chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Electroencephalogram, Fatigue, Seizure
Clinical narrative: Seizures; Mini stroke; Tired; A spontaneous report was received from a consumer concerning a 73-year-old male who received Moderna Covid-19 vaccine and experienced seizures, mini stroke, confused, agitated, eyes were abnormal, memory impairment, and tired.   The patient's medical history included heart attack and stent placement in 2011. His relevant concomitant medications include acetylsalicylic acid, candesartan cilexetil, clopidogrel bisulfate, diltiazem hydrochloride, ezetimibe, adenosine, gabapentin, metoprolol tartrate and rosuvastatin calcium.  The patient received their first of two planned doses of mRNA-1273 on 14 Jan 2021. On 10 Feb 2021, 30 minutes prior to the onset of the events, the patient received his second of two planned doses of mRNA-1273 (Lot#010M20A) intramuscularly in left deltoid for the prophylaxis of COVID-19 infection.   On 10 Feb 2021, With in 30 minutes of receiving the vaccination, the patient had a seizure. They took him to the hospital, where he had a computerized tomography (CT) scan, blood work and had a consult. After consult, they said, it's a mini stroke. They released him and told her if it happens again call 911. He felt so tired and went to sleep at home. Around 17:00 dinner time, he woke up looked very blankly, and his wife reported knowing he had another seizure. She reported he ran to his keys saying, "I have to go", seemed confused, agitated and didn't know where he was. She called 911 andhe was transported to the hospital in an ambulance.  Around 19:00 the same day, he was admitted to do scans overnight. Around 21:00, patient's eyes were abnormal, he became agitated again and nurses confirmed he was having another seizure. 30 minutes later, he was talking to his wife and daughter as if he didn't remember anything. He mentioned some metallic taste in his mouth.  On 11 Feb 2021, they did an electroencephalogram (EEG) and confirmed that he was having seizure. He was prescribed seizure medication and released him from hospital. However, the patient and his wife reported not wanting him to take the medication as they believe the events were due to the vaccine. Treatment information was not provided.   Action taken with vaccine is not applicable as the patient received both the doses.  The outcomes of the events, seizures, mini stroke, and tired, were recovered.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  The patient's medical history of heart attack and concomitant medication use can be confounding factor. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Dizziness, Haemorrhage
Clinical narrative: Saw a lot of blood on the water when she was taking a shower; arthritis act up; dizzy; A spontaneous report was received from a 76-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and felt dizzy, arthritis come up, and saw a lot of blood on the water when she was taking a shower.  The patient's medical history included arthritis. No relevant concomitant medications were reported.  On 09 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 007M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 09 Feb 2021, the patient felt dizzy after receiving the Moderna vaccine. On 10 Feb, 2021 the patient reported that her arthritis had come up and she took two aspirins. The patient reported blood on the water while she was taking a shower.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the reported event of dizziness and arthritis, a causal relationship cannot be excluded. Although a temporal association exist, there is still not enough information to assess the causal association between the event saw blood  and mRNA-1273 . Critical details such as the source  of blood patient's medical history is lacking. Further information has been requested
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Myalgia
Clinical narrative: Second dose was taken 14 days after 1st dose; Headache; Body aches; A spontaneous report received from a consumer concerning a 48-year-old male patient who received the second dose of Moderna COVID-19 vaccine and second dose was taken 14 days after 1st dose and experienced headache, and body aches.  The patient's medical history was not included/ unknown. Patient's concomitant was not included/ unknown.    Patient received 1st vaccine on 29 JAN 2021 (Lot number 029L20A)  and had no symptoms.  On 11-FEB-2021, the patient received the second of two planned doses of mRNA-1273 (Batch #: 013M20A) intramuscularly for prophylaxis of COVID-19 infection.   Patient received the second vaccine on 11 FEB 2021 and reported the development of headache, and body aches. Patient stated having been told by his employer that he needed to take the second dose. Patient realized after receiving the second vaccination that maybe he took the second dose too early. Second dose was taken 14 days after 1st dose. Treatment for events included naproxen .  Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event headache, and body aches, were unknown at the time of this report. The outcome of event second dose was taken 14 days after 1st does and experienced was considered resolved on 11 FEB 2021.; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot #029L20A, with associated AEs. 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.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Needle issue, Underdose
Clinical narrative: During vaccination, needle came loose and 50% of the vaccine was spilled; During vaccination, needle came loose and 50% of the vaccine was spilled; A spontaneous report was received from a physician's assistant concerning a 34-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and during vaccination, needle came loose (device connection issue) and 50% of the vaccine was spilled (underdose).  The patient's medical history was not provided.  Concomitant product use was not provided.  The patient received their first of two planned doses of mRNA-1273 (batch number not provided) on an unknown date.  On 11 Feb 2021, on the same day as the onset of events, the patient received their second of two planned doses of mRNA-1273 (batch number: 038K20A) in the left arm for prophylaxis of COVID-19 infection.  On 11 Feb 2021, during vaccination, the needle came loose and 50% of the vaccine was spilled.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, the action taken with the drug in response to the events was not applicable.   The outcome of the events, during vaccination, needle came loose and 50% of the vaccine was spilled, was considered recovered/resolved on 11 Feb 2021.; Reporter's Comments: This report refers to a case of Underdose due to loose needle for mRNA-1273, lot # 038K20A with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eye pruritus, Overdose, Rash macular
Clinical narrative: Itchy eyes; Redness on the face; Rash just below her neck and above her chest; blotchiness but no hives; Readministered the vaccine to the patient thinking the first vial was empty; A spontaneous report received from a consumer concerning a 66-year-old female patient who received the first dose of Moderna COVID-19 vaccine and where the patient felt the needle go in but didn't feel the liquid and had developed itchy eyes, redness on the face, rash just below her neck and above her chest, and was readministered the vaccine to the patient thinking the first vial was empty.  The patient's medical history was not provided. Patient's concomitant was not provided.    On 12-FEB-2021, the patient received their first of two planned doses of mRNA-1273 in her right arm (Batch #: 024M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 12Feb2021 patient experienced itchy eyes, redness on the face, and a rash just below her neck and above her chest. There was "blotchiness but no hives". She had the same type of reaction as she does to orange peels. She had no trouble breathing. She took some diphenhydramine hydrochloride to help. The nurse also re-administered the vaccine to the patient thinking the first vial was empty and as the patient felt the needle go in but didn't feel the liquid.  Action taken with mRNA-1273 in response to the events were not provided.   The outcome of events itchy eyes, redness on the face, rash just below her neck and above her chest were unknown at the time of this report. The outcome of events the patient felt the needle go in but didn't feel the liquid was considered resolved on 12-Feb-2021 and readministered the vaccine to the patient thinking the first vial was empty were considered resolved on an unspecified date in Feb-2021.; Reporter's Comments: This case concerns a 66 year old, female patient, who experienced a non-serious unexpected event of eye pruritus, erythema, rash macular, after receiving first dose mRNA-1273. This report refers to a case of overdose for mRNA-1273 (lot # 024M20A), with no associated AEs. 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. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: Bell's Palsy; A spontaneous report received from a Healthcare Professional concerning, 81-year-old female patient who received the first dose of Moderna COVID-19 vaccine and was hospitalized for Bell's Palsy.   The patient's medical history was not included/ unknown. There were no concomitant medications provided.    On 15-JAN-2021, the patient received their first of two planned doses of mRNA-1273 (Batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection.   Patient was hospitalized on 19Jan2021 because developed Bell's palsy. Patient was observed because it was thought that she had a stroke. It was not a stroke. On 22Jan2021 the patient left the hospital. Second dose of Moderna COVID-19 vaccine is scheduled on 12Feb2021. Reporter wanted to know if patient should get second dose of Moderna COVID-19 vaccine.   Treatment information was not provided.    Action taken with mRNA-1273 in response to the event was not provided.    The outcome of the event was unknown/not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the reported events, a causal relationship cannot be excluded.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Breath sounds abnormal, Chest discomfort, Choking, Headache
Clinical narrative: Severe flu symptoms; feeling incapacitated; Gagging; Feeling like humming and buzzing (motor-like); Throat constriction/contraction; Eye/vision distorted and were constricted; Felt like head would explode; forehead and headache; Forehead/head constriction; Constriction/contraction of chest; A spontaneous report was received from a consumer, a 74-year-old female patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced, feeling like humming and buzzing (motor-like), throat constriction/contraction, eye/vision distorted and were constricted, felt like head would explode, forehead/head constriction, constriction/contraction of chest, severe flu symptoms, feeling incapacitated, and gagging.  The patient's medical history was not reported. No concomitant medications were reported.  On 10 Feb 2021, prior to the onset of events, the patient received their second planned doses of mRNA-1273 (batch number: 030M20A), intramuscular for the prophylaxis of COVID-19 infection.  The patient reported that she had adverse reactions after administering the vaccine around 2:00 on 10 Feb 2021. Later, the patient went to bed. On 11 Feb 2021, at midnight, the patient started feeling like that she was humming and buzzing from the waist up; throat was constricted and contracted; gagged a few times; vision/eyes were constricted and vision was distorted; forehead, and head ache felt constricted and felt like it was going to take off and was so tight. Later, it moved to chest, the constriction/contraction was so tight that and felt like someone was standing on it. The patient stated that these feelings were all above the waist and lasted for about an hour and ten minutes and just stopped on the same day. The next day on 12 Feb 2021, about six hours later, the patient had regular side effects which started about 10 hours after the shot. The patient was fine for about six hours then had severe flu symptoms and was feeling just incapacitated. The patient just got rid of these flu symptoms around 1 pm on the same day. The patient wanted to know if these were allergy symptoms. No treatment medication information was provided  Action taken with second dose of mRNA-1273 in response to the events was not applicable.   The outcome of the events, feeling like humming and buzzing (motor-like), throat constriction/contraction, eye/vision distorted and were constricted, felt like head would explode, forehead/head constriction, constriction/contraction of chest, and gagging were recovered on 11 Feb 2021 and that of event severe flu symptoms was recovered on 12 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Metamorphopsia, Tension headache, Throat tightness
Clinical narrative: Severe flu symptoms; feeling incapacitated; Gagging; Feeling like humming and buzzing (motor-like); Throat constriction/contraction; Eye/vision distorted and were constricted; Felt like head would explode; forehead and headache; Forehead/head constriction; Constriction/contraction of chest; A spontaneous report was received from a consumer, a 74-year-old female patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced, feeling like humming and buzzing (motor-like), throat constriction/contraction, eye/vision distorted and were constricted, felt like head would explode, forehead/head constriction, constriction/contraction of chest, severe flu symptoms, feeling incapacitated, and gagging.  The patient's medical history was not reported. No concomitant medications were reported.  On 10 Feb 2021, prior to the onset of events, the patient received their second planned doses of mRNA-1273 (batch number: 030M20A), intramuscular for the prophylaxis of COVID-19 infection.  The patient reported that she had adverse reactions after administering the vaccine around 2:00 on 10 Feb 2021. Later, the patient went to bed. On 11 Feb 2021, at midnight, the patient started feeling like that she was humming and buzzing from the waist up; throat was constricted and contracted; gagged a few times; vision/eyes were constricted and vision was distorted; forehead, and head ache felt constricted and felt like it was going to take off and was so tight. Later, it moved to chest, the constriction/contraction was so tight that and felt like someone was standing on it. The patient stated that these feelings were all above the waist and lasted for about an hour and ten minutes and just stopped on the same day. The next day on 12 Feb 2021, about six hours later, the patient had regular side effects which started about 10 hours after the shot. The patient was fine for about six hours then had severe flu symptoms and was feeling just incapacitated. The patient just got rid of these flu symptoms around 1 pm on the same day. The patient wanted to know if these were allergy symptoms. No treatment medication information was provided  Action taken with second dose of mRNA-1273 in response to the events was not applicable.   The outcome of the events, feeling like humming and buzzing (motor-like), throat constriction/contraction, eye/vision distorted and were constricted, felt like head would explode, forehead/head constriction, constriction/contraction of chest, and gagging were recovered on 11 Feb 2021 and that of event severe flu symptoms was recovered on 12 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Cardiomyopathy
Clinical narrative: cardiomyopathy; A spontaneous report received from a Healthcare Professional concerning, 72-year-old female patient who received the second dose of Moderna COVID-19 vaccine and develop cardiomyopathy.   The patient's medical history was not included. Patient's concomitant was not included.    On 01-FEB-2021, the patient received their second of two planned doses of mRNA-1273 (Batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection.   Physician called and stated that his wife received the second Moderna COVID-19 vaccination on 01-FEB-2021 and on 05-FEB-2021 she developed cardiomyopathy. He stated that he would like for someone in the medical department to call him back.   Treatment information was not provided/ unknown.   Action taken with mRNA-1273 in response to the event was not provided/unknown.   The outcome of the event was unknown/not reported.; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood pressure measurement, Dizziness, Headache, Vomiting
Clinical narrative: Very dizzy; Threw up; Episode of afib; Light headache; A spontaneous report was received from a consumer (patient), 63 years-old female patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced, episode of A-fib (atrial fibrillation), very dizzy (dizziness), threw up (vomiting), and light headache (headache).  The patient's medical history included episode of A-fib. Current conditions included diabetic and high blood pressure. No concomitant medications were reported.  On 03 FEB 2021, seven days prior to the onset of events, the patient received their first of planned doses of mRNA-1273 (batch number: 038K20A), intramuscular in the left arm for the prophylaxis of COVID-19 infection.  It was reported that two days ago, the patient had an episode of atrial fibrillation on 10 FEB 2021. The patient doesn't know if it was from the vaccine or something else. The patient usually has 2-3 times of atrial fibrillation a year. She didn't have any other side effects at all right after the vaccine. The patient was a diabetic and didn't call her doctor about this, because it went away. The patient described the atrial fibrillation episode as uncomfortableness and beating of the heart. The patient has an appointment with her cardiologist 2 days before her second shot, and she'd ask him about it. The patient was also wondering that the side effects occurred 8 or 9 days after the shot. She has high blood pressure and took a measurement, and it was normal at 93 (unknown units). The patient had the injection on her left arm because she has a diabetic monitor on right arm. The patient didn't take any treatment for the side effect except one time she took acetaminophen about three days ago when she had a light headache. On 12 FEB 2021, at about 10 am in the morning, the patient got very dizzy and had to sit down on the floor, and she threw up. After that, the patient was feeling fine. The patient gave consent to follow up from safety and to her doctor. No further treatment medications were reported.  Action taken with second dose of mRNA-1273 in response to the events was not reported.   The outcome of the events, episode of A-fib, and light headache were unknown and that of events very dizzy, and vomiting was recovering.; 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.  The patient's medical history of having 2-3 times of atrial fibrillation a year, diabetic and high blood pressure are the risk factors and confounds to the causality.
Sex: U
Vaccine: COVID19
Symptoms: Device connection issue, Incorrect dose administered
Clinical narrative: Patient received less than half the dose; the needle and syringe detached; A spontaneous report  received from a physician concerning a patient of unknown age and gender, who received dose of Moderna COVID-19 vaccine and think they received half the dose (incorrect dose administered) and the needle and syringe detached (device connection issue).   The patient's medical history was not included. Patient's concomitant was not included.    On unknown date, the patient received their unknown of two planned doses of mRNA-1273 unknown arm (Batch #: unkown) intramuscularly for prophylaxis of COVID-19 infection.   Physician stated that the needle and syringe detached, and they think the patient received less than half the dose.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the events was resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered and device connection issue for mRNA-1273 (lot # unknown) with no associated AEs reported.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Delirium, Dizziness, Nausea, Nightmare
Clinical narrative: felt delirious; felt lightheaded; had a terrible dream; felt nauseous; A spontaneous report was received from a consumer reporting on himself, an 88-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and felt delirious/MedDRA PT: delirious, felt nauseous/MedDRA PT: nausea, felt lightheaded/MedDRA PT: lightheadedness, and had a terrible dream/MedDRA PT: terrifying dreams.   The patient's medical history was not provided. Concomitant medication use was not provided.   On 11 Feb 2021, the patient received their second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. The patient reported that during the night, he felt lightheaded, had a terrible dream, felt nauseous and delirious. The patient felt better the following day and his primary care physician was aware of the side effects. Treatment for the events included paracetamol.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events of felt delirious, felt nauseous, felt lightheaded and had a terrible dream were considered recovering/resolving.; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested. Company assessed the event to be unlikely related to company product.
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old received the 1st dose of the vaccine; A spontaneous report was received from a pharmacist concerning a 17-year-old, patient who received the first dose of Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unspecified date, it was reported that a 17-year-old received the first dose of the vaccine. No treatment information was reported.   Action taken with mRNA-1273 in response to the event was not reported  The outcome of the event, 17-year-old patient received the 1st dose of the vaccine, was resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old) for mRNA-1273 (lot number unknown) with no associated AEs reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness, Product administered at inappropriate site, Vaccination site erythema
Clinical narrative: Administered the vaccine below the deltoid or at the end of the deltoid; Symptoms are as if got the flu shot; Warm; Hard; Tired; Red area on arm the size of a quarter; Headache; A spontaneous report was received from a nurse who is a 70-year-old, white female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced administered vaccine below the deltoid or at the bottom of the deltoid/incorrect route of product administration, tired/fatigue, headache, red area on arm the size of a quarter/injection site erythema, warm/injection site warmth and hard/injection site induration, and symptoms are as if got the flu shot/influenza like illness.  The patient's medical history was not provided. No concomitant medications were reported.  On 11 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) in the right arm intramuscularly for prophylaxis of COVID-19 infection.   On 11 Feb 2021, the patient reported, the Moderna COVID-19 vaccine was administered below the deltoid or at the end of the deltoid. The patient also reported she was tired and had a headache and there was a red, warm and hard area the size of a quarter on her arm. She stated, her symptoms were like that of when she received the flu vaccine.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, administered vaccine below the deltoid or at the bottom of the deltoid/incorrect route of product administration, was considered resolved on 11 Feb 2021.  The outcome of the events, tired/fatigue, headache, red area on arm the size of a quarter/injection site erythema, warm/injection site warmth and hard/injection site induration, and symptoms are as if got the flu shot/influenza like illness, were considered unknown.; Reporter's Comments: This is a case of 70--year-old, female patient who was administered mRNA-1273 and experienced below the deltoid or at the bottom of the deltoid (vaccine administered at inappropriate site) Lot # BATCH # 026L20A. The other events temporarily association with product and a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site warmth
Clinical narrative: Administered the vaccine below the deltoid or at the end of the deltoid; Symptoms are as if got the flu shot; Warm; Hard; Tired; Red area on arm the size of a quarter; Headache; A spontaneous report was received from a nurse who is a 70-year-old, white female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced administered vaccine below the deltoid or at the bottom of the deltoid/incorrect route of product administration, tired/fatigue, headache, red area on arm the size of a quarter/injection site erythema, warm/injection site warmth and hard/injection site induration, and symptoms are as if got the flu shot/influenza like illness.  The patient's medical history was not provided. No concomitant medications were reported.  On 11 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) in the right arm intramuscularly for prophylaxis of COVID-19 infection.   On 11 Feb 2021, the patient reported, the Moderna COVID-19 vaccine was administered below the deltoid or at the end of the deltoid. The patient also reported she was tired and had a headache and there was a red, warm and hard area the size of a quarter on her arm. She stated, her symptoms were like that of when she received the flu vaccine.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, administered vaccine below the deltoid or at the bottom of the deltoid/incorrect route of product administration, was considered resolved on 11 Feb 2021.  The outcome of the events, tired/fatigue, headache, red area on arm the size of a quarter/injection site erythema, warm/injection site warmth and hard/injection site induration, and symptoms are as if got the flu shot/influenza like illness, were considered unknown.; Reporter's Comments: This is a case of 70--year-old, female patient who was administered mRNA-1273 and experienced below the deltoid or at the bottom of the deltoid (vaccine administered at inappropriate site) Lot # BATCH # 026L20A. The other events temporarily association with product and a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Incorrect route of product administration, Injected limb mobility decreased, Insomnia
Clinical narrative: I can't move my arm/can't bring my arm up to my breast and obviously over my head/this really limits my mobility; it was that upper joint area that was throbbing; couldn't sleep much because it was excruciating; extreme pain in my shoulder/excruciating pain in my shoulder/that top part, that ball and socket was excruciating to move; Vaccine given too high up in my arm/it felt like it was going into my bone at the top; Chills; my whole arm hurt/it's excruciating when I attempt to be mobile; A spontaneous report was received from a consumer (United States) concerning herself, a 72-year-old female who received Moderna's COVID-19 vaccine (mRNA-1273), who experienced the following events: I'm concerned it was given too high up in my arm/it felt like it was going into m y bone at the top/MedDRA PT: inappropriate route of vaccination, that top part, that ball and socket was excruciating to move/MedDRA PT: joint pain, I can't move my arm/can't bring my arm up to my breast and obviously over my head/this really limits my mobility/MedDRA PT: injected limb mobility decreased, chills, my whole arm hurt/it's excruciating when I attempt to be mobile/MedDRA PT: pain in arm, couldn't sleep much because it was excruciating/MedDRA PT: sleep difficult, it was that upper joint area that was throbbing/MedDRA PT: throbbing pain, band ack to the same pain I had after the injection/MedDRA PT: shoulder pain.   The patient's medical history included cancer and child birth x 2. Concomitant medication use was not provided.   On 03 Feb 2021, the patient received the first of two planned doses of mRNA-1273 ([LOT 029L20A]) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    Action taken with mRNA-1273 in response to the events was not reported.   The even of  "a couple of patients received their dose at 7 hours" was considered recovered/resolved (date unspecified).; Reporter's Comments: This case concerns a 72-year-old female who had NS unexpected Incorrect route of product administration and NS unexpected injected limb mobility decreased, painful arm, throbbing pain, insomnia and NS expected arthralgia, chills. The events occurred the same day as first dose of mRNA-1273. Treated with Tylenol. Events ongoing. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: I can't move my arm/can't bring my arm up to my breast and obviously over my head/this really limits my mobility; it was that upper joint area that was throbbing; couldn't sleep much because it was excruciating; extreme pain in my shoulder/excruciating pain in my shoulder/that top part, that ball and socket was excruciating to move; Vaccine given too high up in my arm/it felt like it was going into my bone at the top; Chills; my whole arm hurt/it's excruciating when I attempt to be mobile; A spontaneous report was received from a consumer (United States) concerning herself, a 72-year-old female who received Moderna's COVID-19 vaccine (mRNA-1273), who experienced the following events: I'm concerned it was given too high up in my arm/it felt like it was going into m y bone at the top/MedDRA PT: inappropriate route of vaccination, that top part, that ball and socket was excruciating to move/MedDRA PT: joint pain, I can't move my arm/can't bring my arm up to my breast and obviously over my head/this really limits my mobility/MedDRA PT: injected limb mobility decreased, chills, my whole arm hurt/it's excruciating when I attempt to be mobile/MedDRA PT: pain in arm, couldn't sleep much because it was excruciating/MedDRA PT: sleep difficult, it was that upper joint area that was throbbing/MedDRA PT: throbbing pain, band ack to the same pain I had after the injection/MedDRA PT: shoulder pain.   The patient's medical history included cancer and child birth x 2. Concomitant medication use was not provided.   On 03 Feb 2021, the patient received the first of two planned doses of mRNA-1273 ([LOT 029L20A]) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    Action taken with mRNA-1273 in response to the events was not reported.   The even of  "a couple of patients received their dose at 7 hours" was considered recovered/resolved (date unspecified).; Reporter's Comments: This case concerns a 72-year-old female who had NS unexpected Incorrect route of product administration and NS unexpected injected limb mobility decreased, painful arm, throbbing pain, insomnia and NS expected arthralgia, chills. The events occurred the same day as first dose of mRNA-1273. Treated with Tylenol. Events ongoing. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: punctured vial was left out at room temp and opened for more than 6 hours; A spontaneous report was received from a healthcare provider concerning a 32-year-old, female patient who received a vaccine at her work place when the punctured vial was left out at room temperature and opened for more than 6 hours (expired product administered).   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     On unknown date, the patient received their first of two planned doses of mRNA-1273 (Batch number: 026L20A ) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    Patient received a vaccine at her work place when the punctured vial was left out at room temperature and opened for more than 6 hours.   Treatment information was not provided.   The event was considered resolved on an unknown date.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273 (lot # 026L20A)  with no associated AEs reported.
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Received first dose of Moderna and second dose was Pfizer; A spontaneous report was received from a consumer who is a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and received first dose of Moderna and second dose was Pfizer/wrong product administered   The patient's medical history was not provided. No concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient reported her first dose of the vaccine was from Moderna and her second dose was from Pfizer.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the event, received first dose of Moderna and second dose was Pfizer/wrong product administered, was considered resolved.; Reporter's Comments: This report refers to a case of wrong product administered with second dose with Pfizer vaccine and with no associated AEs reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient was administered a dose of the vaccine from punctured vial that was punctured for more; A spontaneous report was received from a pharmacist  concerning a patient who experienced patient had been administered a dose from a punctured vial that had been punctured for more than hours.    The patient's medical history was not provided.  Concomitant product use was not provided/unknown by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.    Treatment information was not provided.    Action taken with mRNA-1273 in response to the event(s) was not provided.  The outcome of the event(s) was not reported.; Reporter's Comments: This case concerns a patient of unknown age and gender who experienced nonserious unexpected event of Expired product administered with mRNA-1273 (Lot # unknown), with no associated adverse events.  Reporter stated that patient was given "vaccine from a punctured vial that had been punctured for more than hours".  The event occurred the same day as the first dose of mRNA-1273. Very limited information has been provided at this time.  Further information has been requested.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Vaccination site pain
Clinical narrative: Injection site pain and tenderness; 16 year old patient administered the vaccine; A spontaneous report was received from a health care provider regarding a 16-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) inappropriately at the age of 16 and experienced injection site pain and tenderness/vaccination site pain.  The patient's medical history was not included. Products known to have been used by the patient were Vitamin D3 and ethinylestradiol, ferrous fumarate, norethisterone.  On 12 Feb 2021, prior to the onset of the events, the patient inappropriately received the first of two doses of mRNA-1273 (Lot number: 031M20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.    On 13 Feb 2021, the day after the vaccine was given the patient experienced injection site pain and tenderness.  Treatment information was not provided.  Action taken with mRNA-1273 was not reported.  The outcome of the events, vaccine being given inappropriately to a 16-year-old, was considered resolved on 12 Feb 2021.  The event, vaccine site pain and tenderness, was unknown.; Reporter's Comments: This case concerns a 16-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 031M20A), reporting Product administered to patient of inappropriate age with associated adverse event of vaccination site pain. Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Exposure via skin contact, Underdose
Clinical narrative: vaccine was coming out of the syringe and needle; seems that patient did not have the full dose; vaccine came out of syringe running down the patients arm; A spontaneous report was received from a Pharmacist regarding a male patient who received first dose of Moderna Covid-19 vaccine and vaccine came out of syringe (device connection issue) running down the patients arm (exposure via skin contact). It seems that patient did not receive the full dose (underdose).  The patient's medical history was not provided. No concomitant medications were provided. No information on allergies.   On 13-FEB-2021, prior to the onset of events, the patient received first of two planned doses of Covid-19 vaccine for the prophylaxis of Covid-19 infection. According to Pharmacist, while administering the vaccine using 25G pharmacy needle, as soon as he pushed down the plunger, vaccine came out of syringe and needle running down the patients arm. Patient didn't seem to get the full dose and he is a lean guy, did not feel anything during administration. Pharmacist was enquiring with Medical information center at Moderna whether it is safe to give another dose. He was informed that in case of deviation from recommended dose, dose should not be repeated, and the patient should be closely followed for safety outcomes.  Action taken with the 2nd dose of vaccine was not reported.  The events, vaccine came out of syringe running down the patients arm and seems that patient did not receive the full dose, were resolved on 13 Feb 2021.; Reporter's Comments: This case concerns a 68-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot: unknown), reporting device connection issue, underdose and exposure via skin contact without any associated adverse events.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Angina pectoris, Nausea, Vomiting
Clinical narrative: angina; a stomachache that lasted for 10 hours; nausea; vomited 1 time; A spontaneous report was received from a consumer  concerning an 82-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced angina (angina pectoris), stomachache (abdominal pain upper), nausea and vomiting 1 time.  The patient's medical history included 3 stents in the heart and angina.  Concomitant product use was not reported.  On 03 Feb 2021, approximately 26 hours prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number unknown) in the left arm for prophylaxis of COVID-19 infection.  The reporter stated that 26 hours after receiving the vaccine, he had a stomachache that lasted for 10 hours. The patient also experienced nausea and vomited 1 time.  Early in the week of 08 Feb 2021, the patient reported experiencing angina, which he stated he had not had for a very long time. The patient reported that no treatment medications were taken for these side effects.  The patient stated that he will follow up with his cardiologist.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event, angina, was unknown.  The events, stomachache, nausea, and vomiting, were considered recovered/resolved.; 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 of abdominal pain, nausea and vomitting, a causal relationship cannot be excluded. The patient's medical history of 3 stents in the heart and angina confounds to the causality of Angina Pectoris.
Sex: F
Vaccine: COVID19
Symptoms: Hospitalisation
Clinical narrative: Hospitalized; A regulatory report was received from a consumer  concerning a female patient who experienced hospitalization.    The patient's medical history was not provided.  Concomitant product use was not provided/unknown by the reporter.    The patient received her first of two planned doses of mRNA-1273 Batch number not provided on 11-JAN-2021 for prophylaxis of COVID-19 infection.    The patient received the first dose of the Moderna COVID-19 vaccine on 11Jan2021. On 07Feb2021 she was hospitalized for reasons she didn't want to specify and returned home on 11Feb2021. She missed her appointment for her second dose on 08Feb2021because of the hospitalization. She didn't want a callback because she says that this was not related to the vaccine, so no further information was gathered.  Treatment information was not provided/unknown.    The second dose of mRNA-1273 was temporarily withheld in response to the event.  The event of hospitalization was considered recovered/resolved on 11 Feb 2021.; 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: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Loss of consciousness
Clinical narrative: Severe anaphylaxis allergic reaction; Passed out on the ground; A spontaneous report was received from a consumer concerning a 22-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and passed out on the ground and had a severe anaphylaxis allergic reaction.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     On an unknown date, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.    About 10 minutes after receiving the second dose of the Moderna vaccine, the patient passed out on the ground having a severe anaphylaxis allergic reaction.  Treatment for the event included two doses of epinephrine IM in addition to diphenhydramine, ondansetron, and steroids to prevent a rebound reaction. 911 was called and after epinephrine and diphenhydramine were administered, the patient was immediately transported to the hospital where she stayed for 6 more hours for observation, fluids, and further medications.    Action taken with mRNA-1273 in response to the events was not applicable.  The events, passed out on the ground and severe anaphylaxis allergic reaction, were considered resolved; 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.  Anaphylactic reaction is a listed event in CCDS.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Vaccine was withdrawn from arm and some of the vaccine dripped out; A spontaneous report was received from a consumer regarding herself, a 44-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced some of vaccine leaking out of the injection site/accidental underdose.  The patient's medical history was not included. Products known to have been used by the patient were not included.  First dose information was not provided.  On 11 Feb 2021, prior to the onset of the events, the patient received the second of two doses of mRNA-1273 (Lot number: 016M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 11 Feb 2021, as the needle was withdrawn, some of the vaccine leaked out. The patient is concerned about underdose.   Treatment information was not provided.  Action taken with mRNA-1273 was not applicable.  The outcome of the events, vaccine leaking out when needle was withdrawn, was considered resolved.; Reporter's Comments: This case concerns a 44-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Accidental underdose without any associated adverse events.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Urinary tract infection
Clinical narrative: UTI; cough; A spontaneous report was received from a consumer concerning a patient who developed/experienced  hospitalization for 7 days  UTI, cough, MedDRA PT: hospitalization, urinary tract infection, cough   The patient's medical history was not provided.   The patient received their first of two planned doses of mRNA-1273 .Batch number not provided  Treatment information was unknown. The patient scheduled to received the second shot of the vaccine.  Patients reports having a bad reaction to the first shot; starting cough, and ended up with a UTI and ended up in the hospital for 7 days.  Action taken with mRNA-1273 in response to the events were unknown. The outcome of the events were not reported.; Reporter's Comments: This case concerns a female of unknown age who experienced a "bad reaction to the first shot" and then was hospitalized with a serious unexpected event of UTI and a NS unexpected event of cough. The events occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown.  Based on 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.