chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received 1st dose in 2021 and 2nd dose on 14-JUN-2023 of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2021).   On 14-JUN-2023, the patient received the 2nd dose of Shingrix. On 14-JUN-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: received 1st dose in 2021 and 2nd dose on 14-JUN-2023 of Shingrix). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 15-JUN-2023 The reporter who stated that a patient received her second dose of Shingrix the day before reporting which was more than 6 months between the first and second dose. The reporter did not consent to follow-up. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Inappropriate diluent/non-approved diluent to reconstitute the powder; Inappropriate diluent/non-approved diluent to reconstitute the powder; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA910A, expiry date 20-MAR-2024) for prophylaxis.   On 15-JUN-2023, the patient received Menveo. On 15-JUN-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Inappropriate diluent/non-approved diluent to reconstitute the powder) and inappropriate dose of vaccine administered (Verbatim: Inappropriate diluent/non-approved diluent to reconstitute the powder). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 15-JUN-2023 The reporter informed that earlier that day there was a vial of the liquid component of Menveo left without the powder component.  According to the healthcare professional that indicated that the product had probably been administered using a non-approved diluent to reconstitute the powder. The vaccine administration facility was the same as primary reporter. The reporter did not have details on the patients as it was unknown who it was. However, healthcare professional stated that only two doses had been administered that day, so it could be one or the other. The reporter consented to follow up. The patient had probably been administered with Menveo using a non-approved diluent to reconstitute the powder, which led to wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered. This was 1 of 2 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR085388:same reporter
Age: 1.33
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Boostrix - Tdap instead of Dtap; Boostrix - Tdap instead of Dtap; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 16-month-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number TR292, expiry date 03-NOV-2024) for prophylaxis.   On 15-JUN-2023, the patient received Boostrix. On 15-JUN-2023, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: Boostrix - Tdap instead of Dtap) and inappropriate age at vaccine administration (Verbatim: Boostrix - Tdap instead of Dtap). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-JUN-2023 The reporter was a medical assistant. The healthcare professional asked for any adverse reaction expected. During the call permission for follow up was not requested. The reporter reported that the administration of a Tdap (Boostrix) instead of Infanrix (Dtap) to a 16 month-old patient, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator: 07-Jun-2023; No adverse event; Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 07-Jun-2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 024H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Jun-2023, 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 08-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 07-Jun-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 07-Jun-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 07-Jun-2023).    Dosage text for suspect product was reported as unknown. Concomitant medication was not reported. Individual vials or intact cartons were 4 of vial size 2.5 ml. Date the vial was initially stored in the refrigerator was 07-Jun-2023. Vial did not under go temperature excursion.  Treatment medication was not reported.  This case contains information for the 4th of 5 doses described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-728778 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728778:Master case(Dose 1 of 5)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial expired on 6Jun2023, was initially stored in refrigerator on 7Jun2023 and administered on 8Jun2023; No adverse event; Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry), PRODUCT STORAGE ERROR (Vial expired on 6Jun2023, was initially stored in refrigerator on 7Jun2023 and administered on 8Jun2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 024H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Jun-2023, 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 08-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial expired on 6Jun2023, was initially stored in refrigerator on 7Jun2023 and administered on 8Jun2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry), PRODUCT STORAGE ERROR (Vial expired on 6Jun2023, was initially stored in refrigerator on 7Jun2023 and administered on 8Jun2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry) and PRODUCT STORAGE ERROR (Vial expired on 6Jun2023, was initially stored in refrigerator on 7Jun2023 and administered on 8Jun2023).    Concomitant drugs were not reported. Pharmacist stated that perhaps 5 doses of the bivalent vaccine which was expired on 06-Jun-2023 were administered. Vial size was reported as 2.5ML. Date the vial was initially stored in the refrigerator was 7Jun2023. Dates of administration of vaccine was reported as 1 dose on 7Jun2023 and 4 doses on 8Jun2023.  The vial had not undergone any temperature excursions.  Treatment medications were not provided. The case corresponds to 5th out of 5 patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-728778.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728778:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Wrong product administered
Clinical narrative: 2 doses of Moderna bivalent were administered after expiration date; First dose of  Moderna bivalent were administered after expiration date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 doses of Moderna bivalent were administered after expiration date), WRONG PRODUCT ADMINISTERED (First dose of  Moderna bivalent were administered after expiration date) and NO ADVERSE EVENT (no adverse event) in an elderly 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. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first 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, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 doses of Moderna bivalent were administered after expiration date), WRONG PRODUCT ADMINISTERED (First dose of  Moderna bivalent were administered after expiration date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 doses of Moderna bivalent were administered after expiration date), WRONG PRODUCT ADMINISTERED (First dose of  Moderna bivalent were administered after expiration 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (2 doses of Moderna bivalent were administered after expiration date) and WRONG PRODUCT ADMINISTERED (First dose of  Moderna bivalent were administered after expiration date).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: 2 doses of Moderna bivalent were administered after expiration date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 doses of Moderna bivalent were administered after expiration date) and NO ADVERSE EVENT (no adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first 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 EXPIRED PRODUCT ADMINISTERED (2 doses of Moderna bivalent were administered after expiration date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 doses of Moderna bivalent were administered after expiration 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 (2 doses of Moderna bivalent were administered after expiration date).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Moderna bivalent should have discarded the vial  on 13-Jun-2023, but the dose was administered on 14-Jun-2023; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna bivalent should have discarded the vial  on 13-Jun-2023, but the dose was administered on 14-Jun-2023) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 065H22A and AS7165B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (lot-EN9581) on 15-Feb-2021, PFIZER BIONTECH COVID-19 VACCINE (lot-EN6204) on 08-Mar-2021 and PFIZER BIONTECH COVID-19 VACCINE (lot-FF2588) on 25-Sep-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 30-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Jun-2023, received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .5 milliliter. On 14-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna bivalent should have discarded the vial  on 13-Jun-2023, but the dose was administered on 14-Jun-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna bivalent should have discarded the vial  on 13-Jun-2023, but the dose was administered on 14-Jun-2023) 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 (Moderna bivalent should have discarded the vial  on 13-Jun-2023, but the dose was administered on 14-Jun-2023).    No concomitant medication was reported. It was reported that It was a brand new vial that was pulled from the freezer.  The new vials in the freezer don't have expiration dates and there was no way to know that it was expired. Th vial size was 2.5 mL and was stored in the refrigerator on 12-Jun-2023. The vial did not undergo any temperature excursions.  No treatment medication was reported.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Haematocrit, Haematocrit abnormal
Clinical narrative: hematocrit was 63.2; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HAEMATOCRIT ABNORMAL (hematocrit was 63.2) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A, 037A21B, 021F21A and 049L21A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 in November 2020.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced HAEMATOCRIT ABNORMAL (hematocrit was 63.2). At the time of the report, HAEMATOCRIT ABNORMAL (hematocrit was 63.2) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2017, Haematocrit: 48.4. In 2018, Haematocrit: 43.8 and 43.5. In 2020, Haematocrit: 42.4. On 09-Jun-2021, Haematocrit: 47.6. In May 2022, Haematocrit: abnormal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The patient did not have a genetic marker. Reporter found that polycythemia can occur in 60 and older. Patient had the first two treatments where they take a pint of blood once a month to get the hematocrit to come down.The patient had hematocrit within normal limits up until June 2021. The patient was trying to find out if there was a correlation, or if anybody reported, between that hematologic problem  and the Moderna vaccine.  No treatment medication was reported.   This case was linked to MOD-2023-729260 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Immunisation reaction, Renal disorder
Clinical narrative: also being treated for dialysis; Vaccination adverse reaction; This spontaneous case was reported by a patient and describes the occurrence of RENAL DISORDER (also being treated for dialysis) and IMMUNISATION REACTION (Vaccination adverse reaction) in a 71-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 7164B) for COVID-19 prophylaxis.     The patient's past medical history included Bypass surgery in August 2022.    On 27-Oct-2022, 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 RENAL DISORDER (also being treated for dialysis) and IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, RENAL DISORDER (also being treated for dialysis) was resolving and IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        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 medication details not reported by the reporter. Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine was unknown. Patient was being treated with dialysis.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Madarosis, Thyroid function test
Clinical narrative: hair loss; eyebrows are almost gone; This spontaneous case was reported by a patient and describes the occurrence of ALOPECIA (hair loss) and MADAROSIS (eyebrows are almost gone) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B22A, 039K20A, 028L20A and 012F21A) for COVID-19 prophylaxis.     The patient did not have previous COVID-19 diagnosis.  The patient's past medical history included Thyroid activity decreased. Concurrent medical conditions included Blood pressure high.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ALOPECIA (hair loss) and MADAROSIS (eyebrows are almost gone). At the time of the report, ALOPECIA (hair loss) and MADAROSIS (eyebrows are almost gone) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Thyroid function test: not related..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ALOPECIA (hair loss) and MADAROSIS (eyebrows are almost gone) to be related.    Concomitant medication not reported.   In the past, patient had high cholesterol.  The patient went to see her Dermatologist and they confirm it might be related to the covid vaccine. Her medical doctor did a thyroid test and it was not related. They even change her medication, and it was not the thyroid causing it. She took thyroid medication.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; administered a vaccine past the expiry date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered a vaccine past the expiry date) and NO ADVERSE EVENT (No adverse event) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 044H22A) for COVID-19 prophylaxis.     Patient did not report relevant medical history/conditions, allergy, concomitant diseases and risk factor (including any previous COVID-19 diagnosis).     On 14-Jun-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 14-Jun-2023 at 2:48 PM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered a vaccine past the expiry date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered a vaccine past the expiry 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 (administered a vaccine past the expiry date).    Patient did not received any other vaccine 4 weeks prior to Covid-19 vaccine.  Concomitant product use was not provided by the reporter.  On 05-Mar-2021 patient received his first moderna covid-19 vaccine (lot number: - 013A21A), on 02-Apr-2021, patient received his second moderna covid-19 vaccine (lot number: - 046A21A), on 03-Jan-2022, patient received his third moderna covid-19 vaccine (lot number: - 013H21B) and on 26-Jul-2022, patient received his fourth moderna covid-19 vaccine (lot number:- 055A22A). Expiry date of the suspect vaccine fifth dose was reported as 10-Jun-2023. Time of fifth dose vaccination was reported as 14:48 (2:48 P.M).  Treatment information was not provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, INIT
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute myocardial infarction, Hypoxia
Clinical narrative: ACUTE NON ST ELEVATION MI HYPOXIA
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: NEUROPATHY
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: TRANSIENT CEREBRAL ISCHEMIA
Age: 74.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Firmness, redness, warmth at injection site, area of erythema around injection site about 15 cm
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypotension
Clinical narrative: HYPOTENSION
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Rash, Somnolence
Clinical narrative: Mom called our office on 5/24/2023 and states that she took child to the doctor that day because she had developed a full body rash and is sleeping more. Physician ruled it as a reaction to the MMR vaccine received on 5/5/2023. Nothing prescibed.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Symptom recurrence, Transient ischaemic attack
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE TRANSIENT CEREBRAL ISCHEMIA HYPOTENSION 9/6/2022,  12/19/2022,  1/20/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Symptom recurrence
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE NON ST ELEVATION MI 12/12/2022  -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient was given the Moderna vaccine in assumption that it expired on 04/06/2023. When it was being documented after the vaccine was given it was found that it actually expired on 03/11/2023 - 2 days prior to it being given. The expiration date was for the date that it was expired from being stored in the refrigerator instead of the actual expiration date of the vaccine. Saw patient on 03/27/2023 for further catch up vaccines and he was doing fine. No problems from Moderna vaccine that he received that was expired.
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute myocardial infarction
Clinical narrative: ACUTE ST ELEVATION MI, ANTERIOR WALL
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Discomfort, Fatigue, Pyrexia, Rash
Clinical narrative: Fever, Tiredness, Discomfort and Rash.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Embolic stroke
Clinical narrative: ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN ACUTE DVT OF LEFT THIGH, UNSPECIFIED VEIN
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Malaise, Tremor
Clinical narrative: Was shaking when getting out of the car seat and has been "out of it" all day. Temp of 99.6.  After getting home from the office visit.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Mar2023 at 14:00 as dose 4 (booster), single (Lot number: GJ6743) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnea" (ongoing), notes: Current: Sleep apnea; "skin rashes" (ongoing), notes: Current: skin rashes; "kidney stone" (unspecified if ongoing); "hepatitis A" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received the paxlovid treatment from 06Jun2023 to 11Jun2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300223829 same patient, different drugs/events;
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Arteriosclerosis, Deep vein thrombosis, Epilepsy
Clinical narrative: G40.919 EPILEPSY, INTRACTABLE 4/4/2023 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN ARTERIOSCLEROTIC CARDIOVASCULAR DISEASE WO ANGINA
Age: 72.0
Sex: F
Vaccine: UNK
Symptoms: Hypertension, Lacunar stroke, Reversible ischaemic neurological deficit, Transient ischaemic attack
Clinical narrative: G45.9 TRANSIENT CEREBRAL ISCHEMIA 3/29/2023 HTN (HYPERTENSION) I63.81 ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 3/29/2023 HTN (HYPERTENSION) I63.9 REVERSIBLE ISCHEMIC NEUROLOGIC DEFICIT SYNDROME 4/11/2023 HTN (HYPERTENSION)
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Biopsy lymph gland normal, Lymphadenopathy, Mammogram abnormal
Clinical narrative: I had my annual mammogram on April 20, 2023.  The mammogram showed a prominent right ancillary lymph node, enlarged from my previous 2022 mammogram and an immediate ultra sound was recommended.  My previous 2022 annual mammogram showed no englarged lymph nodes.  On April 21, I had an ultra sound which showed the right ancillary lymph nodes had 5mm cortical thickening  and the radiologist and my PPC recommended a biopsy.   On May 16 I had a needle  biopsy at a local Medical Center.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Embolic stroke
Clinical narrative: ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Dementia with Lewy bodies, Hypotension
Clinical narrative: ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 3/29/2023 LEWY BODY DEMENTIA, UNSPECIFIED SEVERITY, WO BEHAVIORAL DISTURBANCE. HYPOTENSION 4/12/2023 LEWY BODY DEMENTIA, UNSPECIFIED SEVERITY, WO BEHAVIORAL DISTURBANCE.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blood pressure increased, Injected limb mobility decreased, Joint range of motion decreased, Loss of personal independence in daily activities
Clinical narrative: As reported by patient: "Within an hour, I had excruciating shoulder joint pain, which radiated into the collar bone and down the arm. It felt like a spear was being shoved into the joint in time with my pulse. This went on for 3 days, and began to lessen on the 4th. I was unable to lay down or sleep for 4 days. Last night was the 1st time I was able to lay down and sleep. Also, my BP skyrocketed. It hovered around 170 over 95 for the 1st 3 days, and around 160 over 90 on the 4th. Today it's 135 over 82, when I checked. I completely cut out coffee and any salt, and took Ramipril 2x daily, but it didn't bring it down. My left arm range of motion was nothing for almost 3 days. He had to help me dress. It is starting to come back. I can now lift my arm up to chest level."
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Sleep disorder
Clinical narrative: As reported by patient: "Within an hour, I had excruciating shoulder joint pain, which radiated into the collar bone and down the arm. It felt like a spear was being shoved into the joint in time with my pulse. This went on for 3 days, and began to lessen on the 4th. I was unable to lay down or sleep for 4 days. Last night was the 1st time I was able to lay down and sleep. Also, my BP skyrocketed. It hovered around 170 over 95 for the 1st 3 days, and around 160 over 90 on the 4th. Today it's 135 over 82, when I checked. I completely cut out coffee and any salt, and took Ramipril 2x daily, but it didn't bring it down. My left arm range of motion was nothing for almost 3 days. He had to help me dress. It is starting to come back. I can now lift my arm up to chest level."
Age: 61.0
Sex: F
Vaccine: COVID19-2, VARZOS, VARZOS
Symptoms: Mobility decreased, Muscular weakness, Pain, Sleep disorder
Clinical narrative: received shingrix vaccine on 5/13 and started having mild pain off and on.  by 5/18 symptoms got more severe. symptoms including raising arm with pain, lessen range of motion, and weakness in the hand. then off and on until now some days have been better but in the last 2 weeks, symptoms have not gotten milder but staying constant and also pain wakes patient up. pt has been taking aleve and excedrin migraine on a daily bases and using cold and warm compresses.
Age: 61.0
Sex: F
Vaccine: COVID19-2, VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity, Sleep disorder
Clinical narrative: received shingrix vaccine on 5/13 and started having mild pain off and on.  by 5/18 symptoms got more severe. symptoms including raising arm with pain, lessen range of motion, and weakness in the hand. then off and on until now some days have been better but in the last 2 weeks, symptoms have not gotten milder but staying constant and also pain wakes patient up. pt has been taking aleve and excedrin migraine on a daily bases and using cold and warm compresses.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction
Clinical narrative: ACUTE ST ELEVATION MI, ANTERIOR WALL
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Brain fog, Cognitive disorder, Coordination abnormal, Fall, Slow speech
Clinical narrative: Patient reports having decrease in coordination, increase brain fog, slow cognitive responses and speech responses. Multiple falls. Lasted 2 days
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose #3 was administered to early.     Pt was supposed to be scheduled for a lab collection not vaccine administration.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Facial paresis, Hemiparesis, Symptom recurrence, Transient ischaemic attack
Clinical narrative: TRANSIENT CEREBRAL ISCHEMIA RIGHT FACIAL MUSCLE WEAKNESS 12/16/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient experienced a rash further down the arm from the injection site on Friday (next day). She states rash had improved and was barely noticeable by the time she came to pharmacy to notify us on (06/13/2023). She only prompted the visited because she concerned if she should get the second dose/ make us aware. No treatment or therapy was recommended.
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Given expired vaccine, no adverse event.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: receiving the Pfizer vaccine series and COVID 19; receiving the Pfizer vaccine series and COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "receiving the Pfizer vaccine series and COVID 19".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300106905 same patient/reporter; different dose/AE;
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoxia, Symptom recurrence
Clinical narrative: HYPOXIA 11/16/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoxia
Clinical narrative: HYPOXIA
Age: 42.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccination, no adverse reaction observed.
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired Vaccine, no adverse events observed
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ADULT OBSTRUCTIVE SLEEP APNEA
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Ischaemic stroke, Subdural haematoma
Clinical narrative: ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 3/31/2023 WEAKNESS ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 3/31/2023 TRAUMATIC SUBDURAL HEMATOMA, INIT
Age: 10.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: On 5/23/2023 at approximately 1638 hours, the patient received an expired dose (0.2mL) of Pfizer COID Bivalent Booster. During the 15 minute monitoring time, the patient did not experience any symptoms. Attempted to contact guardian after patient exit the clinic, call attempts were unsuccessful.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Obstructive sleep apnoea syndrome
Clinical narrative: OBSTRUCTIVE SLEEP APNEA PERIPHERAL NEUROPATHY
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Sarcoidosis
Clinical narrative: Pfizer vaccine was administered - reported by patient- ? NO LOT NUMBER WERE SUPPLIED ------------------------------------------------------------------------------------------------------------------- ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 4/24/2023 SARCOIDOSIS
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Injection site pain, Pain, Sleep disorder, Vaccination complication
Clinical narrative: From Dr.s notes on 06/16/2023 office visit. HPI The patient was seen 06/07/23 for 16 yo WCC by NP, received MenQuadfi left deltoid and Bexsero right deltoid and patient has been experiencing right upper arm pain since the evening of the immunization. The patient relays that he felt a deeper pain with the administration of the vaccine in his right arm, he describes the needle as being pushed in further. This was different than what he noted for the left upper arm immunization administration.  Update:The patient relays that he continues to experience upper right arm pain, he has a pain level of 3/10 at rest, but when adducts his right arm across his body, the pain increases, he is able to perform daily living tasks, the initial nights after receiving the vaccine in hurt to sleep on his right upper arm, the patient did not note any redness nor swelling at the injection site, no numbness or tingling in his right arm. Used Ibuprofen 400 mg and warm compresses - not much improvement. The patient leaves tomorrow to attend a work training, this summer working at a  barbecue restaurant, so he will doing a number of different tasks. Today is currently 9 days out from the day of the vaccine  Pain over deltoid muscle has patient adducts upper arm across his body, TTP to deep palpation over the deltoid muscle, FROm B shoulder and B elbows, normal internal and external rotation. In assessing the patient's history and symptoms, I do feel that the right upper arm pain is most likely due to a complication with the administration of the Bexsero vaccine and not as likely due to the ingredients in the vaccine, discussed with the patient that the symptoms could arise from inflammation from the muscle area, I would continue to recommend warm compresses, Ibuprofen 600 mg 2-3x/day, taking with food. I would recommend avoiding activity that produces pain in the muscle area involved. I also discussed if pain is persisting at 2-3 weeks out, I would consider an MRI of the soft tissue/muscles and joint space of the right upper arm next.  Recommend submit VAERS form, will have the Triage Nurse submit this with the information obtained at the visit today.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram cerebral, Arteriogram carotid, Balance disorder, Blood test, Cerebrovascular accident
Clinical narrative: Cryptogenic stroke, preceeded by dizziness and loss of balance, headache.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Magnetic resonance imaging head abnormal, Scan with contrast, Ultrasound Doppler
Clinical narrative: Cryptogenic stroke, preceeded by dizziness and loss of balance, headache.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Generalised anxiety disorder, Hypoxia
Clinical narrative: J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/19/2023 GENERALIZED ANXIETY DISORDER R09.02 HYPOXIA 3/19/2023 GENERALIZED ANXIETY DISORDER
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired Vaccine, no adverse events observed
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Syncope, Tremor
Clinical narrative: Patient received both vaccines and then began to faint and shake.  Spoke to patient until she regained normalcy and then laid her back and elevated her feet. Provided patient with lollipop and an ice pack. Checked patients blood pressure and observed her for 15minutes. once she was feeling better she was able to go home.
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine, no adverse events observed
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 11/6/2022 --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine, no adverse effect was observed
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain, Diarrhoea, Injection site erythema, Pyrexia, Vomiting
Clinical narrative: Pt. reported sever abdominal cramping and diarrhea in the evening of 06/17/23.  Pt. also reported she had vomiting, low grade fever and  approximately a 2 inch oval of redness around the injection site.  Pt. had called an after hours triage. Pt. did not seek medical attention other than triage call.  Today 06/19/23, pt. reports diarrhea, vomiting , fever, and abdominal pain are absent.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Aortic dilatation, Osteoporotic fracture, Thoracic vertebral fracture
Clinical narrative: Pfizer vaccine was administered  - reported by patient- ? NO LOT NUMBER WERE SUPPLIED ---------------------------------------------------------------------------------------------------------------------------- ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/29/2023 THORACIC VERTEBRAL OSTEOPOROTIC FX, INIT ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/29/2023 ABDOMINAL AORTIC ECTASIA ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/29/2023 THORACIC VERTEBRAL OSTEOPOROTIC FX, INIT
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia supraventricular, Blood pressure increased, Cardiac monitoring, Echocardiogram, Electrocardiogram
Clinical narrative: #1 approximately 24 hours post injection, redness, swelling and pain in left deltoid area, fever 100.6 for 36 hours, severe fatigue about 5 days post injection #2 approximately 6 weeks post injection pt noticed mild to moderate fatigue and heart pounding and racing.  BP 160/110.  Saw PCP 9/28/21 BP & pulse still elevated started on Amlodipine 5mg, eventually upped to 10mg and referred to cardiologist, Dr.  Currently diagnosed with high blood pressure and atrial arrythmia
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: #1 approximately 24 hours post injection, redness, swelling and pain in left deltoid area, fever 100.6 for 36 hours, severe fatigue about 5 days post injection #2 approximately 6 weeks post injection pt noticed mild to moderate fatigue and heart pounding and racing.  BP 160/110.  Saw PCP 9/28/21 BP & pulse still elevated started on Amlodipine 5mg, eventually upped to 10mg and referred to cardiologist, Dr.  Currently diagnosed with high blood pressure and atrial arrythmia
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia
Clinical narrative: #1 approximately 24 hours post injection, redness, swelling and pain in left deltoid area, fever 100.6 for 36 hours, severe fatigue about 5 days post injection #2 approximately 6 weeks post injection pt noticed mild to moderate fatigue and heart pounding and racing.  BP 160/110.  Saw PCP 9/28/21 BP & pulse still elevated started on Amlodipine 5mg, eventually upped to 10mg and referred to cardiologist, Dr.  Currently diagnosed with high blood pressure and atrial arrythmia