chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore left injection site arm; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (Sore left injection site arm) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore left injection site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.   This case was linked to MOD-2022-539791 (Patient Link).
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. The vial was initially stored in the refrigerator on 14 Mar 2022. The vial did not undergo any temperature excursions. Treatment information was unknown.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging neck, Pain in extremity, Palpitations, Paraesthesia, Sleep disorder
Clinical narrative: sore arm/right leg aching; Fluttering in chest, whole chest area; prickly feeling going from shoulders to fingers and into legs; Woke up during the night with the same symptoms but worse.; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (sore arm/right leg aching), PALPITATIONS (Fluttering in chest, whole chest area), PARAESTHESIA (prickly feeling going from shoulders to fingers and into legs) and SLEEP DISORDER (Woke up during the night with the same symptoms but worse.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035H21A) for COVID-19 vaccination.     Patient had no history of COVID-19.  The patient's past medical history included Cardiac disorder NOS. Concurrent medical conditions included Spinal stenosis.   On 30-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm/right leg aching), PALPITATIONS (Fluttering in chest, whole chest area), PARAESTHESIA (prickly feeling going from shoulders to fingers and into legs) and SLEEP DISORDER (Woke up during the night with the same symptoms but worse.). At the time of the report, PAIN IN EXTREMITY (sore arm/right leg aching), PALPITATIONS (Fluttering in chest, whole chest area), PARAESTHESIA (prickly feeling going from shoulders to fingers and into legs) and SLEEP DISORDER (Woke up during the night with the same symptoms but worse.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging neck: showed arthritis showed arthritis but nothing showing symptoms coming from my neck..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that patient continuing to have same symptoms but not as intense. She could feel prickly/funny feeling in chest. It was subtle. When she goes to bed a night it was more intense. Caller stated that she had seen her PCP and she had been telling that she thought it was something to do with her neck. Caller stated she had a nerve conduction study there was something from her elbow down that would have indicated something in her right ring and pinky finger, but she did not had anything there.   No treatment information was reported.   This case was linked to MOD-2021-075190 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2022: Follow-up received contains no new information.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging neck, Musculoskeletal discomfort, Nerve conduction studies abnormal, Palpitations, Paraesthesia
Clinical narrative: sore arm/right leg aching; Fluttering in chest, whole chest area; prickly feeling going from shoulders to fingers and into legs; Woke up during the night with the same symptoms but worse.; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (sore arm/right leg aching), PALPITATIONS (Fluttering in chest, whole chest area), PARAESTHESIA (prickly feeling going from shoulders to fingers and into legs) and SLEEP DISORDER (Woke up during the night with the same symptoms but worse.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035H21A) for COVID-19 vaccination.     Patient had no history of COVID-19.  The patient's past medical history included Cardiac disorder NOS. Concurrent medical conditions included Spinal stenosis.   On 30-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm/right leg aching), PALPITATIONS (Fluttering in chest, whole chest area), PARAESTHESIA (prickly feeling going from shoulders to fingers and into legs) and SLEEP DISORDER (Woke up during the night with the same symptoms but worse.). At the time of the report, PAIN IN EXTREMITY (sore arm/right leg aching), PALPITATIONS (Fluttering in chest, whole chest area), PARAESTHESIA (prickly feeling going from shoulders to fingers and into legs) and SLEEP DISORDER (Woke up during the night with the same symptoms but worse.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging neck: showed arthritis showed arthritis but nothing showing symptoms coming from my neck..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that patient continuing to have same symptoms but not as intense. She could feel prickly/funny feeling in chest. It was subtle. When she goes to bed a night it was more intense. Caller stated that she had seen her PCP and she had been telling that she thought it was something to do with her neck. Caller stated she had a nerve conduction study there was something from her elbow down that would have indicated something in her right ring and pinky finger, but she did not had anything there.   No treatment information was reported.   This case was linked to MOD-2021-075190 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2022: Follow-up received contains no new information.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ulnar nerve injury, Vaccine positive rechallenge
Clinical narrative: sore arm/right leg aching; Fluttering in chest, whole chest area; prickly feeling going from shoulders to fingers and into legs; Woke up during the night with the same symptoms but worse.; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (sore arm/right leg aching), PALPITATIONS (Fluttering in chest, whole chest area), PARAESTHESIA (prickly feeling going from shoulders to fingers and into legs) and SLEEP DISORDER (Woke up during the night with the same symptoms but worse.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035H21A) for COVID-19 vaccination.     Patient had no history of COVID-19.  The patient's past medical history included Cardiac disorder NOS. Concurrent medical conditions included Spinal stenosis.   On 30-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm/right leg aching), PALPITATIONS (Fluttering in chest, whole chest area), PARAESTHESIA (prickly feeling going from shoulders to fingers and into legs) and SLEEP DISORDER (Woke up during the night with the same symptoms but worse.). At the time of the report, PAIN IN EXTREMITY (sore arm/right leg aching), PALPITATIONS (Fluttering in chest, whole chest area), PARAESTHESIA (prickly feeling going from shoulders to fingers and into legs) and SLEEP DISORDER (Woke up during the night with the same symptoms but worse.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging neck: showed arthritis showed arthritis but nothing showing symptoms coming from my neck..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that patient continuing to have same symptoms but not as intense. She could feel prickly/funny feeling in chest. It was subtle. When she goes to bed a night it was more intense. Caller stated that she had seen her PCP and she had been telling that she thought it was something to do with her neck. Caller stated she had a nerve conduction study there was something from her elbow down that would have indicated something in her right ring and pinky finger, but she did not had anything there.   No treatment information was reported.   This case was linked to MOD-2021-075190 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2022: Follow-up received contains no new information.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle strain
Clinical narrative: "lifted some heavy stuff and "tweaked his lower back"; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE STRAIN ("lifted some heavy stuff and "tweaked his lower back") in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Flu vaccine (Route:IM) in 2021 and J&J. Past adverse reactions to the above products included Fall with Flu vaccine; and No adverse event with J&J. Concurrent medical conditions included High cholesterol. Concomitant products included SIMVASTATIN for an unknown indication.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced MUSCLE STRAIN ("lifted some heavy stuff and "tweaked his lower back"). On 08-Apr-2022, MUSCLE STRAIN ("lifted some heavy stuff and "tweaked his lower back") had resolved.            No treatment medications was reported.   This case was linked to MOD-2022-539697 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Liver function test
Clinical narrative: second Booster dose recieved 0.5ml; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (second Booster dose recieved 0.5ml) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028K21A, 026A21A, 037A21B and 032B21A) for COVID-19 vaccination.     The patient's past medical history included Varicose veins from 12-Dec-2012 to 17-May-2017, Prediabetes on 22-May-2015, Wound infection (After surgery) on 26-Nov-2021, Stent placement (Biliary duct) on 25-Aug-2021 and Pancreaticoduodenectomy (Surgery on 18 Nov 2021) on 23-Nov-2021. Concurrent medical conditions included Drug allergy, Penicillin allergy, Hypothyroidism since 14-Nov-2011, Tobacco abuse since 14-Nov-2011, Gastroesophageal reflux disease since 12-Dec-2012, Anxiety since 12-Dec-2012, Depression since 12-Dec-2012, Varicose veins (Left lower extremity with complications) since 16-Dec-2015, Acute pancreatitis (Idiopathic) since 24-Mar-2021, Transaminitis since 24-Mar-2021, Bile duct obstruction NOS since 26-Mar-2021, Pancreatic mass since 26-Mar-2021, Obesity since 26-Mar-2021, Type 2 diabetes mellitus since 30-Jun-2021, Pancreatic adenocarcinoma (Whipple by Dr. 18/11/2021) since 25-Aug-2021 and Hyperbilirubinemia since 17-Aug-2021.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 07-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 07-Apr-2022, the patient experienced ACCIDENTAL OVERDOSE (second Booster dose recieved 0.5ml). At the time of the report, ACCIDENTAL OVERDOSE (second Booster dose recieved 0.5ml) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Liver function test: high (High) Elevated LFTs.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patients fourth dose was as per Moderna recommendation that dose given on 27 Aug 2021 needed to be re-done. No treatment medications were reported.   This case was linked to MOD-2022-539677 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received 1st dose on 23-Aug-2021 and 2nd dose on 29-Sept-2021; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 23-Aug-2021 and 2nd dose on 29-Sept-2021) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939906 and 032B21A) for COVID-19 vaccination.     No known drug allergies were reported. It was unknown if patient ever have tested or diagnosed COVID positive.  The patient's past medical history included Jaundice on 29-May-2019, Ureteropelvic junction obstruction on 16-Oct-2019, Ureteropelvic junction stone on 16-Oct-2019, Fever on 13-Jul-2020, Abdominal pain on 16-Sep-2021, Upper abdominal pain on 08-Nov-2021 and Bacteremia on 08-Mar-2021. Concurrent medical conditions included Hyperlipidemia since 11-Mar-2009, Prediabetes since 24-Apr-2018, Metastatic carcinoma since 29-May-2019, Colon cancer stage IV since 13-Jun-2019, Hyperglycemia since 13-Jun-2019, Type 2 diabetes mellitus since 13-Jun-2019, Metastatic colon cancer since 03-Dec-2019, Ileus since 08-Dec-2019, Perihepatic abscess since 16-Jul-2020, Pancreatitis since 09-Aug-2021, Duodenal ulcer since 17-Sep-2021, Failure to thrive since 16-Sep-2021, Malignant neoplasm of ascending colon since 16-Sep-2021, Protein-calorie malnutrition since 17-Sep-2021 and Sepsis since 11-Nov-2021. Concomitant products included INSULIN for Type 2 diabetes mellitus.   On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 29-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 29-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 23-Aug-2021 and 2nd dose on 29-Sept-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 23-Aug-2021 and 2nd dose on 29-Sept-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication were provided.   This case was linked to MOD-2022-539688 (Patient Link).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Migraine
Clinical narrative: Migraine headaches after second dose for 2 weeks; flu like symptoms for a week to a week and a week and a half; This spontaneous case was reported by a patient and describes the occurrence of MIGRAINE (Migraine headaches after second dose for 2 weeks) and INFLUENZA LIKE ILLNESS (flu like symptoms for a week to a week and a week and a half) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 025A21A) for COVID-19 vaccination.     The patient's past medical history included Sinus operation NOS in 1989. Concurrent medical conditions included Sinusitis (The patient typically has sinus attacks annually in April).   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced MIGRAINE (Migraine headaches after second dose for 2 weeks) and INFLUENZA LIKE ILLNESS (flu like symptoms for a week to a week and a week and a half). The patient was treated with CYCLOBENZAPRINE at a dose of 5 milligram once a day and PREDNISONE at an unspecified dose and frequency. At the time of the report, MIGRAINE (Migraine headaches after second dose for 2 weeks) and INFLUENZA LIKE ILLNESS (flu like symptoms for a week to a week and a week and a half) had resolved.            No concomitant medication was reported. A non -smoker patient typically has sinus attacks annually in April. These attacks were so bad that the patient had a sinus surgery in 1989. About 7 years ago the patient started getting sinus attacks again each April. The patient reported that in year 2022 the patient had no sinus attack.  The patient reported no side effect from first dose of Moderna COVID -19 vaccine. Further he reported about the visit to urgent care for migraine headache. He received medication for the migraine headaches. The patient went to urgent care over the flu symptoms. Urgent care gave the patient cyclobenzaprine 5mg once daily. The patient was also given Prednisone on a tapering schedule.   This case was linked to MOD-2022-539871 (Patient Link).
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombocytopenia
Clinical narrative: COVID-19 vaccine induced thrombocytopenia; This literature-non-study case was reported in a literature article and describes the occurrence of THROMBOCYTOPENIA (COVID-19 vaccine induced thrombocytopenia) in a 25-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.      No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOCYTOPENIA (COVID-19 vaccine induced thrombocytopenia) (seriousness criterion medically significant). At the time of the report, THROMBOCYTOPENIA (COVID-19 vaccine induced thrombocytopenia) outcome was unknown. Related      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered THROMBOCYTOPENIA (COVID-19 vaccine induced thrombocytopenia) to be related.    No concomitant and treatment medications were reported  Company Comment: This spontaneous case concerns a 25-year-old, female patient with no reported medical history, who experienced the unexpected, serious (medically significant) adverse event of special interest Thrombocytopenia. The event occurred on an unspecified date after receiving a dose of mRNA-1273 vaccine. Clinical course, including presenting symptoms and etiologic investigations, and treatment details were not provided in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 25-year-old, female patient with no reported medical history, who experienced the unexpected, serious (medically significant) adverse event of special interest Thrombocytopenia. The event occurred on an unspecified date after receiving a dose of mRNA-1273 vaccine. Clinical course, including presenting symptoms and etiologic investigations, and treatment details were not provided in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Headache, Pain, Pyrexia
Clinical narrative: miserable at night; pain on his left side; was weak and could not get out of bed; pain in the injection site; Fever; head pounding; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (miserable at night), PAIN (pain on his left side), ASTHENIA (was weak and could not get out of bed), VACCINATION SITE PAIN (pain in the injection site) and PYREXIA (Fever) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (for his other doses.). Past adverse reactions to the above products included No adverse event with Pfizer vaccine. Concomitant products included TRAZODONE and ROSUVASTATIN for an unknown indication.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced FEELING ABNORMAL (miserable at night), PAIN (pain on his left side), ASTHENIA (was weak and could not get out of bed), VACCINATION SITE PAIN (pain in the injection site), PYREXIA (Fever) and HEADACHE (head pounding). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (miserable at night), PAIN (pain on his left side), ASTHENIA (was weak and could not get out of bed), VACCINATION SITE PAIN (pain in the injection site), PYREXIA (Fever) and HEADACHE (head pounding) was resolving.            The patient reported third concomitant medication which he could not remember. The patient took Acetaminophen in the middle of the night and then took two acetaminophen the afternoon of 13-Apr-2022.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: miserable at night; pain on his left side; was weak and could not get out of bed; pain in the injection site; Fever; head pounding; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (miserable at night), PAIN (pain on his left side), ASTHENIA (was weak and could not get out of bed), VACCINATION SITE PAIN (pain in the injection site) and PYREXIA (Fever) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (for his other doses.). Past adverse reactions to the above products included No adverse event with Pfizer vaccine. Concomitant products included TRAZODONE and ROSUVASTATIN for an unknown indication.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced FEELING ABNORMAL (miserable at night), PAIN (pain on his left side), ASTHENIA (was weak and could not get out of bed), VACCINATION SITE PAIN (pain in the injection site), PYREXIA (Fever) and HEADACHE (head pounding). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (miserable at night), PAIN (pain on his left side), ASTHENIA (was weak and could not get out of bed), VACCINATION SITE PAIN (pain in the injection site), PYREXIA (Fever) and HEADACHE (head pounding) was resolving.            The patient reported third concomitant medication which he could not remember. The patient took Acetaminophen in the middle of the night and then took two acetaminophen the afternoon of 13-Apr-2022.
Age: 83.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial expired on 29-Jan-2022 and was stored in the refrigerator.; A nurse administered 4 doses of expired Moderna Covid-19 vaccine.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A nurse administered 4 doses of expired Moderna Covid-19 vaccine.) and PRODUCT STORAGE ERROR (The vial expired on 29-Jan-2022 and was stored in the refrigerator.) in an 83-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A nurse administered 4 doses of expired Moderna Covid-19 vaccine.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 29-Jan-2022 and was stored in the refrigerator.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A nurse administered 4 doses of expired Moderna Covid-19 vaccine.) and PRODUCT STORAGE ERROR (The vial expired on 29-Jan-2022 and was stored in the refrigerator.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  The vial was initially stored in the refrigerator on 11-Feb-2022. The vial did not undergo any temperature excursions. Also reported dose administered after 30-day use by date or after manufacturer date of expiry. The patient received 1/2 dose booster on 11-Feb-2022.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2022: Follow up received contains no new information.
Age: 82.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: product storage error; A nurse administered 4 doses of expired Moderna Covid-19 vaccine.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A nurse administered 4 doses of expired Moderna Covid-19 vaccine.) and PRODUCT STORAGE ERROR (product storage error) in an 82-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 11-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A nurse administered 4 doses of expired Moderna Covid-19 vaccine.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A nurse administered 4 doses of expired Moderna Covid-19 vaccine.) and PRODUCT STORAGE ERROR (product storage error) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator on 04-Feb-2022, 11-Feb-2022, 18-Feb-2022.  No concomitant medication information provided. No treatment medication information provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2022: Non-significant follow up
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Plantar fasciitis
Clinical narrative: Severe exhaustion started 24 hours after getting second booster Planter facitious started 24 hours after getting second booster.   I also got planter fac after getting my 1st booster covid shot back in October.   I know it started around my booster shot but don't have a real time frame.    I have never had this in my life and seems strange to get it right after each booster shot.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: Menstrual-period is 5 days late
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Injury associated with device
Clinical narrative: Error: Patient Accidentally Stuck by Needle-
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Barium enema abnormal, Colectomy, Intussusception
Clinical narrative: Ileocolic intussusception requiring right colectomy
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID positive, hospitalization
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: vaccine breakthrough event
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Blood test normal, COVID-19, Computerised tomogram normal, Condition aggravated
Clinical narrative: After the first two Pfizer shots, ~6 months later I developed a buzzing in my ear, echo with higher pitched noises & subsequently tested ny hearing after developing these symptoms & found to have  a sudden hearing loss, all in my right ear. The symptoms began Nov 23, 2021.  I was put on 3 weeks of a high dosage of Prednisone, and this helped to recover most of my hearing in my right ear & the buzzing & echo also lessened. I also had MRI & CT scan done, all negative. On January 8, 2022 once I finished my prednisone & allowed a few weeks for that to leave my system, I got my 3rd Pfizer booster shot. This was after my sudden hearing loss had reversed. About one week later, for a day, my symptoms all went away but then by January 30th, they all returned & worse than ever. I went on a second round of oral prednisone, which slowed the sudden hearing loss, but did not recover much & the tinnitus symptoms never stopped. Then we tried 3 steroid injections in my right ear, beginning March 3, 2022, which helped for a few weeks, but since all symptoms have returned again & especially as I contracted COVID on 4/12/2022.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deafness unilateral, Sudden hearing loss, Symptom recurrence, Tinnitus, Vitamin D decreased
Clinical narrative: After the first two Pfizer shots, ~6 months later I developed a buzzing in my ear, echo with higher pitched noises & subsequently tested ny hearing after developing these symptoms & found to have  a sudden hearing loss, all in my right ear. The symptoms began Nov 23, 2021.  I was put on 3 weeks of a high dosage of Prednisone, and this helped to recover most of my hearing in my right ear & the buzzing & echo also lessened. I also had MRI & CT scan done, all negative. On January 8, 2022 once I finished my prednisone & allowed a few weeks for that to leave my system, I got my 3rd Pfizer booster shot. This was after my sudden hearing loss had reversed. About one week later, for a day, my symptoms all went away but then by January 30th, they all returned & worse than ever. I went on a second round of oral prednisone, which slowed the sudden hearing loss, but did not recover much & the tinnitus symptoms never stopped. Then we tried 3 steroid injections in my right ear, beginning March 3, 2022, which helped for a few weeks, but since all symptoms have returned again & especially as I contracted COVID on 4/12/2022.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None Stated.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood creatinine increased, Blood test abnormal, Blood urea increased, Glomerular filtration rate, Glomerulonephritis rapidly progressive
Clinical narrative: Developed Crescentic glomerulonephritis -routine bloodwork alerted to the condition and was admitted to hospital 3/6/2022 with GFR of 15.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Renal impairment
Clinical narrative: Developed Crescentic glomerulonephritis -routine bloodwork alerted to the condition and was admitted to hospital 3/6/2022 with GFR of 15.
Age: 19.0
Sex: M
Vaccine: ANTH, JEV1, TYP, YF
Symptoms: Allergy test, Blood immunoglobulin E, Cough, Dysphagia, Lacrimation increased
Clinical narrative: Subjective complaint of generalized pruritis, lip swelling, difficulty swallowing, cough, red watery eyes and rhinorrhea and objective documentation of urticaria, pharyngeal erythema and decreased O2 sat after receipt of receipt of JE #1( JEV 18J89E), Typhoid ViCP #1(R1F78), YF-VAX (U2933AA)  #1 and Anthrax #1 (MIP 300046A) on 21 May 2020 with onset at about 20 minutes.  He has subsequently tolerated JE-VC and Anthrax vaccine doses, therefore I am unable to annotate vaccine route, vaccine site, or dose # in series.
Age: 19.0
Sex: M
Vaccine: ANTH, JEV1, TYP, YF
Symptoms: Lip swelling, Ocular hyperaemia, Oxygen saturation decreased, Pharyngeal erythema, Pruritus
Clinical narrative: Subjective complaint of generalized pruritis, lip swelling, difficulty swallowing, cough, red watery eyes and rhinorrhea and objective documentation of urticaria, pharyngeal erythema and decreased O2 sat after receipt of receipt of JE #1( JEV 18J89E), Typhoid ViCP #1(R1F78), YF-VAX (U2933AA)  #1 and Anthrax #1 (MIP 300046A) on 21 May 2020 with onset at about 20 minutes.  He has subsequently tolerated JE-VC and Anthrax vaccine doses, therefore I am unable to annotate vaccine route, vaccine site, or dose # in series.
Age: 19.0
Sex: M
Vaccine: ANTH, JEV1, TYP, YF
Symptoms: Rhinorrhoea, Urticaria
Clinical narrative: Subjective complaint of generalized pruritis, lip swelling, difficulty swallowing, cough, red watery eyes and rhinorrhea and objective documentation of urticaria, pharyngeal erythema and decreased O2 sat after receipt of receipt of JE #1( JEV 18J89E), Typhoid ViCP #1(R1F78), YF-VAX (U2933AA)  #1 and Anthrax #1 (MIP 300046A) on 21 May 2020 with onset at about 20 minutes.  He has subsequently tolerated JE-VC and Anthrax vaccine doses, therefore I am unable to annotate vaccine route, vaccine site, or dose # in series.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: vaccine breakthrough event
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests normal, Chills, Influenza like illness, Tinnitus
Clinical narrative: After a nap, woke to chills and flu like symptoms. Noticed ringing in my left ear. This has continued ever since and most locally in the left ear. It is now a year later and although I sometimes don't notice the ringing as much as I used to, it hasn't gone away. It is best for me not to focus on it or it'll drive me crazy.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling, Magnetic resonance imaging, Muscle spasms, Pain in extremity
Clinical narrative: My back starting having spasms and I had a lot of joint pain and has not stopped since vaccination. This wasn't an issue until I was vaccinated. My arm hurt until about 4/11/2022. It is a 24/7 spasm. Medications and physical therapy has not helped. Now all the sudden my ankles are swelling up. I am still dealing with this at this time.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: My back starting having spasms and I had a lot of joint pain and has not stopped since vaccination. This wasn't an issue until I was vaccinated. My arm hurt until about 4/11/2022. It is a 24/7 spasm. Medications and physical therapy has not helped. Now all the sudden my ankles are swelling up. I am still dealing with this at this time.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Intermittent tinnitus that occurs multiple times daily as a high pitch sound in both ears that can feel overwhelming.  This began within a few weeks after I received the 2nd dose of Moderna.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None Stated.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Feeling hot, Resuscitation, Unresponsive to stimuli
Clinical narrative: Resident reported he was feeling Hot and requested for Air to be turn on and also requested for a Cup of Ice. All his request was Provided. At 8:52am Resident was checked and told writer he feels better and requested for Ice this time which was provided. At about 10:15am writer went to administer Resident meds and found resident on unresponsive. Pt is full code so CPR initiated,911 called and V/S during CPR was B/P, 218/161,175,BS 159.911 arrived at 10:25 and took over CPR.RP made aware of changes. Resident pronounced Deceased by 911 at 10:50pm.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19 pneumonia
Clinical narrative: acute respiratory failure secondary to Covid pneumonia
Age: 17.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Extraneous dose of MCV4 was administered to the patient. This was the patient's third MCV4 vaccine. The patient did not report being in distress after receiving the vaccine. Currently attempting to reach the parent to notify them of the extra dose. The MCV4 dose was accidentally administered instead of Hepatitis A, so the patient will need to return for the Hepatitis A vaccine.
Age: 46.0
Sex: M
Vaccine: UNK
Symptoms: Gastrointestinal haemorrhage, Liver disorder
Clinical narrative: Attacked the liver; hemorrhage of gastro
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Myelitis transverse
Clinical narrative: Diagnosis  - Transverse myelitis
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Diarrhoea, Dry eye, Feeling abnormal, Gastric disorder
Clinical narrative: Immediately after vaccine, I got really sick and couldn't raise my left arm. My arm was sore at the injection site and was swollen, it tripled in size. My arm turned purple, I was running a fever, and had stomach issues with vomiting and diarrhea. I felt like I was in a fog for over a month. Eventually my arm started oozing liquid about 9 days later. I went to my doctor the next day and eventually over time, I got on 3 rounds of antibiotics. My arm is discolored and purple and it is very noticeable. It is blotchy and has a raised spot to this day. I was diagnosed with Cellulitis. I was born with an infection in my eyes and partially blind in my left eye. The shot triggered my eye issues and it immediately started watering. My doctor said it was the worse case of dry eye. With every COVID vaccine I had made it worse. I have had 3 COVID vaccines. I am now still on steroid eye drops. I was taking taking steroid eye drops 3 times a day and now I am down to 1 time a day. I am also on a second eye drop prescription as well as the steroid eye drops. I also have to buy OTC eye drops that is expensive. I never had to have any kind of eye drops before vaccination.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Injection site swelling, Lacrimation increased, Malaise, Peripheral swelling
Clinical narrative: Immediately after vaccine, I got really sick and couldn't raise my left arm. My arm was sore at the injection site and was swollen, it tripled in size. My arm turned purple, I was running a fever, and had stomach issues with vomiting and diarrhea. I felt like I was in a fog for over a month. Eventually my arm started oozing liquid about 9 days later. I went to my doctor the next day and eventually over time, I got on 3 rounds of antibiotics. My arm is discolored and purple and it is very noticeable. It is blotchy and has a raised spot to this day. I was diagnosed with Cellulitis. I was born with an infection in my eyes and partially blind in my left eye. The shot triggered my eye issues and it immediately started watering. My doctor said it was the worse case of dry eye. With every COVID vaccine I had made it worse. I have had 3 COVID vaccines. I am now still on steroid eye drops. I was taking taking steroid eye drops 3 times a day and now I am down to 1 time a day. I am also on a second eye drop prescription as well as the steroid eye drops. I also have to buy OTC eye drops that is expensive. I never had to have any kind of eye drops before vaccination.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash macular, Skin discolouration, Skin weeping, Vomiting
Clinical narrative: Immediately after vaccine, I got really sick and couldn't raise my left arm. My arm was sore at the injection site and was swollen, it tripled in size. My arm turned purple, I was running a fever, and had stomach issues with vomiting and diarrhea. I felt like I was in a fog for over a month. Eventually my arm started oozing liquid about 9 days later. I went to my doctor the next day and eventually over time, I got on 3 rounds of antibiotics. My arm is discolored and purple and it is very noticeable. It is blotchy and has a raised spot to this day. I was diagnosed with Cellulitis. I was born with an infection in my eyes and partially blind in my left eye. The shot triggered my eye issues and it immediately started watering. My doctor said it was the worse case of dry eye. With every COVID vaccine I had made it worse. I have had 3 COVID vaccines. I am now still on steroid eye drops. I was taking taking steroid eye drops 3 times a day and now I am down to 1 time a day. I am also on a second eye drop prescription as well as the steroid eye drops. I also have to buy OTC eye drops that is expensive. I never had to have any kind of eye drops before vaccination.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Fever, fatigue, sore arm
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: admitted to hospital with breakthrough COVID infection
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient came in to get information about scheduling her covid vaccine on 4/111/22 and she filled out the VAR form given to her.  When she turned in the VAR she stated she did not want vaccine today but would come back the next day.  Patient returned to pharmacy and I gave the VAR she filled out the day before to the technician to enter her vaccine for her second dose of covid 19 vaccine.  She did not have card but had image on her phone. I did not look at phone since I looked her vaccination record. I viewed the date of her last vaccine and deemed it was   ok to give her second dose base on the date of her first vaccine. I did not view which vaccine she received. I reviewed the VAR and prepared the 0.5 ml Moderna vaccine and proceeded to give patient the immunization.  After the vaccination the patient returned to the counter and said she wanted Pfizer.  I told the patient that the CDC approved mixing and matching vaccines..  Upon further investigation that is only the case in certain circumstances for the primary series and for boosters.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Mild soreness at injection site, continuing more than 24 hours. It does not interfere with my functioning. Pain rating is 1/10 (with 10 being severe).
Age: 54.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Back pain, Chills, Fatigue, Injection site pruritus, Injection site swelling
Clinical narrative: The swelling at the point of injection was the size of about a half of a golf ball. It was also itchy at injection site. The pain progressed across my arm and back. I also experienced fatigue and chills.
Age: 54.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Pain in extremity
Clinical narrative: The swelling at the point of injection was the size of about a half of a golf ball. It was also itchy at injection site. The pain progressed across my arm and back. I also experienced fatigue and chills.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: admitted /hospitalized with breakthrough COVID infection
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient came to our health department to be seen in our family healthcare services. Patient's mother showed the nurse her COVID card and asked if it was a mistake that she had received a Moderna vaccination.  The nurse questioned whether they had inadvertently written the wrong thing. Passed the information along to this nurse who then followed up with the clinic to see what vaccine had been given. Spoke with clinic on the phone and requested a copy of vaccination records from the day. Was later faxed the information which did not contain any lot number information but did state that the patient did receive a first dose Moderna vaccine at their site in their left deltoid on May 27th, 2021.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Fatigue, Injection site pruritus, Injection site swelling
Clinical narrative: The swelling at the point of injection was the size of about a half of a golf ball. It was also itchy at injection site. The pain progressed across my arm, back, and eventually entire body. I also experienced fatigue and chills. This all lasted over 2-3 days.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: The swelling at the point of injection was the size of about a half of a golf ball. It was also itchy at injection site. The pain progressed across my arm, back, and eventually entire body. I also experienced fatigue and chills. This all lasted over 2-3 days.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: admitted/hospitalized with breakthrough COVID infection
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: Received booster (3rd dose) on November 23rd.  Shortly after (4-5 weeks / around Jan 4th) I began to experience Tinnitus.  Scheduled an appointment with audiologist on February 24, 2022 to discuss and confirm Tinnitus.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: admission/hospitalization with breakthrough COVID
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy colon abnormal, Colon cancer, Colonoscopy abnormal, Computerised tomogram, Influenza like illness
Clinical narrative: had flu like symptoms for approximately 24 hours following time of the vaccine injections In December, i was diagnosed with cancer of the transverse colon during my annual colonoscopy.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Positron emission tomogram
Clinical narrative: had flu like symptoms for approximately 24 hours following time of the vaccine injections In December, i was diagnosed with cancer of the transverse colon during my annual colonoscopy.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Electrocardiogram, Gait disturbance, Vertigo
Clinical narrative: Experienced vertigo, dizziness beardly able to walk or eat for three days, 4 days later I received physical therapy and it helped a lot. In total about 2-3 weeks of dizziness.