chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Rash
Clinical narrative: Rash; Aching joints; This spontaneous case was reported by a physician and describes the occurrence of RASH (Rash) and ARTHRALGIA (Aching joints) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received third dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and dose of ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced RASH (Rash) and ARTHRALGIA (Aching joints). At the time of the report, RASH (Rash) and ARTHRALGIA (Aching joints) was resolving.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered RASH (Rash) to be possibly related. No further causality assessment was provided for ARTHRALGIA (Aching joints).    No concomitant drug reported. No treatment information was provided by the reporter.  The causality for Humira injection for event Rash and for Aching joint was not related with action taken as unknown.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dizziness, Malaise, Nausea, Vaccination site pain
Clinical narrative: Malaise; Lightheadedness; Pain at the injection site / sore arm; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Malaise), DIZZINESS (Lightheadedness), VACCINATION SITE PAIN (Pain at the injection site / sore arm), CHILLS (Chills) and NAUSEA (Nausea) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056M21A) for COVID-19 vaccination.     No Medical History information was reported.  On 16-May-2022 at 3:30 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022 at 5:00 AM, the patient experienced MALAISE (Malaise), DIZZINESS (Lightheadedness), VACCINATION SITE PAIN (Pain at the injection site / sore arm), CHILLS (Chills) and NAUSEA (Nausea). On 17-May-2022 at 8:00 AM, MALAISE (Malaise), DIZZINESS (Lightheadedness), CHILLS (Chills) and NAUSEA (Nausea) had resolved. At the time of the report, VACCINATION SITE PAIN (Pain at the injection site / sore arm) had not resolved.     Concomitant product use was not provided by the reporter.  The patient received second booster on 16-May-2022 at 3:30 PM afternoon and experienced several AEs on 17-May-2022 between 5:00 AM to 8:00 AM morning. They were the most significant of all 4 shots. The patient experienced pain at the injection site, chills, malaise, nausea and lightheadedness. Events had subsided, except for a sore arm.  Treatment information was not provided.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Vaccination site pruritus
Clinical narrative: got Covid-19 on 18JAN2022; got Covid-19 on 18JAN2022; itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (got Covid-19 on 18JAN2022), COVID-19 (got Covid-19 on 18JAN2022) and VACCINATION SITE PRURITUS (itching at the injection site) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A and 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, the patient experienced VACCINATION SITE PRURITUS (itching at the injection site). On 18-Jan-2022, the patient experienced DRUG INEFFECTIVE (got Covid-19 on 18JAN2022) and COVID-19 (got Covid-19 on 18JAN2022). At the time of the report, DRUG INEFFECTIVE (got Covid-19 on 18JAN2022), COVID-19 (got Covid-19 on 18JAN2022) and VACCINATION SITE PRURITUS (itching at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2022, COVID-19: positve (Positive) positive.         No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.  The patient didn't not take booster dose company comment This spontaneous case reported by a consumer, concerns a 43 year old female patient with no medical history reported, who experienced the unexpected, non-serious AESI of Covid 19 with a positive covid-19 test, about 5 months after receiving the 2 dose of mRNA-1273 vaccine in the covid 19 vaccination series. Drug Ineffective (Lack of Drug Effect) was noted. The patient had received the 2 primary doses with Moderna vaccine at an interval of about 27 Days and it was reported that he did not take any booster dose. Details of treatment were not provided. Event outcome was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case reported by a consumer, concerns a 43 year old female patient with no medical history reported, who experienced the unexpected, non-serious AESI of Covid 19 with a positive covid-19 test, about 5 months after receiving the 2 dose of mRNA-1273 vaccine in the covid 19 vaccination series. Drug Ineffective (Lack of Drug Effect) was noted. The patient had received the 2 primary doses with Moderna vaccine at an interval of about 27 Days and it was reported that he did not take any booster dose. Details of treatment were not provided. Event outcome was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Laboratory test, Myalgia, Somnolence
Clinical narrative: sleeps all the time; muscle pain in legs, shoulder/ bad aches all over the body; tired; This spontaneous case was reported by a patient family member or friend and describes the occurrence of SOMNOLENCE (sleeps all the time), MYALGIA (muscle pain in legs, shoulder/ bad aches all over the body) and FATIGUE (tired) 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 dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (sleeps all the time), MYALGIA (muscle pain in legs, shoulder/ bad aches all over the body) and FATIGUE (tired). At the time of the report, SOMNOLENCE (sleeps all the time), MYALGIA (muscle pain in legs, shoulder/ bad aches all over the body) and FATIGUE (tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: normal (normal) Normal. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medications were reported. Reporter's friend's wife who had the Moderna Covid-19 vaccine experienced the same problems as of reporter. Patient was transported to the hospital where they ran some tests on patient. No treatment drugs were reported   This case was linked to MOD-2022-568297 (Patient Link).
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired vial was stored in the refrigerator on 12 May 2022 and adminstered on 13 May 2022; expired dose of Moderna Covid-19 vaccine was administered / Dose administered after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose of Moderna Covid-19 vaccine was administered / Dose administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Expired vial was stored in the refrigerator on 12 May 2022 and adminstered on 13 May 2022) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose of Moderna Covid-19 vaccine was administered / Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vial was stored in the refrigerator on 12 May 2022 and adminstered on 13 May 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose of Moderna Covid-19 vaccine was administered / Dose administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Expired vial was stored in the refrigerator on 12 May 2022 and adminstered on 13 May 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that on 12-May-2022, the vial was initially stored in the refrigerator. 9 doses of expired Moderna Covid-19 vaccine was administered on 13-May-2022. The vial did not undergo any temperature excursions. No information on treatment was reported.   This case was linked to MOD-2022-568727, MOD-2022-568779, MOD-2022-568780, MOD-2022-568782, MOD-2022-568783, MOD-2022-568787, MOD-2022-568795, MOD-2022-568797 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Hypokinesia, Influenza like illness, Loss of personal independence in daily activities, Pain
Clinical narrative: Started to feel like he had the flu; Achy; Couldn't really move much; Felt like everything was heavy; Hard to get up out of bed; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Started to feel like he had the flu), PAIN (Achy), HYPOKINESIA (Couldn't really move much), DISCOMFORT (Felt like everything was heavy) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Hard to get up out of bed) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Started to feel like he had the flu), PAIN (Achy), HYPOKINESIA (Couldn't really move much), DISCOMFORT (Felt like everything was heavy) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Hard to get up out of bed). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Started to feel like he had the flu), PAIN (Achy), HYPOKINESIA (Couldn't really move much), DISCOMFORT (Felt like everything was heavy) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Hard to get up out of bed) outcome was unknown.      Concomitant product use was not provided by the reporter.  The patient received 3 doses of the Moderna covid-19 vaccine. He started to feel like he had the flu. He was achy, couldn't really move much, felt like everything was heavy, and it was hard to get up out of bed. He took ibuprofen after the 3rd dose of the vaccine. Dates of administration and lot numbers unknown.   This case was linked to MOD-2022-568850 (Patient Link).
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial expired on 25-MAR-2022 and Vial initially stored in refrigerator on 02-MAY-2022; 5 doses administered to patients after Moderna vaccine expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses administered to patients after Moderna vaccine expired) and PRODUCT STORAGE ERROR (Vial expired on 25-MAR-2022 and Vial initially stored in refrigerator on 02-MAY-2022) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 doses administered to patients after Moderna vaccine expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial expired on 25-MAR-2022 and Vial initially stored in refrigerator on 02-MAY-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 doses administered to patients after Moderna vaccine expired) and PRODUCT STORAGE ERROR (Vial expired on 25-MAR-2022 and Vial initially stored in refrigerator on 02-MAY-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 13-May-2022, patient received the first booster dose. The patient did not report any adverse reactions to this dose. Vial did not undergo any temperature excursions.  No treatment medications were reported.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vaccine was expired on 25-Mar-2022, initially stored in the refrigerator on 02-May-2022 and administered on 13-May-2022; The vaccine expired on 25-Mar-2022 and administered on 13-May-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (The vaccine was expired on 25-Mar-2022, initially stored in the refrigerator on 02-May-2022 and administered on 13-May-2022) and EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 25-Mar-2022 and administered on 13-May-2022) in a 67-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 25-Mar-2022 and administered on 13-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was expired on 25-Mar-2022, initially stored in the refrigerator on 02-May-2022 and administered on 13-May-2022). At the time of the report, PRODUCT STORAGE ERROR (The vaccine was expired on 25-Mar-2022, initially stored in the refrigerator on 02-May-2022 and administered on 13-May-2022) and EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 25-Mar-2022 and administered on 13-May-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  HCP stated that their facility had an error where 5 doses of the Moderna COVID-19 vaccine was administered after the expiration date of 25-Mar-2022. The administration occurred on 13-May-2022. None of the 5 patients had reported any adverse reactions to this dose. The vial was initially stored in the refrigerator on 02-May-2022. The vial did not undergo any temperature excursions.  No treatment information was reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Flu like symptoms after receiving the second dose of the Moderna Covid 19 Vaccine; Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine; Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine; Body ache after receiving the second dose of the Moderna Covid 19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms after receiving the second dose of the Moderna Covid 19 Vaccine), VACCINATION SITE ERYTHEMA (Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine), VACCINATION SITE PAIN (Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine) and MYALGIA (Body ache after receiving the second dose of the Moderna Covid 19 Vaccine) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023MCOA) for COVID-19 vaccination.     The patient did not had COVID positive test or diagnosis.  Concurrent medical conditions included Penicillin allergy (Penicillin), Food allergy (spicy food), Palpitations and Thyroid disorder NOS. Concomitant products included CILNIDIPINE, OLMESARTAN MEDOXOMIL (BENICAR), LEVOTHYROXINE SODIUM (SYNTHROID), ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN, PANTOPRAZOLE, METFORMIN, HYDROXYCARBAMIDE (HYDROXYUREA), CALCIUM and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms after receiving the second dose of the Moderna Covid 19 Vaccine), VACCINATION SITE ERYTHEMA (Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine), VACCINATION SITE PAIN (Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine) and MYALGIA (Body ache after receiving the second dose of the Moderna Covid 19 Vaccine). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms after receiving the second dose of the Moderna Covid 19 Vaccine), VACCINATION SITE ERYTHEMA (Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine), VACCINATION SITE PAIN (Pain and redness in the site of injection after receiving the 2 primary doses of the Moderna Covid 19 Vaccine) and MYALGIA (Body ache after receiving the second dose of the Moderna Covid 19 Vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   She had heart palpitations before due to her thyroid problems. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2022: Live follow-up received contains no new information.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient administered with vaccine from vial exposed at room temp for more than 24 hours / vial punctured more than 12 hours; Patient administered with vaccine from vial exposed at room temp for more than 24 hours / vial punctured more than 12 hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered with vaccine from vial exposed at room temp for more than 24 hours / vial punctured more than 12 hours) and PRODUCT STORAGE ERROR (Patient administered with vaccine from vial exposed at room temp for more than 24 hours / vial punctured more than 12 hours) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005M21A, 062G20A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2022 at 2:02 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2022 at 2:02 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered with vaccine from vial exposed at room temp for more than 24 hours / vial punctured more than 12 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient administered with vaccine from vial exposed at room temp for more than 24 hours / vial punctured more than 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered with vaccine from vial exposed at room temp for more than 24 hours / vial punctured more than 12 hours) and PRODUCT STORAGE ERROR (Patient administered with vaccine from vial exposed at room temp for more than 24 hours / vial punctured more than 12 hours) 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 vial was first punctured on 11-May-2022 at 9:30am and was left at room temperature from then on. The number of doses/vials was 1 dose. The date of vial was initially stored in the refrigerator was not reported. The vial did not undergo any temperature excursions. The vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) for 53 hours. The vial was stored post puncture at room temperature. The frequency was reported as times per.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Immunisation reaction
Clinical narrative: Report Adverse Event; vaccine administration past expiration date; This spontaneous case was reported by a nurse and describes the occurrence of IMMUNISATION REACTION (Report Adverse Event) and EXPIRED PRODUCT ADMINISTERED (vaccine administration past expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Report Adverse Event) and EXPIRED PRODUCT ADMINISTERED (vaccine administration past expiration date). At the time of the report, IMMUNISATION REACTION (Report Adverse Event) and EXPIRED PRODUCT ADMINISTERED (vaccine administration past expiration date) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.    No treatment information was reported.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain in the left arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (pain in the left arm) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059H21A, 024M20A and 013L20A) for COVID-19 vaccination.     The patient never had COVID positive test or diagnosis and no other vaccines were given to the patient within 1 month prior to Moderna COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: FLU SYRINGE (Allergies: Became severely ill in the 1970's after a flu shot) in 1970. Past adverse reactions to the above products included Illness with FLU SYRINGE. Concurrent medical conditions included Kidney stones (Start Date: 5 to 6 years ago, no  recent change in status reported) and Enlarged prostate (Start Date: years ago, Recent change in status was unknown.).   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 14-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 14-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (pain in the left arm). At the time of the report, VACCINATION SITE PAIN (pain in the left arm) had resolved.            Concomitant medication reported included Unknown enlarged prostate medication.  The patient reported that after receiving their first Moderna booster dose on 14-Jan-2022, the patient experienced pain in the left arm that lasted several weeks and then resolved. The patient's height reported as 5 feet 10 inch and the patient mentioned that the patient was shrinking.  No treatment information was provided.   This case was linked to MOD-2022-569083 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, COVID-19, Incomplete course of vaccination, SARS-CoV-2 test
Clinical narrative: Anxiety/ stress/ brain fog/ nerves; COVID-19 diagnosis; Only got 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Anxiety/ stress/ brain fog/ nerves), COVID-19 (COVID-19 diagnosis) and INCOMPLETE COURSE OF VACCINATION (Only got 1st dose) in a 60-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 045221A) for COVID-19 vaccination.     The had no allergies.  Concurrent medical conditions included Vertigo.    On 09-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANXIETY (Anxiety/ stress/ brain fog/ nerves), COVID-19 (COVID-19 diagnosis) and INCOMPLETE COURSE OF VACCINATION (Only got 1st dose). At the time of the report, ANXIETY (Anxiety/ stress/ brain fog/ nerves) and COVID-19 (COVID-19 diagnosis) had not resolved and INCOMPLETE COURSE OF VACCINATION (Only got 1st dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: covid diagnosis after 1st dose (Positive) COVID Diagnosis after 1st dose.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  It was unknown whether the patient received other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient did not received any further doses and only got first dose. Recent change in patient status was worsening.  Treatment medications included anxiety and stress medication.  Company comment-This spontaneous case concerns a 60-year-old male patient, with no relevant medical history reported, who experienced the non-serious unexpected AESI of COVID-19 unspecified days after first dose of mRNA-1273 vaccine. COVID test done on an unknown date was positive. Patient experienced stress, nerves, brain fog and anxiety after first dose. No further doses were taken- Incomplete course of vaccination was noted. He consulted a physician for the same and was advised anxiety and stress medicine. The Symptoms have worsened and ongoing. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 60-year-old male patient, with no relevant medical history reported, who experienced the non-serious unexpected AESI of COVID-19 unspecified days after first dose of mRNA-1273 vaccine. COVID test done on an unknown date was positive. Patient experienced stress, nerves, brain fog and anxiety after first dose. No further doses were taken- Incomplete course of vaccination was noted. He consulted a physician for the same and was advised anxiety and stress medicine. The Symptoms have worsened and ongoing. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain, COVID-19, Diarrhoea, Dysgeusia, Myalgia
Clinical narrative: Covid-19; metallic taste; abdominal pain; Diarrhea; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (metallic taste), ABDOMINAL PAIN (abdominal pain), DIARRHOEA (Diarrhea), MYALGIA (muscle aches) and COVID-19 (Covid-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient had no known drug allergies.     On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2022 at 1:00 PM, the patient experienced DYSGEUSIA (metallic taste). 14-May-2022 at 1:00 PM, the patient experienced ABDOMINAL PAIN (abdominal pain), DIARRHOEA (Diarrhea) and MYALGIA (muscle aches). On an unknown date, the patient experienced COVID-19 (Covid-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 14-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, DYSGEUSIA (metallic taste), ABDOMINAL PAIN (abdominal pain), DIARRHOEA (Diarrhea) and MYALGIA (muscle aches) had not resolved and COVID-19 (Covid-19) outcome was unknown.            Concomitant products were not provided. Patient was not taking any other medications or products within 2 weeks of starting COVID-19 treatment. Patient previously received COVID-19 vaccine.  Company Comment: This spontaneous case concerns a patient of unknown age and gender, with no relevant medical history, who experienced the unexpected AESI of COVID-19, the unexpected events Dysgeusia, Abdominal pain, Diarrhea and the expected event Myalgia. The events occurred on an unknown date interval after receiving the third dose of mRNA-1273 Vaccine. The patient experienced the events on the same day of taking Paxlovid as treatment for COVID-19. The outcome of the events was reported as unknown. The patient's concomitant treatment of Paxlovid remain as a confounder for the occurrence of the events Dysgeusia, Abdominal pain, Diarrhea and Myalgia. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender, with no relevant medical history, who experienced the unexpected AESI of COVID-19, the unexpected events Dysgeusia, Abdominal pain, Diarrhea and the expected event Myalgia. The events occurred on an unknown date interval after receiving the third dose of mRNA-1273 Vaccine. The patient experienced the events on the same day of taking Paxlovid as treatment for COVID-19. The outcome of the events was reported as unknown. The patient's concomitant treatment of Paxlovid remain as a confounder for the occurrence of the events Dysgeusia, Abdominal pain, Diarrhea and Myalgia. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: Headache (Slight); Sore arm; Low grade temperature; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache (Slight)), PAIN IN EXTREMITY (Sore arm) and PYREXIA (Low grade temperature) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     It was reported that patient has never been diagnosed/tested positive for COVID-19.  Concurrent medical conditions included Drug allergy (Allergy to Sulfa), Lupus nephritis (Lupkynis (Vaclosporin) from 01-Dec-2021 for Lupus nephritis, bid, 7.9 mg 6 pills/ day, LOT 4244068AA) and Sjogren's syndrome. Concomitant products included MYCOPHENOLATE MOFETIL HYDROCHLORIDE (CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]) for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache (Slight)), PAIN IN EXTREMITY (Sore arm) and PYREXIA (Low grade temperature). At the time of the report, HEADACHE (Headache (Slight)), PAIN IN EXTREMITY (Sore arm) and PYREXIA (Low grade temperature) outcome was unknown.            The patient received both dose (1st and 2nd dose) in the morning (am).  The patient reported that she did not had adverse effect with the first 3 Moderna shots, low grade temperature, headache (slight) and sore arm but nothing out of the ordinary.   No treatment information was provided.   This case was linked to MOD-2022-538122, MOD-2022-569112, MOD-2022-569113 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain
Clinical narrative: minor pain discomfort directly across the chest below breast/band of minor pain; minor pain discomfort directly across the chest below breast/2 inches high/discomfort after the last 3 doses; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (minor pain discomfort directly across the chest below breast/band of minor pain) and CHEST DISCOMFORT (minor pain discomfort directly across the chest below breast/2 inches high/discomfort after the last 3 doses) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Adhesive tape allergy, Benign prostatic hyperplasia and Blood pressure high. Concomitant products included TAMSULOSIN for Benign prostatic hyperplasia, VALSARTAN for Blood pressure high, VITAMINS NOS (DAILY VITAMINS), L-CITRULLINE, CUCURBITA PEPO SEED, SERENOA REPENS FRUIT, SITOSTEROL, ZINC OXIDE (PROSTATE PLUS), CURCUMA LONGA (TURMERIC [CURCUMA LONGA]), PYCNOGENOL, CORDYCEPS SINENSIS (CORDYCEPS), VITAMIN B3 and L-ARGININE [ARGININE] for an unknown indication.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 2021, the patient experienced CHEST PAIN (minor pain discomfort directly across the chest below breast/band of minor pain) and CHEST DISCOMFORT (minor pain discomfort directly across the chest below breast/2 inches high/discomfort after the last 3 doses). At the time of the report, CHEST PAIN (minor pain discomfort directly across the chest below breast/band of minor pain) and CHEST DISCOMFORT (minor pain discomfort directly across the chest below breast/2 inches high/discomfort after the last 3 doses) had not resolved.            patient reported, got symptoms about 2 days after the shot. Patient felt 2 inches high discomfort straight across his chest and was more prominent on the right side. Pain was away from the side of heart, continued on a straight line across the chest and went directly under the heart side. Patient felt discomfort once in a while throughout the day but mostly felt it when he was cooking dinner. Patient told it took a day for an episode to start after vaccination and he could not remember how long they lasted for but patient was still experiencing. Patient had not gone to the doctor for labs or tests about myocarditis/pericarditis.  No treatment medication was reported by reporter.   This case was linked to MOD-2022-569116, MOD-2022-569123 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2022: Patient details, Reporter updated, Start date of vaccine, Medical History, Concomitant medications updated.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain
Clinical narrative: minor pain discomfort directly across the chest below breast/band of minor pain; minor pain discomfort directly across the chest below breast/2 inches high/more prominent on the right side; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (minor pain discomfort directly across the chest below breast/band of minor pain) and CHEST DISCOMFORT (minor pain discomfort directly across the chest below breast/2 inches high/more prominent on the right side) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040O21A, 010A21A and 088D21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Adhesive tape allergy, Benign prostatic hyperplasia and Hypertension. Concomitant products included TAMSULOSIN for Benign prostatic hyperplasia, VALSARTAN for Hypertension, VITAMINS NOS (DAILY VITAMINS), L-CITRULLINE, L-ARGININE [ARGININE], CUCURBITA PEPO SEED, SERENOA REPENS FRUIT, SITOSTEROL, ZINC OXIDE (PROSTATE PLUS), CURCUMA LONGA (TURMERIC [CURCUMA LONGA]), PYCNOGENOL, CORDYCEPS SINENSIS (CORDYCEPS) and VITAMIN B3 for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (minor pain discomfort directly across the chest below breast/band of minor pain) and CHEST DISCOMFORT (minor pain discomfort directly across the chest below breast/2 inches high/more prominent on the right side). At the time of the report, CHEST PAIN (minor pain discomfort directly across the chest below breast/band of minor pain) and CHEST DISCOMFORT (minor pain discomfort directly across the chest below breast/2 inches high/more prominent on the right side) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication information provided. Patient not gone to the doctor for labs or tests about myocarditis/pericarditis.   This case was linked to MOD-2022-569116, MOD-2022-569121 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2022: Follow-up  Significant information -Patient details, Reporter updated, Start date of vaccine, Medical History, Concomitant updated
Age: 59.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Diarrhoea, Dysgeusia
Clinical narrative: diarrhea/more than 8 liquid water stools; Bad taste -Metalic/bitter taste with in 1 hour of taking first dose of Paxlovid; This spontaneous case was reported by a nurse and describes the occurrence of DYSGEUSIA (Bad taste -Metalic/bitter taste with in 1 hour of taking first dose of Paxlovid) and DIARRHOEA (diarrhea/more than 8 liquid water stools) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056MZ1A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Previously administered products included for COVID-19 vaccination: Pfizer / BioNTech (Dose Number: 1 Batch/Lot No: EK9231 Location of injection: Left Arm) on 27-Dec-2020, Pfizer / BioNTech (Dose Number: 2 Batch/Lot No: EL1283 Location of injection: Left Arm) on 17-Jan-2021 and Pfizer / BioNTech (Dose Number: 3 Batch/Lot No: FF2590 Location of injection: Left Arm) on 21-Dec-2021. Past adverse reactions to the above products included No adverse event with Pfizer /BioNTech and Pfizer Concurrent medical conditions included Hypertension and Drug allergy (Sulfa Allergy). Concomitant products included LOSARTAN POTASSIUM (COZAAR), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), FOLIC ACID, CURCUMA LONGA (TURMERIC [CURCUMA LONGA]), CYANOCOBALAMIN (B-12) and ESTROVEN for an unknown indication.   On 06-May-2022 at 5:30 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 11-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSGEUSIA (Bad taste -Metalic/bitter taste with in 1 hour of taking first dose of Paxlovid). On 13-May-2022 at 9:15 AM, the patient experienced DIARRHOEA (diarrhea/more than 8 liquid water stools). At the time of the report, DYSGEUSIA (Bad taste -Metalic/bitter taste with in 1 hour of taking first dose of Paxlovid) and DIARRHOEA (diarrhea/more than 8 liquid water stools) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication included Estroven Complete Multi-symptom.  The patient received the 4th dose of Paxlovid on 13-May-2022 and 8th dose of Paxlovid on 14-May-2022, then had watery liquid stools for more than 8 times and the physician was notified of the same.  On 15-May-2022, the patient had liquid stools for one time in the morning and no stools during the night after receiving the evening doses.  The device date was reported as 16-May-2022.  Treatment information was not provided.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune thyroiditis, Crohn's disease
Clinical narrative: Crohn's disease; Hashimotos disease; This spontaneous case was reported by a pharmacist and describes the occurrence of AUTOIMMUNE THYROIDITIS (Hashimotos disease) and CROHN'S DISEASE (Crohn's disease) in a 31-year-old female 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced AUTOIMMUNE THYROIDITIS (Hashimotos disease) (seriousness criterion medically significant). On an unknown date, the patient experienced CROHN'S DISEASE (Crohn's disease) (seriousness criterion medically significant). At the time of the report, AUTOIMMUNE THYROIDITIS (Hashimotos disease) and CROHN'S DISEASE (Crohn's disease) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. The patient received the 1st booster shot and on 08Nov2021 the patient was diagnosed with immunocompromised conditions: Hashimotos disease and Crohn's disease after November 8th, 2021. The Pharmacist stated that the patient has received 3 doses so far, primary series (2 doses) and 1st booster dose. No treatment medications were reported.  Company comment-This spontaneous case concerns a 31-year-old female patient, with no medical history reported, who experienced the serious (medically significant) unexpected events of Autoimmune thyroiditis (AESI) and Crohn's disease unspecified days after first booster dose of mRNA-1273 vaccine. No further details on primary vaccination schedule, clinical course, lab test results and treatment received were reported. Outcome of the events was unknown at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 31-year-old female patient, with no medical history reported, who experienced the serious (medically significant) unexpected events of Autoimmune thyroiditis (AESI) and Crohn's disease unspecified days after first booster dose of mRNA-1273 vaccine. No further details on primary vaccination schedule, clinical course, lab test results and treatment received were reported. Outcome of the events was unknown at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Electrocardiogram, Heart rate, Hypertension
Clinical narrative: High Blood Pressure (180mmHg) 5 days  after first shot,Blood Pressure went out of control, 5 days  after first shot; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (High Blood Pressure (180mmHg) 5 days after first shot, Blood Pressure went out of control, 5 days  after first shot) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.  Concurrent medical conditions included Borderline hypertension (Never had to take medications to control blood pressure.) On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced HYPERTENSION (High Blood Pressure (180mmHg) 5 days after first shot, Blood Pressure went out of control, 5 days  after first shot). The patient was treated with LISINOPRIL ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HYPERTENSION (High Blood Pressure (180mmHg) 5 days  after first shot, Blood Pressure went out of control, 5 days after first shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 180 (High) 180mmHg. On an unknown date, Electrocardiogram: result not reported ER staff did not tell him anything about his EKG, so he assumes that it was normal. On an unknown date, Heart rate: 100 100 BPM. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient never had COVID disease. No concomitant product use was provided.  The patient visited the emergency room and they did EKG and started him on blood pressure medications. The second shot was taken on 23-Apr-2021.  On 17-May-2022, his Blood Pressure was under control while he uses medications. He states that after vaccination, his blood pressure never went back to normal or borderline, without medications.