chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia
Clinical narrative: MUSCLE ACHES ALONG THE FRONT OF THIGHS; PAINFUL ARM AT THE SITE OF INJECTION; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced muscle aches along the front of thighs, and painful arm at the site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle aches along the front of thighs and painful arm at the site of injection was not reported. This report was non-serious. This case, from the same reporter is linked to 20211124852.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF AN EXPIRED JANSSEN VACCINE; This spontaneous report received from a consumer concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced administration of an expired janssen vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired janssen vaccine was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: MOMENTARY ARM PAIN; FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 21-SEP-2021) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAY-2021, the patient experienced momentary arm pain. On 10-MAY-2021, the patient experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from momentary arm pain, and fatigue on 10-MAY-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous report received from a patient via a company representative concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch numbers were not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced covid-19. The action taken with covid-19 vaccine  was not applicable. The outcome of covid-19 was not reported. This report was non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Feeling abnormal, Heart rate, Heart rate increased
Clinical narrative: got bad shortness or breath; high heart rate; felt faint while driving; didn't feel good at all; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (got bad shortness or breath), HEART RATE INCREASED (high heart rate), DIZZINESS (felt faint while driving) and FEELING ABNORMAL (didn't feel good at all) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Depression. Concomitant products included ESCITALOPRAM for Depression.    On 29-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced DYSPNOEA (got bad shortness or breath), HEART RATE INCREASED (high heart rate), DIZZINESS (felt faint while driving) and FEELING ABNORMAL (didn't feel good at all). At the time of the report, DYSPNOEA (got bad shortness or breath), HEART RATE INCREASED (high heart rate), DIZZINESS (felt faint while driving) and FEELING ABNORMAL (didn't feel good at all) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Nov-2021, Heart rate: high (High) high heart rate.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment medication was reported. Patient reported that, the events lasted almost 45 minutes. Reporter stated that On 03 Nov 2021 while walking to class, patient experienced shortness of breath again. Also reported that, patient was not going to get the second Moderna shot.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Was given the first Moderna shot twice; Patient received second dose 23 days apart from 1st one; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Was given the first Moderna shot twice) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose 23 days apart from 1st one) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     Concurrent medical conditions included Disability.   On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021, the patient experienced EXTRA DOSE ADMINISTERED (Was given the first Moderna shot twice) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose 23 days apart from 1st one). On 28-Aug-2021, EXTRA DOSE ADMINISTERED (Was given the first Moderna shot twice) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose 23 days apart from 1st one) had resolved.            No Concomitant medication information was reported.  No treatment medications were provided. Patient had no symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: Follow-up received, contains primary reporters information updated,Patient demographics, Medical history,vaccination information, event information and narrative was updated accordingly.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Headache, Hyperhidrosis
Clinical narrative: covered with sweat; muscle weakness in legs; nerve pain in legs, shooting pain in the legs; joint pain, mostly in right wrist; felt very fatigued; 101 degrees F temperature/ fever lasted all day and night/ max temperature 102 Fahrenheit/ struggled with her temperature (fever)/ fever resolved (morning); ongoing headache; sore right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore right arm), HYPERHIDROSIS (covered with sweat), MUSCULAR WEAKNESS (muscle weakness in legs), NEURALGIA (nerve pain in legs, shooting pain in the legs) and ARTHRALGIA (joint pain, mostly in right wrist) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Nerve pain. Previously administered products included for an unreported indication: PFIZER BIONTECH COVID-19 VACCINE (first dose 24-FEB-2021 with lot number  EN6202 and second dose 22-MAR-2021 with lot number  ER8782) from 24-Feb-2021 to 22-Mar-2021.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Oct-2021, the patient experienced PAIN IN EXTREMITY (sore right arm) and HEADACHE (ongoing headache). On 28-Oct-2021, the patient experienced HYPERHIDROSIS (covered with sweat), MUSCULAR WEAKNESS (muscle weakness in legs), NEURALGIA (nerve pain in legs, shooting pain in the legs), ARTHRALGIA (joint pain, mostly in right wrist), FATIGUE (felt very fatigued) and PYREXIA (101 degrees F temperature/ fever lasted all day and night/ max temperature 102 Fahrenheit/ struggled with her temperature (fever)/ fever resolved (morning)). On 29-Oct-2021, PYREXIA (101 degrees F temperature/ fever lasted all day and night/ max temperature 102 Fahrenheit/ struggled with her temperature (fever)/ fever resolved (morning)) had resolved. At the time of the report, PAIN IN EXTREMITY (sore right arm), HYPERHIDROSIS (covered with sweat), MUSCULAR WEAKNESS (muscle weakness in legs), NEURALGIA (nerve pain in legs, shooting pain in the legs), ARTHRALGIA (joint pain, mostly in right wrist) and FATIGUE (felt very fatigued) outcome was unknown and HEADACHE (ongoing headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Oct-2021, Body temperature: 101 fahrenheit (High) 101 degrees Fahrenheit and max temperature 102 Fahrenheit.         Reporter had reported that she had no known drug or food allergies. She did not take any medications daily. No treatment medications were reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Neuralgia, Pain in extremity, Pyrexia
Clinical narrative: covered with sweat; muscle weakness in legs; nerve pain in legs, shooting pain in the legs; joint pain, mostly in right wrist; felt very fatigued; 101 degrees F temperature/ fever lasted all day and night/ max temperature 102 Fahrenheit/ struggled with her temperature (fever)/ fever resolved (morning); ongoing headache; sore right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore right arm), HYPERHIDROSIS (covered with sweat), MUSCULAR WEAKNESS (muscle weakness in legs), NEURALGIA (nerve pain in legs, shooting pain in the legs) and ARTHRALGIA (joint pain, mostly in right wrist) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Nerve pain. Previously administered products included for an unreported indication: PFIZER BIONTECH COVID-19 VACCINE (first dose 24-FEB-2021 with lot number  EN6202 and second dose 22-MAR-2021 with lot number  ER8782) from 24-Feb-2021 to 22-Mar-2021.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Oct-2021, the patient experienced PAIN IN EXTREMITY (sore right arm) and HEADACHE (ongoing headache). On 28-Oct-2021, the patient experienced HYPERHIDROSIS (covered with sweat), MUSCULAR WEAKNESS (muscle weakness in legs), NEURALGIA (nerve pain in legs, shooting pain in the legs), ARTHRALGIA (joint pain, mostly in right wrist), FATIGUE (felt very fatigued) and PYREXIA (101 degrees F temperature/ fever lasted all day and night/ max temperature 102 Fahrenheit/ struggled with her temperature (fever)/ fever resolved (morning)). On 29-Oct-2021, PYREXIA (101 degrees F temperature/ fever lasted all day and night/ max temperature 102 Fahrenheit/ struggled with her temperature (fever)/ fever resolved (morning)) had resolved. At the time of the report, PAIN IN EXTREMITY (sore right arm), HYPERHIDROSIS (covered with sweat), MUSCULAR WEAKNESS (muscle weakness in legs), NEURALGIA (nerve pain in legs, shooting pain in the legs), ARTHRALGIA (joint pain, mostly in right wrist) and FATIGUE (felt very fatigued) outcome was unknown and HEADACHE (ongoing headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Oct-2021, Body temperature: 101 fahrenheit (High) 101 degrees Fahrenheit and max temperature 102 Fahrenheit.         Reporter had reported that she had no known drug or food allergies. She did not take any medications daily. No treatment medications were reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 2 expired booster doses administered/0.25 mL of expired doses were given; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 expired booster doses administered/0.25 mL of expired doses were given) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A, 032L20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 expired booster doses administered/0.25 mL of expired doses were given). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (2 expired booster doses administered/0.25 mL of expired doses were given) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information provided.  No treatment medication information provided   Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: Follow up received and stated that patient felt fine and with no side effects.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Fear, Insomnia
Clinical narrative: Could not sleep; Scared; "turned bright red, like a lobster" after she showered/Redness; tired; nausea but could not throw up; aches; fever/the second night I was showering and had a fever; chills/the second night I was showering and had a fever; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Could not sleep), FEAR (Scared), ERYTHEMA ("turned bright red, like a lobster" after she showered/Redness), FATIGUE (tired) and NAUSEA (nausea but could not throw up) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A, 032120A and 051E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high since 2018, High cholesterol since 2019, Latex allergy (Had latex rubber bands in mouth for braces. Mouth swelled up. Drooled.) since 2009 and Drug allergy (Had a paper cut on eye. Given sulfa drug as antibiotic. Eye swelled. Weeped. Turned red.) since 1982. Concomitant products included LOSARTAN for Blood pressure high, ATORVASTATIN for High cholesterol.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced FEAR (Scared), ERYTHEMA ("turned bright red, like a lobster" after she showered/Redness), FATIGUE (tired), NAUSEA (nausea but could not throw up), MYALGIA (aches), PYREXIA (fever/the second night I was showering and had a fever) and CHILLS (chills/the second night I was showering and had a fever). On 22-Feb-2021, the patient experienced INSOMNIA (Could not sleep). The patient was treated with DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 26-Feb-2021, INSOMNIA (Could not sleep) had resolved. At the time of the report, FEAR (Scared) and ERYTHEMA ("turned bright red, like a lobster" after she showered/Redness) had resolved and FATIGUE (tired), NAUSEA (nausea but could not throw up), MYALGIA (aches), PYREXIA (fever/the second night I was showering and had a fever) and CHILLS (chills/the second night I was showering and had a fever) outcome was unknown.            This case was linked to MOD-2021-371729 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: Follow up received. Patient demographic details added, medical history added and additional events added.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Could not sleep; Scared; "turned bright red, like a lobster" after she showered/Redness; tired; nausea but could not throw up; aches; fever/the second night I was showering and had a fever; chills/the second night I was showering and had a fever; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Could not sleep), FEAR (Scared), ERYTHEMA ("turned bright red, like a lobster" after she showered/Redness), FATIGUE (tired) and NAUSEA (nausea but could not throw up) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A, 032120A and 051E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high since 2018, High cholesterol since 2019, Latex allergy (Had latex rubber bands in mouth for braces. Mouth swelled up. Drooled.) since 2009 and Drug allergy (Had a paper cut on eye. Given sulfa drug as antibiotic. Eye swelled. Weeped. Turned red.) since 1982. Concomitant products included LOSARTAN for Blood pressure high, ATORVASTATIN for High cholesterol.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced FEAR (Scared), ERYTHEMA ("turned bright red, like a lobster" after she showered/Redness), FATIGUE (tired), NAUSEA (nausea but could not throw up), MYALGIA (aches), PYREXIA (fever/the second night I was showering and had a fever) and CHILLS (chills/the second night I was showering and had a fever). On 22-Feb-2021, the patient experienced INSOMNIA (Could not sleep). The patient was treated with DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 26-Feb-2021, INSOMNIA (Could not sleep) had resolved. At the time of the report, FEAR (Scared) and ERYTHEMA ("turned bright red, like a lobster" after she showered/Redness) had resolved and FATIGUE (tired), NAUSEA (nausea but could not throw up), MYALGIA (aches), PYREXIA (fever/the second night I was showering and had a fever) and CHILLS (chills/the second night I was showering and had a fever) outcome was unknown.            This case was linked to MOD-2021-371729 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: Follow up received. Patient demographic details added, medical history added and additional events added.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Difficulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing) 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 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced DYSPNOEA (Difficulty breathing). On 02-Nov-2021, DYSPNOEA (Difficulty breathing) had resolved.            Concomitant medications was not reported. Treatment medications was not reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose, Expired product administered
Clinical narrative: Administered expirated vaccines to 29 employees and used vials which were thawed before 29Oct2021; 29 employees were vaccinated with 0.5ml Oct29th2021 as a booster; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expirated vaccines to 29 employees and used vials which were thawed before 29Oct2021) and ACCIDENTAL OVERDOSE (29 employees were vaccinated with 0.5ml Oct29th2021 as a booster) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.  On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expirated vaccines to 29 employees and used vials which were thawed before 29Oct2021) and ACCIDENTAL OVERDOSE (29 employees were vaccinated with 0.5ml Oct29th2021 as a booster). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered expirated vaccines to 29 employees and used vials which were thawed before 29Oct2021) and ACCIDENTAL OVERDOSE (29 employees were vaccinated with 0.5ml Oct29th2021 as a booster) had resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Pharmacist reported that they had used the look up tool that shown expiry date 29-Oct-2021 and on the box is 01-Nov-2021 for frozen vials, but vials were thawed before 29-Oct2-021.  No concomitant medications were reported.  No treatment medications were provided.  Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: Follow up received contains non significant information. On 08-Nov-2021: Follow up received contains non significant information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 23 patients received expired dose of the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (23 patients received expired dose of the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (23 patients received expired dose of the vaccine). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (23 patients received expired dose of the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported.  No treatment medication details was reported.  The reporter believes the vail was initially stored in the refrigerator on 19 Oct 2021. the vial had not underwent any temperature excursions.   This case was linked to MOD-2021-373198 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: Follow-up received on contains non significant information
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Joint swelling, Swelling
Clinical narrative: DVT in groin of right leg and DVT behind the left knee; swelling in the back of the knee; swelling in the groin; This spontaneous case was reported by a consumer and describes the occurrence of DEEP VEIN THROMBOSIS (DVT in groin of right leg and DVT behind the left knee) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039L20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included DVT (because of chemotherapy but it was under control).   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In October 2012, the patient experienced SWELLING (swelling in the groin). In October 2021, the patient experienced DEEP VEIN THROMBOSIS (DVT in groin of right leg and DVT behind the left knee) (seriousness criterion medically significant) and JOINT SWELLING (swelling in the back of the knee). At the time of the report, DEEP VEIN THROMBOSIS (DVT in groin of right leg and DVT behind the left knee), SWELLING (swelling in the groin) and JOINT SWELLING (swelling in the back of the knee) outcome was unknown.     No concomitant medication details were provided.  It was reported that patient was on blood thinners for at least 7 years (Feb-2014).  Treatment included: Doubled blood thinners for two weeks and was given something for pain.  Company Comment - This case concerns a 76-year-old female patient with relevant medical history of DVT at least 7 years ago because of chemotherapy, who experienced the unexpected, serious event deep vein thrombosis (AESI) and non-serious unexpected events of swelling and joint swelling. The events occurred on an unknown date approximately 9 months after the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable since the events occurred after the second dose. The relevant medical history of DVT at least 7 years ago because of chemotherapy remains a confounder. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Sender's Comments: This case concerns a 76-year-old female patient with relevant medical history of DVT at least 7 years ago because of chemotherapy, who experienced the unexpected, serious event deep vein thrombosis (AESI) and non-serious unexpected events of swelling and joint swelling. The events occurred on an unknown date approximately 9 months after the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable since the events occurred after the second dose. The relevant medical history of DVT at least 7 years ago because of chemotherapy remains a confounder. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Dyspepsia, Feeling cold, Feeling hot, Fine motor skill dysfunction
Clinical narrative: feel a little beat up; No motor skills, couldn't get out of bed , couldn't reach for my phone; felt freezing; feverish; shaking uncontrollably; like I was seizing; heart burn; acid reflux; felt hot; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking uncontrollably), DISCOMFORT (like I was seizing), DYSPEPSIA (heart burn), GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux) and FEELING HOT (felt hot) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced TREMOR (shaking uncontrollably), DISCOMFORT (like I was seizing), DYSPEPSIA (heart burn), GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux), FEELING HOT (felt hot), FINE MOTOR SKILL DYSFUNCTION (No motor skills, couldn't get out of bed , couldn't reach for my phone), FEELING COLD (felt freezing) and PYREXIA (feverish). On an unknown date, the patient experienced MALAISE (feel a little beat up). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 02-Nov-2021, TREMOR (shaking uncontrollably), DISCOMFORT (like I was seizing), DYSPEPSIA (heart burn), GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux), FEELING HOT (felt hot) and PYREXIA (feverish) had resolved. At the time of the report, MALAISE (feel a little beat up) had not resolved and FINE MOTOR SKILL DYSFUNCTION (No motor skills, couldn't get out of bed , couldn't reach for my phone) and FEELING COLD (felt freezing) had resolved.            No concomitant medications were reported.   This case was linked to MOD-2021-373361 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease, Malaise, Pyrexia, Tremor
Clinical narrative: feel a little beat up; No motor skills, couldn't get out of bed , couldn't reach for my phone; felt freezing; feverish; shaking uncontrollably; like I was seizing; heart burn; acid reflux; felt hot; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking uncontrollably), DISCOMFORT (like I was seizing), DYSPEPSIA (heart burn), GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux) and FEELING HOT (felt hot) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced TREMOR (shaking uncontrollably), DISCOMFORT (like I was seizing), DYSPEPSIA (heart burn), GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux), FEELING HOT (felt hot), FINE MOTOR SKILL DYSFUNCTION (No motor skills, couldn't get out of bed , couldn't reach for my phone), FEELING COLD (felt freezing) and PYREXIA (feverish). On an unknown date, the patient experienced MALAISE (feel a little beat up). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 02-Nov-2021, TREMOR (shaking uncontrollably), DISCOMFORT (like I was seizing), DYSPEPSIA (heart burn), GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux), FEELING HOT (felt hot) and PYREXIA (feverish) had resolved. At the time of the report, MALAISE (feel a little beat up) had not resolved and FINE MOTOR SKILL DYSFUNCTION (No motor skills, couldn't get out of bed , couldn't reach for my phone) and FEELING COLD (felt freezing) had resolved.            No concomitant medications were reported.   This case was linked to MOD-2021-373361 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Skin test
Clinical narrative: anaphylactic reaction; This literature-study case was reported in a literature article and describes the occurrence of ANAPHYLACTIC REACTION (anaphylactic reaction) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.       The patient's past medical history included Anaphylaxis (patient previously has self-reported cause which include Venom, food, Moderna first dosage (immediate generalized pruritus, followed by asthma exacerbation, tongue swelling, myalgia)).   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (anaphylactic reaction) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (anaphylactic reaction) outcome was unknown. Possible    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Skin test: positive (Positive) Immediate reaction:  positive(1:100), positive (Positive) late phase reaction: positive and positive (Positive) Delayed reaction: positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ANAPHYLACTIC REACTION (anaphylactic reaction) to be possibly related.    Concomitant product use was not provided by the reporter.   Treatment information was not provided.  Self-reported reactions to products containing PEG (polyethylene glycol) were no for Toothpaste & Colonoscopy prep. No COVID-19 infection reported for the patient. Anaphylaxis to vaccination was after desensitization was none  Company comment: This is a literature case concerning a 59-year-old female patient with medical history of anaphylaxys, who experienced the serious expected event of ANAPHYLACTIC REACTION after  receiving the first  dose of Moderna COVID-19 vaccine. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Sender's Comments: This is a literature case concerning a 59-year-old female patient with medical history of anaphylaxys, who experienced the serious expected event of ANAPHYLACTIC REACTION after  receiving the first  dose of Moderna COVID-19 vaccine. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: clots in her lungs and on a ventilator; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (clots in her lungs and on a ventilator) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (clots in her lungs and on a ventilator) (seriousness criteria hospitalization prolonged and medically significant). At the time of the report, PULMONARY EMBOLISM (clots in her lungs and on a ventilator) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by reporter. Treatment medication not reported.  Company comment: This case concerns a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) with no relevant medical history who experienced the serious unexpected event (AESI) of pulmonary embolism on unknown date after receiving a dose of the vaccine on unknown date. Limited information. Rechallenge is not applicable, since no further dosing is expected. The benefit-risk relationship is not affected by this report; Sender's Comments: This case concerns a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) with no relevant medical history who experienced the serious unexpected event (AESI) of pulmonary embolism on unknown date after receiving a dose of the vaccine on unknown date. Limited information. Rechallenge is not applicable, since no further dosing is expected. The benefit-risk relationship is not affected by this report
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021; Product storage error; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021) and PRODUCT STORAGE ERROR (Product storage error) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021) and PRODUCT STORAGE ERROR (Product storage error). On 06-Oct-2021, EXPIRED PRODUCT ADMINISTERED (gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021) and PRODUCT STORAGE ERROR (Product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Second dose administered after exposure to room temperature greater than 24 hours; Second dose administered after exposure to room temperature greater than 24 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Second dose administered after exposure to room temperature greater than 24 hours) and PRODUCT STORAGE ERROR (Second dose administered after exposure to room temperature greater than 24 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Second dose administered after exposure to room temperature greater than 24 hours) and PRODUCT STORAGE ERROR (Second dose administered after exposure to room temperature greater than 24 hours). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Second dose administered after exposure to room temperature greater than 24 hours) and PRODUCT STORAGE ERROR (Second dose administered after exposure to room temperature greater than 24 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information provided. Storage condition at the time of the excursion: refrigerated storage. Maximum temperature reached: 10 degrees Celsius. Excursion duration: 1 hour 20 minutes. Date vial(s) moved from freezer to refrigerator: 01-Oct-2021.   This case was linked to MOD-2021-374037 (Patient Link).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Headache, Pyrexia, Vomiting
Clinical narrative: other side of back is pain; Chills; Fever; threw up two times; Headache; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (other side of back is pain), CHILLS (Chills), PYREXIA (Fever), VOMITING (threw up two times) and HEADACHE (Headache) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A and 061E21A) for COVID-19 vaccination. No Medical History information was reported. On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Nov-2021, 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 experienced BACK PAIN (other side of back is pain), CHILLS (Chills), PYREXIA (Fever), VOMITING (threw up two times) and HEADACHE (Headache). At the time of the report, BACK PAIN (other side of back is pain), CHILLS (Chills), PYREXIA (Fever), VOMITING (threw up two times) and HEADACHE (Headache) was resolving. No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021). On 06-Oct-2021, EXPIRED PRODUCT ADMINISTERED (gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pyrexia, Rash, Sneezing, Vaccination site erythema
Clinical narrative: big oval area that is a lighter red to his elbow; larger kind of rash area on his injections arm down to his elbow; on the injection arm he has a red area about an inch and a half around the injection site, the injections site he can see the red dot; fever; sneezing; This spontaneous case was reported by a dentist and describes the occurrence of ERYTHEMA (big oval area that is a lighter red to his elbow), SNEEZING (sneezing), RASH (larger kind of rash area on his injections arm down to his elbow), VACCINATION SITE ERYTHEMA (on the injection arm he has a red area about an inch and a half around the injection site, the injections site he can see the red dot) and PYREXIA (fever) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Oct-2021, the patient experienced SNEEZING (sneezing) and PYREXIA (fever). On 31-Oct-2021, the patient experienced ERYTHEMA (big oval area that is a lighter red to his elbow), RASH (larger kind of rash area on his injections arm down to his elbow) and VACCINATION SITE ERYTHEMA (on the injection arm he has a red area about an inch and a half around the injection site, the injections site he can see the red dot). On 01-Nov-2021, SNEEZING (sneezing) and PYREXIA (fever) had resolved. At the time of the report, ERYTHEMA (big oval area that is a lighter red to his elbow), RASH (larger kind of rash area on his injections arm down to his elbow) and VACCINATION SITE ERYTHEMA (on the injection arm he has a red area about an inch and a half around the injection site, the injections site he can see the red dot) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment information was reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered after exposure to room temperature >24 hours; temperature excursion that occurred on Oct6th. Fridge's door was not closed all the way, and temperature was out of range for about 1 hour and 20 minutes; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature >24 hours) and PRODUCT STORAGE ERROR (temperature excursion that occurred on Oct6th. Fridge's door was not closed all the way, and temperature was out of range for about 1 hour and 20 minutes) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature >24 hours) and PRODUCT STORAGE ERROR (temperature excursion that occurred on Oct6th. Fridge's door was not closed all the way, and temperature was out of range for about 1 hour and 20 minutes). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature >24 hours) and PRODUCT STORAGE ERROR (temperature excursion that occurred on Oct6th. Fridge's door was not closed all the way, and temperature was out of range for about 1 hour and 20 minutes) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were provided by the reporter.  No Treatment Information were provided by the reporter.   This case was linked to MOD-2021-374037, MOD-2021-374037 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: Follow-up received Contains suspect start date were given