chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Vaccination site pain
Clinical narrative: mild flu-like symptoms; soreness in arm shot location; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (mild flu-like symptoms) and VACCINATION SITE PAIN (soreness in arm shot location) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A, 029A21A, 045J21A and 002M21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (mild flu-like symptoms) and VACCINATION SITE PAIN (soreness in arm shot location). At the time of the report, INFLUENZA LIKE ILLNESS (mild flu-like symptoms) and VACCINATION SITE PAIN (soreness in arm shot location) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Reported stated that previous vaccine shots and booster gave mild flu-like symptoms and soreness in arm shot location which all resolved in 2 days.  It was unknown if the patient experienced any additional symptoms/events.  No treatment information was provided.   This case was linked to MOD-2022-687681 (Patient Link).
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No Adverse event; they accidentally gave the 2nd dose of the Moderna vaccine to a patient 21 days after the 1st dose; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (they accidentally gave the 2nd dose of the Moderna vaccine to a patient 21 days after the 1st dose) and NO ADVERSE EVENT (No Adverse event) in a 19-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 057A22A and 057A22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 23-Nov-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Dec-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (they accidentally gave the 2nd dose of the Moderna vaccine to a patient 21 days after the 1st dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (they accidentally gave the 2nd dose of the Moderna vaccine to a patient 21 days after the 1st dose) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (they accidentally gave the 2nd dose of the Moderna vaccine to a patient 21 days after the 1st dose).    No concomitant medication was provided by the reporter.  Nurse practitioner reports that they accidentally gave the 2nd dose of the Moderna vaccine to a patient 21 days after the 1st dose.   No treatment medication was provided by the reporter.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Thyroid function test
Clinical narrative: hair loss; This spontaneous case was reported by a patient and describes the occurrence of ALOPECIA (hair loss) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     The patient's past medical history included Fever. Concomitant products included INFLUENZA VACCINE for an unknown indication.    On 07-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (hair loss). The patient was treated with MINOXIDIL (ROGAINE) at an unspecified dose and frequency. At the time of the report, ALOPECIA (hair loss) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Thyroid function test: Normal.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient hair was very long at one point, but now it's very thin. She stated that it started after  the Moderna vaccine. Then patient had her flu shot the next week. She wonders if she took them too close together. Patient states she didn't have a reaction before the Moderna. Patient felt it was overnight that she started losing hair. Patient did not have this issue with the other shots. Did not get any reaction. She did have a small fever last spring.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 1) on 08-Apr-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose 2) on 29-Apr-2021 and PFIZER BIONTECH COVID-19 VACCINE (Dose 3) on 04-Nov-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 27-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Dec-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter. No treatment medication was provided by the reporter.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for Covid) in a 76-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient's past medical history included Pacemaker insertion (cardiac) (Patient had pacemaker which was implanted before she got the Covid-19 vaccines.). Previously administered products included for Product used for unknown indication: HEPATITIS B VACCINE on 26-Sep-2022 and INFLUENZA VACCINE on 26-Sep-2022. Past adverse reactions to the above products included No adverse event with HEPATITIS B VACCINE and INFLUENZA VACCINE.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 25-Nov-2022, the patient experienced COVID-19 (tested positive for Covid). At the time of the report, COVID-19 (tested positive for Covid) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Nov-2022, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  On an unknown dates, patient had received 1st dose, 2nd dose, Booster dose of moderna vaccines with unknown batch/lot numbers and unknown routes.   It was reported that patient felt light headed and fatigued and lost her sense of taste and unable to eat at that time. It was reported that patient symptoms were prolonged and she went to the urgent care on 2 Dec 2022. She was on isolation for 18 days.  Treatment medication was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered an expired of Moderna monovalent vaccine to a patient today; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered an expired of Moderna monovalent vaccine to a patient today) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered an expired of Moderna monovalent vaccine to a patient today) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered an expired of Moderna monovalent vaccine to a patient today) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered an expired of Moderna monovalent vaccine to a patient today).    No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: He has not received the second shot; No Adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He has not received the second shot) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He has not received the second shot) and NO ADVERSE EVENT (No Adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He has not received the second shot) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not reported.  It was reported patient received last received moderna on 12-May-2022. Patient had not received second shot. It was unknown patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment medications were not reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Administered vaccine 6 days after the 30 day beyond use date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine 6 days after the 30 day beyond use date.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine 6 days after the 30 day beyond use date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered vaccine 6 days after the 30 day beyond use date.) had not resolved and NO ADVERSE EVENT (No adverse event) outcome was unknown.      The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Administered vaccine 6 days after the 30 day beyond use date.).    No concomitant medications were reported. On 15-Dec-2022 6:05PM: Nurse was called to ask a question and website states that vials are viable 7 days after the 30-day storage in the refrigerator. Reporter states that they administered a bivalent Moderna COVID-19 vaccine to an adult patient 6 days after the 30 day beyond use date. Dose administered after 30-day Use By Date.   Vial size? 0.4 mL, 2.5 mL or 5.5 mL: Bivalent blue cap adult. No vial was undergone to any temperature excursions.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Temperature excursion occurred on  29-Nov-2022; No Adverse Event; Total of 16 doses were administered on 29-Nov-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Total of 16 doses were administered on 29-Nov-2022), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on  29-Nov-2022) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 29-Nov-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Total of 16 doses were administered on 29-Nov-2022). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on  29-Nov-2022) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Total of 16 doses were administered on 29-Nov-2022), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on  29-Nov-2022) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Total of 16 doses were administered on 29-Nov-2022) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on  29-Nov-2022).    No concomitant medications were reported. A total of 16 doses were administered on 29-Nov-2022 (5), 30-Nov-2022 (4), 1-Dec-2022 (2), 2-Dec-2022 (2), 3-Dec-2022 (1), and 5-Dec-2022.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-687892 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-687892:
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: No adverse event; Temperature excursion occurred on 29Nov2022; Poor quality vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29Nov2022), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 29-Nov-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29Nov2022) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29Nov2022), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29Nov2022) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    No concomitant medication was reported.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  On 29-Nov-2022, temperature excursion occurred.  A total of 16 doses were administered in 6 days. 5 doses on 29-Nov-2022, 4 doses on 30-Nov-2022, 2 doses on 01-Dec-2022, 2 doses on 02-Dec-2022, 1 dose on 03-Dec-2022 and 2 doses on 05-Dec-2022.  No treatment medication was reported.  This case contains information for the 1st of 5 patients who received vaccine on 29-Nov-2022.   This case was linked to US-MODERNATX, INC.-MOD-2022-687786, US-MODERNATX, INC.-MOD-2022-687788, US-MODERNATX, INC.-MOD-2022-687785, US-MODERNATX, INC.-MOD-2022-687787 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-687786:Same reporter US-MODERNATX, INC.-MOD-2022-687788:Same reporter US-MODERNATX, INC.-MOD-2022-687785:Same reporter US-MODERNATX, INC.-MOD-2022-687787:Same reporter
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received Moderna Covid-19 vaccine after the 30 day past use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine after the 30 day past use by date) and NO ADVERSE EVENT (No adverse event) in a 93-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 041H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (First booster dose Lot number 029H21B ) on 08-Dec-2021 and Moderna COVID-19 Vaccine (Second booster dose Lot number 059M21 A) on 19-May-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 15-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine after the 30 day past use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine after the 30 day past use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine after the 30 day past use by date).    No concomitant medication was provided by the reporter.  Patient received Moderna Covid-19 vaccine after the 30 day past use by date no information was available on the patients primary Moderna Covid-19 vaccines. No other adverse reactions reported.  No treatment medication was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Bowel movement irregularity, Feeding disorder, Weight
Clinical narrative: loss of weight; inability to eat; have to move their bowels immediately; decreased blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (loss of weight), FEEDING DISORDER (inability to eat), BOWEL MOVEMENT IRREGULARITY (have to move their bowels immediately) and BLOOD PRESSURE DECREASED (decreased blood pressure) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WEIGHT DECREASED (loss of weight), FEEDING DISORDER (inability to eat), BOWEL MOVEMENT IRREGULARITY (have to move their bowels immediately) and BLOOD PRESSURE DECREASED (decreased blood pressure). The patient was treated with CILGAVIMAB, TIXAGEVIMAB (EVUSHELD) at an unspecified dose and frequency. At the time of the report, WEIGHT DECREASED (loss of weight), FEEDING DISORDER (inability to eat), BOWEL MOVEMENT IRREGULARITY (have to move their bowels immediately) and BLOOD PRESSURE DECREASED (decreased blood pressure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: Decreased. On an unknown date, Weight: loss of weight.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  Patient was prescribed with Evushield for the symptoms. Reporter reported that while she was looking for Evushield, the medication which was prescribed for the symptoms that she experienced after getting the 1st booster dose of the Moderna Covid vaccine, she met 2 patients (no identifiers except for gender and age group) who were also looking for the same medication due to the same symptoms (inability to eat because they have to move their bowels immediately, loss of weight and decreased blood pressure) she had post Moderna vaccination.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: loss of weight; inability to eat; have to move their bowels immediately; decreased blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (loss of weight), FEEDING DISORDER (inability to eat), BOWEL MOVEMENT IRREGULARITY (have to move their bowels immediately) and BLOOD PRESSURE DECREASED (decreased blood pressure) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WEIGHT DECREASED (loss of weight), FEEDING DISORDER (inability to eat), BOWEL MOVEMENT IRREGULARITY (have to move their bowels immediately) and BLOOD PRESSURE DECREASED (decreased blood pressure). The patient was treated with CILGAVIMAB, TIXAGEVIMAB (EVUSHELD) at an unspecified dose and frequency. At the time of the report, WEIGHT DECREASED (loss of weight), FEEDING DISORDER (inability to eat), BOWEL MOVEMENT IRREGULARITY (have to move their bowels immediately) and BLOOD PRESSURE DECREASED (decreased blood pressure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: Decreased. On an unknown date, Weight: loss of weight.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  Patient was prescribed with Evushield for the symptoms. Reporter reported that while she was looking for Evushield, the medication which was prescribed for the symptoms that she experienced after getting the 1st booster dose of the Moderna Covid vaccine, she met 2 patients (no identifiers except for gender and age group) who were also looking for the same medication due to the same symptoms (inability to eat because they have to move their bowels immediately, loss of weight and decreased blood pressure) she had post Moderna vaccination.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Blood test, Computerised tomogram
Clinical narrative: abdominal pain/Her pain is still ongoing; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (abdominal pain/Her pain is still ongoing) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient's past medical history included Urinary infection.    On 05-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced ABDOMINAL PAIN (abdominal pain/Her pain is still ongoing). At the time of the report, ABDOMINAL PAIN (abdominal pain/Her pain is still ongoing) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: They had done many tests including blood tests and a CT scan. Her pain is still ongoing today. On an unknown date, Computerised tomogram: They had done many tests including blood tests and a CT scan. Her pain is still ongoing today.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not reported.  Patient did not other vaccines in the 4 weeks prior COVID-19 vaccine. In the middle of Oct patient went to emergency room with abdominal pain. Patient received first dose in may-2021. Second dose and first booster at unknown times.  Treatment medications were not reported.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary mass, Blood test, Computerised tomogram, Pain
Clinical narrative: abdominal pain/Her pain is still ongoing; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (abdominal pain/Her pain is still ongoing) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient's past medical history included Urinary infection.    On 05-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced ABDOMINAL PAIN (abdominal pain/Her pain is still ongoing). At the time of the report, ABDOMINAL PAIN (abdominal pain/Her pain is still ongoing) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: They had done many tests including blood tests and a CT scan. Her pain is still ongoing today. On an unknown date, Computerised tomogram: They had done many tests including blood tests and a CT scan. Her pain is still ongoing today.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not reported.  Patient did not other vaccines in the 4 weeks prior COVID-19 vaccine. In the middle of Oct patient went to emergency room with abdominal pain. Patient received first dose in may-2021. Second dose and first booster at unknown times.  Treatment medications were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Doses Administered Past BUD; no adverse event; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses Administered Past BUD) and NO ADVERSE EVENT (no adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 prophylaxis.     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 EXPIRED PRODUCT ADMINISTERED (Doses Administered Past BUD) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses Administered Past BUD) and NO ADVERSE EVENT (no adverse event) outcome was unknown.            Concomitant product use was not provided by the reporter.   No treatment information was provided. Date Shipped: 22 Feb 2021 Approx BUD: 26 Mar 2021
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Muscular weakness, Paralysis
Clinical narrative: completely paralyzed temporarily/inability to move my limbs for maybe an hour or two; Muscle weakness; not feeling bad but not really very energetic; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (completely paralyzed temporarily/inability to move my limbs for maybe an hour or two) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PARALYSIS (completely paralyzed temporarily/inability to move my limbs for maybe an hour or two) (seriousness criterion medically significant), MUSCULAR WEAKNESS (Muscle weakness) and ASTHENIA (not feeling bad but not really very energetic). At the time of the report, PARALYSIS (completely paralyzed temporarily/inability to move my limbs for maybe an hour or two), MUSCULAR WEAKNESS (Muscle weakness) and ASTHENIA (not feeling bad but not really very energetic) outcome was unknown.            The patient birth year was given as PRIVATE and body weight as 194. The patient was not sure about age at vaccination whether 83 or 84. It was probably 84. The patient had the first two right away, within two four weeks or so and that the third shot was about the one year ago, that was the problem.  Company comment: This spontaneous case concerns male patient of unknown age (patient reports he was either 83 or 84-years-old) with no medical history reported, who experienced the unexpected, serious (medically significant) event of paralysis an unknown time after a dose of mRNA-1273.222. the patient reports that he felt muscle weakness, with complete temporarily paralysis, as well as asthenia. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns male patient of unknown age (patient reports he was either 83 or 84-years-old) with no medical history reported, who experienced the unexpected, serious (medically significant) event of paralysis an unknown time after a dose of mRNA-1273.222. the patient reports that he felt muscle weakness, with complete temporarily paralysis, as well as asthenia. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: no adverse event; Patient received 0.25ml of Bivalent booster instead of 0.5 ml; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (no adverse event) in a 37-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis.     The patient had been diagnosed or tested positive for COVID-19. No chronic and acute illness at the time of vaccination and one month prior.  Concomitant products included INFLUENZA VACCINE INACT SPLIT 4V (FLUARIX QUADRIVALENT) for an unknown indication.    On 07-Oct-2022 at 5:00 PM, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 07-Oct-2022 at 5:00 PM, the patient experienced ACCIDENTAL UNDERDOSE (Patient received 0.25ml of Bivalent booster instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient received 0.25ml of Bivalent booster instead of 0.5 ml).    Patient received Dose 1 of Moderna on 25-Feb-2021 (batch number: 023M20A, left deltoid, dose of 0.5 ml) and dose 2 of Moderna on 25-Mar-2021 (Batch number: 016B21A, left deltoid, dose of 0.5 ml). No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Got covid vaccine booster and arm got swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Got covid vaccine booster and arm got swollen) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Got covid vaccine booster and arm got swollen). At the time of the report, VACCINATION SITE SWELLING (Got covid vaccine booster and arm got swollen) had not resolved.            No relevant concomitant medications were reported.   The reporter's causality for the event of got covid vaccine booster and arm got swollen with Adalimumab Solution for Injection was not provided.  No treatment information was provided.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: Dose 1 received on 17Nov2021 and Dose 2 not received; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Dose 1 received on 17Nov2021 and Dose 2 not received) and NO ADVERSE EVENT (No adverse event) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 prophylaxis.     The patient had no allergies to medications, food and other products. The patient had no acute illness at the time of vaccination and up to one month before. The patient had no chronic or long-standing health conditions.  Concomitant products included INFLUENZA VACCINE INACT SPLIT 4V (FLUARIX QUADRIVALENT) for an unknown indication.    On 17-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Dose 1 received on 17Nov2021 and Dose 2 not received) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Dose 1 received on 17Nov2021 and Dose 2 not received) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT DOSE OMISSION ISSUE (Dose 1 received on 17Nov2021 and Dose 2 not received).    Patient reported no adverse event.  Treatment medications were not reported.   This case was linked to MOD-2022-665491 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Temperature excursion occurred on 29 Nov 2022. A total of 16 doses were administered on 29 Nov 2022 (5), 30 Nov 2022 (4), 1 Dec 2022 (2), 2 Dec 2022 (2), 3 Dec 2022 (1), and 5 Dec 2022 (2); No adverse event; Poor quality vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29 Nov 2022. A total of 16 doses were administered on 29 Nov 2022 (5), 30 Nov 2022 (4), 1 Dec 2022 (2), 2 Dec 2022 (2), 3 Dec 2022 (1), and 5 Dec 2022 (2)) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Nov-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29 Nov 2022. A total of 16 doses were administered on 29 Nov 2022 (5), 30 Nov 2022 (4), 1 Dec 2022 (2), 2 Dec 2022 (2), 3 Dec 2022 (1), and 5 Dec 2022 (2)) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29 Nov 2022. A total of 16 doses were administered on 29 Nov 2022 (5), 30 Nov 2022 (4), 1 Dec 2022 (2), 2 Dec 2022 (2), 3 Dec 2022 (1), and 5 Dec 2022 (2)) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29 Nov 2022. A total of 16 doses were administered on 29 Nov 2022 (5), 30 Nov 2022 (4), 1 Dec 2022 (2), 2 Dec 2022 (2), 3 Dec 2022 (1), and 5 Dec 2022 (2)).    No Concomitant medications were provided. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that temperature excursion was occurred on 29 Nov 2022. A total of 16 doses were administered on 29 Nov 2022 (5), 30 Nov 2022 (4), 1 Dec 2022 (2), 2 Dec 2022 (2), 3 Dec 2022 (1), and 5 Dec 2022 (2).  No treatment medications were provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A, 031L20A and 028L208A) for COVID-19 prophylaxis.     No parental vaccine exposure was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown. Not Provided      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.   This case was linked to MOD-2022-687666 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Myocarditis, Myopericarditis, Pericarditis
Clinical narrative: myocarditis; myopericarditis; pericarditis; 30% decrease in my diving performance approximately.; This Initial case was previously missing the following minimum criteria: Unidentifiable reporter. Upon receipt of follow-up information on 12Dec2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown"; MYOPERICARDITIS (medically significant), outcome "unknown"; PERICARDITIS (medically significant), outcome "unknown"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "30% decrease in my diving performance approximately.".  Additional information: world's current top static breath-hold freediver - he officially held his breath for 10 minutes and 30 seconds - has been diagnosed with myocarditis and pericarditis 40 days after his second dose of the Pfizer vaccine and can't even get close to his record anymore. I also have a family member who had a heart attack after his second dose of Pfizer then ended up getting covid anyway and spreading it to his household. I'm genuinely curious how common heart issues/inflamation/blood clots are. On 11Nov2021 it was reported, world record for static apnea, diagnosed with myocarditis after Pfizer injection possibly it will be the end for his sports career 30% decrease in my diving performance approximately.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Full blood count, Monocyte count, Monocyte count increased, Pain
Clinical narrative: great deal of pain for several days; absolute monocytes which were slightly elevated; was weak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A 66-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose number unknown: Booster), for COVID-19 immunization. The following information was reported: PAIN (non-serious), outcome "recovered", described as "great deal of pain for several days"; MONOCYTE COUNT INCREASED (non-serious), outcome "unknown", described as "absolute monocytes which were slightly elevated"; ASTHENIA (non-serious), outcome "recovered", described as "was weak". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient recently got new annual vaccine for Covid 19 after having all the available vaccines and boosters. The patient had a very strong reaction to the vaccine and was weak and in a great deal of pain for several days.  All symptoms have since resolved. The day after vaccine, the patient had CBC lab which had been previously scheduled.  All results were normal except the absolute monocytes which were slightly elevated. The patient asked if vaccine can cause elevated monocytes. Medical inquiry was forwarded to MI.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.