chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Product was administered after having been exposed to 45 hours of out-of-range temps reaching a Max 0f 13.4 C/Freezer was exposed to excursions; Administration after 45 hours excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product was administered after having been exposed to 45 hours of out-of-range temps reaching a Max 0f 13.4 C/Freezer was exposed to excursions) and EXPIRED PRODUCT ADMINISTERED (Administration after 45 hours excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 056M21A) for COVID-19 vaccination.     No Medical History information was reported.  On 03-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration after 45 hours excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product was administered after having been exposed to 45 hours of out-of-range temps reaching a Max 0f 13.4 C/Freezer was exposed to excursions). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Product was administered after having been exposed to 45 hours of out-of-range temps reaching a Max 0f 13.4 C/Freezer was exposed to excursions) and EXPIRED PRODUCT ADMINISTERED (Administration after 45 hours excursion) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  It was reported that the product was administered after having been exposed to 45 hours of out-of-range temps reaching a max of 13.4 C.  The date the vial was initially stored in the refrigerator was reported as unknown.  It was reported that provider removed vials from freezer as needed, stored in the refrigerator and did not mark BUD date or keep vaccine tracking records.  It was reported that freezer was exposed to excursions but the provider contacted and indicated the vaccine was considered viable.  Treatment information was not provided.   This case was linked to MOD-2022-583131 (E2B Linked Report).; Sender's Comments:  MOD-2022-583131:MOD-2022-583493 (same reporter case)
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Dysgeusia - moderate bitter/metallic taste in mouth. Onset within 30 mins of taking first dose. Lasts several hours. Does not change taste of food or liquid. Improved within 8hrs after last dose; This spontaneous case was reported by an other health care professional and describes the occurrence of DYSGEUSIA (Dysgeusia - moderate bitter/metallic taste in mouth. Onset within 30 mins of taking first dose. Lasts several hours. Does not change taste of food or liquid. Improved within 8hrs after last dose) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 024M20A and 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (No drug was reported). Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE from 13-Apr-2022 to 22-May-2022, FLUTICASONE PROPIONATE from 13-Apr-2022 to 22-May-2022, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) from 30-May-2022 to 01-Jun-2022 and DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) from 24-May-2022 to 25-May-2022 for an unknown indication.   On 14-Jan-2021 at 6:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021 at 6:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021 at 6:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2022 at 9:00 AM, the patient experienced DYSGEUSIA (Dysgeusia - moderate bitter/metallic taste in mouth. Onset within 30 mins of taking first dose. Lasts several hours. Does not change taste of food or liquid. Improved within 8hrs after last dose). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 26-May-2022 to 30-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. On 30-May-2022, DYSGEUSIA (Dysgeusia - moderate bitter/metallic taste in mouth. Onset within 30 mins of taking first dose. Lasts several hours. Does not change taste of food or liquid. Improved within 8hrs after last dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 vaccine  Device Date was reported as 03-Jun-2022
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Administered with vaccine which underwent temperature excursion; Administered with vaccine which underwent temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered with vaccine which underwent temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Administered with vaccine which underwent temperature excursion) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005M21A, 065f21A, 018B21A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered with vaccine which underwent temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Administered with vaccine which underwent temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered with vaccine which underwent temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Administered with vaccine which underwent temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter  It was reported that there was a temperature excursion involving 14 Moderna Covid-19 vials. Reporter mentioned that they have 4 thermometers but only the data logger recorded a temperature excursion on 02-May-2022, plus 5.11F which occurred for 7 minutes; thermometer in the freezer and the other 2 data loggers did not record any.  It was reported that vials were stored in freezer and after temperature excursion the vials were quarantined in the freezer.  No treatment medication was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2022: Updated reporter's name and patient's information. Suspect dosage information was added.
Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test, Symptom recurrence
Clinical narrative: Runny nose; mild sore throat; Symptoms have reappeared 5 days after completing; This spontaneous case was reported by a patient and describes the occurrence of RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (mild sore throat) and SYMPTOM RECURRENCE (Symptoms have reappeared 5 days after completing) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Drug allergy (unknown drug).   On 09-Dec-2021 at 7:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2022 at 12:15 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 31-May-2022, the patient experienced RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (mild sore throat) and SYMPTOM RECURRENCE (Symptoms have reappeared 5 days after completing). At the time of the report, RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (mild sore throat) and SYMPTOM RECURRENCE (Symptoms have reappeared 5 days after completing) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         No concomitant medication information provided. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. No treatment information provided. Patient previously received a COVID-19 Vaccine.    Device Date was 03-Jun-2022
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient was administered with vaccine which underwent temperature excursion; Patient was administered with vaccine which underwent temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine which underwent temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine which underwent temperature excursion) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005M21A, 065f21A, 018B21A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine which underwent temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine which underwent temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine which underwent temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine which underwent temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was reported Moderna vials had a temperature excursion involving 14 Moderna Covid-19 vials, mentioned that they have 4 thermometers data logger recorded a temperature excursion on 02 May 2022 of deviation plus 5.11F temperature which occurred for 7minutes duration.This was just found out when they had an inspection with the state department and they were advised to call Moderna to determine the viability of these vaccines.  It was reported that the vials were stored in freezer while temperature excursion, Now the vials were quarantined in the freezer and the vaccine state was reported as  still frozen i.e frozen at that time the temperature excursion happened.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2022: Follow up received: Patient demography and suspect drug dose details.
Age: 72.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Pain
Clinical narrative: soreness; This spontaneous case was reported by a patient and describes the occurrence of PAIN (soreness) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product LEUPRORELIN ACETATE (LUPRON) for an unknown indication.    No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 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 started LEUPRORELIN ACETATE (LUPRON) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN (soreness). At the time of the report, PAIN (soreness) had resolved.      No concomitant medication was provided by reporter. It was reported that in 2022, the patient experienced soreness and in 2022 the event resolved. Causality of Leuprorelin Acetate (Lupron) for the event pain was reported as probable. It was unknown If the patient was enrolled in a COVID-19 vaccine trail.  No treatment medication was provided by reporter.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose administered on 26-Feb-2021 and second dose administered on 30-Sep-2021; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 26-Feb-2021 and second dose administered on 30-Sep-2021) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient has no allergies to medications, foods, and other products.    On 26-Feb-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 26-Feb-2021 and second dose administered on 30-Sep-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 26-Feb-2021 and second dose administered on 30-Sep-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient has no acute illness at the time of vaccination and up to one month before.  No concomitant medications were provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2022-572300 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: vaccine which underwent temperature excursion; administered with vaccine which underwent temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine which underwent temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine which underwent temperature excursion) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005M21A, 065f21A, ER8734 and EP7534) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine which underwent temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine which underwent temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine which underwent temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine which underwent temperature excursion) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided by the reporter  It was reported that there was a temperature excursion involving 14 Moderna Covid-19 vials. Reporter mentioned that they have 4 thermometers but only the data logger recorded a temperature excursion on 02-May-2022, plus 5.11F which occurred for 7 minutes; thermometer in the freezer and the other 2 data loggers did not record any.  It was reported that vials were stored in freezer and after temperature excursion the vials were quarantined in the freezer.  No treatment medication was provided by the reporter.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea, SARS-CoV-2 test
Clinical narrative: feeling nauseous; Dizzy; This spontaneous case was reported by a patient and describes the occurrence of NAUSEA (feeling nauseous) and DIZZINESS (Dizzy) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Allergies (medications, food and other products) were not reported. It was reported that no vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Previously administered products included for COVID-19 vaccination: Pfizer (1st primary dose:), Pfizer (1st booster dose) and PFIZER BIONTECH COVID-19 VACCINE (2nd primary dose). Past adverse reactions to the above products included No adverse reaction with PFIZER BIONTECH COVID-19 VACCINE, Pfizer and Pfizer.    On 06-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jun-2022, the patient experienced NAUSEA (feeling nauseous) and DIZZINESS (Dizzy). At the time of the report, NAUSEA (feeling nauseous) and DIZZINESS (Dizzy) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 test: positive (Positive) Positive.         For the Pfizer doses patient didn't have any side effects.  Concomitant medications were given for blood pressure and cholesterol.  Patient had side effects after getting the second booster dose for Moderna. Patient received it that day on 06Jun2022 and 1 hour later started feeling nauseous and dizzy, the symptoms were still ongoing.  It was reported that AE's didn't cause patient to seek medical care (office visit, Urgent care, ER, hospitalized). Patient would visit in future if symptoms persist.  No treatment medication were reported.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: sore left arm; extreme fatigue starting 6 hours after her first dose and lasting for two days; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (sore left arm) and FATIGUE (extreme fatigue starting 6 hours after her first dose and lasting for two days) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore left arm) and FATIGUE (extreme fatigue starting 6 hours after her first dose and lasting for two days). In January 2021, FATIGUE (extreme fatigue starting 6 hours after her first dose and lasting for two days) had resolved. At the time of the report, VACCINATION SITE PAIN (sore left arm) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Patient reported that her left arm hurt so much that she had to ice her arm.   This case was linked to MOD-2022-583835, MOD-2022-583836 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore left arm; extreme fatigue starting 6 hours after her first dose and lasting for two days; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (sore left arm) and FATIGUE (extreme fatigue starting 6 hours after her first dose and lasting for two days) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore left arm) and FATIGUE (extreme fatigue starting 6 hours after her first dose and lasting for two days). In January 2021, FATIGUE (extreme fatigue starting 6 hours after her first dose and lasting for two days) had resolved. At the time of the report, VACCINATION SITE PAIN (sore left arm) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Patient reported that her left arm hurt so much that she had to ice her arm.   This case was linked to MOD-2022-583835, MOD-2022-583836 (Patient Link).
Sex: F
Vaccine: COVID19, UNK
Symptoms: Bedridden, Blood glucose, Decreased appetite, Fatigue, Hyperglycaemia
Clinical narrative: was not hungry; stayed in bed for four days; did not feel good; sugar levels runs at 600; Sick; tired; itch/starting to itch; Osteoarthritis/having issues with her joints , had lumps on her joints. She was stiff and in a lot of pain.; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (was not hungry), BEDRIDDEN (stayed in bed for four days), MALAISE (did not feel good), HYPERGLYCAEMIA (sugar levels runs at 600) and ILLNESS (Sick) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced DECREASED APPETITE (was not hungry), BEDRIDDEN (stayed in bed for four days), MALAISE (did not feel good), HYPERGLYCAEMIA (sugar levels runs at 600), ILLNESS (Sick), FATIGUE (tired), PRURITUS (itch/starting to itch) and OSTEOARTHRITIS (Osteoarthritis/having issues with her joints , had lumps on her joints. She was stiff and in a lot of pain.). At the time of the report, DECREASED APPETITE (was not hungry), BEDRIDDEN (stayed in bed for four days), MALAISE (did not feel good), HYPERGLYCAEMIA (sugar levels runs at 600), ILLNESS (Sick), FATIGUE (tired), PRURITUS (itch/starting to itch) and OSTEOARTHRITIS (Osteoarthritis/having issues with her joints , had lumps on her joints. She was stiff and in a lot of pain.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: 600 (High) 600.         Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.  Causality of RISANKIZUMAB (SKYRIZI) was reported as the reporter's causality for the events itch, osteoarthritis, was not hungry, stayed in bed for four days, did not feel good, sugar level run at 600 and tired was not provided.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Illness, Malaise, Osteoarthritis, Pruritus
Clinical narrative: was not hungry; stayed in bed for four days; did not feel good; sugar levels runs at 600; Sick; tired; itch/starting to itch; Osteoarthritis/having issues with her joints , had lumps on her joints. She was stiff and in a lot of pain.; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (was not hungry), BEDRIDDEN (stayed in bed for four days), MALAISE (did not feel good), HYPERGLYCAEMIA (sugar levels runs at 600) and ILLNESS (Sick) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced DECREASED APPETITE (was not hungry), BEDRIDDEN (stayed in bed for four days), MALAISE (did not feel good), HYPERGLYCAEMIA (sugar levels runs at 600), ILLNESS (Sick), FATIGUE (tired), PRURITUS (itch/starting to itch) and OSTEOARTHRITIS (Osteoarthritis/having issues with her joints , had lumps on her joints. She was stiff and in a lot of pain.). At the time of the report, DECREASED APPETITE (was not hungry), BEDRIDDEN (stayed in bed for four days), MALAISE (did not feel good), HYPERGLYCAEMIA (sugar levels runs at 600), ILLNESS (Sick), FATIGUE (tired), PRURITUS (itch/starting to itch) and OSTEOARTHRITIS (Osteoarthritis/having issues with her joints , had lumps on her joints. She was stiff and in a lot of pain.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: 600 (High) 600.         Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.  Causality of RISANKIZUMAB (SKYRIZI) was reported as the reporter's causality for the events itch, osteoarthritis, was not hungry, stayed in bed for four days, did not feel good, sugar level run at 600 and tired was not provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Patient reported fever; Chills; body ache; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Patient reported fever), CHILLS (Chills) and MYALGIA (body ache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PYREXIA (Patient reported fever), CHILLS (Chills) and MYALGIA (body ache). On 26-Oct-2021, PYREXIA (Patient reported fever), CHILLS (Chills) and MYALGIA (body ache) had resolved.            No concomitant information was reported.. No treatment information was provided.  Patient spent the day in bed.   This case was linked to MOD-2022-583834 (Patient Link).
Age: 32.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Diarrhoea
Clinical narrative: Diarrhea. So much watery, loose diarrhea; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (Diarrhea. So much watery, loose diarrhea) in a 32year old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    No Medical History information was reported.   On 10-Dec-2021 at 11:15 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 02-Jun-2022 at 6:45 PM, the patient experienced DIARRHOEA (Diarrhea. So much watery, loose diarrhea). At the time of the report, DIARRHOEA (Diarrhea. So much watery, loose diarrhea) had not resolved. Not Provided          Concomitant product include -cold medicine from 31-MAY-2022.  Treatment details was not reported by the reporter.  Pfizer have permission to contact about this report but does not have permission to contact the patient's healthcare provider. The Device Date was reported as  02-Jun- 2022.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: A little bit of allergic reaction; This spontaneous case was reported by a patient and describes the occurrence of HYPERSENSITIVITY (A little bit of allergic reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (A little bit of allergic reaction). At the time of the report, HYPERSENSITIVITY (A little bit of allergic reaction) outcome was unknown.            No concomitant medication information was provided.  On an unspecified date patient received the first booster as the third dose.  No treatment medication information was provided.   This case was linked to MOD-2021-028783, MOD-2021-042448, MOD-2022-583961 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Loss of personal independence in daily activities, Pain in extremity, Pyrexia
Clinical narrative: I can hardly get undressed and dressed and it's it's falling.; my arm is very sore; horrible chills; I had a temperature of 100.4. This spontaneous case was reported by a patient and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I can hardly get undressed and dressed and it's it's falling.), CHILLS (horrible chills), PYREXIA (I had a temperature of 100.4.) and PAIN IN EXTREMITY (my arm is very sore) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jun-2022, the patient experienced CHILLS (horrible chills) and PYREXIA (I had a temperature of 100.4.). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I can hardly get undressed and dressed and it's it's falling.) and PAIN IN EXTREMITY (my arm is very sore). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I can hardly get undressed and dressed and it's it's falling.), CHILLS (horrible chills), PYREXIA (I had a temperature of 100.4.) and PAIN IN EXTREMITY (my arm is very sore) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.4 (High) 100.4. No concomitant medication information provided. On 03-Jun-2022, patient received the second booster dose. On Jun-2022 patient had sore arm and could hardly get undressed and dressed. No treatment medication information provided. This case was linked to MOD-2021-028783, MOD-2021-042448, MOD-2022-583956 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: A female patient had a breakthrough infection after vaccination but it is unknown if she received Moderna vaccines; This spontaneous case was reported by a patient family member or friend and describes the occurrence of BREAKTHROUGH COVID-19 (A female patient had a breakthrough infection after vaccination but it is unknown if she received Moderna vaccines) in a female 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BREAKTHROUGH COVID-19 (A female patient had a breakthrough infection after vaccination but it is unknown if she received Moderna vaccines). At the time of the report, BREAKTHROUGH COVID-19 (A female patient had a breakthrough infection after vaccination but it is unknown if she received Moderna vaccines) outcome was unknown.            No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: dose was administered to patient after the beyond use date after the vaccine was thawed out in the refrigeraor after 30 days; dose was administered to patient after the beyond use date after the vaccine was thawed out in the refrigeraor after 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was administered to patient after the beyond use date after the vaccine was thawed out in the refrigeraor after 30 days) and PRODUCT STORAGE ERROR (dose was administered to patient after the beyond use date after the vaccine was thawed out in the refrigeraor after 30 days) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 057M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was administered to patient after the beyond use date after the vaccine was thawed out in the refrigeraor after 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (dose was administered to patient after the beyond use date after the vaccine was thawed out in the refrigeraor after 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose was administered to patient after the beyond use date after the vaccine was thawed out in the refrigeraor after 30 days) and PRODUCT STORAGE ERROR (dose was administered to patient after the beyond use date after the vaccine was thawed out in the refrigeraor after 30 days) 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 vial was initially stored in refrigerator on 25-Apr-2022. The vial did not undergo any temperature excursion. It was reported patients were administered from 2 separate vials of same lot number. Dose administered on 27MAY2022 with beyond use date being on 25MAY2022 as per HCP from 2 separate vials from the same lot number.   Treatment was reported as unknown.    This case was linked to MOD-2022-583974 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (possible that doses were given after expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 033K21-2A) 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 EXPIRED PRODUCT ADMINISTERED (possible that doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (possible that doses were given after expiration date) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided by the reporter. It was reported they have 20 vials of Moderna vaccine, Caller not know if they had a shelf life extension. They have quite a bit of it in the freezer. No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Magnetic resonance imaging, Sensory disturbance
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s):  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Jan2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization; glatiramer acetate (COPAXONE), since 18Dec2021 (Batch/Lot number: unknown) at 20 mg daily. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 moderna vaccine (First dose), administration date: May2021; Covid-19 moderna vaccine (Second dose), administration date: Jul2021, for MS relapse. The following information was reported: SENSORY DISTURBANCE (non-serious), outcome "unknown", described as "slight sensory disturbances". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for glatiramer acetate was unknown. Course of the event: Description: suspects vaccine reaction. She reports that after the 1st (May21) and 2nd (Jul21) Corona vaccination from- Moderna, very slight relapsing symptoms get slight sensory disturbances She interpreted it as a vaccination reaction Jan2022- Corona vaccination from BioTech again very light, relapsing light symptoms, i.e. light, Sensory disturbance, not long lasting  She interpreted it as a vaccination reaction- reports from MRI in Aug2021 showing new MS lesions. Comparison to MRI Aug2020,- there were no new lesions    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, SARS-CoV-2 test, Weight, Weight decreased
Clinical narrative: Lost 40 pounds; Allergies; This is a solicited report received from contactable reporter (Consumer or other non HCP). The reporter is the patient. Other Case identifier: 2K-163-4391676-00.  A 68-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) subcutaneous for rheumatoid arthritis. The patient's relevant medical history included: "When Patient Knit And Crochet Hands Hurt /Its Painful" (unspecified if ongoing), notes: When patient knit and crochet hands hurt /its painful. The patient's concomitant medications were not reported. The following information was reported: WEIGHT DECREASED (medically significant), outcome "unknown", described as "Lost 40 pounds"; HYPERSENSITIVITY (non-serious), outcome "not recovered", described as "Allergies". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Never tested positive; Weight: Lost 40 pounds. It was unknown if patient was enrolled in a Covid-19 vaccine trial. Causality assessment was not provided. The reporter's causality assessment between the events and suspect drugs was not reported.   The reporter's assessment of the causal relationship of "lost 40 pounds" and "allergies" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from a non-contactable reporter (Nurse). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2022 at 16:00 as dose 4 (booster), single (Lot number: F54989), in left arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN D3. Past drug history included: No, reaction(s): "allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26May2022) Positive, notes: testing positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medications with in 2weeks product vitamin d3, brand nature made; product= centrum silver, brand= centrum.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (pregnant) received BNT162b2 (BNT162B2), in May2021 as dose 1, single (Batch/Lot number: unknown), in Jun2021 as dose 2, single (Batch/Lot number: unknown) and in Nov2021 as dose 3, (booster) single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunisation. Date of last menstrual period: 08Nov2021. The patient was 29  pregnant at the event onset. The patient is expected to deliver a baby(s) on 15Aug2022. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset May2022, outcome "unknown", COVID-19 (medically significant) with onset May2022, outcome "recovering" and all described as "Covid-19". Therapeutic measures were taken as a result of covid-19.  Clinical Course: last menstrual date: 08Nov2021, delivery date: 15Aug2022, gestational period: 29. Anti-viral details: product COVID 19 Treatment, Paxlovid, start on 18May2022 from 22May2022,  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 as dose 2, single (Lot number: Eng198) at the age of 52 years, in right arm for COVID-19 immunisation; COVID-19 vaccine MRNA (MRNA 1273) (MODERNA COVID-19 VACCINE), on 18Dec2021 as dose 3 (booster), single (Lot number: T60h21a), in right arm for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: treatment of COVID-19; treatment of COVID-19; This is a spontaneous report received from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 04Mar2021 as dose 1, single (batch/lot number: unknown), in left arm, on 25Mar2021 as dose 2, single (batch/lot number: unknown), in right arm and on 19Nov2021 as dose 3 (booster), single (batch/lot number: unknown) at the age of 64 years, in right arm for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "treatment of COVID-19". The patient underwent the following laboratory tests and procedures: RAT: (unspecified date) unknown results; (22May2022) negative; (25May2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.