chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with expired dose of vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired dose of vaccine) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022 at 9:15 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired dose of vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with expired dose of vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided. It was reported that vial was initially stored in the refrigerator on 07 Apr 2022 at 1:00 pm and the vial did not undergo any temperature excursions. No adverse event had been noted on the patient so far. No treatment medications were provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Somnambulism
Clinical narrative: Sleep walking; This spontaneous case was reported by a consumer and describes the occurrence of SOMNAMBULISM (Sleep walking) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Sleep walking (She had one episode of sleep walking 40 years ago, but has no history of sleep walking since then).   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SOMNAMBULISM (Sleep walking). At the time of the report, SOMNAMBULISM (Sleep walking) outcome was unknown.            Patient was on concomitant medication, but did not specify the names.  It was reported that the patient drove her car and opened the sunroof at 3 am. Patient had done all this in her sleep and did not recall it. The next morning she went to her car, and saw the sunroof was opened about 6 inches, it triggered patient's memory that she was driving with the sunroof open at 3 am and it was raining.  Treatment information was not reported.   This case was linked to MOD-2022-535830, MOD-2022-535838, MOD-2022-535849 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2022: Follow-up received contains signification information. Causality updated.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Somnambulism, Wound
Clinical narrative: Sleep walking; she wound up on the kitchen floor, curled up in a fetal position; This spontaneous case was reported by a consumer and describes the occurrence of SOMNAMBULISM (Sleep walking) and WOUND (she wound up on the kitchen floor, curled up in a fetal position) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Sleep walking (The patient had one episode of sleep walking 40 years ago).   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, the patient experienced SOMNAMBULISM (Sleep walking). 07-Apr-2022, the patient experienced WOUND (she wound up on the kitchen floor, curled up in a fetal position). At the time of the report, SOMNAMBULISM (Sleep walking) and WOUND (she wound up on the kitchen floor, curled up in a fetal position) outcome was unknown.            Concomitant medication details included the patient was on concomitant medication but had not specified the names. No treatment medications were reported.  It was reported that the patient received the first booster dose. It was also reported that the patient had drove the car and opened the sunroof at 3 am. The patient had done all this in sleep and had not recalled it. The next morning, the patient went to the car, and saw the sunroof was open about 6 inches, it triggered the patient memory, that the patient was driving with the sunroof open at 3 am and it was raining. It was further reported that the night after receiving both doses of the booster dose, the patient had experienced episodes of sleep walking. Contact was certain this was because of the vaccine.   This case was linked to MOD-2022-535830, MOD-2022-535838, MOD-2022-535842 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2022: Follow up received included significant information: Event start date and as reported causality were updated.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Congestive cardiomyopathy
Clinical narrative: dilated cardiomyopathy; This spontaneous case was reported by a consumer and describes the occurrence of CONGESTIVE CARDIOMYOPATHY (dilated cardiomyopathy) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Egg allergy (Egg products).   In November 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONGESTIVE CARDIOMYOPATHY (dilated cardiomyopathy) (seriousness criteria death and medically significant). The patient died on 20-Nov-2021. The reported cause of death was Dilated cardiomyopathy. An autopsy was performed, but no results were provided.            Patient had not tested positive for COVID  test or diagnosis. No other vaccines was taken by patient within 1 month prior to moderna covid-19 vaccine.The medical history was none except allergy. No concomitant and treatment medication was reported.  Company comment: This is a spontaneous case concerning a 44-year-old, female patient with relevant medical history of food allergy to egg products and vaccine history of receiving mRNA-1273 vaccine as the first dose of Covid-19 vaccine in Covid-19 vaccination in series, who experienced the unexpected serious (death and medically significant) AESI event of dilated cardiomyopathy. The event occurrence was unknown with respect to the second dose of mRNA-1273 vaccine administration. It was reported that the patient died within 2 days after receiving the second dose of mRNA-1273 vaccine. The reported cause of death was dilated cardiomyopathy. Autopsy was performed however the autopsy findings has not been reported. The medical history of food allergy to egg products remain confounder for the event dilated cardiomyopathy. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 44-year-old, female patient with relevant medical history of food allergy to egg products and vaccine history of receiving mRNA-1273 vaccine as the first dose of Covid-19 vaccine in Covid-19 vaccination in series, who experienced the unexpected serious (death and medically significant) AESI event of dilated cardiomyopathy. The event occurrence was unknown with respect to the second dose of mRNA-1273 vaccine administration. It was reported that the patient died within 2 days after receiving the second dose of mRNA-1273 vaccine. The reported cause of death was dilated cardiomyopathy. Autopsy was performed however the autopsy findings has not been reported. The medical history of food allergy to egg products remain confounder for the event dilated cardiomyopathy. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Dilated cardiomyopathy
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Inflammation, Pelvic pain, Urethritis noninfective
Clinical narrative: Felt like flushing on the left side of the heart; Inflammation under the left arm (injected arm); Feels Inflammation on Urethra near left kidney; Feels like pelvic pain on the left side; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Felt like flushing on the left side of the heart), INFLAMMATION (Inflammation under the left arm (injected arm)), URETHRITIS NONINFECTIVE (Feels Inflammation on Urethra near left kidney) and PELVIC PAIN (Feels like pelvic pain on the left side) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A, 010M20A and 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia and Arthritis (for ever).   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced INFLAMMATION (Inflammation under the left arm (injected arm)). On 05-Nov-2021, the patient experienced FLUSHING (Felt like flushing on the left side of the heart). In November 2021, the patient experienced URETHRITIS NONINFECTIVE (Feels Inflammation on Urethra near left kidney) and PELVIC PAIN (Feels like pelvic pain on the left side). The patient was treated with SULFAMETHOXAZOLE;TRIMETHOPRIM at an unspecified dose and frequency. On 05-Nov-2021, INFLAMMATION (Inflammation under the left arm (injected arm)) had resolved. At the time of the report, FLUSHING (Felt like flushing on the left side of the heart), URETHRITIS NONINFECTIVE (Feels Inflammation on Urethra near left kidney) and PELVIC PAIN (Feels like pelvic pain on the left side) outcome was unknown.            No concomitant drug was reported. On 05-Nov-2021, the patient felt like flushing on the left side of the heart only one time. The patient also had Inflammation under the left arm (injected arm) for 2 days. About 3-4 days after vaccination, the patient felt Inflammation on Urethra near left kidney. The patient states, "It feels like pelvic pain on the left side." The patient visited the emergency room. Other treatment medication was reported as 3 courses of antibiotics (SMZ/TMP) and prophylaxis antifungal oral tablets.   This case was linked to MOD-2022-535880 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Felt like flushing on the left side of the heart; Inflammation under the left arm (injected arm); Feels Inflammation on Urethra near left kidney; Feels like pelvic pain on the left side; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Felt like flushing on the left side of the heart), INFLAMMATION (Inflammation under the left arm (injected arm)), URETHRITIS NONINFECTIVE (Feels Inflammation on Urethra near left kidney) and PELVIC PAIN (Feels like pelvic pain on the left side) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A, 010M20A and 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia and Arthritis (for ever).   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced INFLAMMATION (Inflammation under the left arm (injected arm)). On 05-Nov-2021, the patient experienced FLUSHING (Felt like flushing on the left side of the heart). In November 2021, the patient experienced URETHRITIS NONINFECTIVE (Feels Inflammation on Urethra near left kidney) and PELVIC PAIN (Feels like pelvic pain on the left side). The patient was treated with SULFAMETHOXAZOLE;TRIMETHOPRIM at an unspecified dose and frequency. On 05-Nov-2021, INFLAMMATION (Inflammation under the left arm (injected arm)) had resolved. At the time of the report, FLUSHING (Felt like flushing on the left side of the heart), URETHRITIS NONINFECTIVE (Feels Inflammation on Urethra near left kidney) and PELVIC PAIN (Feels like pelvic pain on the left side) outcome was unknown.            No concomitant drug was reported. On 05-Nov-2021, the patient felt like flushing on the left side of the heart only one time. The patient also had Inflammation under the left arm (injected arm) for 2 days. About 3-4 days after vaccination, the patient felt Inflammation on Urethra near left kidney. The patient states, "It feels like pelvic pain on the left side." The patient visited the emergency room. Other treatment medication was reported as 3 courses of antibiotics (SMZ/TMP) and prophylaxis antifungal oral tablets.   This case was linked to MOD-2022-535880 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Inflammation, Pelvic pain, Urethritis noninfective
Clinical narrative: Patient received first dose on 26-Jan-2021 and Second dose on 26-Mar-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 26-Jan-2021 and Second dose on 26-Mar-2021) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia (for ever) and Arthritis (for ever).   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 26-Jan-2021 and Second dose on 26-Mar-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 26-Jan-2021 and Second dose on 26-Mar-2021) outcome was unknown.            Concomitant medications details were not reported by the reporter.  Treatment details were not reported by the reporter.   This case was linked to MOD-2022-535866 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received first dose on 26-Jan-2021 and Second dose on 26-Mar-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 26-Jan-2021 and Second dose on 26-Mar-2021) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia (for ever) and Arthritis (for ever).   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 26-Jan-2021 and Second dose on 26-Mar-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 26-Jan-2021 and Second dose on 26-Mar-2021) outcome was unknown.            Concomitant medications details were not reported by the reporter.  Treatment details were not reported by the reporter.   This case was linked to MOD-2022-535866 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Disorientation, Fatigue, Headache, Illness
Clinical narrative: Very bad reactions; unsteady; Never been this sick from vaccines, Stay in bed all day; Disoriented; Fever 101°F for 8 hours; Nausea; Very bad headache; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Very bad reactions), BALANCE DISORDER (unsteady), ILLNESS (Never been this sick from vaccines, Stay in bed all day), DISORIENTATION (Disoriented) and PYREXIA (Fever 101°F for 8 hours) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L21B and 052E2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Depression, Anxiety and Breast cancer. Previously administered products included for Product used for unknown indication: Pfizer (1st dose, Batch number: ER8733, Adverse reaction lasted 3 days.) on 02-Apr-2021, Pfizer (2nd dose and Batch number: EW0172) on 23-Apr-2021. Past adverse reactions to the above products included Fatigue with Pfizer; and No adverse event with Pfizer. Concurrent medical conditions included Allergy to antibiotic (Cipro), Allergy to antibiotic (Bactrim), Allergy to antibiotic (Azithromycin), Drug allergy (Zantac), Drug allergy (Nexium), Drug allergy (Omeprazole), Drug allergy (Protonix), Drug allergy (Tizanidine) and Drug allergy (Antihistamines). Concomitant products included CITALOPRAM, ZIPRASIDONE, LORAZEPAM, GABAPENTIN, LETROZOLE, VITAMIN C [ASCORBIC ACID], VITAMIN E [VITAMIN E NOS], VITAMIN D [VITAMIN D NOS] and CALCIUM for an unknown indication.   On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022, the patient experienced VACCINATION COMPLICATION (Very bad reactions), BALANCE DISORDER (unsteady), ILLNESS (Never been this sick from vaccines, Stay in bed all day), DISORIENTATION (Disoriented), PYREXIA (Fever 101°F for 8 hours), NAUSEA (Nausea), HEADACHE (Very bad headache) and FATIGUE (Extreme fatigue). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 08-Apr-2022, VACCINATION COMPLICATION (Very bad reactions), BALANCE DISORDER (unsteady), ILLNESS (Never been this sick from vaccines, Stay in bed all day), DISORIENTATION (Disoriented), NAUSEA (Nausea), HEADACHE (Very bad headache) and FATIGUE (Extreme fatigue) had resolved. At the time of the report, PYREXIA (Fever 101°F for 8 hours) had resolved.            She did not tested positive for Covid-19 and did not received any other vaccine within 1 month prior to Moderna Covid-19 vaccine.  Other concomitant products include Bupropion SR and Multivitamins.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Nausea, Pyrexia
Clinical narrative: Very bad reactions; unsteady; Never been this sick from vaccines, Stay in bed all day; Disoriented; Fever 101°F for 8 hours; Nausea; Very bad headache; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Very bad reactions), BALANCE DISORDER (unsteady), ILLNESS (Never been this sick from vaccines, Stay in bed all day), DISORIENTATION (Disoriented) and PYREXIA (Fever 101°F for 8 hours) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L21B and 052E2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Depression, Anxiety and Breast cancer. Previously administered products included for Product used for unknown indication: Pfizer (1st dose, Batch number: ER8733, Adverse reaction lasted 3 days.) on 02-Apr-2021, Pfizer (2nd dose and Batch number: EW0172) on 23-Apr-2021. Past adverse reactions to the above products included Fatigue with Pfizer; and No adverse event with Pfizer. Concurrent medical conditions included Allergy to antibiotic (Cipro), Allergy to antibiotic (Bactrim), Allergy to antibiotic (Azithromycin), Drug allergy (Zantac), Drug allergy (Nexium), Drug allergy (Omeprazole), Drug allergy (Protonix), Drug allergy (Tizanidine) and Drug allergy (Antihistamines). Concomitant products included CITALOPRAM, ZIPRASIDONE, LORAZEPAM, GABAPENTIN, LETROZOLE, VITAMIN C [ASCORBIC ACID], VITAMIN E [VITAMIN E NOS], VITAMIN D [VITAMIN D NOS] and CALCIUM for an unknown indication.   On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022, the patient experienced VACCINATION COMPLICATION (Very bad reactions), BALANCE DISORDER (unsteady), ILLNESS (Never been this sick from vaccines, Stay in bed all day), DISORIENTATION (Disoriented), PYREXIA (Fever 101°F for 8 hours), NAUSEA (Nausea), HEADACHE (Very bad headache) and FATIGUE (Extreme fatigue). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 08-Apr-2022, VACCINATION COMPLICATION (Very bad reactions), BALANCE DISORDER (unsteady), ILLNESS (Never been this sick from vaccines, Stay in bed all day), DISORIENTATION (Disoriented), NAUSEA (Nausea), HEADACHE (Very bad headache) and FATIGUE (Extreme fatigue) had resolved. At the time of the report, PYREXIA (Fever 101°F for 8 hours) had resolved.            She did not tested positive for Covid-19 and did not received any other vaccine within 1 month prior to Moderna Covid-19 vaccine.  Other concomitant products include Bupropion SR and Multivitamins.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: very bad reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (very bad reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2022, the patient experienced VACCINATION COMPLICATION (very bad reaction). At the time of the report, VACCINATION COMPLICATION (very bad reaction) outcome was unknown.            It was reported that patient had received a 2nd booster Moderna Covid-19 vaccine on 30Mar2022 and had "very bad reactions" that started on 31Mar2022 at morning. No concomitant medication was reported. No treatment information were reported.
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: 2nd booster of 0.3 mL was given; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (2nd booster of 0.3 mL was given) 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) .3 milliliter. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (2nd booster of 0.3 mL was given). At the time of the report, ACCIDENTAL OVERDOSE (2nd booster of 0.3 mL was given) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant mediations were not reported Treatment information was not reported
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: expired Moderna vaccine administered past 12 hours puncture time; expired Moderna vaccine administered past 12 hours puncture time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered past 12 hours puncture time) and PRODUCT STORAGE ERROR (expired Moderna vaccine administered past 12 hours puncture time) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered past 12 hours puncture time). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (expired Moderna vaccine administered past 12 hours puncture time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered past 12 hours puncture time) and PRODUCT STORAGE ERROR (expired Moderna vaccine administered past 12 hours puncture time) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received 2nd booster dose. Date the vial was initially stored in the refrigerator: 4-APR-2022 Date(s) and time(S) vial was first punctured: 4-APR-2022 at 1:55 PM Date(s) and time(s) of administration of vaccine: 5-APR-2022 at 9:00 AM - 1:40 PM EST How was the vial stored post puncture RT/fridge: Refrigerator Did the vial undergo any temperature excursions: No  No concomitant medications was provided. No treatment medications was provided.
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Immunisation reaction, Tremor
Clinical narrative: very bad reaction; Shaking; uncontrollable freezing; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (very bad reaction), TREMOR (Shaking) and FEELING COLD (uncontrollable freezing) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (very bad reaction), TREMOR (Shaking) and FEELING COLD (uncontrollable freezing). At the time of the report, VACCINATION COMPLICATION (very bad reaction), TREMOR (Shaking) and FEELING COLD (uncontrollable freezing) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Heart rate, Lower limb fracture
Clinical narrative: Broke right leg after 2nd vaccine; Dizzy Spells after 2nd dose; Fatigue after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of LOWER LIMB FRACTURE (Broke right leg after 2nd vaccine), DIZZINESS (Dizzy Spells after 2nd dose) and FATIGUE (Fatigue after 2nd dose) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 024M20A) for COVID-19 vaccination.     The patient's past medical history included Skin cancer (4 years ago, Removed by dermatologist, Patient has been visiting dermatologist regularly.) in 2018.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced DIZZINESS (Dizzy Spells after 2nd dose) and FATIGUE (Fatigue after 2nd dose). In October 2021, the patient experienced LOWER LIMB FRACTURE (Broke right leg after 2nd vaccine). On 05-Jan-2022, LOWER LIMB FRACTURE (Broke right leg after 2nd vaccine), DIZZINESS (Dizzy Spells after 2nd dose) and FATIGUE (Fatigue after 2nd dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, Heart rate: 144 (High) 144 BPM.         No concomitant medication were provided.  The patient got a cast after right leg broken.   This case was linked to MOD-2022-535957 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: expired Moderna vaccine administered past 12 hours puncture time; expired Moderna vaccine administered past 12 hours puncture time; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered past 12 hours puncture time) and PRODUCT STORAGE ERROR (expired Moderna vaccine administered past 12 hours puncture time) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered past 12 hours puncture time). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (expired Moderna vaccine administered past 12 hours puncture time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered past 12 hours puncture time) and PRODUCT STORAGE ERROR (expired Moderna vaccine administered past 12 hours puncture time) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received 2nd booster dose. It was reported that first booster dose of Moderna COVID-19 vaccine was administered to the patient with more than 12 hours after the vial was first punctured. The vial was initially stored in the refrigerator on 04-Apr-2022. The vial was first punctured on 04-Apr-2022 at 1:55 PM and vaccine was administered on 05-Apr-2022 at 9:00 AM - 1:40 PM EST. The vial was stored in refrigerator post puncture.   Total amount of time the vial was exposed to room temperature range was reported as unknown, the vial was not exposed to room temperature for >24 hours.  The vial did not undergo any temperature excursions.  No concomitant medications was provided. No treatment medications was provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: expired Moderna vaccine administered past 12 hours puncture time; expired Moderna vaccine administered past 12 hours puncture time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered past 12 hours puncture time) and PRODUCT STORAGE ERROR (expired Moderna vaccine administered past 12 hours puncture time) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered past 12 hours puncture time). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (expired Moderna vaccine administered past 12 hours puncture time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered past 12 hours puncture time) and PRODUCT STORAGE ERROR (expired Moderna vaccine administered past 12 hours puncture time) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was provided. Patient received 2nd booster dose. Date the vial was initially stored in the refrigerator was reported as 4-APR-2022 Date(s) and time(S) vial was first punctured reported as 4-APR-2022 at 1:55 PM Date(s) and time(s) of administration of vaccine was 5-APR-2022 at 9:00 AM - 1:40 PM The vial was stored in Refrigerator after post puncture. It was reported that the vial doesn't undergone any temperature excursions and total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was Unknown. it was reported that not more than 24hours the vial was exposed. No treatment information was provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired Moderna vaccine administered past 12 hours puncture time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered past 12 hours puncture time) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered past 12 hours puncture time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered past 12 hours puncture time) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator: 4APR2022. Date(s) and time(S) vial was first punctured: 4APR2022 at 1:55 PM. Vial did not undergo any temperature excursions. It was reported that 7 doses of the Moderna COVID-19 vaccine were administered to patients more than 12 hours after the vial was first punctured. HCP stated that she would like to get information on stability of the Moderna vaccine that was administered to patients past 12 hours puncture time. No treatment information was provided by the reporter. No concomitant medications were provided by the reporter.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Moderna COVID-19 vaccine was administered to the patient with more than 12 hours after the vial was first punctured; The vial was first punctured on 04-Apr-2022 and administered on 05-Apr-2022. The vial was stored in refrigerator post puncture; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to the patient with more than 12 hours after the vial was first punctured) and PRODUCT STORAGE ERROR (The vial was first punctured on 04-Apr-2022 and administered on 05-Apr-2022. The vial was stored in refrigerator post puncture) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE (Primary series J and J Vaccine). Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE.    On 05-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2022, the patient experienced PRODUCT STORAGE ERROR (The vial was first punctured on 04-Apr-2022 and administered on 05-Apr-2022. The vial was stored in refrigerator post puncture). On 05-Apr-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to the patient with more than 12 hours after the vial was first punctured). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to the patient with more than 12 hours after the vial was first punctured) and PRODUCT STORAGE ERROR (The vial was first punctured on 04-Apr-2022 and administered on 05-Apr-2022. The vial was stored in refrigerator post puncture) 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 patient took the 1st booster vaccine.  It was reported that first booster dose of Moderna COVID-19 vaccine was administered to the patient with more than 12 hours after the vial was first punctured. The vial was initially stored in the refrigerator on 04-Apr-2022. The vial was first punctured on 04-Apr-2022 at 1:55 PM and vaccine was administered on 05-Apr-2022 at 9:00 AM - 1:40 PM EST. The vial was stored in refrigerator post puncture.   Total amount of time the vial was exposed to room temperature range was reported as unknown, the vial was not exposed to room temperature for >24 hours.  The vial did not undergo any temperature excursions.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: expired Moderna vaccine administered past 12 hours puncture time; expired Moderna vaccine administered past 12 hours puncture time; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered past 12 hours puncture time) and PRODUCT STORAGE ERROR (expired Moderna vaccine administered past 12 hours puncture time) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered past 12 hours puncture time). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (expired Moderna vaccine administered past 12 hours puncture time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered past 12 hours puncture time) and PRODUCT STORAGE ERROR (expired Moderna vaccine administered past 12 hours puncture time) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient took 1st booster vaccine. It was reported that the vial was initially stored in the refrigerator on 04-Apr-2022. The vial was first punctured on 04-Apr-2022 at 1:55 PM and administration of vaccine on 05-Apr-2022 at 9:00 AM - 1:40 PM. The vial was stored in refrigerator post puncture. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was reported as unknown, the vial was not exposed to room temperature for >24 hours. The vial did not undergo any temperature excursions. No treatment information was reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was first punctured on 04-Apr-2022, was stored in refrigerator post puncture and expired vaccine administered on 05-Apr-2022, past 12 hours puncture time.; expired Moderna vaccine administered past 12 hours puncture time; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered past 12 hours puncture time) and PRODUCT STORAGE ERROR (The vial was first punctured on 04-Apr-2022, was stored in refrigerator post puncture and expired vaccine administered on 05-Apr-2022, past 12 hours puncture time.) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022 at 9:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022 at 9:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered past 12 hours puncture time). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was first punctured on 04-Apr-2022, was stored in refrigerator post puncture and expired vaccine administered on 05-Apr-2022, past 12 hours puncture time.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered past 12 hours puncture time) and PRODUCT STORAGE ERROR (The vial was first punctured on 04-Apr-2022, was stored in refrigerator post puncture and expired vaccine administered on 05-Apr-2022, past 12 hours puncture time.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received the second booster dose of Moderna Covid-19 vaccine on 05-Apr-2022 (lot number : 045L21A, expiry date : 05-Jul-2022).  No concomitant drug was reported.  It was reported that the vial was initially stored in the refrigerator on 04-Apr-2022. The vial was first punctured on 04-Apr-2022 at 1:55 PM and administration of vaccine on 05-Apr-2022 at 9:00 AM . The vial was stored in refrigerator post puncture. Total amount of time the vial was exposed to room temperature range was reported as unknown, the vial was not exposed to room temperature for more than 24 hours. The vial did not undergo any temperature excursions.  No treatment information was reported.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received expired doses; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired doses) in a 45-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 068h21a) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received expired doses) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator on 14-Mar-2022.  No concomitant medications were reported  No treatment medications were reported   This case was linked to MOD-2022-536011 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2022: Live Follow up  received contained  Significant information reporter correct name was provided and date the vial was  initially stored in the refrigerator was reported and narrative updated.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Dyspnoea, Feeling abnormal, Heart rate
Clinical narrative: Feeling very bad 2 days after 2nd booster; Terrible bloating after 2nd booster; Stomach pain after 2nd booster; Short Breath after 2nd booster; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling very bad 2 days after 2nd booster), ABDOMINAL DISTENSION (Terrible bloating after 2nd booster), ABDOMINAL PAIN UPPER (Stomach pain after 2nd booster) and DYSPNOEA (Short Breath after 2nd booster) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L21B, 045C21A, 010A21A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2022, the patient experienced FEELING ABNORMAL (Feeling very bad 2 days after 2nd booster), ABDOMINAL DISTENSION (Terrible bloating after 2nd booster), ABDOMINAL PAIN UPPER (Stomach pain after 2nd booster) and DYSPNOEA (Short Breath after 2nd booster). The patient was treated with DICYCLOMINE [DICYCLOVERINE] at a dose of 20 milligram and SIMETHICONE at a dose of 125 milligram. At the time of the report, FEELING ABNORMAL (Feeling very bad 2 days after 2nd booster), ABDOMINAL DISTENSION (Terrible bloating after 2nd booster), ABDOMINAL PAIN UPPER (Stomach pain after 2nd booster) and DYSPNOEA (Short Breath after 2nd booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 74 (Inconclusive) 74 BPM. On an unknown date, Oxygen saturation: 98 (Inconclusive) 98.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided. The HCP called her and notified her that they gave too much (same as initial shot) for the 2nd booster. Patient went to her doctor on 07APR2022 The doctor thinks it might be stomach flu.. The patient states that the treatment medications did not help.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation
Clinical narrative: Feeling very bad 2 days after 2nd booster; Terrible bloating after 2nd booster; Stomach pain after 2nd booster; Short Breath after 2nd booster; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling very bad 2 days after 2nd booster), ABDOMINAL DISTENSION (Terrible bloating after 2nd booster), ABDOMINAL PAIN UPPER (Stomach pain after 2nd booster) and DYSPNOEA (Short Breath after 2nd booster) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L21B, 045C21A, 010A21A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2022, the patient experienced FEELING ABNORMAL (Feeling very bad 2 days after 2nd booster), ABDOMINAL DISTENSION (Terrible bloating after 2nd booster), ABDOMINAL PAIN UPPER (Stomach pain after 2nd booster) and DYSPNOEA (Short Breath after 2nd booster). The patient was treated with DICYCLOMINE [DICYCLOVERINE] at a dose of 20 milligram and SIMETHICONE at a dose of 125 milligram. At the time of the report, FEELING ABNORMAL (Feeling very bad 2 days after 2nd booster), ABDOMINAL DISTENSION (Terrible bloating after 2nd booster), ABDOMINAL PAIN UPPER (Stomach pain after 2nd booster) and DYSPNOEA (Short Breath after 2nd booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 74 (Inconclusive) 74 BPM. On an unknown date, Oxygen saturation: 98 (Inconclusive) 98.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided. The HCP called her and notified her that they gave too much (same as initial shot) for the 2nd booster. Patient went to her doctor on 07APR2022 The doctor thinks it might be stomach flu.. The patient states that the treatment medications did not help.