experienced MALAISE (there was general malaise), MALAISE (feeling a little sick) and PYREXIA (fever with booster). The patient was treated with PEDIALYTE FREEZER POPS [ASPARTAME;CARMELLOSE;CITRIC ACID;FRUCTOSE;GLUCOSE;POTASSIUM CHLORIDE;POTASSIUM SORBATE;SODIUM BENZOATE;SODIUM CITRATE] for Adverse event, at an unspecified dose and frequency. On 15-Sep-2021, MALAISE (there was general malaise), MALAISE (feeling a little sick), HEADACHE (I did get a headache), PYREXIA (fever with booster) and MYALGIA (sore arm) had resolved. At the time of the report, PAIN IN EXTREMITY (pain in arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: negative (Negative) Antibody test negative..         The patient was also taking Cagament and Hygil concomitantly. The patient was again tested for antibodies after receiving the 3rd dose, which was also negative. The patient didn't had side effects from the first two doses. The patient experienced a fever, headache, and sore arm after receiving the 3rd dose. She said that the pain in the arm and headache started the same evening of the shot. The feeling of general malaise, fever, and feeling sick started the following day. The headache lasted for 1 - 1.5 days and the sore arm lasted for a couple of days. All other symptoms only lasted for a day after which she felt fine.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided by the reporter. Treatment medication was not given.   This case was linked to MOD-2021-350559 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash
Clinical narrative: Left arm was sore at the injection site; She has a rash around the area she received injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Left arm was sore at the injection site) and VACCINATION SITE RASH (She has a rash around the area she received injection) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Oct-2021, the patient experienced VACCINATION SITE PAIN (Left arm was sore at the injection site) and VACCINATION SITE RASH (She has a rash around the area she received injection). At the time of the report, VACCINATION SITE PAIN (Left arm was sore at the injection site) and VACCINATION SITE RASH (She has a rash around the area she received injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment medications were not provided by the reporter.   Reporter did not allow further contact
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Myalgia, Pyrexia, Vaccination complication
Clinical narrative: Strong reaction; Felt like a "kick in the pants"; Body aches; Fever for 5 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Strong reaction), FEELING ABNORMAL (Felt like a "kick in the pants"), MYALGIA (Body aches) and PYREXIA (Fever for 5 days) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Lymphedema.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Strong reaction), FEELING ABNORMAL (Felt like a "kick in the pants"), MYALGIA (Body aches) and PYREXIA (Fever for 5 days). At the time of the report, VACCINATION COMPLICATION (Strong reaction), FEELING ABNORMAL (Felt like a "kick in the pants"), MYALGIA (Body aches) and PYREXIA (Fever for 5 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 medication information was not provided by the reporter. Treatment information was not provided by the reporter.   This case was linked to MOD-2021-350345 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Jaw disorder, Muscle spasms, Muscular weakness, Myalgia
Clinical narrative: Muscle spasms in the legs; Achy sore weakness that is dreadful, not comfortable and agonizing / achiness is all over the body; Jaw is hurting; Has jaw issues; Haven't had much of an appetite; Is generally feeling unwell; Achy sore weakness that is dreadful, not comfortable and agonizing / achiness is all over the body; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Muscle spasms in the legs), MUSCULAR WEAKNESS (Achy sore weakness that is dreadful, not comfortable and agonizing / achiness is all over the body), PAIN IN JAW (Jaw is hurting), JAW DISORDER (Has jaw issues) and DECREASED APPETITE (Haven't had much of an appetite) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE (ZUBSOLV) for an unknown indication.   On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Aug-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 MUSCLE SPASMS (Muscle spasms in the legs), MUSCULAR WEAKNESS (Achy sore weakness that is dreadful, not comfortable and agonizing / achiness is all over the body), PAIN IN JAW (Jaw is hurting), JAW DISORDER (Has jaw issues), DECREASED APPETITE (Haven't had much of an appetite), VACCINATION COMPLICATION (Is generally feeling unwell) and MYALGIA (Achy sore weakness that is dreadful, not comfortable and agonizing / achiness is all over the body). At the time of the report, MUSCLE SPASMS (Muscle spasms in the legs), MUSCULAR WEAKNESS (Achy sore weakness that is dreadful, not comfortable and agonizing / achiness is all over the body), PAIN IN JAW (Jaw is hurting), JAW DISORDER (Has jaw issues), DECREASED APPETITE (Haven't had much of an appetite), VACCINATION COMPLICATION (Is generally feeling unwell) and MYALGIA (Achy sore weakness that is dreadful, not comfortable and agonizing / achiness is all over the body) outcome was unknown.      No treatment information was provided.   This case was linked to MOD-2021-350356 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw, Vaccination complication
Clinical narrative: Muscle spasms in the legs; Achy sore weakness that is dreadful, not comfortable and agonizing / achiness is all over the body; Jaw is hurting; Has jaw issues; Haven't had much of an appetite; Is generally feeling unwell; Achy sore weakness that is dreadful, not comfortable and agonizing / achiness is all over the body; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Muscle spasms in the legs), MUSCULAR WEAKNESS (Achy sore weakness that is dreadful, not comfortable and agonizing / achiness is all over the body), PAIN IN JAW (Jaw is hurting), JAW DISORDER (Has jaw issues) and DECREASED APPETITE (Haven't had much of an appetite) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE (ZUBSOLV) for an unknown indication.   On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Aug-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 MUSCLE SPASMS (Muscle spasms in the legs), MUSCULAR WEAKNESS (Achy sore weakness that is dreadful, not comfortable and agonizing / achiness is all over the body), PAIN IN JAW (Jaw is hurting), JAW DISORDER (Has jaw issues), DECREASED APPETITE (Haven't had much of an appetite), VACCINATION COMPLICATION (Is generally feeling unwell) and MYALGIA (Achy sore weakness that is dreadful, not comfortable and agonizing / achiness is all over the body). At the time of the report, MUSCLE SPASMS (Muscle spasms in the legs), MUSCULAR WEAKNESS (Achy sore weakness that is dreadful, not comfortable and agonizing / achiness is all over the body), PAIN IN JAW (Jaw is hurting), JAW DISORDER (Has jaw issues), DECREASED APPETITE (Haven't had much of an appetite), VACCINATION COMPLICATION (Is generally feeling unwell) and MYALGIA (Achy sore weakness that is dreadful, not comfortable and agonizing / achiness is all over the body) outcome was unknown.      No treatment information was provided.   This case was linked to MOD-2021-350356 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Vaccination site pain
Clinical narrative: Headache; injection site was sufficiently sore; head to toe body aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), VACCINATION SITE PAIN (injection site was sufficiently sore) and MYALGIA (head to toe body aches) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), VACCINATION SITE PAIN (injection site was sufficiently sore) and MYALGIA (head to toe body aches). At the time of the report, HEADACHE (Headache), VACCINATION SITE PAIN (injection site was sufficiently sore) and MYALGIA (head to toe body aches) had resolved. Not Provided          No concomitant medication was provided  Treatment medication was not provided by the reporter  Reporter was informed by my father on 10Oct2021 that a close family friend received a Moderna Covid-19 booster (third shot) from his local health department. The patient (SW, male) is likely in his 70s and  it had been >8months since his second shot. Patient had more severe side effects than the second shot. He got the shot Thursday am and had a headache by 10 pm. The injection  site was sufficiently sore to avoid all contact and he had head to toe body aches all through the night. Symptoms reduced by Friday am and were completely gone by Friday evening.   This case was linked to MOD-2021-350359 (Patient Link).