chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site swelling
Clinical narrative: Red swelling; Red swelling; Injection in left arm but cannot assure it was intramuscular; A spontaneous report was received from a consumer who is a 60-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and got injection in left arm but cannot assure it was intramuscular, red and swelling (injection site erythema and injection site swelling).   The patient's medical history was not provided. No concomitant medications were reported.  On 11 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) in the left arm for prophylaxis of COVID-19 infection.   On 11 Jan 2021, after the first dose of vaccine, the patient confirmed that she was fine but had a small pinhead were the vaccine was injected and was not sure if she got the injection via intramuscularly in the left arm. On 20 Jan 2021, when patient woke up, she found with red swelling that continued to grow at the time of this report. Treatment for the event included unspecified antibiotic.   Action taken with mRNA-1273 in response to the events were not provided.   The outcome of the events, injection in left arm but cannot assure it was intramuscular was considered resolved on 11 Jan 2021. The outcome of events red swelling was considered not resolved and was continuing at the time o this report.; Reporter's Comments: This case concerns a 60-year-old female with a NS unexpected event of Incorrect route of product administration and NS expected events of Injection site erythema and Injection site swelling.  The expected events occurred 10 days after first dose mRNA-1273 (lot # unknown). Treatment included an antibiotic. Based on current available information and temporal association between the use of the product and the start date of the associated adverse events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Vaccination site discharge
Clinical narrative: 0.5 mL leaked out of patient's arm; vacination site discharge; A spontaneous report was received from a pharmacist concerning a patient of unknown age and unknown gender who received the Moderna COVID-19 vaccine and experienced incorrect dose administered and Vaccination site discharge.  A different nurse administered vaccine to patient and they noticed 0.5mL leak out of patient's arm.  Moderna vaccine, it  was a second dose, administered to just one patient. Pharmacist wants to know if they should repeat dose. Only 1 injection was involved, and Pharmacist has no patient specific information. Ok for safety to contact. HCP wants in writing.   The patient's medical history was not provided.  Concomitant product use was not reported by the reporter.     On 04 Feb 2021, the patient received their first of two planned doses of mRNA-1273  Batch number not provided on unknown date. Prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273  Batch number not provided intramuscularly in the for prophylaxis of COVID-19 infection.    On 04 Feb 2021, a different nurse administered vaccine to patient and they noticed 0.5mL leak out of patient's arm., the injection site leaked. Moderna vaccine was a second dose, administered to just one patient. Pharmacist wants to know if they should repeat dose. Only 1 injection was involved, and Pharmacist has no patient specific information. Ok for safety to contact. HCP wants in writing.  Treatment information was not provided.     Action taken with mRNA-1273 in response to the events incorrect dose administered and Vaccination site discharge  was not applicable.  The outcome of the event was considered as recovered on 04 Feb 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered and Vaccination site discharge for mRNA-1273.  There were no reported adverse events associated with this case.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: UTI after second dose; A spontaneous report was received from healthcare professional concerning a female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced UTI after second dose.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unspecified date, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  On 03 Feb 2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  On an unknown date, after receiving the second dose of vaccination, the patient developed UTI. Treatment included antibiotics.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The outcome for the event, UTI after second dose 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.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis
Clinical narrative: Appendicitis pain; A spontaneous report was received from a nurse concerning a 48-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced appendicitis pain.  The patient's medical history was not provided. Concomitant medications reported included omeprazole, venlafaxine hydrochloride, trazodone and spironolactone. (batch number: 041L20A) On 11 Jan 2021, seventeen days prior to onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number: 041L20A) intramuscularly in her left arm for the prophylaxis of COVID-19 infection.  On 28 Jan 2021, after the vaccine administration, the patient experienced appendicitis pain, hence on 30 Jan 2021, she underwent appendicectomy.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of event, appendicitis pain was considered unknown at the time of his report.; Reporter's Comments: This case of appendicitis in a 48-year-old, female patient 17 days after the administration of  mRNA-1273 vaccine(batch number: 041L20A) as assessed as unlikely associated with the vaccine administration based on then natural history of the disease and based on duration and outcome (appendectomy), it was most likely an ongoing inflammatory process.
Sex: F
Vaccine: COVID19
Symptoms: Cyanosis, Incorrect route of product administration, Superficial vein prominence
Clinical narrative: vaccine was injected directly into her vein/artery; bulging veins; nail beds turned blue; A spontaneous report was received from a consumer concerning a female patient, of unknown age, who developed bulging veins and nail beds turned blue after receiving a first dose of Moderna's  COVID-19 vaccine administered directly into her vein/artery.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 07-JAN-2021 prior to the onset of the events, patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) unknown route of administration. On 03-FEB-2021, patient received their second of two planned doses of mRNA-1273 (Lot number: unknown) unknown route of administration for prophylaxis of COVID-19 infection.    The patient was administered mRNA-1273 vaccine directly into vein/artery, on 07-JAN-2021, and developed bulging veins and nail beds turned blue. Treatment for the event included ice pad. EMTs checked blood pressure and monitor the patient for several minutes.  There was no change planned to the dosing schedule of mRNA-1273 in response to the event.  The patient received both scheduled dose of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The event, vaccine administered directly into vein/artery was considered resolved.   The outcome for the event bulging veins and nail beds turned blue not provided.    .; 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. Very limited information regarding these events has been provided at this time. Further information is requested.
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer
Clinical narrative: Breast cancer; A spontaneous report was received on 05 Feb 2021 from a consumer concerning an unknown age, female patient who received Moderna's COVID-19 vaccine and diagnosed with breast cancer.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 20 Jan 2021, patient received their first of two planned doses of mRNA-1273(Lot number: unknown), for the prophylaxis of COVID-19 infection.  On 03 Feb 2021, the patient was diagnosed with breast cancer.     Action taken the second dose of mRNA-1273 in response to the events was not reported.  The outcome of the event, breast cancer was not resolved.  The assessment of the causality by reporter was, there was no relation between the vaccine and the diagnosis of cancer, but as the event occurred after the administration of the Moderna COVID-19 vaccine.; Reporter's Comments: Based on the current available information, the event was diagnosed 15 days after the administration of mRNA-1273.  Due to the nature of development of breast cancer, the event was assessed as unlikely related.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Malaise, Neuropathy peripheral, Vaccination site swelling
Clinical narrative: Sharp pains in feet (neuropathy); Bad diarrhea; Felt yucky and not feeling good at all; Arm swollen on the same side of injection; A spontaneous report was received from a consumer who was also a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced sharp pains in feet (neuropathy)/ neuropathy peripheral, arm swollen on same side of injection/ injection site swelling, bad diarrhea/ diarrhea, and feeling yucky and not good at all/ malaise.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 03 Feb 2021, approximately at 12:00 pm, the patient received their first of two planned doses of mRNA-1273 (Lot number: 010M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 04 Feb 2021, the patient started experiencing symptoms of sharp pains in his feet (neuropathy), bad diarrhea, felt yucky and not feeling good at all.   On 05 Feb 2021, the patient reported that the symptoms did not abate, however they were improving.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the events, sharp pains in feet (neuropathy), arm swollen on same side of injection, bad diarrhea and felt yucky and not good at all, was resolving.; Reporter's Comments: Based on the current available information and a  temporal association between the use of the product and the onset of the reported events a causal relationship cannot be excluded.  Injection site swelling is consistent with the known safety profile of the vaccine.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Underdose
Clinical narrative: Something occurred in the syringe that not the 0.5 mL entered her arm and part spilt out; Something occurred in the syringe that not the 0.5 mL entered her arm and part spilt out; A spontaneous/solicited report was received from a consumer concerning herself, a 76 year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and reported that  something occurred in the syringe so that the 0.5 mL did not enter her arm and part spilt out/device connection issue and underdose.  The patient's medical history included breast cancer and cholesterol (not further specified). Products known to have been used by the patient, within two weeks prior to the event, included medicine for blood pressure (not further specified), vitamins, atorvastatin calcium and nebivolol hydrochloride.  On 22 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 026L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 22 Jan 2021, during administration, the patient reported that something occurred in the syringe so that the 0.5 mL did not enter her arm and part spilt out. No treatment information was provided.   The second dose of mRNA-1273 was scheduled for 18 Feb 2021. Action taken with mRNA-1273 in response to the events was not reported.  The events, something occurred in the syringe so that the 0.5 mL did not enter her arm and part spilt out, were considered resolved on 22 Jan 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered, and underdose for mRNA-1273, lot # 026L20A with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Urinary tract infection, Vaccination site bruising, Vaccination site erythema, Vaccination site pain
Clinical narrative: Warm to the touch injection site; Bruise on injection site; Itching left arm injection site; Redness on the side of the injection site; Pain left arm (with movement); Urinary tract infection; Headache; A spontaneous report was received from a consumer, concerning herself, a 71-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed urinary tract infection, warm to the touch injection site, pain left arm (with movement), bruise on injection site, itching left arm injection site, headache and redness on the side of the injection site.  The patient's medical history provided included cystitis. Concomitant product use was not provided by the reporter.  On 27 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot # 004M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 27 Jan 2021, after the first dose of vaccine administration, the patient developed headache. On 03 Feb 2021 (Wednesday) the patient experienced urinary tract infection and took one capsule of cephalexin 500mg. Later, on 04 Feb 2021, the patient's left arm of injection site had started itching and her arm was hurt on movement. When she checked in the mirror, she noticed a bruise on injection site and the side of the injection site was red and also was little warm to the touch. She thought the skin reaction might have been triggered by the cephalexin, hence she did not continue the antibiotic, but she also confirmed that she had no reactions anywhere else on the body.  Action taken with mRNA-1273 in response to the events were unknown.  The outcome of event, headache was considered to be resolved on 28 Jan 2021. The outcome of the events, urinary tract infection, warm to the touch injection site, pain left arm (with movement), bruise on injection site, itching left arm injection site and redness on the side of the injection site were considered unknown at the time of this report.; Reporter's Comments: Based on the current information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. Patient's medical history of cystitis is a confounder for urinary tract infection.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Warm to the touch injection site; Bruise on injection site; Itching left arm injection site; Redness on the side of the injection site; Pain left arm (with movement); Urinary tract infection; Headache; A spontaneous report was received from a consumer, concerning herself, a 71-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed urinary tract infection, warm to the touch injection site, pain left arm (with movement), bruise on injection site, itching left arm injection site, headache and redness on the side of the injection site.  The patient's medical history provided included cystitis. Concomitant product use was not provided by the reporter.  On 27 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot # 004M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 27 Jan 2021, after the first dose of vaccine administration, the patient developed headache. On 03 Feb 2021 (Wednesday) the patient experienced urinary tract infection and took one capsule of cephalexin 500mg. Later, on 04 Feb 2021, the patient's left arm of injection site had started itching and her arm was hurt on movement. When she checked in the mirror, she noticed a bruise on injection site and the side of the injection site was red and also was little warm to the touch. She thought the skin reaction might have been triggered by the cephalexin, hence she did not continue the antibiotic, but she also confirmed that she had no reactions anywhere else on the body.  Action taken with mRNA-1273 in response to the events were unknown.  The outcome of event, headache was considered to be resolved on 28 Jan 2021. The outcome of the events, urinary tract infection, warm to the touch injection site, pain left arm (with movement), bruise on injection site, itching left arm injection site and redness on the side of the injection site were considered unknown at the time of this report.; Reporter's Comments: Based on the current information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. Patient's medical history of cystitis is a confounder for urinary tract infection.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Injection site erythema, Injection site pruritus, Musculoskeletal stiffness
Clinical narrative: Possible cellulitis; left arm stiff; itchy redness on the area of injection; itchy redness on the area of injection; A spontaneous report was received from consumer concerning a 84-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced itchy redness the injection site on her left arm, her left arm is stiff, and possible cellulitis.  The patient's medical history and concomitant product use were not provided.  On 28-Jan-2021, the patient received the first of two planned doses of mRNA-1273, (Lot number 007M20A), intramuscularly into her left arm for prophylaxis of Covid-19 infection.  On the morning of 05-Feb-2021 the patient noticed, itchy redness, 4X6 inches in size, 4 inches below the injection site on her left arm and her left arm is stiff. The patient was examined by her doctor that same day and was prescribed Doxycycline for a possible cellulitis.  No relevant laboratory tests were ordered.   Action taken with mRNA-1273 in response to the event  was not provided.  The outcome of the events, itchy redness, 4X6 inches in size, 4 inches below the injection site on her left arm and her left arm is stiff and possible cellulitis were unknown.; Reporter's Comments: This case concerns an 84-year-old female who experienced a serious unexpected event of cellulitis along with a NS unexpected events of stiffness and injection site pruritus and NS expected event of injection site erythema.  The events occurred 9 days after the first dose of mRNA-1273. Treatment included doxycycline. 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: Diarrhoea, Nausea, Pyrexia, Syncope
Clinical narrative: Fainted; Diarrhea; Nausea; Warm body temperature; A spontaneous report was received from a consumer, regarding herself, a 82-year-old, female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fainted, diarrhea, nausea and warm body temperature.  The patient's medical history reported included ulcerative colitis. Concomitant product use was not provided.  On 04 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot Number: 038K20A) intramuscularly for prophylaxis of COVID-19 infection.   On 04 Feb 2021, in the evening, after receiving the vaccine, the patient was fainted and started to experience diarrhea, nausea and warm body temperature. The event fainted was considered to be medically significant. Treatment for the events not provided.  Action taken with the second dose of mRNA-1273 in response to the events were not reported.   The outcome for the events, fainted, diarrhea, nausea and warm body temperature were resolved on 05 Feb 2021.; 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: Incorrect dose administered
Clinical narrative: Third of the vaccine leaked out of patients arm; A spontaneous report was received from a nurse, concerning a 57-year-old female patient, who received Moderna's COVID-19 vaccine and the third of vaccine leaked out of patient's arm.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 05 Feb 2021, prior to the onset of the event, the patient received her first of two planned doses of mRNA-1273 (Lot number: 013M20A) for prophylaxis of Covid-19 infection.  On 05 Feb 2021, while nurses was administering patient's first dose of vaccine, the dose was leaked out of patient's arm (almost third of the dose leaked out). However, the nurse was not exposed to the vaccine. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events were not reported.  The event, third of vaccine leaked out of patient's arm was considered resolved on 05-Feb-2021.; Reporter's Comments: This case report concerns a non-serious unexpected event of a 57-year-old female patient who experienced third of vaccine leaked out of patient's arm. (Incomplete dose administered) for mRNA-1273, lot # 013M20A. There were no reported AEs associated with this case of incomplete dose administered.
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Chest pain, Fatigue
Clinical narrative: AFIB; really tired; chest pain; A spontaneous report was received from a consumer concerning a himself, a 75-year-old male who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced atrial fibrillation, chest pain and really tired.   The patient's medical history included atrial fibrillation with ablation 3 years ago. No relevant concomitant medications were reported.   On 01 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lo038A20A) intramuscularly for prophylaxis of COVID-19 infection.   On 02 Feb 2021, the patient woke up at 2:30 a.m. with chest pain, which "has" subsided (date not reported).  On 03 Feb 2021, the patient was really tired.   On 04 Feb 2021, the patient felt great.  On 05 Feb 2021, at 6:30 a.m., the patient went into atrial fibrillation.   Action taken with mRNA-1273 in response to the events was not reported.   The event of chest pain was recovered/resolved. The event of really tired was recovered/resolved on 04 Feb 2021. The outcome of the event of atrial fibrillation 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. However, the patient's age and history of atrial fibrillation with ablation are risk factors and confounds causality assessment.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Lumbar puncture, Magnetic resonance imaging brain, Magnetic resonance imaging neck, Magnetic resonance imaging thoracic, Myelitis transverse
Clinical narrative: Tansverse myelitis; A spontaneous report  was received from a physician, who was also a 50-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced transverse myelitis.  The patient's medical history included cervical disc disease and low testosterone.  Concomitant medications included testosterone cypionate and anastrozole.  The patient reported that he had no acute illnesses at the time of vaccination and up to one month before.  He had no allergies to medications, food, or other products.  On 30 Dec 2020 at 12:00 pm, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On or about 07 Jan 2021, the patient began experiencing numbness in both feet.  Thinking it could be related to his prior cervical disc disease causing myelopathic symptoms, hence, the patient saw a spine surgeon, who ordered a cervical magnetic resonance image (MRI) which revealed of no acute changes. On or about 18 Jan 2021, the patient began having problems with leg weakness and difficulty in standing and walking.  That same day, he underwent urgent MRIs of his thoracic and lumbar spines which showed a lesion on the anterior thoracic cord.  The patient was referred to a neurologist who diagnosed the patient with transverse myelitis.  Subsequently, follow-up MRIs with contrast, MRI of the brain, and lumbar puncture for CSF analysis were completed but no other causes of his symptoms were identified.  At the time of this report, the patient's legs were always numb (numbness propagated proximally with activity), his legs were weak, gait was unstable, he noted sexual dysfunction, and he had frequent "electrical" sensations.  A follow-up thoracic MRI was completed on 05 Feb 2021 (results pending at time of this report).    Treatment for the event included intravenous immunoglobulin (IVIG) infusions for five days (to start on 06 Jan 2021).    The action taken with mRNA-1273 in response to the event was withdrawn (regarding dose two, the patient reported: "N/A not given").  The event, transverse myelitis, was considered not resolved at the time of this report.  The physician assessed the event of transverse myelitis as related to mRNA-1273.; 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.  However, it is noted that follow-up MRIs with contrast, MRI of the brain, and lumbar puncture for CSF analysis were completed and no other causes of his symptoms were identified but confirmation of the event was not reported.  Also, the patient's comorbidities (cervical disc disease and low testosterone) may contribute to the patient's symptoms and confounds causality assessment. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Possible vaccine administration via Subcutaneous Route; A spontaneous report was received from a nurse concerning a 36 year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced Subcutaneously Administered vaccine (incorrect route of product administration).  The patient's medical history was not provided.  Concomitant product use was not provided/unknown by the reporter.     The patient received their second of two planned doses of mRNA-1273 LOT # 013L20A on 05-FEB-2021 for prophylaxis of COVID-19 infection.    Female Nursing Practitioner called to report possible vaccine administration via Subcutaneous route. The patient had not reported any side effects. Treatment information was not provided/unknown.    Action taken with mRNA-1273 in response to the event was not provided/unknown.  The event, Subcutaneously Administered vaccine was considered recovered/resolved on 05 Feb 2021.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273, lot # 013L20A with no associated AEs.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Hypoxia, SARS-CoV-2 test positive
Clinical narrative: Hypoxic; Tested positive for COVID; A spontaneous report was received from a physician concerning a 79-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hypoxic and tested positive for COVID-19.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 12 Jan 2021, approximately 1 day prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number not provided) intramuscularly for prophylaxis of COVID-19 infection.  On 13 Jan 2021, the patient started showing symptoms of COVID and she tested positive for the virus that same day. She received Regeneron antibody infusion. On 16 Jan 2021 (day 4), the patient became hypoxic and was admitted to the hospital for 2 days. The patient was discharged not needing oxygen.  She was greatly improved on Day 7. Treatment provided included Regeneron antibody infusion.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events hypoxia and COVID-19 was unknown.; Reporter's Comments: The patient had COVID symptoms one day after mRNA-1273 vaccine administration. The events were consistent with increased risk of respiratory complications associated with viral infection in pandemic set up. Based on test results the events are assessed as unlikely related to mRNA-1273.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Full amount of the dose was not fully administered; Some of the vaccine leaked down the patient's arm; A spontaneous report was received from a healthcare professional concerning an 80-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the full amount of the dose was not fully administered (LLTs: vaccine underdose / syringe connection issue).   The patient's medical history was not provided. No concomitant medications were reported.  On 04 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection.   On 04 Feb 2021, a physician's assistant administered the Moderna COVID-19 vaccine to a patient and stated, that the full amount of the dose was not full administered. Some of the vaccine leaked down the patient's arm.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, full amount of the dose was not fully administered issue and some of the vaccine leaked down the patient's arm, were considered resolved on 04 Feb 2021.; Reporter's Comments: The reporter refers to a case of vaccine underdose and syringe connection issue for mRNA-1273 vaccine, batch number not provided, with no associated AEs. Causality of these events is not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine administration via Subcutaneous Route; A spontaneous report was received from a nurse concerning a 28-year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced Subcutaneously Administered vaccine/ incorrect route of product administration.  Concomitant product use was not provided by the reporter.      The patient received their first of two planned doses of mRNA-1273 Batch number not provided.  The patient received their second of two planned doses of mRNA-1273 (Lot number 013L20A) via subcutaneous route  for prophylaxis of COVID-19 infection.    Female Nursing Practitioner called to report Possible vaccine administration via Subcutaneous Route,  on 05FEB2021. The patients have not reported any side effects.   Treatment information was not provided.    The event, Subcutaneously Administered vaccine was considered recovered/resolved on 05 Feb 2021.; Reporter's Comments: This report refers to a case of product administration error for mRNA-1273 (Lot number 013L20A). There were no associated AEs with this event of inappropriate route of vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Device connection issue, Incorrect dose administered
Clinical narrative: the patient received part of the dose; did not receive the full dose as part of the liquid spilled out; A spontaneous report was received from a healthcare professional concerning a patient, of unknown gender and age, who was administered Moderna's COVID-19 vaccine and received part of the dose and did not receive the full dose as part of the liquid spilled out (device connection issue).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 05 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 031L20A) intramuscularly for prophylaxis of Covid-19 infection.  It was reported that during administration of the Moderna COVID 19 vaccine on 05 Feb 2021, the patient did not receive the full dose as part of the liquid spilled out. Consent for follow up given.  No treatment information was provided.  Action taken with the first dose of mRNA-1273 in response to the event was not reported.  The events, received part of the dose and did not receive the full dose as part of the liquid spilled out, were considered resolved on an unknown date.; Reporter's Comments: This report refers to a case of incorrect dose administered, and device connection issue for mRNA-1273, lot # 031L20A with no associated AEs.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: Vaccine ran down individual's arm; syringe which malfunctioned; A spontaneous report was received from a pharmacist concerning a 68, year old, male patient who experienced an incomplete dose administration of Moderna's COVID-19 vaccine, when the syringe malfunctioned and the vaccine ran down the patients arm.   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.     On 05 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 029L20A) intramuscularly, the injection side/site not given for prophylaxis of COVID-19 infection.    The reporter, a pharmacist, called from a clinic. On 05 Feb 2021, one of the immunizers attempted to give a second dose using the agency supplied syringe which, malfunctioned and the vaccine ran down the patient's arm.  Treatment information was not provided/unknown.     Action taken with mRNA-1273 in response to the event(s) was not provided.  The events incomplete dose administration of vaccine and syringe issue were considered recovered/resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered, and syringe issue for mRNA-1273, lot # 029L20A with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hepatic cirrhosis, Skin disorder
Clinical narrative: developed cirrhosis; scalp infection; Headache; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed cirrhosis, scalp infection and headache.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On unknown date, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.   On unknown date, the patient who developed cirrhosis and scalp infection. Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events who developed cirrhosis, scalp infection and headache was unknown.; Reporter's Comments: Very limited information regarding the events of cirrhosis and scalp infection have been provided at this time.  Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Vaccine administered without waiting fifteen minutes at room temperature; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and vaccine administered without waiting fifteen minutes at room temperature.   The patient's medical history was not provided. No relevant concomitant medications were reported.  It was not reported when the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   It was stated from the reporter, we had vaccine that had been completely thawed, and it was administered without waiting fifteen minutes at room temperature. This was at a Mas Vaccination site and we have no knowledge of how many were vaccinated prior to the vials being at room temperature. Reporter made an estimated guess of fifteen to twenty individuals who have been vaccinated prior to the vaccine coming to room temperature. Reporter was looking for clarification on if the vaccine always needed to be brought to room temperature and why. She stated if we need to always have the vaccine at room temperature before vaccinating, that it was not clear in the instructions. No further information was provided.  No treatment information was provided.  Action taken with RNA-1273 in response to the event was not applicable.  The outcome of the event was considered as recovered.; Reporter's Comments: This report refers to a case of product administration error for mRNA-1273 with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Incorrect dose administered
Clinical narrative: a leakage from the syringe; a leakage from the syringe; A spontaneous report was received from a consumer, concerning a 25 year-old female patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced leakage from the syringe while it was being administered/device connection issue, underdose.  The patient's medical history was not provided. No concomitant medications were reported.  On 05 Feb2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 032L20A), intramuscular in the right arm for prophylaxis of COVID-19 infection.   On the same day, while the vaccine was being administered, the patient reported there was leakage from the syringe and she questioned a vaccine underdose.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The event  leakage from the syringe was considered as resolved.; Reporter's Comments: This report refers to a case of device connection issue, and incorrect dose administered for mRNA-1273, lot # 032L20Awith no associated AEs.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Cough, Malaise, SARS-CoV-2 test positive
Clinical narrative: Tested positive for covid-19; Upset stomach; Dry cough; Feeling unwell; A spontaneous report was received from a consumer, concerning a male patient of unspecified age, who received Moderna's COVID-19 vaccine and tested positive for Covid-19 and experienced upset stomach, dry cough and did not generally feel well.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 14 Jan 2021, prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of Covid-19 infection.   On 15 Jan 2021, after the first dose of vaccine, the patient was presented with upset stomach, dry cough, and he did not generally feel well. On 26 Jan 2021, the patient tested positive for Covid-19 and was hospitalized from 29 Jan 2021 to 02 Feb 2021. No further information was provided at the time of this report.  Reporter denied consent to follow-up. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events were not reported.  The outcome for events, tested positive for Covid-19, upset stomach, dry cough, and did not generally feel well were considered to be unknown.; Reporter's Comments: This case concerns a male patient, who experienced a serious unexpected event of SARS-CoV-2 test positive after receiving mRNA-1273. Very limited information regarding this event has been provided at this time. The event of Covid test positive is assessed as unlikely related to mRNA-1273. There is no consent for follow-up, so no further information has been requested.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17-year-old received the first shot of moderna vaccine; A spontaneous report was received from a nurse concerning a 17-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced 17-year-old received the first shot of Moderna vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, approximately 0 days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient received their first dose of the vaccine at 17 years old. She was turned away from getting her second dose due to her age. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was unknown.   The event, 17-year-old received the first shot of Moderna vaccine, was considered resolved on an unknown date.; Reporter's Comments: This case report concerns a non-serious unexpected event of 17-year-old received the first shot of Moderna vaccine (inappropriate age at vaccine administration  for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of inappropriate age at vaccine administration.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product colour issue
Clinical narrative: Second dose of the Moderna vaccine was light pink color; Color of the vaccine is pink; A spontaneous report was received from a consumer, concerning a patient of unknown age and gender, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), which resulted in events, second dose of the Moderna vaccine was light pink color/poor quality product administered and color of the vaccine is pink/product colour issue.  The patient's medical history was not provided. No concomitant medications were reported.  On an unknown date, prior to the onset of events, the patient received their first dose of mRNA-1273 (Lot number: unknown), for prophylaxis of COVID-19 infection.  The patient stated that the vaccine was supposed to be white to off-white in color. The patient received the second dose of the Moderna vaccine on an unknown date and the color of the vaccine was light pink. The patient was concerned if the vaccine was stored improperly. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the events, second dose of the Moderna vaccine was light pink color and color of the vaccine is pink, were reported as resolved on an unknown date.; Reporter's Comments: This report refers to a case of poor quality product administered, and product color issue for mRNA-1273 with no associated AEs.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Cough, Fatigue, Headache
Clinical narrative: Covid-19; Strep throat; Slid down the wall and passed out; Hacky cough; Slight headache; Tired; Fever; A spontaneous report was received from a consumer concerning a 73-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced hacky cough, slight headache, tired, slight fever of 100.4, covid-19, strep throat and passed out.  The patient's medical history included artificial hips. Concomitant medications reported included salbutamol, fluticasone propionate, salmeterol xinafoate, salbutamol sulfate, apixaban, mirabegron, metoprolol, cetirizine hydrochloride, colecalciferol, zinc, ascorbic acid and rutoside for unspecified indication.   On 11 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection.   Reporter stated that the patient was not aware of being exposed to COVID on 10 Jan 2021. They found out the following week after receiving the vaccine. The patient had COVID test on 19 Jan 2021 and tested positive.   On 14 Jan 2021, the patient developed hacky cough, slight headache, tired, slight fever of 100.4 degree fahrenheit. The treatment information included fluticasone propionate, salbutamol, steroids, montelukast and azithromycin.  On 17 Jan 2021, the patient got up to go to the bathroom and slid down the wall and passed out. The treatment information included fluticasone propionate, salbutamol, steroids, montelukast and azithromycin.  Action taken with RNA-1273 in response to the event was not provided.  The outcome of the events hacky cough, slight headache, tired, slight fever of 100.4, covid-19, strep throat and passed out was unknown.; Reporter's Comments: This case concerns a 73-year-old male with a serious expected event of loss of consciousness along with a NS unexpected COVID-19, streptococcal pharyngitis, cough and NS expected fever, headache, fatigue.  Event onset 9 days after the first dose of mRNA-1273. Treatment included fluticasone, salbutamol, steroids, azithromycin. 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.
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Pharyngitis streptococcal, Pyrexia, SARS-CoV-2 test, Streptococcus test
Clinical narrative: Covid-19; Strep throat; Slid down the wall and passed out; Hacky cough; Slight headache; Tired; Fever; A spontaneous report was received from a consumer concerning a 73-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced hacky cough, slight headache, tired, slight fever of 100.4, covid-19, strep throat and passed out.  The patient's medical history included artificial hips. Concomitant medications reported included salbutamol, fluticasone propionate, salmeterol xinafoate, salbutamol sulfate, apixaban, mirabegron, metoprolol, cetirizine hydrochloride, colecalciferol, zinc, ascorbic acid and rutoside for unspecified indication.   On 11 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection.   Reporter stated that the patient was not aware of being exposed to COVID on 10 Jan 2021. They found out the following week after receiving the vaccine. The patient had COVID test on 19 Jan 2021 and tested positive.   On 14 Jan 2021, the patient developed hacky cough, slight headache, tired, slight fever of 100.4 degree fahrenheit. The treatment information included fluticasone propionate, salbutamol, steroids, montelukast and azithromycin.  On 17 Jan 2021, the patient got up to go to the bathroom and slid down the wall and passed out. The treatment information included fluticasone propionate, salbutamol, steroids, montelukast and azithromycin.  Action taken with RNA-1273 in response to the event was not provided.  The outcome of the events hacky cough, slight headache, tired, slight fever of 100.4, covid-19, strep throat and passed out was unknown.; Reporter's Comments: This case concerns a 73-year-old male with a serious expected event of loss of consciousness along with a NS unexpected COVID-19, streptococcal pharyngitis, cough and NS expected fever, headache, fatigue.  Event onset 9 days after the first dose of mRNA-1273. Treatment included fluticasone, salbutamol, steroids, azithromycin. 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.