chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2022, the patient received fourth 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 10-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) was resolving.            Patient had allergic reaction to Unspecified drug. Concomitant medication was not reported. Patient had Rebound COVID-19 on 02-Jun-2022 which was recovering. The patient taking was not taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient had previously received a COVID-19 Vaccine. Device Date :03-Jun-2022.  Company comment: This spontaneous case concerns a 63-year-old female patient with no medical history reported, who experienced the unexpected non-serious AESI event of COVID-19, which occurred unspecified days after receiving fourth dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 10-may-2022 to 14-may-202. She was tested positive (rebound covid-19) again 19 days after the treatment with Paxlovid. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 63-year-old female patient with no medical history reported, who experienced the unexpected non-serious AESI event of COVID-19, which occurred unspecified days after receiving fourth dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 10-may-2022 to 14-may-202. She was tested positive (rebound covid-19) again 19 days after the treatment with Paxlovid. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: The patient had chiils; The patient had fever; Body aches for 36 hours. Patient was in bed for 36 hours; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (The patient had chiils), PYREXIA (The patient had fever) and MYALGIA (Body aches for 36 hours. Patient was in bed for 36 hours) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 12-Apr-2021, the patient experienced CHILLS (The patient had chiils), PYREXIA (The patient had fever) and MYALGIA (Body aches for 36 hours. Patient was in bed for 36 hours). At the time of the report, CHILLS (The patient had chiils), PYREXIA (The patient had fever) and MYALGIA (Body aches for 36 hours. Patient was in bed for 36 hours) had resolved.     Concomitant product use was not provided by the reporter.  Patient was in bed for 36 hours.  It was reported that patient had no side effects on her first Moderna Covid-19 vaccine.  Treatment information was not provided.   This case was linked to MOD-2022-583862 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid / 3 days later had a return of symptoms and have been positive with symptoms for 5 days now; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Jun-2022 and was forwarded to Moderna on 06-Jun-2022.    This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for Covid / 3 days later had a return of symptoms and have been positive with symptoms for 5 days now) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065k21a) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Unknown historical drug). Concomitant products included SERTRALINE for an unknown indication.   On 05-Apr-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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for Covid / 3 days later had a return of symptoms and have been positive with symptoms for 5 days now). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 24-May-2022 to 28-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for Covid / 3 days later had a return of symptoms and have been positive with symptoms for 5 days now) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         Patient had been vaccinated plus received 2 Moderna boosters.  Patient tested positive for Covid, took Paxlovid, then 3 days later had a return of symptoms and had been positive with symptoms for 5 days as of 01-Jun-2022.  Device date was reported as 01-Jun-2022; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning an 48-year-old female patient with  medical history of Drug allergy (Unknown historical drug), products included SERTRALINE and  PAXLOVID for COVID-19 treatment from 24-May-2022 to 28-May-2022 who experienced the unexpected event of COVID-19 unknown days after  4th dose of  mRNA-1273 vaccine. On May-2022, SARS-CoV-2 test: positive The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Cancer screening, Fatigue, Feeling abnormal, Musculoskeletal chest pain
Clinical narrative: She  think she is allergic to something in the vaccine; She stated that in 2May2022 she started to get pain in her arm; second week of December she got bad, and right ribcage was hurting, and starting felling a lot of pain.; This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (second week of December she got bad, and right ribcage was hurting, and starting felling a lot of pain.), PAIN IN EXTREMITY (She stated that in 2May2022 she started to get pain in her arm) and ALLERGY TO VACCINE (She  think she is allergic to something in the vaccine) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A, 029K20A and 034K20A) for COVID-19 vaccination.     Concurrent medical conditions included Dust allergy.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced MUSCULOSKELETAL CHEST PAIN (second week of December she got bad, and right ribcage was hurting, and starting felling a lot of pain.). On 02-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (She stated that in 2May2022 she started to get pain in her arm). On an unknown date, the patient experienced ALLERGY TO VACCINE (She  think she is allergic to something in the vaccine). At the time of the report, MUSCULOSKELETAL CHEST PAIN (second week of December she got bad, and right ribcage was hurting, and starting felling a lot of pain.) and ALLERGY TO VACCINE (She  think she is allergic to something in the vaccine) outcome was unknown and PAIN IN EXTREMITY (She stated that in 2May2022 she started to get pain in her arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, Positron emission tomogram: results not reported results not reported.         The patient never had COVID + test or diagnosis. The patient had no history related to mentioned adverse events and both Acute and Chronic illnesses at the time of vaccination. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. Concomitant medications were not provided by the reporter.  The patient received first booster dose on 28-Oct-2021. It was reported that patient did not experience a similar event in the past.  Due to the adverse event patient visited Emergency room where she got studies done. For pain in arm doctor gave anti-inflammatories and told her not get the second booster.   This case was linked to MOD-2022-583859 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nasopharyngitis, Pain in extremity, Spinal pain, Weight
Clinical narrative: She  think she is allergic to something in the vaccine; She stated that in 2May2022 she started to get pain in her arm; second week of December she got bad, and right ribcage was hurting, and starting felling a lot of pain.; This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (second week of December she got bad, and right ribcage was hurting, and starting felling a lot of pain.), PAIN IN EXTREMITY (She stated that in 2May2022 she started to get pain in her arm) and ALLERGY TO VACCINE (She  think she is allergic to something in the vaccine) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A, 029K20A and 034K20A) for COVID-19 vaccination.     Concurrent medical conditions included Dust allergy.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced MUSCULOSKELETAL CHEST PAIN (second week of December she got bad, and right ribcage was hurting, and starting felling a lot of pain.). On 02-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (She stated that in 2May2022 she started to get pain in her arm). On an unknown date, the patient experienced ALLERGY TO VACCINE (She  think she is allergic to something in the vaccine). At the time of the report, MUSCULOSKELETAL CHEST PAIN (second week of December she got bad, and right ribcage was hurting, and starting felling a lot of pain.) and ALLERGY TO VACCINE (She  think she is allergic to something in the vaccine) outcome was unknown and PAIN IN EXTREMITY (She stated that in 2May2022 she started to get pain in her arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, Positron emission tomogram: results not reported results not reported.         The patient never had COVID + test or diagnosis. The patient had no history related to mentioned adverse events and both Acute and Chronic illnesses at the time of vaccination. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. Concomitant medications were not provided by the reporter.  The patient received first booster dose on 28-Oct-2021. It was reported that patient did not experience a similar event in the past.  Due to the adverse event patient visited Emergency room where she got studies done. For pain in arm doctor gave anti-inflammatories and told her not get the second booster.   This case was linked to MOD-2022-583859 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy to vaccine, Musculoskeletal chest pain, Pain in extremity, Positron emission tomogram
Clinical narrative: She  think she is allergic to something in the vaccine; She stated that in 2May2022 she started to get pain in her arm; second week of December she got bad, and right ribcage was hurting, and starting felling a lot of pain.; This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (second week of December she got bad, and right ribcage was hurting, and starting felling a lot of pain.), PAIN IN EXTREMITY (She stated that in 2May2022 she started to get pain in her arm) and ALLERGY TO VACCINE (She  think she is allergic to something in the vaccine) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A, 029K20A and 034K20A) for COVID-19 vaccination.     Concurrent medical conditions included Dust allergy.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced MUSCULOSKELETAL CHEST PAIN (second week of December she got bad, and right ribcage was hurting, and starting felling a lot of pain.). On 02-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (She stated that in 2May2022 she started to get pain in her arm). On an unknown date, the patient experienced ALLERGY TO VACCINE (She  think she is allergic to something in the vaccine). At the time of the report, MUSCULOSKELETAL CHEST PAIN (second week of December she got bad, and right ribcage was hurting, and starting felling a lot of pain.) and ALLERGY TO VACCINE (She  think she is allergic to something in the vaccine) outcome was unknown and PAIN IN EXTREMITY (She stated that in 2May2022 she started to get pain in her arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, Positron emission tomogram: results not reported results not reported.         The patient never had COVID + test or diagnosis. The patient had no history related to mentioned adverse events and both Acute and Chronic illnesses at the time of vaccination. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. Concomitant medications were not provided by the reporter.  The patient received first booster dose on 28-Oct-2021. It was reported that patient did not experience a similar event in the past.  Due to the adverse event patient visited Emergency room where she got studies done. For pain in arm doctor gave anti-inflammatories and told her not get the second booster.   This case was linked to MOD-2022-583859 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Foot pain; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Foot pain) 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.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Foot pain). At the time of the report, PAIN IN EXTREMITY (Foot pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The nurse asked whether she should take a Medrol dose pack first for her foot pain or take her booster dose of the Moderna COVID-19 vaccination before she goes on vacation in a few weeks. No treatment  medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: One week after taking the second dose of your Covid 19 vaccine my mind cleared up a great deal,My other symptoms have improved,the improvement in my brain is outstanding; This spontaneous case was reported by a patient and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (One week after taking the second dose of your Covid 19 vaccine my mind cleared up a great deal,My other symptoms have improved,the improvement in my brain is outstanding ) 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 Chronic fatigue (suffering with Chronic Fatigue for eighteen years), Cerebral disorder (fogged brain, searching for words and difficulty with simple math) and Short-term memory loss.    In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (One week after taking the second dose of your Covid 19 vaccine my mind cleared up a great deal,My other symptoms have improved,the improvement in my brain is outstanding ). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (One week after taking the second dose of your Covid 19 vaccine my mind cleared up a great deal,My other symptoms have improved,the improvement in my brain is outstanding ) outcome was unknown.            No information on concomitant medication was reported. The patient was suffering with a fogged brain, short term memory loss, searching for words and difficulty with simple math. One week after taking the second dose of COVID-19 vaccine the patient's mind cleared up a great deal. No information on treatment medications was reported.   This case was linked to MOD-2022-583933 (Patient Link).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Headache, Somnolence
Clinical narrative: Upset stomach; Headache; Fatigue; Sleepiness; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (Sleepiness), ABDOMINAL DISCOMFORT (Upset stomach), HEADACHE (Headache) and FATIGUE (Fatigue) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer vaccine, Pfizer vaccine (Patient received 3 doses of Pfizer vaccine) and Pfizer vaccine. Past adverse reactions to the above products included No adverse event with Pfizer vaccine, Pfizer vaccine and Pfizer vaccine.    On 20-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2022, the patient experienced SOMNOLENCE (Sleepiness), HEADACHE (Headache) and FATIGUE (Fatigue). On 21-May-2022, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (Sleepiness), ABDOMINAL DISCOMFORT (Upset stomach), HEADACHE (Headache) and FATIGUE (Fatigue) had not resolved.            No relevant concomitant medications were reported. It was reported that, 3-3.5 hours after receiving a booster dose of the vaccine patient started to experience fatigue, sleepiness, and headache. The next day he had an upset stomach, and his fatigue started to become more off and on. His symptoms have continued nonstop ever since.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Gait inability, Mobility decreased
Clinical narrative: could not get out of bed; She could not walk for 2 days/ She is finally getting mobility with one leg; had severe knee and joint pain; she was tired; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MOBILITY DECREASED (could not get out of bed), GAIT INABILITY (She could not walk for 2 days/ She is finally getting mobility with one leg), ARTHRALGIA (had severe knee and joint pain) and FATIGUE (she was tired) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (Her mother previously received 3 doses of the Pfizer vaccine Dose 1), Pfizer vaccine (Dose 3) and Pfizer vaccine (Dose 2). Past adverse reactions to the above products included No adverse event with Pfizer vaccine, Pfizer vaccine and Pfizer vaccine.    On 02-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2022, the patient experienced MOBILITY DECREASED (could not get out of bed), GAIT INABILITY (She could not walk for 2 days/ She is finally getting mobility with one leg), ARTHRALGIA (had severe knee and joint pain) and FATIGUE (she was tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MOBILITY DECREASED (could not get out of bed), ARTHRALGIA (had severe knee and joint pain) and FATIGUE (she was tired) outcome was unknown and GAIT INABILITY (She could not walk for 2 days/ She is finally getting mobility with one leg) was resolving.            Patient was not on any concomitant medications. It was reported that, patient was super active before vaccination. Patient was hoping that she would be able to have mobility in the other leg. All the symptoms started 24 hours after vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: The vials were frozen and underwent 4 temperature excursions total; 7 doses given from 5 vials were eventually punctured and used after the 2nd excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (The vials were frozen and underwent 4 temperature excursions total) and POOR QUALITY PRODUCT ADMINISTERED (7 doses given from 5 vials were eventually punctured and used after the 2nd excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 016J21-2A) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (The vials were frozen and underwent 4 temperature excursions total). an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (7 doses given from 5 vials were eventually punctured and used after the 2nd excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (The vials were frozen and underwent 4 temperature excursions total) and POOR QUALITY PRODUCT ADMINISTERED (7 doses given from 5 vials were eventually punctured and used after the 2nd excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  On 13-Jan-2022 the freezer got to 5.4F for 15 minutes, then returned to the appropriate temperature range. On 20-Jan-2022 the freezer got to 6.1F for 15 minutes, then returned to the appropriate temperature range. On 11-Feb-2022 the freezer got to 10.8F for 10 hours and 15 minutes overnight into 12-Feb-2022, then returned to the appropriate temperature range. On 25-Feb-2022 the freezer got to 22.6F and was out of range for 20 hours total into 26-Feb-2022 then returned to the appropriate temperature range. The storage condition at the time of the excursion was frozen.  The vials were moved from freezer to refrigerator on 1 dose/vial on 20-Jan-2022. No visual inspection was done, noting any vaccine state change. No treatment medication reported.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vials were frozen & underwent 4 temperature excursions; 7 doses given from 5 vials that underwent more than 1 temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vials were frozen & underwent 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (7 doses given from 5 vials that underwent more than 1 temperature excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 016J21-2A) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Vials were frozen & underwent 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (7 doses given from 5 vials that underwent more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vials were frozen & underwent 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (7 doses given from 5 vials that underwent more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  On 13Jan2022 the freezer got to 5.4F for 15 minutes, then returned to the appropriate temperature range. On 20Jan2022 the freezer got to 6.1F for 15 minutes, then returned to the appropriate temperature range. On 11Feb2022 the freezer got to 10.8F for 10 hours and 15 minutes overnight into 12Feb2022, then returned to the appropriate temperature range. On 25Feb2022 the freezer got to 22.6F & was out of range for 20 hours total into 26Feb2022 then returned to the appropriate temperature range. Date vial moved from freezer to refrigerator was 1dose/vial on 25Jan2022. Number of vials/doses impacted was 7 doses/5 vials. 5 vials were eventually punctured & used after the 2nd excursion.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: The vials were frozen and underwent 4 temperature excursions total; 7 doses given from 5 vials were eventually punctured and used after the 2nd excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (The vials were frozen and underwent 4 temperature excursions total) and POOR QUALITY PRODUCT ADMINISTERED (7 doses given from 5 vials were eventually punctured and used after the 2nd excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 016J21-2A) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (The vials were frozen and underwent 4 temperature excursions total) and POOR QUALITY PRODUCT ADMINISTERED (7 doses given from 5 vials were eventually punctured and used after the 2nd excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (The vials were frozen and underwent 4 temperature excursions total) and POOR QUALITY PRODUCT ADMINISTERED (7 doses given from 5 vials were eventually punctured and used after the 2nd 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.  On 13-Jan-2022 the freezer got to 5.4F for 15 minutes, then returned to the appropriate temperature range. On 20-Jan-2022 the freezer got to 6.1F for 15 minutes, then returned to the appropriate temperature range. On 11-Feb-2022 the freezer got to 10.8F for 10 hours and 15 minutes overnight into 12-Feb-2022, then returned to the appropriate temperature range. On 25-Feb-2022 the freezer got to 22.6F and was out of range for 20 hours total into 26-Feb-2022 then returned to the appropriate temperature range. The storage condition at the time of the excursion was frozen.  The vials were moved from freezer to refrigerator on 1 dose/vial on 30-Jan-2022. No visual inspection was done, noting any vaccine state change.  Treatment information was not provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: mild side effects; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (mild side effects) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient was never a smoker and did not have any unhealthy habits. Since COVID-19 started in March 2020, she never got sick once, Never a cold or sniffles.  Concurrent medical conditions included Non-smoker.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (mild side effects). At the time of the report, IMMUNISATION REACTION (mild side effects) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported. The reporter stated that no one in the family got a flu shot, but they all never got the flu. The patient was the epitome of health, she watched everything she ate, Ate everything organic and read all of the labels on everything. Had a salad at least once a day and made different homemade vegetable soups every week to eat and also the patient exercised multiple times a week . She could beat her 26 year old daughter and 31 years old in an arm wrestling contest because she would go to the gym at least 4 times a week and do a combination of step cardio classes and body sculpting muscle building classes. The patient didn't have any unhealthy habits. She was in the medical field as a certified registered nurse anesthetist. Because of this, she was extremely clean and health was a big priority to her. She kept herself and her Husband in check and they were both aging very well because of their healthy habits she helped them develop. Being a nurse anesthetist, the patient work above and monitor peoples airways all day as she put them to sleep and help them come to before and after surgery. Because of dealing with airways, and no vaccine out for months, that is why she had to take time off of work. The patient worked at a laser surgery center where they did a lot of same day elective procedures. Post the mild side effects from the shot, there was nothing to take her out for a day or anything. After this, she went about her life working and exercising how she normally does. Treatment information was unknown.   This case was linked to MOD-2022-584103 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: After testing negative, symptoms returned and received positive result; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (After testing negative, symptoms returned and received positive result) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     The patient had no known allergies.  Concomitant products included CALCIUM, COLECALCIFEROL (CALCIUM +VIT D) for an unknown indication.    On 12-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (After testing negative, symptoms returned and received positive result). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 25-May-2022 to 30-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (After testing negative, symptoms returned and received positive result) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jun-2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive and negative (Negative) Negative.         The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  The patient had reported after testing negative, symptoms had returned and patient had received positive result on 04-Jun-2022.  Company Comment: This spontaneous case reported by a patient concerns a 64-year-old female patient, with no relevant medical history, who experienced unexpected, non-serious AESI Covid19 on an unknown date after receiving a fourth dose of mRNA-1273.  She was treated with Nirmatrelvir/Ritonavir (Paxlovid), after which she tested negative for Covid19.  However, around 5 days later the symptoms returned, and she tested positive again.  The ongoing Covid19 pandemic could be a contributory factor.  The benefit risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case reported by a patient concerns a 64-year-old female patient, with no relevant medical history, who experienced unexpected, non-serious AESI Covid19 on an unknown date after receiving a fourth dose of mRNA-1273.  She was treated with Nirmatrelvir/Ritonavir (Paxlovid), after which she tested negative for Covid19.  However, around 5 days later the symptoms returned, and she tested positive again.  The ongoing Covid19 pandemic could be a contributory factor.  The benefit risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Fatigue, Feeling abnormal, Hypertension, Pyrexia
Clinical narrative: experienced high blood pressure; wanted to go to bed and felt miserable; fever; tiredness; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HYPERTENSION (experienced high blood pressure), FEELING ABNORMAL (wanted to go to bed and felt miserable), PYREXIA (fever) and FATIGUE (tiredness) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (experienced high blood pressure), FEELING ABNORMAL (wanted to go to bed and felt miserable), PYREXIA (fever) and FATIGUE (tiredness). At the time of the report, HYPERTENSION (experienced high blood pressure), FEELING ABNORMAL (wanted to go to bed and felt miserable), PYREXIA (fever) and FATIGUE (tiredness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) High.     mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.       Concomitant drugs were not reported. Husband stated that his wife had side effects from all 3 previous doses of the Moderna COVID-19 vaccine It was reported that patient's symptoms lasted for one and a half days. Treatment medications were not provided.   This case was linked to MOD-2022-584197, MOD-2022-584194, MOD-2022-584196 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Fatigue, Feeling abnormal, Hypertension, Pyrexia
Clinical narrative: Experienced high blood pressure; felt miserable; fever; tired, She just wanted to go to bed; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HYPERTENSION (Experienced high blood pressure), FEELING ABNORMAL (felt miserable), PYREXIA (fever) and FATIGUE (tired, She just wanted to go to bed) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (Experienced high blood pressure), FEELING ABNORMAL (felt miserable), PYREXIA (fever) and FATIGUE (tired, She just wanted to go to bed). At the time of the report, HYPERTENSION (Experienced high blood pressure), FEELING ABNORMAL (felt miserable), PYREXIA (fever) and FATIGUE (tired, She just wanted to go to bed) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high blood pressure (High) High Blood pressure.         No concomitant medications were reported. No treatment details were reported. It was reported that the patient had high blood pressure after vaccination and always wanted to go to bed. Events were lasted for one and a half days.   This case was linked to MOD-2022-584186, MOD-2022-584196 (Patient Link).   Reporter did not allow further contact
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Antibody test abnormal, Blood immunoglobulin G increased, Dyspnoea, Fatigue
Clinical narrative: Doctor cannot explain why antibody levels are so high; Fast heavy breathing; 15360.8 au/ml for antibody test and supposed to be lower than 50 to be normal.; sick; short of breath; very tired; Fast heavy breathing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 18Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "chronic kidney stage 3" (unspecified if ongoing); "interchange of vaccine" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Corona vac (Dose 1, Anatomical location: Arm), administration date: May2021, for covid 19 immunization; Corona vac (dose 2, Anatomical location: Arm), administration date: Jun2021, for covid 19 immunization. The following information was reported: DYSPNOEA (non-serious) with onset 18Nov2021, outcome "unknown", RESPIRATORY RATE INCREASED (non-serious), outcome "unknown" and all described as "Fast heavy breathing"; FATIGUE (non-serious) with onset 18Nov2021, outcome "unknown", described as "very tired"; DYSPNOEA (non-serious), outcome "unknown", described as "short of breath"; BLOOD IMMUNOGLOBULIN G INCREASED (non-serious), outcome "unknown", described as "Doctor cannot explain why antibody levels are so high"; ANTIBODY TEST ABNORMAL (non-serious), outcome "unknown", described as "15360.8 au/ml for antibody test and supposed to be lower than 50 to be normal."; ILLNESS (non-serious), outcome "unknown", described as "sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Husband had two COVID-19 vaccines in another country. On 18Nov had Pfizer COVID-19 Vaccine, the booster was short of breath and very tired. Thought he was jet lagged. Then he had antibody test on 10Dec His IgG was 15,368 eu/mL and normal is less than 50. Not sure what is causing this issue He was totally fine He feels fine. Has kidney issues. Caller mentions something about he may have had kidney issues before. Doctor cannot explain why antibody levels are so high and recommended another test. Think patient might need a kidney transplant now Doctor wants patient to get another booster dose of COVID-19 Caller and patient are nervous because it was so bad Had another test at (company name) Antibody levels are still 4,000 Heard people who had COVID after a kidney transplant and it was pretty nasty    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Investigation, Respiratory rate increased
Clinical narrative: Doctor cannot explain why antibody levels are so high; Fast heavy breathing; 15360.8 au/ml for antibody test and supposed to be lower than 50 to be normal.; sick; short of breath; very tired; Fast heavy breathing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 18Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "chronic kidney stage 3" (unspecified if ongoing); "interchange of vaccine" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Corona vac (Dose 1, Anatomical location: Arm), administration date: May2021, for covid 19 immunization; Corona vac (dose 2, Anatomical location: Arm), administration date: Jun2021, for covid 19 immunization. The following information was reported: DYSPNOEA (non-serious) with onset 18Nov2021, outcome "unknown", RESPIRATORY RATE INCREASED (non-serious), outcome "unknown" and all described as "Fast heavy breathing"; FATIGUE (non-serious) with onset 18Nov2021, outcome "unknown", described as "very tired"; DYSPNOEA (non-serious), outcome "unknown", described as "short of breath"; BLOOD IMMUNOGLOBULIN G INCREASED (non-serious), outcome "unknown", described as "Doctor cannot explain why antibody levels are so high"; ANTIBODY TEST ABNORMAL (non-serious), outcome "unknown", described as "15360.8 au/ml for antibody test and supposed to be lower than 50 to be normal."; ILLNESS (non-serious), outcome "unknown", described as "sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Husband had two COVID-19 vaccines in another country. On 18Nov had Pfizer COVID-19 Vaccine, the booster was short of breath and very tired. Thought he was jet lagged. Then he had antibody test on 10Dec His IgG was 15,368 eu/mL and normal is less than 50. Not sure what is causing this issue He was totally fine He feels fine. Has kidney issues. Caller mentions something about he may have had kidney issues before. Doctor cannot explain why antibody levels are so high and recommended another test. Think patient might need a kidney transplant now Doctor wants patient to get another booster dose of COVID-19 Caller and patient are nervous because it was so bad Had another test at (company name) Antibody levels are still 4,000 Heard people who had COVID after a kidney transplant and it was pretty nasty    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Peripheral swelling
Clinical narrative: sharp chest pain on the left side of her body; arm is swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 30-year-old female patient received BNT162b2 (BNT162B2), on 24May2022 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: PERIPHERAL SWELLING (non-serious) with onset 25May2022, outcome "unknown", described as "arm is swollen"; CHEST PAIN (non-serious) with onset 25May2022, outcome "unknown", described as "sharp chest pain on the left side of her body".  Additional information: Patient wanted to know if this is a side effect of the vaccine and does not want to get her 2nd dose as she doesn't know what will happen.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Eye pain
Clinical narrative: Increased eye pain; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP).  A 43-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "migraines" (unspecified if ongoing), notes: concurrent condition. Concomitant medication(s) included: VENLAFAXINE; TOPAMAX; IBUPROFEN [IBUPROFEN SODIUM]. The following information was reported: EYE PAIN (non-serious) with onset Oct2021, outcome "recovered", described as "Increased eye pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Ear infection, Nasal congestion, Oropharyngeal pain, Productive cough
Clinical narrative: respiratory; sore throat; ear infection; congestion; cough; cough progressively worsened and became productive; low grade fever; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 15-year-old male patient received BNT162b2 (BNT162B2), on 06Jan2022 as dose 3 (booster), single (Lot number: FL3209) at the age of 15 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DOXYCYCLINE taken for acne. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Site of injection: L. arm (Left Arm), Covid-19 Vaccine name: Pfizer, Batch/Lot number: EW0167), administration date: 17May2021, when the patient was 14-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE, Site of injection: L. arm (Left Arm), Covid-19 Vaccine name: Pfizer, Batch/Lot number: EW0191), administration date: 09Jun2021, when the patient was 14-year-old, for COVID-19 Immunization. The following information was reported: COUGH (non-serious) with onset 09May2022, outcome "unknown"; PRODUCTIVE COUGH (non-serious) with onset 09May2022, outcome "unknown", described as "cough progressively worsened and became productive"; PYREXIA (non-serious) with onset 09May2022, outcome "unknown", described as "low grade fever"; NASAL CONGESTION (non-serious) with onset 18May2022, outcome "unknown", described as "congestion"; EAR INFECTION (non-serious) with onset 20May2022, outcome "unknown"; RESPIRATORY DISORDER (non-serious), outcome "unknown", described as "respiratory"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: It was unknown whether patient have Sars-CoV2 antibodies at diagnosis. The patient was not hospitalized. The patient was not admitted to an intensive care unit. The patient did not display clinical signs at rest indicative of severe systemic illness. Patient had cough and sore throat during initial 10 days. Cough progressively worsened and became productive week of 09May2022. One day of low grade fever. Congestion began 18May2022 and ear infection documented 20May2022. Patient's outcome with Covid-19 was recovering. It was unknown from how many days from SARS-CoV2 diagnosis did it take before the SARS-CoV2 antigen test became negative. The patient was not a smoker/former smoker. The patient was taking other medication routinely prior to the event being reported which included: MVI, Doxycycline 50 mg 2 tab QD for acne. The patient did not have any pre-existing disease worsened during the SARS-CoV2 infection. The patient had not been treated with immunomodulating or immunosuppressing medication or received any other vaccines around the time of covid-19 vaccination.  No follow-up attempts are possible. No further information is expected.