chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Adverse event, Alopecia, Blister, Pruritus, Swollen tongue
Clinical narrative: SIDE EFFECTS; THROAT SQUEEZED; TONGUE SWELLED; ITCHING; WOUND UP ON SCALP; BLISTERS ON THE SKIN AND MOUTH; HAIR STARTED FALLING OUT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 21-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced some side effects (Dose number in series 1). The patient received non-company suspect Pfizer covid-19 vaccine (tozinameran) (Dose number in series 2) (form of admin, and route of admin were not reported, batch number: FK9896 expiry: UNKNOWN) dose was not reported, start therapy date was not reported for prophylactic vaccination.  On an unspecified date, the patient experienced throat squeezed, tongue swelled, itching, wound up on scalp, blisters on the skin and mouth, and hair started falling out (Dose number in series 2). Patient got a shot of Pfizer from the gray cap formulation. Patient was asking for a list of the inactive ingredients (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The outcome of the side effects, throat squeezed, tongue swelled, itching, wound up on scalp, blisters on the skin and mouth and hair started falling out was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness, Wound
Clinical narrative: SIDE EFFECTS; THROAT SQUEEZED; TONGUE SWELLED; ITCHING; WOUND UP ON SCALP; BLISTERS ON THE SKIN AND MOUTH; HAIR STARTED FALLING OUT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 21-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced some side effects (Dose number in series 1). The patient received non-company suspect Pfizer covid-19 vaccine (tozinameran) (Dose number in series 2) (form of admin, and route of admin were not reported, batch number: FK9896 expiry: UNKNOWN) dose was not reported, start therapy date was not reported for prophylactic vaccination.  On an unspecified date, the patient experienced throat squeezed, tongue swelled, itching, wound up on scalp, blisters on the skin and mouth, and hair started falling out (Dose number in series 2). Patient got a shot of Pfizer from the gray cap formulation. Patient was asking for a list of the inactive ingredients (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The outcome of the side effects, throat squeezed, tongue swelled, itching, wound up on scalp, blisters on the skin and mouth and hair started falling out was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ADVERSE EVENT NOS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced adverse event nos. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse event nos was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Peripheral swelling
Clinical narrative: SWOLLEN HANDS; SORES ON KNUCKLES; This spontaneous report received from a patient concerned an adult female of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. It was unknown if patient was pregnant.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, one total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included golimumab. On an unspecified date, the patient was hospitalized for unspecified days, with complaint of  swollen hands, sores on knuckles and was on wheelchair. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sores on knuckles and swollen hands was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220337665-COVID-19 VACCINE AD26.COV2.S-sores on knuckles. This event(s) is labeled per RSI and is therefore considered potentially related.  20220337665-COVID-19 VACCINE AD26.COV2.S-swollen hands. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: TERRIBLE EXPERIENCE; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced terrible experience. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of terrible experience was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: NEGATIVE SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced negative side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of negative side effects was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Rash
Clinical narrative: This spontaneous report received from a patient via a company representative concerned an elderly female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: senile osteoporosis. The patient previously received Covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced rash and bone pain (Dose number in series 1). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rash was not recovered and recovered from bone pain. On an unspecified date non-company suspect drugs abaloparatide (injection, subcutaneous, batch number was not reported, expiry: unknown) 80 ug, 1 times every 1 day, therapy dates were not reported for senile osteoporosis. The action taken with Tymlos treatment was not reported. The patient additionally received non-company vaccine Spikevax (Moderna) (Dose number in series 2) (form of admin, route of admin, and batch number were not reported, expiry: unknown), dose was not reported, start therapy date were not reported, administered for prophylactic vaccination. It was unknown whether patient had any adverse event following vaccination with Spikevax (Moderna) (Dose number in series 2). This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Impaired quality of life, Memory impairment, Nerve injury
Clinical narrative: NERVE DAMAGE; FOG LIKE STATE OF AWARENESS AND FELT LIKE IN HELL; QUALITY OF LIFE CHANGED FOREVER; TROUBLE STATING HOW SHE FEEL AND REMEMBERING WHAT TO TELL THE DOCTOR AND IMPORTANT DATES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient's mother died recently. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced nerve damage, fog like state of awareness and felt like in hell, quality of life changed forever, and trouble stating how she feel and remembering what to tell the doctor and important dates. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nerve damage, and fog like state of awareness and felt like in hell, and the outcome of trouble stating how she feel and remembering what to tell the doctor and important dates and quality of life changed forever was not reported. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was stored in the refrigerator on 24 Jan 2022 and administered to the patient on 09 Mar 2022; Pharmacy gave Moderna Covid-19 vaccine past its beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date) and PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 24 Jan 2022 and administered to the patient on 09 Mar 2022) in a 59-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 24 Jan 2022 and administered to the patient on 09 Mar 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date) and PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 24 Jan 2022 and administered to the patient on 09 Mar 2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the vaccine was transferred from the freezer to the refrigerator on 24 Jan 2022 and the vial did not undergo any temperature excursions. The pharmacist wrote an expiration date of 24 Mar 2022 on the Moderna Covid-19 vaccine instead of 24 Feb 2022. It was unknown on which arm the patient had received the vaccine. No other adverse events or side effects were reported. No treatment medications were reported.
Age: 48.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The nurse stated that when the lot number of Moderna COVID-19 vaccine of 010A21A was entered into the expiration date lot number look up the expiration date was 14-Aug-2021. No treatment medications were reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: diagnosed with Covid-19 after vaccination; diagnosed with Covid-19 after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (diagnosed with Covid-19 after vaccination) and COVID-19 (diagnosed with Covid-19 after vaccination) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, the patient experienced DRUG INEFFECTIVE (diagnosed with Covid-19 after vaccination) and COVID-19 (diagnosed with Covid-19 after vaccination). At the time of the report, DRUG INEFFECTIVE (diagnosed with Covid-19 after vaccination) and COVID-19 (diagnosed with Covid-19 after vaccination) outcome was unknown.            No concomitant medications was provided by the reporter. Patient was diagnosed with COVID-19 and went to the infusion where patient received the package of stuff on 14 Dec 2021.  Company Comment: This spontaneous case concerns a 69-year-old female patient, with no medical history reported, who experienced the unexpected non serious AESI of COVID 19 which occurred approximately 9 months after the first dose of mRNA-1273 vaccine administration. Drug ineffective was also captured as an additional event. Ongoing Pandemic could be confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-513388 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Mar-2022: Follow-up received contain No new information; Sender's Comments: This spontaneous case concerns a 69-year-old female patient, with no medical history reported, who experienced the unexpected non serious AESI of COVID 19 which occurred approximately 9 months after the first dose of mRNA-1273 vaccine administration. Drug ineffective was also captured as an additional event. Ongoing Pandemic could be confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Immunodeficiency
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNODEFICIENCY (she had become immunocompromised) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product RITUXIMAB (RITUXAN) for an unknown indication. No Medical History information was reported. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 15-Dec-2021, the patient started RITUXIMAB (RITUXAN) (unknown route) at an unspecified dose. On 15-Dec-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced IMMUNODEFICIENCY (she had become immunocompromised) (seriousness criterion medically significant). At the time of the report, IMMUNODEFICIENCY (she had become immunocompromised) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered IMMUNODEFICIENCY (she had become immunocompromised) to be not related. No concomitant medication was reported. Patient's doctor recommended that she get a 4th full dose dose. Patient advised Pharmacist that she had become immunocompromised after taking Rituxan. Patient started taking Rituxan on 15 Dec 2021 but Pharmacist did not know the reason. Pharmacist asked if he should he give patient the 4th dose or not. Lot number and Patient's demographics were not provided. No treatment information was reported. Company comment: This spontaneous case concerns a female patient of an unknown age with no medical history reported, who experienced the unexpected serious event of Immunodeficiency (seriousness criteria medically significant) which occurred 1 month after the third dose (booster dose) of mRNA- 1273 Vaccine. It was reported that patient had become immunocompromised after taking Rituxan the co-suspect product. The co-suspect product of Rituxan could remain a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. This case was linked to MOD-2022-513412 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 16-Mar-2022: Follow up report include no new information. On 16-Mar-2022: Follow up report include no new information. Sender's Comments: This spontaneous case concerns a female patient of an unknown age with no medical history reported, who experienced the unexpected serious event of Immunodeficiency (seriousness criteria medically significant) which occurred 1 month after the third dose (booster dose) of mRNA- 1273 Vaccine. It was reported that patient had become immunocompromised after taking Rituxan the co-suspect product. The co-suspect product of Rituxan could remain a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Acute myocarditis; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Acute myocarditis) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Acute myocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (Acute myocarditis) outcome was unknown. Related      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDITIS (Acute myocarditis) to be related.    Concomitant and treatment medications information was not provided.  Patient presented with acute chest pain.  Company Comment: This literature non-study case concerns a 22 year old male patient with no medical history reported , who experienced Serious ( hospitalization , medically significant ) , expected event of myocarditis which occurred on an unknown date after vaccination with the 2nd dose of mRNA-1273 vaccine . It was reported that this patient presented with acute chest pain. The details surrounding this event were not reported since the full text of this literature for review is not available.The event outcome was reported as unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report. The reviewer has limited information regarding this case as mentioned since the full text was not available at the time of the medical review   This case was linked to MOD-2022-513533, MOD-2022-513580, MOD-2022-513581.; Sender's Comments: This literature non-study case concerns a 22 year old male patient with no medical history reported , who experienced Serious ( hospitalization , medically significant ) , expected event of myocarditis which occurred on an unknown date after vaccination with the 2nd dose of mRNA-1273 vaccine . It was reported that this patient presented with acute chest pain. The details surrounding this event were not reported since the full text of this literature for review is not available.The event outcome was reported as unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report. The reviewer has limited information regarding this case as mentioned since the full text was not available at the time of the medical review.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Acute Myocarditis; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Acute Myocarditis) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.       No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Acute Myocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (Acute Myocarditis) outcome was unknown. Related      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDITIS (Acute Myocarditis) to be related.    No concomitant and treatment medications were provided.  Company Comment: This is a literature non-study case concerning a 22-year-old male patient with no reported medical history, who was hospitalized due to the expected, serious (medically significant) adverse event of special interest of Myocarditis (reported as Acute myocarditis), after receiving the second dose of mRNA-1273 vaccine. Date of vaccination and onset of event was not specified. Clinical course, diagnostic tests and treatment details were not provided in the case. At the time of reporting, the outcome of the event Acute myocarditis was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-513579, MOD-2022-513533, MOD-2022-513581 (Patient Link).; Sender's Comments: This is a literature non-study case concerning a 22-year-old male patient with no reported medical history, who was hospitalized due to the expected, serious (medically significant) adverse event of special interest of Myocarditis (reported as Acute myocarditis), after receiving the second dose of mRNA-1273 vaccine. Date of vaccination and onset of event was not specified. Clinical course, diagnostic tests and treatment details were not provided in the case. At the time of reporting, the outcome of the event Acute myocarditis was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Chest pain, Inflammation, Myalgia, Pain in extremity
Clinical narrative: inflammation; left part of his chest, arm and back Pain is ongoing; left part of his chest pain; left part of his chest, arm  pain; left shoulder muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (inflammation), BACK PAIN (left part of his chest, arm and back Pain is ongoing), CHEST PAIN (left part of his chest pain), PAIN IN EXTREMITY (left part of his chest, arm  pain) and MYALGIA (left shoulder muscle pain) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Janssen and Janssen (DOSE: 1) on 27-Mar-2021. Past adverse reactions to the above products included No adverse reaction with Janssen and Janssen.   On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced BACK PAIN (left part of his chest, arm and back Pain is ongoing), CHEST PAIN (left part of his chest pain), PAIN IN EXTREMITY (left part of his chest, arm  pain) and MYALGIA (left shoulder muscle pain). In February 2022, the patient experienced INFLAMMATION (inflammation). The patient was treated with NAPROXEN for Inflammation, Muscle pain, Chest pain, Back pain and Pain in arm, at an unspecified dose and frequency and INDOMETHACIN [INDOMETACIN] for Inflammation, Muscle pain, Chest pain, Back pain and Pain in arm, at an unspecified dose and frequency. At the time of the report, INFLAMMATION (inflammation) outcome was unknown and BACK PAIN (left part of his chest, arm and back Pain is ongoing), CHEST PAIN (left part of his chest pain), PAIN IN EXTREMITY (left part of his chest, arm  pain) and MYALGIA (left shoulder muscle pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2022, X-ray: inflammation patient went to ER and got X rays- according to the HCP has inflammation.   Concomitant medication includes: High blood pressure medication Following the vaccination the patient experienced events in third week of November. Reporter reported that the patient took naproxen and Indomethacin anti-inflammatory medication which didn't help.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: X-ray
Clinical narrative: inflammation; left part of his chest, arm and back Pain is ongoing; left part of his chest pain; left part of his chest, arm  pain; left shoulder muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (inflammation), BACK PAIN (left part of his chest, arm and back Pain is ongoing), CHEST PAIN (left part of his chest pain), PAIN IN EXTREMITY (left part of his chest, arm  pain) and MYALGIA (left shoulder muscle pain) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Janssen and Janssen (DOSE: 1) on 27-Mar-2021. Past adverse reactions to the above products included No adverse reaction with Janssen and Janssen.   On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced BACK PAIN (left part of his chest, arm and back Pain is ongoing), CHEST PAIN (left part of his chest pain), PAIN IN EXTREMITY (left part of his chest, arm  pain) and MYALGIA (left shoulder muscle pain). In February 2022, the patient experienced INFLAMMATION (inflammation). The patient was treated with NAPROXEN for Inflammation, Muscle pain, Chest pain, Back pain and Pain in arm, at an unspecified dose and frequency and INDOMETHACIN [INDOMETACIN] for Inflammation, Muscle pain, Chest pain, Back pain and Pain in arm, at an unspecified dose and frequency. At the time of the report, INFLAMMATION (inflammation) outcome was unknown and BACK PAIN (left part of his chest, arm and back Pain is ongoing), CHEST PAIN (left part of his chest pain), PAIN IN EXTREMITY (left part of his chest, arm  pain) and MYALGIA (left shoulder muscle pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2022, X-ray: inflammation patient went to ER and got X rays- according to the HCP has inflammation.   Concomitant medication includes: High blood pressure medication Following the vaccination the patient experienced events in third week of November. Reporter reported that the patient took naproxen and Indomethacin anti-inflammatory medication which didn't help.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood pressure fluctuation, Inflammation
Clinical narrative: inflammation; left part of his chest, arm and back Pain is ongoing; left part of his chest pain; left part of his chest, arm  pain; left shoulder muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (inflammation), BACK PAIN (left part of his chest, arm and back Pain is ongoing), CHEST PAIN (left part of his chest pain), PAIN IN EXTREMITY (left part of his chest, arm  pain) and MYALGIA (left shoulder muscle pain) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Janssen and Janssen (DOSE: 1) on 27-Mar-2021. Past adverse reactions to the above products included No adverse reaction with Janssen and Janssen.   On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced BACK PAIN (left part of his chest, arm and back Pain is ongoing), CHEST PAIN (left part of his chest pain), PAIN IN EXTREMITY (left part of his chest, arm  pain) and MYALGIA (left shoulder muscle pain). In February 2022, the patient experienced INFLAMMATION (inflammation). The patient was treated with NAPROXEN for Inflammation, Muscle pain, Chest pain, Back pain and Pain in arm, at an unspecified dose and frequency and INDOMETHACIN [INDOMETACIN] for Inflammation, Muscle pain, Chest pain, Back pain and Pain in arm, at an unspecified dose and frequency. At the time of the report, INFLAMMATION (inflammation) outcome was unknown and BACK PAIN (left part of his chest, arm and back Pain is ongoing), CHEST PAIN (left part of his chest pain), PAIN IN EXTREMITY (left part of his chest, arm  pain) and MYALGIA (left shoulder muscle pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2022, X-ray: inflammation patient went to ER and got X rays- according to the HCP has inflammation.   Concomitant medication includes: High blood pressure medication Following the vaccination the patient experienced events in third week of November. Reporter reported that the patient took naproxen and Indomethacin anti-inflammatory medication which didn't help.
Sex: M
Vaccine: COVID19
Symptoms: Immunodeficiency
Clinical narrative: Patient became immunocompromised and started to receive chemotherapy after getting booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNODEFICIENCY (Patient became immunocompromised and started to receive chemotherapy after getting booster dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNODEFICIENCY (Patient became immunocompromised and started to receive chemotherapy after getting booster dose) (seriousness criterion medically significant). At the time of the report, IMMUNODEFICIENCY (Patient became immunocompromised and started to receive chemotherapy after getting booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that patient received first, second and booster dose with a regular schedule, but became immunocompromised after he received his booster dose. He started to receive chemotherapy and was asking about the forth dose due to his new condition.  Company Comment: This is a spontaneous case concerning a male patient of unknown age with no reported medical history, who experienced the unexpected serious event of Immunodeficiency. Patient became immunocompromised and started to receive chemotherapy after getting booster dose of mRNA-1273 vaccine. No further information was disclosure and follow up was not granted. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a male patient of unknown age with no reported medical history, who experienced the unexpected serious event of Immunodeficiency. Patient became immunocompromised and started to receive chemotherapy after getting booster dose of mRNA-1273 vaccine. No further information was disclosure and follow up was not granted. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Immunocompromised patient took 0.25 ml for his third dose; This spontaneous case was reported by a patient and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised patient took 0.25 ml for his third dose) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 016M20A and 026720A) for COVID-19 vaccination.     The patient's past medical history included Immunomodulatory therapy (Patient has cancer and is on immunotherapy) since an unknown date. Concurrent medical conditions included Immunocompromised (Patient is immunocompromised) and Bladder cancer (Bladder cancer started two months ago and is in remission).   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 04-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised patient took 0.25 ml for his third dose). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised patient took 0.25 ml for his third dose) outcome was unknown.            Patient's height was reported as 70 inches. Patient did not ever tested or diagnosed with COVID. Patient did not receive any other vaccines within 1 month prior to Moderna COVID-19 vaccine. Patient had the two primary doses and the third dose was a half dose. He states he didn't know at the time that he was supposed to get a full dose. No concomitant medications were reported.
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: On 10Nov2021, one of my nurses have a dose of Moderna Covid-19 vaccine that was 3 days past manufacturer's expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (On 10Nov2021, one of my nurses have a dose of Moderna Covid-19 vaccine that was 3 days past manufacturer's expiration date.) in a 39-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (On 10Nov2021, one of my nurses have a dose of Moderna Covid-19 vaccine that was 3 days past manufacturer's expiration date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (On 10Nov2021, one of my nurses have a dose of Moderna Covid-19 vaccine that was 3 days past manufacturer's expiration date.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported.  No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 5 doses were given from a vial exposed to several temperature excursions; 5 doses were given from a vial exposed to several temperature excursions; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses were given from a vial exposed to several temperature excursions) and PRODUCT STORAGE ERROR (5 doses were given from a vial exposed to several temperature excursions) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 doses were given from a vial exposed to several temperature excursions). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (5 doses were given from a vial exposed to several temperature excursions). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 doses were given from a vial exposed to several temperature excursions) and PRODUCT STORAGE ERROR (5 doses were given from a vial exposed to several temperature excursions) outcome was unknown.      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.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Vaccination site pain
Clinical narrative: Fever; Strong headache; Pain in the arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE (Strong headache) and VACCINATION SITE PAIN (Pain in the arm of injection) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), HEADACHE (Strong headache) and VACCINATION SITE PAIN (Pain in the arm of injection). At the time of the report, PYREXIA (Fever), HEADACHE (Strong headache) and VACCINATION SITE PAIN (Pain in the arm of injection) had resolved.            No concomitant medications reported. No treatment information was provided.   Reporter did not allow further contact
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy, Vaccination site movement impairment
Clinical narrative: could not use arm/out of commission; Swelling under left arm pit; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (could not use arm/out of commission) and VACCINATION SITE LYMPHADENOPATHY (Swelling under left arm pit) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (could not use arm/out of commission) and VACCINATION SITE LYMPHADENOPATHY (Swelling under left arm pit). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (could not use arm/out of commission) and VACCINATION SITE LYMPHADENOPATHY (Swelling under left arm pit) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No Concomitant product use was reported.  The reporter stated that the patient experienced long lasting reaction from their first dose. The patient stated that they could not use arm, out of commission and after a week experienced swelling under left arm pit. The patient spoke to doctor who said it would go away after a while.  No treatment information was provided.   This case was linked to MOD-2022-513832, MOD-2022-513833 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2022: Follow up document contains No New Information
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chills, Feeling abnormal, Influenza like illness, Tremor
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking), INFLUENZA LIKE ILLNESS (had flu-like symptoms), FEELING ABNORMAL (it laid me out) and CHILLS (shivering) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included High cholesterol. In November 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2020, the patient experienced TREMOR (shaking), INFLUENZA LIKE ILLNESS (had flu-like symptoms), FEELING ABNORMAL (it laid me out) and CHILLS (shivering). At the time of the report, TREMOR (shaking), INFLUENZA LIKE ILLNESS (had flu-like symptoms), FEELING ABNORMAL (it laid me out) and CHILLS (shivering) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: high cholesterol (High) had blood work done. Everything shows up normal. It did show high cholesterol. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. No concomitant product use was reported. Patient had experienced all symptoms on the same day of vaccination. It was also reported that the patient had seen doctors and they said there were no conditions. No treatment information was provided. This case was linked to MOD-2022-513826, MOD-2022-513827 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.; Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) in a 60-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.). In March 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter.  Patient received vaccine in question as a first dose. It was not known which arm the patient received the vaccine. The Nurse reported no adverse reactions or side effects to the Moderna Covid-19 vaccine.  On 3MAR2022 vials were  moved from freezer to refrigerator.Vials were refrigerated at the time of the excursion. There were multiple temperature excursions as reflected above. Maximum Temperature was 49 degrees Farenheight, Minimum Temperature was 37.7 degrees Farenheight. The temperature excursions occurred on 4MAR2022, 5MAR2022, 7MAR2022, 8MAR2022, 8MAR2022, 9MAR2022, and 10MAR2022.    Treatment information was not provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Recieved Moderna COVID-19 vaccine which had undergone multiple temperature excursions; Recieved Moderna COVID-19 vaccine which had undergone multiple temperature excursions; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Recieved Moderna COVID-19 vaccine which had undergone multiple temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Recieved Moderna COVID-19 vaccine which had undergone multiple temperature excursions) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Recieved Moderna COVID-19 vaccine which had undergone multiple temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Recieved Moderna COVID-19 vaccine which had undergone multiple temperature excursions). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Recieved Moderna COVID-19 vaccine which had undergone multiple temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Recieved Moderna COVID-19 vaccine which had undergone multiple temperature excursions) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter.  Patient received vaccine in question as a booster dose. It was not known which arm the patient received the vaccine. The Nurse reported no adverse reactions or side effects to the Moderna Covid-19 vaccine.  On 3-Mar-2022 vials were moved from freezer to refrigerator. Vials were refrigerated at the time of the excursion. There were multiple temperature excursions as reflected above. Maximum Temperature was 49 degrees Fahrenheit, Minimum Temperature was 37.7 degrees Fahrenheit. The temperature excursions occurred on 4MAR2022, 5MAR2022, 7MAR2022, 8MAR2022, 8MAR2022, 9MAR2022, and 10MAR2022.    Treatment information was not provided.