chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Administrated / after a below freezing temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 11-year-old male patient who received HAV (Havrix) (batch number yl532, expiry date 9th September 2023) for prophylaxis.   On 23rd July 2021, the patient received Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The physician reported that a patient was administrated with Havrix after a below freezing temperature excursion, which led to incorrect storage of drug. No adverse event was reported. The reporter consented to follow up. This case is one of 28 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164771:same reporter US-GLAXOSMITHKLINE-US2021164775:same reporter US-GLAXOSMITHKLINE-US2021164789:Same reporter US-GLAXOSMITHKLINE-US2021164795:Same reporter. US-GLAXOSMITHKLINE-US2021164801:Same reporter. US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164777:same reporter US-GLAXOSMITHKLINE-US2021164779:Same reporter. US-GLAXOSMITHKLINE-US2021164802:same reporter US-GLAXOSMITHKLINE-US2021164784:Same reporter. US-GLAXOSMITHKLINE-US2021164793:same reporter US-GLAXOSMITHKLINE-US2021164797:Same reporter. US-GLAXOSMITHKLINE-US2021164800:Same reporter. US-GLAXOSMITHKLINE-US2021164769:same reporter US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164792:same reporter US-GLAXOSMITHKLINE-US2021164803:same reporter US-GLAXOSMITHKLINE-US2021164786:Same reporter. US-GLAXOSMITHKLINE-US2021164794:Same reporter. US-GLAXOSMITHKLINE-US2021164798:Same reporter. US-GLAXOSMITHKLINE-US2021164799:Same reporter. US-GLAXOSMITHKLINE-US2021164798:Same reporter. US-GLAXOSMITHKLINE-US2021164804:Same reporter. US-GLAXOSMITHKLINE-US2021164805:Same reporter. US-GLAXOSMITHKLINE-US2021164806:Same reporter. US-GLAXOSMITHKLINE-US2021164808:Same reporter.
Age: 0.17
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 2 month old patient received a dose of Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old female patient who received DTPa-IPV (Kinrix) (batch number YZ97N, expiry date 26th August 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter reported that the 2 months old patient inadvertently received a dose of Kinrix which led to inappropriate age at vaccine administration.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative via social media concerned a male of unspecified age and of unknown race and ethnic origin. 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) frequency 1 total, dose not reported, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date (also mentioned as 12 day ago), the patient had suspected clinical vaccination failure and suspected covid-19 infection The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and  suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000187875. This case, from the same reporter is linked to 20210802047. Addition information was received from patient on 29-JUL-2021 It was determined that Manufacturer Case Number 20210802047 was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number 20210801064.; Sender's Comments: V0. 20210801064-COVID-19 VACCINE AD26.COV2.S.- Suspected clinical vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Oropharyngeal pain, Poor quality product administered, Product storage error
Clinical narrative: SORE THROAT; HEADACHE; FEVER; PAIN AT THE INJECTION SITE; POOR QUALITY DRUG ADMINISTERED; INCORRECT STORAGE OF DRUG; This spontaneous report received from a health care professional 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 was not reported, administered on 29-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 29-JUL-2021, the subject experienced poor quality drug administered. On 29-JUL-2021, the subject experienced incorrect storage of drug. On an unspecified date, the subject experienced sore throat, headache, fever, and pain at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the poor quality drug administered, sore throat, headache, fever, pain at the injection site and incorrect storage of drug was not reported. This report was non-serious. This case, from the same reporter is linked to 20210802801 and 20210803269.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: SORE THROAT; HEADACHE; FEVER; PAIN AT THE INJECTION SITE; POOR QUALITY DRUG ADMINISTERED; INCORRECT STORAGE OF DRUG; This spontaneous report received from a health care professional 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 was not reported, administered on 29-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 29-JUL-2021, the subject experienced poor quality drug administered. On 29-JUL-2021, the subject experienced incorrect storage of drug. On an unspecified date, the subject experienced sore throat, headache, fever, and pain at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the poor quality drug administered, sore throat, headache, fever, pain at the injection site and incorrect storage of drug was not reported. This report was non-serious. This case, from the same reporter is linked to 20210802801 and 20210803269.
Sex: M
Vaccine: COVID19
Symptoms: Migraine, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINE FAILURE; SUSPECTED COVID-19 INFECTION; RECURRING MIGRAINE HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included recurrent migraine headache. 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 caught covid-19 and symptoms were moderate at the point of reporting. The patient had a recurring migraine headache, chills, congestion and heavy pain to chest especially when the patient coughs or sneezes. The patient experienced suspected clinical vaccine failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccine failure, suspected covid-19 infection and recurring migraine headache was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210804055-COVID-19 VACCINE AD26.COV2.S.- Suspected clinical vaccine failure. This event is considered not related. The event has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Injection site pain, Insomnia
Clinical narrative: INSOMNIA/LOSE SOME SLEEP; HIGH BODY TEMPERATURE; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 39 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies, no known medical conditions and does not take any medications at the time of reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021, the subject experienced insomnia/lose some sleep. On 02-AUG-2021, the subject experienced high body temperature. On 02-AUG-2021, the subject experienced injection site pain. Laboratory data included: Body temperature (NR: not provided) high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from high body temperature, and insomnia/lose some sleep, and the outcome of injection site pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: BODY PAIN; CHILLS; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced body pain, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever and body pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cerebral thrombosis
Clinical narrative: BLOOD CLOTS IN BRAIN; This spontaneous report received from a patient via a company representative concerned a female of unspecified age, race and ethnic origin. 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, expiry: unknown) dose was not reported, 1 total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  Two weeks later on an unknown date in MAR-2021, the patient experienced blood clots in brain and died from blood clot in her brain. It was reported that, the plug was pulled after one week. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  This report was serious (Death).; Sender's Comments: V0: This spontaneous report received from a patient via a company representative concerned a female of unspecified age and ethnicity, who experienced blood clots in brain two weeks after receiving Janssen Covid-19 vaccine Ad26.COV2.S. It was reported that, the plug was pulled after one week. The patient died from blood clots in brain. It was unspecified if an autopsy was performed. The patient's height, and weight were not reported. No past medical history, concurrent conditions, and concomitant medications were reported. Information is limited in this case, and the occurrence of blood clots in brain could represent background incidence of such events in the general population. Hence, the relationship to the vaccination is considered unclassifiable. Additional information has been requested.; Reported Cause(s) of Death: BLOOD CLOT IN BRAIN
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: HAS NOT HAD A MENSTRUAL PERIOD FOR 7 MONTHS; This spontaneous report received from a patient via a company representative 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced has not had a menstrual period for 7 months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of has not had a menstrual period for 7 months was not reported. This report was non-serious. This case, from the same reporter is linked to 20210818191.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Mass, Myalgia, Nasopharyngitis
Clinical narrative: PAIN TO LUMP UNDER NECK/EAR/CHIN; LUMP UNDER NECK; BACK MUSCLE PAIN; TIRED; LUMP UNDER EAR  AND CHIN THAT ARE GROWING; MILD COUGH; LIKE A COLD; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes, hypertension, high cholesterol, non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient had no history of drug abuse/illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041421A expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the patient experienced mild cough. On 03-APR-2021, the patient experienced like a cold. On 27-JUL-2021, the patient experienced lump under ear and chin that are growing. On 03-AUG-2021, the patient experienced back muscle pain. On 03-AUG-2021, the patient experienced tired. On 07-AUG-2021, the patient experienced lump under neck. On 09-AUG-2021, the patient experienced pain to lump under neck/ear/chin.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lump under ear and chin that are growing, back muscle pain, mild cough, tired, like a cold, lump under neck, and pain to lump under neck/ear/chin. This report was non-serious.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Neck mass, Pain
Clinical narrative: PAIN TO LUMP UNDER NECK/EAR/CHIN; LUMP UNDER NECK; BACK MUSCLE PAIN; TIRED; LUMP UNDER EAR  AND CHIN THAT ARE GROWING; MILD COUGH; LIKE A COLD; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes, hypertension, high cholesterol, non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient had no history of drug abuse/illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041421A expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the patient experienced mild cough. On 03-APR-2021, the patient experienced like a cold. On 27-JUL-2021, the patient experienced lump under ear and chin that are growing. On 03-AUG-2021, the patient experienced back muscle pain. On 03-AUG-2021, the patient experienced tired. On 07-AUG-2021, the patient experienced lump under neck. On 09-AUG-2021, the patient experienced pain to lump under neck/ear/chin.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lump under ear and chin that are growing, back muscle pain, mild cough, tired, like a cold, lump under neck, and pain to lump under neck/ear/chin. This report was non-serious.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Feeding disorder, Headache, Injection site pain, Pruritus
Clinical narrative: RASH  AROUND THE BELLY AND ON THE BREAST/A LOT OF RASH ON HER BACK; FEVER; HEADACHES; DIFFICULTY SWALLOWING; NOT ABLE TO EAT; ITCHING UNDER THE BREAST; RIGHT ARM IS SORE AT  THE INJECTION SITE AND IT FEELS HARD; This spontaneous report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. The patient's past medical history included: anemia, and concurrent conditions included: no alcohol use, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies, and no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, and expiry: UNKNOWN) dose was not reported, administered on 06-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On AUG-2021, the patient experienced right arm is sore at the injection site and it feels hard. On 06-AUG-2021, the patient experienced difficulty swallowing. On 06-AUG-2021, the patient experienced not able to eat. On 06-AUG-2021, the patient experienced itching under the breast. On 06-AUG-2021, the patient experienced fever. On 06-AUG-2021, the patient experienced headaches. On 07-AUG-2021, the patient experienced rash around the belly and on the breast/a lot of rash on her back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash around the belly and on the breast/a lot of rash on her back, and the outcome of fever, difficulty swallowing, headaches, not able to eat, itching under the breast and right arm is sore at the injection site and it feels hard was not reported. This report was non-serious.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: RASH  AROUND THE BELLY AND ON THE BREAST/A LOT OF RASH ON HER BACK; FEVER; HEADACHES; DIFFICULTY SWALLOWING; NOT ABLE TO EAT; ITCHING UNDER THE BREAST; RIGHT ARM IS SORE AT  THE INJECTION SITE AND IT FEELS HARD; This spontaneous report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. The patient's past medical history included: anemia, and concurrent conditions included: no alcohol use, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies, and no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, and expiry: UNKNOWN) dose was not reported, administered on 06-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On AUG-2021, the patient experienced right arm is sore at the injection site and it feels hard. On 06-AUG-2021, the patient experienced difficulty swallowing. On 06-AUG-2021, the patient experienced not able to eat. On 06-AUG-2021, the patient experienced itching under the breast. On 06-AUG-2021, the patient experienced fever. On 06-AUG-2021, the patient experienced headaches. On 07-AUG-2021, the patient experienced rash around the belly and on the breast/a lot of rash on her back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash around the belly and on the breast/a lot of rash on her back, and the outcome of fever, difficulty swallowing, headaches, not able to eat, itching under the breast and right arm is sore at the injection site and it feels hard was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac imaging procedure, Cardiac stress test, Cardiomegaly, Echocardiogram
Clinical narrative: ENLARGED HEART; This spontaneous report received from a patient 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, intramuscular, batch number: Unknown) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On JAN-2019, Laboratory data included: Stress test (NR: not provided) Normal. On JAN-2021, Laboratory data included: Echocardiogram (NR: not provided) Normal. On 09-AUG-2021, the patient experienced enlarged heart. Laboratory data included: Cardiac imaging procedure (NR: not provided) Enlarged heart. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of enlarged heart was not reported. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Hypertension
Clinical narrative: DIZZINESS; ELEVATED BLOOD PRESSURE; ANXIETY; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's past medical history included: migraines, and concurrent conditions included: heavy metals allergy, and highly sensitive to chemicals. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-AUG-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, ascorbic acid, ergocalciferol, and zinc. On 06-AUG-2021, the patient experienced dizziness. On 06-AUG-2021, the patient experienced elevated blood pressure. On 06-AUG-2021, the patient experienced anxiety. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure, had not recovered from dizziness, and the outcome of anxiety was not reported. This report was non-serious.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ARM JUST BEEN TENDER, LITTLE ACHE, AND SORE ON TOUCH; This spontaneous report received from a patient concerned an 88 year old female. The patient's height, and weight were not reported. The patient's past medical history included: periods of depression, and other pre-existing medical conditions included: her blood goes half way in the right side of the neck. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced arm just been tender, little ache, and sore on touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm just been tender, little ache, and sore on touch. This report was non-serious.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: SORE ARM; SHOULDER PAIN; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's past medical history included: brain aneurysms, and fall on job site, and concurrent conditions included: 2 small tears in the left shoulder. The patient was previously treated with naproxen sodium for drug used for unknown indication, and ibuprofen for drug used for unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 04-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On AUG-2021, the patient experienced shoulder pain. On 04-AUG-2021, the patient experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shoulder pain on 06-AUG-2021, and sore arm on AUG-2021. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Hypoaesthesia, Urticaria
Clinical narrative: Bottom lip, chin, jawline feels numb; Bitter taste; hives on forearm, left and right wrist to elbow; A spontaneous report was received from a registered respiratory therapist concerning a 38 year-old, female patient participating in the mRNA-1273 Emergency Use Program and experienced hives on forearm (right and left wrist to elbow), bottom lip numbness, chin numbness, jawline numbness, and bitter taste.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 24 Dec 2020, approximately 24 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (025J20A) intramuscularly for prophylaxis of COVID-19 infection.   On 25 Dec 2020, the patient started to experience hives on her left and right forearm, from wrist to elbow. Self-treatment with Benadryl for this event caused symptoms to reside for 45 mins. On 26 Dec 2020, the patient experienced numbness of her bottom lip, chin, and jawline spreading to the neck up to the left side of the face. Patient notes this feeling as "like getting a Novocain injection". On 26 Dec 2020, the patient also began to experience bitter taste. Treatment for the event included diphenhydramine hydrochloride.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events hives on forearm (right and left wrist to elbow), bottom lip numbness, chin numbness, jawline numbness, and bitter taste were not reported.; Reporter's Comments: This case concerns a 38-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 025J20A), and who experienced the non-serious unlisted events of Urticaria, Hypoaesthesia, and Dysgeusia.  Based on the current available information and temporal association between the use of the product and the onset of events starting on the day after vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nasal dryness, Vaccination site pain
Clinical narrative: headache; scratchy dry nose; feeling tired; arm pain; A spontaneous report was received concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache, scratching dry nose, feeling tired and arm pain.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On unknown date, the patient received their first of two planned doses of mRNA-1273 (lot #unknown) intramuscularly for of COVID-19 infection.   On 28 Dec 2020, the reporter stated that her co-worker received the vaccine last Wednesday. Her coworker reported headache, scratching dry nose, feeling tired and arm pain. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of event, arm pain, was resolved. The outcome of events, headache, scratching dry nose and feeling tired were not reported.; Reporter's Comments: This case concerns a female patient of unknown age, who experienced a non-serious unexpected event of nasal dryness and non-serious expected events of headache, fatigue and vaccination site pain. The events occurred on an unspecified date after first dose of mRNA-1273, lot # unknown. Treatment details were not provided. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypoaesthesia, Injection site pain, Migraine, Nausea
Clinical narrative: chills; Numbness; Pain right above injection site up my arm to back of neck and base of skull like a pulling sensation; some pain at injection site; nausea and headache came in wave; Headaches similar to past migraines; A spontaneous report was received from a nurse concerning a 63 year old patient who was participating in the mRNA-1273 Emergency Use Program and experienced numbness, radiating pain, injection site pain, nausea, migraine, and chills  The patient's medical history, provided by the reporter, included migraines and a positive test for COVID-19 in July 2020.  No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection on 24 Dec 2020.  On 25 Dec 2020, the patient experienced some pain at the injection site which kept her from sleeping on her left arm.  She also experienced pain right above the injection site up her arm to the back of her neck and base of her skull like a pulling sensation.  This was accompanied by nausea, numbness, and headaches like her past migraines.  The injection site pain and radiating pain resolved.    On 27 Dec 2020, the patient experienced chills.   On Dec 28 2020, headaches worsened before resolving.  The numbness, nausea, headaches and chills also resolved.  Treatment medications included Zofran and Excedrin.  Action taken with mRNA-1273 in response to the events was not reported.  The events, injection site pain and radiating pain, were recovered/resolved on 25 Dec 2020.  The events, numbness, nausea, headaches, and chills were recovered/resolved on 28 Dec 2020.; Reporter's Comments: This report concerns a 63-year old female patient  who experienced non-serious events of numbness, radiating pain, injection site pain, nausea, migraine, and chills all occurring within 1 week of her receiving the mRNA-1273. These events were considered as recovering after treatment with Zofran and Excedrin. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: chills; Numbness; Pain right above injection site up my arm to back of neck and base of skull like a pulling sensation; some pain at injection site; nausea and headache came in wave; Headaches similar to past migraines; A spontaneous report was received from a nurse concerning a 63 year old patient who was participating in the mRNA-1273 Emergency Use Program and experienced numbness, radiating pain, injection site pain, nausea, migraine, and chills  The patient's medical history, provided by the reporter, included migraines and a positive test for COVID-19 in July 2020.  No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection on 24 Dec 2020.  On 25 Dec 2020, the patient experienced some pain at the injection site which kept her from sleeping on her left arm.  She also experienced pain right above the injection site up her arm to the back of her neck and base of her skull like a pulling sensation.  This was accompanied by nausea, numbness, and headaches like her past migraines.  The injection site pain and radiating pain resolved.    On 27 Dec 2020, the patient experienced chills.   On Dec 28 2020, headaches worsened before resolving.  The numbness, nausea, headaches and chills also resolved.  Treatment medications included Zofran and Excedrin.  Action taken with mRNA-1273 in response to the events was not reported.  The events, injection site pain and radiating pain, were recovered/resolved on 25 Dec 2020.  The events, numbness, nausea, headaches, and chills were recovered/resolved on 28 Dec 2020.; Reporter's Comments: This report concerns a 63-year old female patient  who experienced non-serious events of numbness, radiating pain, injection site pain, nausea, migraine, and chills all occurring within 1 week of her receiving the mRNA-1273. These events were considered as recovering after treatment with Zofran and Excedrin. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Pain, Pyrexia
Clinical narrative: Body aches all night; Chills; fever of 100.2 deg. Fahrenheit; A spontaneous report was received from a consumer concerning a 60-year-old patient who experienced fever/MedDRA PT: pyrexia, body aches all night/MedDRA PT: pain, and chills/MedDRA PT: chills.  The patient's medical history was not provided by the reporter.  Concomitant products including levothyroxine and Lexapro.  On 29-Dec-2020, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 30-Dec-2020 the patient experienced fever of 100.2 degrees, chills, and body aches.  The events were treated with Tylenol.  At the time of the report the outcome for the events was unknown.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events was not reported.   The reporter did not provide causality for the events.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia oral, Taste disorder
Clinical narrative: taste the medicine in her mouth; Tongue became tingly; Arm was sore and achy; A spontaneous report was received from a consumer concerning a 52-year-old female patient who experienced arm was sore and achy, taste the medicine in her mouth, and tongue became tingly.   The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 (lot: unknown) for prophylaxis of COVID-19 infection in the right arm on 27 Dec 2020.   On 27 Dec 2020, the patient's arm was sore and achy, taste the medicine in her mouth, tongue became tingly.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, arm was sore and achy, was resolved on 29 Dec 2020.  The outcome of the events, taste the medicine in her mouth, and tongue became tingly, was resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Eye swelling
Clinical narrative: swollen eye; eye that hurts really bad; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swollen eye that hurts really bad.  The patient's medical history was not provided. No concomitant medications were reported.   On 24 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot# Unknown).   On an unknown date, the patient experienced swollen eye that hurts really bad. No treatment information was reported.  The Action taken with mRNA-1273 in response to the events was unknown.  The outcome for the event, swollen eye that hurts really bad was unknown.  The reporter did not provide an assessment for the events.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Musculoskeletal stiffness
Clinical narrative: tightness on one side of neck; tightness of shoulder; A report was received from a consumer concerning a 91-year old, female patient who was participating in the mRNA-1273 Emergency Use Program and developed tightness on one side of neck and tightness of shoulder.  The patient's medical history was not provided. Concomitant medications reported included atorvastatin and omeprazole.  On 30 Dec 2020 at 16:30,, approximately 14 hours and 30 minutes prior to the onset of the events, tightness on one side of neck and tightness of shoulder, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 31 Dec 2020 at 7:00 am, the patient woke up and felt a bit of tightness on one side of her neck and shoulder, mostly neck. She said it could be because of the way she slept. No treatment information was provided.  Action taken with mRNA-1273 in response to the event(s) was not reported.  The outcomes of the events, tightness on one side of neck and tightness of shoulder, were unknown  The reporter did not provide an assessment for the events, tightness on one side of neck and tightness of shoulder.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Where the vaccine was shot is real red; real hard bump; Starting to itch; Swollen; hurting a little bit/ Sore; A spontaneous report was received from a 60 year old female consumer concerning herself who was participating in the mRNA-1273 Program and experienced where the vaccine was given red, sore, swollen and starting to itch and a real hard bump.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   After the vaccine administration on 29 Dec 2020, patient experienced left arm pain/sorness. On 30 Dec 2020, patient experienced where the vaccine was given red, swollen and starting to itch and a real hard bump.  Treatment for the event included rubbing alcohol.   Action taken with mRNA-1273 in response to the events was not reported.   If it is known that the event occurred after the second dose of mRNA-1273, include:   The outcome of events, where the vaccine was given red, sore, swollen and starting to itch and a real hard bump, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Lethargy
Clinical narrative: Lethargic; A spontaneous report was received from a consumer, who is a female of an unknown age that received Moderna's COVID-19 Vaccine and experienced lethargy.    The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273, unknown lot, unknown route, unknown location for prophylaxis of COVID-19 infection.   The patient was feeling lethargic the day after receiving the vaccine.   No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, feeling lethargic the day after receiving the vaccine, was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymph node pain, Nasal congestion, Pain, Sensory loss
Clinical narrative: Lot of congestion; Entire upper right side of her body hurts; Loses sensation when she picks up her phone; Lymph nodes hurts a lot; Headache; A spontaneous report was received from a 26 year old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain in lymph nodes, headache,  a lot of congestion, upper right side of her body hurts and she loses sensation when she picks up her phone.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly, in her right deltoid, for prophylaxis of COVID-19 infection.   On 27 Dec 2020, the patient stated that her lymph nodes hurt a lot, she had a headache, a lot of congestion, her entire upper right side of her body hurts and she loses sensation when she picks up her phone. It has been a week and it still hurts. She took paracetamol for the same and guaifenesin for the congestion, which seemed to help a little bit.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events, lymph node pain,  headache, congestion, her entire upper right side of her body hurts, she loses sensation when she picks up her phone, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blood pressure increased, Blood pressure measurement, Body temperature, Fatigue
Clinical narrative: blood pressure increased; Really bad headache; Felt drained; Sick to stomach; Arms felt like they were 50 pounds; Felt kind of funny; felt sick/felt terrible; Little discomfort in arm; Fever; A spontaneous report  was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had experienced fever (pyrexia), discomfort in arm  pain, felt terrible and sick, drained, sick to stomach, really bad headache, arms felt like they were 50 pounds, and felt kind of funny.  The patient's medical history and concomitant product use were not provided by the reporter.  On 28 Dec 2020, the same day as the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot #: 037K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 28 Dec 2020, the first night after receiving the vaccine, the patient reported they had a little fever, little discomfort in arm and felt sick and terrible.  The patient's temperature was 99.5 and 100 degrees Fahrenheit. On 29 Dec 2020, patient  felt ok.  However, on 30 Dec 2020, the patient continued to run a fever, felt sick and drained, had a really bad headache, sick to her stomach,  arms felt like they weighed 50 pounds, and they felt kind of funny.  At one point the patient's blood pressure was 186/106 and had been high on and off since being vaccinated.  At the time of the report, the patient stated that while they were feeling better, they are still experiencing these symptoms.    Action taken with mRNA-1273 in response to the events was not provided/unknown.  The outcome of the events, had a little fever, little discomfort in arm, felt terrible and sick, drained, sick to stomach, really bad headache, arms felt like they were 50 pounds, and felt kind of funny, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Illness, Limb discomfort, Pyrexia
Clinical narrative: blood pressure increased; Really bad headache; Felt drained; Sick to stomach; Arms felt like they were 50 pounds; Felt kind of funny; felt sick/felt terrible; Little discomfort in arm; Fever; A spontaneous report  was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had experienced fever (pyrexia), discomfort in arm  pain, felt terrible and sick, drained, sick to stomach, really bad headache, arms felt like they were 50 pounds, and felt kind of funny.  The patient's medical history and concomitant product use were not provided by the reporter.  On 28 Dec 2020, the same day as the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot #: 037K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 28 Dec 2020, the first night after receiving the vaccine, the patient reported they had a little fever, little discomfort in arm and felt sick and terrible.  The patient's temperature was 99.5 and 100 degrees Fahrenheit. On 29 Dec 2020, patient  felt ok.  However, on 30 Dec 2020, the patient continued to run a fever, felt sick and drained, had a really bad headache, sick to her stomach,  arms felt like they weighed 50 pounds, and they felt kind of funny.  At one point the patient's blood pressure was 186/106 and had been high on and off since being vaccinated.  At the time of the report, the patient stated that while they were feeling better, they are still experiencing these symptoms.    Action taken with mRNA-1273 in response to the events was not provided/unknown.  The outcome of the events, had a little fever, little discomfort in arm, felt terrible and sick, drained, sick to stomach, really bad headache, arms felt like they were 50 pounds, and felt kind of funny, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.