chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, Insomnia, Taste disorder
Clinical narrative: COVID-19; Headache; Bad taste in mouth; Trouble sleeping; This spontaneous case was reported by a patient and describes the occurrence of TASTE DISORDER (Bad taste in mouth), INSOMNIA (Trouble sleeping), COVID-19 (COVID-19) and HEADACHE (Headache) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus, Hashimoto's thyroiditis and Allergy (The patient had allergy after receiving sulpha drugs). Concomitant products included INSULIN LISPRO (HUMALOG) and LEVOTHYROXINE for an unknown indication.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2022, the patient experienced TASTE DISORDER (Bad taste in mouth), INSOMNIA (Trouble sleeping) and HEADACHE (Headache). On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, TASTE DISORDER (Bad taste in mouth), INSOMNIA (Trouble sleeping) and HEADACHE (Headache) had not resolved and COVID-19 (COVID-19) outcome was unknown.            The patient had previously received a COVID-19 Vaccine.  It was reported that on 20-May-2022 the patient started taking COVID-19 treatment. Further device date was reported as 21-May-2022.  Company Comment:  This spontaneous case concerns a 44-year-old female patient with no relevant medical history, who experienced the unexpected non-serious adverse event of special interest COVID-19 that occurred on an unknown date after receiving mRNA-1273 vaccine as third dose in the COVID-19 vaccination series.  No COVID-19 test was reported.  Outcome of the event was reported as unknown. No information was provided on the previous 2 doses of COVID-19 vaccination prior to current mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 44-year-old female patient with no relevant medical history, who experienced the unexpected non-serious adverse event of special interest COVID-19 that occurred on an unknown date after receiving mRNA-1273 vaccine as third dose in the COVID-19 vaccination series.  No COVID-19 test was reported.  Outcome of the event was reported as unknown. No information was provided on the previous 2 doses of COVID-19 vaccination prior to current mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Pyrexia, Vaccination site pain
Clinical narrative: heart pounding due to fever but quickly resolved.; felt feverish; Pharmacist also hit a nerve during the injection process and felt a pain throughout his entire arm.; This spontaneous case was reported by a patient and describes the occurrence of HEART RATE INCREASED (heart pounding due to fever but quickly resolved.), PYREXIA (felt feverish) and VACCINATION SITE PAIN (Pharmacist also hit a nerve during the injection process and felt a pain throughout his entire arm.) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049121A, 060H21A, 040B21A and 027C24A) for COVID-19 vaccination.     The patient's past medical history included Shingles. Concomitant products included ATORVASTATIN, EZETIMIBE (ZETIA), ALIROCUMAB (PRALUENT) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Pharmacist also hit a nerve during the injection process and felt a pain throughout his entire arm.). On 24-May-2022, the patient experienced HEART RATE INCREASED (heart pounding due to fever but quickly resolved.) and PYREXIA (felt feverish). At the time of the report, HEART RATE INCREASED (heart pounding due to fever but quickly resolved.) had resolved and PYREXIA (felt feverish) and VACCINATION SITE PAIN (Pharmacist also hit a nerve during the injection process and felt a pain throughout his entire arm.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.   This case was linked to MOD-2021-083015, MOD-2021-162188 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: diagnosed with COVID in May/had a sore throat; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (diagnosed with COVID in May/had a sore throat) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A, 030M20A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced COVID-19 (diagnosed with COVID in May/had a sore throat). At the time of the report, COVID-19 (diagnosed with COVID in May/had a sore throat) outcome was unknown.            No Concomitant product use was reported.  The reporter was reporting on behalf of their husband who was the patient. The patient received the first booster on 23-Oct-2021. The reporter stated that the patient was diagnosed with COVID in May and also mentioned that the patient had a sore throat.  No treatment information was provided.  Company Comment:  This is a spontaneous case concerning  a male patient of unknown age, with no reported medical history, who experienced the unexpected non-serious AESI event of Covid-19. The event occurred on an unspecified day of May 2022, day after the third dose of mRNA-1273 COVID 19 Vaccine which was administered on October 23, 2021. The event outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: Company Comment:  This is a spontaneous case concerning  a male patient of unknown age, with no reported medical history, who experienced the unexpected non-serious AESI event of Covid-19. The event occurred on an unspecified day of May 2022, day after the third dose of mRNA-1273 COVID 19 Vaccine which was administered on October 23, 2021. The event outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: receiving doses after its beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 022j21a) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported . It was reported that  3 doses from different vials were used and no temperature excursions. It was reported that the vial was initially stored in the refrigerator on 11-Jan- 2022 and beyond use date for that was  11-Feb-2022.  No treatment medication was reported.   This case was linked to MOD-2022-573737 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (feel crummy) 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 23-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2022, the patient experienced ILLNESS (feel crummy). At the time of the report, ILLNESS (feel crummy) outcome was unknown. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter. Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C.) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 069H21A) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C.). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C.) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided. It was reported that there are 4 days temperature data(between 4/1/2022 and 4/4/2022) for the freezer storage unit, however it never reached an acceptable range and was always warm by at least 2 degree C. Between 2/22/21 to 4/26/22 there is no other temperature data available. Total 6640 doses of COVID-19 Moderna Vaccine were received by this facility during this time period and LOT numbers were provided (057M21A, 025L21B, 066H21A, 069H21A, 027H21B, 032F21A, 011F21A, 004F21A, 025C21A, 017C21A, 002C21A, 042B21A, 031B21A, 027B21A, 026B21A, 016B21A, 008B21A, 045A21A, 001B21A, 029A21A, 025A21A, 001A21A). Some vials may have been moved to a refrigerator at some point. There is no temperature data for that storage unit. Treatment information was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: receiving doses after its beyond use date (11 feb2022); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date (11 feb2022)) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 022j21a) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date (11 feb2022)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date (11 feb2022)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  The vial was initially stored in the refrigerator on 11-Jan-2022. Beyond use date reported as 11-Feb-2022.  The vial does not undergo any temperature excursions.   No treatment medications was reported.   This case was linked to MOD-2022-573737 (Patient Link).
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Extremely bitter taste creating strong desire to stop medication; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Extremely bitter taste creating strong desire to stop medication) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2022, the patient experienced COVID-19 (Extremely bitter taste creating strong desire to stop medication). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 21-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Extremely bitter taste creating strong desire to stop medication) had not resolved.            Concomitant medications were not reported.  Company Comment: This spontaneous case concerns a 42-year-old, male patient with no medical history reported who experienced the unexpected, non-serious adverse event of special interest of COVID-19 which occurred approximately 6 months and 22 days after receiving the third dose of mRNA-1273 vaccine. There was no information regarding the first two doses of COVID-19 vaccine.  Patient developed COVID-19 and was treated with Nirmatrelvir, Ritonavir (Paxlovid). He also experienced bitter taste after taking the medication. The clinical course, diagnostic investigations, and further treatment details of COVID-19 were not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 42-year-old, male patient with no medical history reported who experienced the unexpected, non-serious adverse event of special interest of COVID-19 which occurred approximately 6 months and 22 days after receiving the third dose of mRNA-1273 vaccine. There was no information regarding the first two doses of COVID-19 vaccine.  Patient developed COVID-19 and was treated with Nirmatrelvir, Ritonavir (Paxlovid). He also experienced bitter taste after taking the medication. The clinical course, diagnostic investigations, and further treatment details of COVID-19 were not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: possible administration of invalid dose to patient; never reached an acceptable range and was always warm by at least 2 degrees C; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (never reached an acceptable range and was always warm by at least 2 degrees C) and POOR QUALITY PRODUCT ADMINISTERED (possible administration of invalid dose to patient) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 032F21A) 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. In April 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (never reached an acceptable range and was always warm by at least 2 degrees C). On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (possible administration of invalid dose to patient). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (never reached an acceptable range and was always warm by at least 2 degrees C) and POOR QUALITY PRODUCT ADMINISTERED (possible administration of invalid dose to patient) 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.   Concomitant medication list was not provided. There were 4 days temperature data for the freezer storage unit between 1-APR-2022 and 4-APR-2022, however it never reached an acceptable range and was always warm by at least 2 degrees C.   Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     Concurrent medical conditions included Obesity.    On 06-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: positive (Positive) Positive (on day 12), negative (Negative) Negative (on day 9) and negative (Negative) Negative (on day 10).         Patient symptoms was returned scratchy throat and runny nose. Patient was tested positive on rapid antigen test on day 12 after previously clearing symptoms and testing negative on day 9 and 10.   Patient received COVID-19 Treatment (Batch /Lot number : FY9906) From 12-May-2022 to 17-May-2022.  No concomitant medication were reported.   No treatment drug were reported. Company comment: This spontaneous case concerns a patient of unknown age and gender with medical condition of Obesity, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 160 days after administration of third dose of mRNA-1273. There was no information provided regarding the initial two doses. On an unspecified date, SARS-CoV-2 test was done which revealed a positive result. The patient's medical condition of Obesity could be a confounder to the event. Details of concomitant medications, clinical course and treatment were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with medical condition of Obesity, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 160 days after administration of third dose of mRNA-1273. There was no information provided regarding the initial two doses. On an unspecified date, SARS-CoV-2 test was done which revealed a positive result. The patient's medical condition of Obesity could be a confounder to the event. Details of concomitant medications, clinical course and treatment were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Hypoaesthesia, Limb discomfort, Pain in extremity
Clinical narrative: Making decision, mental unclarity; Can not think as clearly as before; fells a lot of pressure in her toes,; lightheadedness; numbness in her toes like a neuropathy, numbness in the ball of the foot and is more in the toes; Throw up  a week after  getting vaccinated; Had soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Making decision, mental unclarity), THINKING ABNORMAL (Can not think as clearly as before), LIMB DISCOMFORT (fells a lot of pressure in her toes,), DIZZINESS (lightheadedness) and HYPOAESTHESIA (numbness in her toes like a neuropathy, numbness in the ball of the foot and is more in the toes) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033H21A, 030B21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy. Concomitant products included AMLODIPINE, SIMVASTATIN, LUTEIN [XANTOFYL], CALCIUM, MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE], TOCOPHEROL (VITAMIN E [TOCOPHEROL]) and CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced CONFUSIONAL STATE (Making decision, mental unclarity), THINKING ABNORMAL (Can not think as clearly as before), LIMB DISCOMFORT (fells a lot of pressure in her toes,), DIZZINESS (lightheadedness), HYPOAESTHESIA (numbness in her toes like a neuropathy, numbness in the ball of the foot and is more in the toes), VOMITING (Throw up  a week after  getting vaccinated) and PAIN IN EXTREMITY (Had soreness in the arm). At the time of the report, CONFUSIONAL STATE (Making decision, mental unclarity), THINKING ABNORMAL (Can not think as clearly as before), LIMB DISCOMFORT (fells a lot of pressure in her toes,), DIZZINESS (lightheadedness), HYPOAESTHESIA (numbness in her toes like a neuropathy, numbness in the ball of the foot and is more in the toes), VOMITING (Throw up  a week after  getting vaccinated) and PAIN IN EXTREMITY (Had soreness in the arm) had not resolved.            Other concomitant medications included besylate 5mg.  The patient stated she did not know the date of  side effect happened.   No treatment medication were provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Thinking abnormal, Vomiting
Clinical narrative: Making decision, mental unclarity; Can not think as clearly as before; fells a lot of pressure in her toes,; lightheadedness; numbness in her toes like a neuropathy, numbness in the ball of the foot and is more in the toes; Throw up  a week after  getting vaccinated; Had soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Making decision, mental unclarity), THINKING ABNORMAL (Can not think as clearly as before), LIMB DISCOMFORT (fells a lot of pressure in her toes,), DIZZINESS (lightheadedness) and HYPOAESTHESIA (numbness in her toes like a neuropathy, numbness in the ball of the foot and is more in the toes) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033H21A, 030B21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy. Concomitant products included AMLODIPINE, SIMVASTATIN, LUTEIN [XANTOFYL], CALCIUM, MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE], TOCOPHEROL (VITAMIN E [TOCOPHEROL]) and CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced CONFUSIONAL STATE (Making decision, mental unclarity), THINKING ABNORMAL (Can not think as clearly as before), LIMB DISCOMFORT (fells a lot of pressure in her toes,), DIZZINESS (lightheadedness), HYPOAESTHESIA (numbness in her toes like a neuropathy, numbness in the ball of the foot and is more in the toes), VOMITING (Throw up  a week after  getting vaccinated) and PAIN IN EXTREMITY (Had soreness in the arm). At the time of the report, CONFUSIONAL STATE (Making decision, mental unclarity), THINKING ABNORMAL (Can not think as clearly as before), LIMB DISCOMFORT (fells a lot of pressure in her toes,), DIZZINESS (lightheadedness), HYPOAESTHESIA (numbness in her toes like a neuropathy, numbness in the ball of the foot and is more in the toes), VOMITING (Throw up  a week after  getting vaccinated) and PAIN IN EXTREMITY (Had soreness in the arm) had not resolved.            Other concomitant medications included besylate 5mg.  The patient stated she did not know the date of  side effect happened.   No treatment medication were provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Horrible bitter taste in mouth; This spontaneous case was reported by an other health care professional and describes the occurrence of DYSGEUSIA (Horrible bitter taste in mouth) in a 50-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.    The patient's past medical history included Long COVID in November 2020. Concurrent medical conditions included Rheumatoid arthritis, Drug allergy (Compazine), Allergy to antibiotic (erythromycin) and Adhesive tape allergy. Concomitant products included PREDNISONE, ESOMEPRAZOLE, FAMOTIDINE (PEPCID [FAMOTIDINE]) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 20-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 18-May-2022, the patient experienced DYSGEUSIA (Horrible bitter taste in mouth). At the time of the report, DYSGEUSIA (Horrible bitter taste in mouth) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was also on Actemra infusion since 06-May-2022.  It was reported that the patient had horrible bitter taste in mouth since 18-May-2022 and had not received any treatment.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: possible administration of invalid dose to patient; never reached an acceptable range and was always warm by at least 2 degrees C; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (never reached an acceptable range and was always warm by at least 2 degrees C) and POOR QUALITY PRODUCT ADMINISTERED (possible administration of invalid dose to patient) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 008B21A) 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. In April 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (never reached an acceptable range and was always warm by at least 2 degrees C). On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (possible administration of invalid dose to patient). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (never reached an acceptable range and was always warm by at least 2 degrees C) and POOR QUALITY PRODUCT ADMINISTERED (possible administration of invalid dose to patient) 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.   Concomitant medication list was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (Individual received full dose instead of booster) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Individual received full dose instead of booster). At the time of the report, ACCIDENTAL OVERDOSE (Individual received full dose instead of booster) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications was not provided by the reporter. Treatment information was not provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. No Medical History information was reported. On 08-Feb-2021 at 11:03 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Feb-2021 at 11:03 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The age of patient was provided as 70.79. Concomitant products were not provided. On 08-Feb-2021 Excursion time was reported at 10:00 A.M and 11 am with temperature as 29 and 35 degrees Fahrenheit, total doses given for the day was 30, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 02-Feb-2021, vial was moved to clinic on 08-Feb-2021. 3 vials were sent to clinic. Vaccine BUD date was 04-Mar-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion for 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Dose administered after more than 1 temperature excursion; Dose administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 11:18 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 11:18 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient's age was reported as 71.49  Concomitant products were not provided.  On 03-Nov-2021 Excursion time was 10:00 A.M., temperature was 35 degrees Fahrenheit, total doses given for the day was 117, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-Oct-2021, vial was moved to clinic on 03-Nov-2021. 6 vials were sent to clinic. Vaccine BUD date was 05-Nov-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of 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.     Concurrent medical conditions included Rheumatoid arthritis, Drug allergy, Grass allergy and Pollen allergy.    On 28-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 09-May-2022 to 14-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had not resolved.            Patient was taking unspecified allergy medications as concomitant medication. The device date was reported as 21-May-2022.  About 4 days after completing Paxlovid, began developing COVID symptoms like congestion, drainage, fatigue, headache, scratchy throat, low grade fever, fatigue.    Company comment: This spontaneous case concerns a patient of unknown age and gender with no relevant medical history,  who experienced the unexpected, non-serious adverse event of special interest of COVID-19, which occurred approximately 2 months after receiving the third dose of mRNA-1273 vaccine. Patient was diagnosed with COVID-19 at an unspecified date and was treated with Nirmatrelvir, Ritonavir (Paxlovid) and completed the course for 6 days. About 4 days after completing Paxlovid, the patient began developing COVID symptoms like congestion, drainage, fatigue, headache, scratchy throat, low grade fever, fatigue. The event has not yet resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no relevant medical history,  who experienced the unexpected, non-serious adverse event of special interest of COVID-19, which occurred approximately 2 months after receiving the third dose of mRNA-1273 vaccine. Patient was diagnosed with COVID-19 at an unspecified date and was treated with Nirmatrelvir, Ritonavir (Paxlovid) and completed the course for 6 days. About 4 days after completing Paxlovid, the patient began developing COVID symptoms like congestion, drainage, fatigue, headache, scratchy throat, low grade fever, fatigue. The event has not yet resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 10:54 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 10:54 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 60.66 years.  Concomitant products were not provided.  On 03-Apr-2021, 20 vials were moved to clinic.   On 30-Mar-2021, the vaccines were moved to fridge.  Proposed beyond use date was 29-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit.  On the date of administration, at 09:00 A.M., the temperature recorded was 34 Fahrenheit that has been reached by the vial.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 9:06 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 9:06 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Vial was stored in cooler 1, on 31-MAR-2021 and the excursion duration at 8 am was 32  taken using a Fisher brand traceable temperature monitor in F.  On  31-MAR-2021, total doses given for the day was 199, condition of vaccine; prior to vaccination was not frozen, vaccine was moved to fridge on 23-MAR-2021, vial was moved to clinic on  31-MAR-2021. 4 vials were moved to clinic. Vaccine BUD date was 22-APR-2021 for batch number 019B21A.  Vials were only punctured right before administration. Vaccines were not frozen at time of administration. Storage condition at the time of the excursion was reported as cooler storage during high-pace COVID-19 vaccination clinic.  No treatment information was provided   This case was linked to MOD-2022-566976 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination. No Medical History information was reported. On 27-Oct-2021 at 12:06 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 12:06 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The age of patient was provided as 71.41. Concomitant products were not provided. On 27-Oct-2021, excursion time was 09 AM and 10 AM  and temperature was 29 and 32 respectively, total doses given for the day was 116, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 29-Sep-2021 and 05-Oct-2021, vial was moved to clinic on 27-Oct-2021. 02 vial was moved to clinic on 29-Sep-2021 and 04 vials was moved to clinic on 05-Oct-2021. Vaccine BUD date was 29-Oct-2021 and 04-Nov-2021. Vial was stored on cooler 1 , on 27-Oct-2021, Excursion duration At 8 AM: 41, 9 AM: 29, 10 AM: 32, 11 AM: 43, 12 AM: 43, 1PM : 43, 2 PM : 46, 3 PM: 46, 4 PM: 46 and 5 PM : 45. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.