chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: swelling after 3 days; This case was reported by a consumer via (Shingrix chatbot) interactive digital media and described the occurrence of swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced swelling. On an unknown date, the outcome of the swelling was unknown.   It was unknown if the reporter considered the swelling to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient received Shingrix on an unknown date and 3 days after vaccination, he/she experienced swelling.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: niece / got the shot / had shingles / never really recovered from them / had them in her skull; more than painful; This case was reported by a consumer and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles and pain.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient's family member. The age at vaccination was not reported. The patient received Shingles vaccine and within a week patient experienced shingles again. The patient had shingles in her skull. The reporter stated that she was the person that reporter heard that getting the shingles after the shot was more than painful than the first time.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Pain in extremity
Clinical narrative: stomach is not right (upset stomach; Chills; sore arm; feeling tired; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included heart valve replacement. Concomitant products included COVID 19 VACCINE.   On 20th April 2021, the patient received the 1st dose of Shingrix (intramuscular). In April 2021, less than a day after receiving Shingrix, the patient experienced upset stomach, chills, pain in arm and tiredness. On an unknown date, the outcome of the upset stomach, chills, pain in arm and tiredness were not recovered/not resolved.   The reporter considered the upset stomach, chills, pain in arm and tiredness to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's wife. The reporter mentioned that Shingrix was administered by a nurse practitioner to patient at around 1pm to 2pm and side effects started 5 am next day. Next morning, the patient woke up feeling tired, sore arm, chills, no fever and his stomach was not right (upset stomach). The reporter read these side effects online and asked how long does these reactions last. The reporter stated that the patient had his heart valve replacement done. She also mentioned that they both received their 2 doses of COVID vaccine a few weeks ago from reporting day. The reporter stated that they did not receive any information from the clinic, therefore did not have lot number, expiration date, or dosage. The reporter consented to follow up.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia
Clinical narrative: reported muscle pain behind her right knee; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included knee operation (3 operations on left knee including implant and rods), rheumatoid arthritis and shingles (mild case a few years ago from the date of reporting).   On 1st November 2020, the patient received the 1st dose of Shingrix. On 2nd November 2020, 1 days after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was not recovered/not resolved.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. After receiving Shingrix, the patient experienced muscle pain behind her right knee. Till the time of reporting, the patient did not receive 2nd dose. The reporter consented to follow up. The reporter did not know Shingrix lot or expiration date.  She gave consent to email Shingrix PI and was given telephone number to share with her healthcare professional.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Laboratory test normal, Malaise, Myalgia, Pyrexia
Clinical narrative: flu like symptoms / viral-like symptoms / Tests for several common viruses came negative; Myalgia; fever; malaise; This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd May 2018, the patient received the 1st dose of Shingrix. On 22nd May 2018, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, myalgia, fever and malaise. On 24th May 2018, the outcome of the influenza-like symptoms, myalgia, fever and malaise were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, myalgia, fever and malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the Shingrix vaccine and developed flu like symptoms, myalgia, fever and malaise.  The patient got better after a couple of days. The patient also had viral-like symptoms but the tests for several common viruses came negative. No vaccine administration information was available to reporter. The reporter consented to follow up. This case had been linked with case US2021090809, reported by the same reporter for patient's husband.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021090809:same reporter (patient's husband)
Sex: F
Vaccine: VARZOS
Symptoms: Viral test negative
Clinical narrative: flu like symptoms / viral-like symptoms / Tests for several common viruses came negative; Myalgia; fever; malaise; This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd May 2018, the patient received the 1st dose of Shingrix. On 22nd May 2018, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, myalgia, fever and malaise. On 24th May 2018, the outcome of the influenza-like symptoms, myalgia, fever and malaise were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, myalgia, fever and malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the Shingrix vaccine and developed flu like symptoms, myalgia, fever and malaise.  The patient got better after a couple of days. The patient also had viral-like symptoms but the tests for several common viruses came negative. No vaccine administration information was available to reporter. The reporter consented to follow up. This case had been linked with case US2021090809, reported by the same reporter for patient's husband.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021090809:same reporter (patient's husband)
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Delayed / doses / first doses in Nov 2019 / second doses yesterday, 4/22/21; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date in November 2019).   On 22nd April 2021, the patient received the 2nd dose of Shingrix. On 22nd April 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose later than the recommended interval, which lead to lengthening of vaccination schedule. The reporter did not consented to follow up. The case is linked with US2021090830, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021090830:Same reporter. Husband's case.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Delayed / doses / first doses in Nov 2019 / second doses yesterday, 4/22/21; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in November 2019).   On 22nd April 2021, the patient received the 2nd dose of Shingrix. On 22nd April 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were reported as follows: The age at vaccination was not reported. Initially, the pharmacist inquired about delayed shingrix doses for a patient and asked should he receive his second dose or restart the series. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter did not consent to follow up. This case has been linked with case US2021090834, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021090834:Same reporter. Wife's case.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: A tingling and prickling sensation in the left arm /and left leg; This case was reported by a consumer via call center representative and described the occurrence of tingling of extremity in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced tingling of extremity. On an unknown date, the outcome of the tingling of extremity was not recovered/not resolved.   It was unknown if the reporter considered the tingling of extremity to be related to Shingrix.  Additional details were provided as follows:  The case was reported by patient herself. The patient received Shingrix vaccine in left arm and experienced tingling and prickling sensation in the left arm and left leg, approximately 2 weeks to a month after receiving vaccine. The reporter reported that the tingling and prickling sensation comes and goes and seems to worsen when lying down at night. The tingling and prickling sensation seems to subside with physical activity. The patient did not yet receive their second dose of Shingrix. The reporter did not consent to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Incorrect dose administered, Pain, Product preparation issue
Clinical narrative: received Shingrix adjuvant alone without the lyophilized antigen component; received Shingrix adjuvant alone without the lyophilized antigen component; pain; chills; This case was reported by a nurse and described the occurrence of pain in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 753RM, expiry date 18th December 2022) for prophylaxis.   Concurrent medical conditions included hypothyroidism.   On 21st April 2021, the patient received the 1st dose of Shingrix. In April 2021, less than a week after receiving Shingrix, the patient experienced pain and chills. On 21st April 2021, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the pain and chills were not recovered/not resolved and the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the pain and chills to be related to Shingrix.  Additional details was reported as follows: The patient received a dose of Shingrix and was administered adjuvant alone without the lyophilized antigen component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient also experienced pain and chills. Leader licensed vocational nurse called to report this situation as well as for guidance on timing for a new dose and side effects expected. The reporter consented to follow up via email or a phone call. The batch number reported in the source document was 753NP, however, it was updated to 753RM as per the sales data sheet.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Soreness at injection site; Muscle soreness; Tiredness; Headache; This case was reported by a consumer and described the occurrence of injection site pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd April 2021, the patient received the 1st dose of Shingrix (intramuscular). On 22nd April 2021, less than a day after receiving Shingrix, the patient experienced injection site pain, muscle soreness, tiredness and headache. On an unknown date, the outcome of the injection site pain, muscle soreness, tiredness and headache were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, muscle soreness, tiredness and headache to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient received the 1st dose of Shingrix in arm and experienced soreness at injection site, muscle soreness, tiredness, and a headache. The reporter consent to follow up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Heart rate, Heart rate increased
Clinical narrative: afib; fast heartbeat; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (afib) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced ATRIAL FIBRILLATION (afib) (seriousness criterion medically significant) and HEART RATE INCREASED (fast heartbeat). At the time of the report, ATRIAL FIBRILLATION (afib) and HEART RATE INCREASED (fast heartbeat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, Heart rate: abnormal (abnormal) Abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment included furosemide, eliquist and flecinade.  Company comment: Very limited information regarding these events has been provided at this time. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: No specific follow-up information recorded.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy, Epistaxis, Erythema, Feeling hot, Headache
Clinical narrative: diagnosed with Bells palsy; face was red,Face turning bright red; Like had a worse sunburn on face; face was red hot,extremly hot; Whole face swollen up; Blood out of nose; face pealed,Top of head pealed,face broke out; Teeth started hurting, every tooth of mouth,Still happening in the back of the teeth; Throat swelling; general aches; headache; little bit of fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (diagnosed with Bells palsy) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced FACIAL PARALYSIS (diagnosed with Bells palsy) (seriousness criterion medically significant), ERYTHEMA (face was red,Face turning bright red), RASH ERYTHEMATOUS (Like had a worse sunburn on face), FEELING HOT (face was red hot,extremly hot), SWELLING FACE (Whole face swollen up), EPISTAXIS (Blood out of nose), SKIN EXFOLIATION (face pealed,Top of head pealed,face broke out), TOOTHACHE (Teeth started hurting, every tooth of mouth,Still happening in the back of the teeth), PHARYNGEAL SWELLING (Throat swelling), MYALGIA (general aches), HEADACHE (headache) and PYREXIA (little bit of fever). At the time of the report, FACIAL PARALYSIS (diagnosed with Bells palsy), ERYTHEMA (face was red,Face turning bright red), RASH ERYTHEMATOUS (Like had a worse sunburn on face), FEELING HOT (face was red hot,extremly hot), SWELLING FACE (Whole face swollen up), EPISTAXIS (Blood out of nose), SKIN EXFOLIATION (face pealed,Top of head pealed,face broke out), TOOTHACHE (Teeth started hurting, every tooth of mouth,Still happening in the back of the teeth), MYALGIA (general aches), HEADACHE (headache) and PYREXIA (little bit of fever) had not resolved and PHARYNGEAL SWELLING (Throat swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There is no concomitant list. Treatment includes a steroid shot from doctor after face broke out.  Company comment: 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, further information has been requested.   Reporter did not allow further contact; Sender'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, further information has been requested.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pharyngeal swelling, Pyrexia, Rash erythematous, Skin exfoliation
Clinical narrative: diagnosed with Bells palsy; face was red,Face turning bright red; Like had a worse sunburn on face; face was red hot,extremly hot; Whole face swollen up; Blood out of nose; face pealed,Top of head pealed,face broke out; Teeth started hurting, every tooth of mouth,Still happening in the back of the teeth; Throat swelling; general aches; headache; little bit of fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (diagnosed with Bells palsy) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced FACIAL PARALYSIS (diagnosed with Bells palsy) (seriousness criterion medically significant), ERYTHEMA (face was red,Face turning bright red), RASH ERYTHEMATOUS (Like had a worse sunburn on face), FEELING HOT (face was red hot,extremly hot), SWELLING FACE (Whole face swollen up), EPISTAXIS (Blood out of nose), SKIN EXFOLIATION (face pealed,Top of head pealed,face broke out), TOOTHACHE (Teeth started hurting, every tooth of mouth,Still happening in the back of the teeth), PHARYNGEAL SWELLING (Throat swelling), MYALGIA (general aches), HEADACHE (headache) and PYREXIA (little bit of fever). At the time of the report, FACIAL PARALYSIS (diagnosed with Bells palsy), ERYTHEMA (face was red,Face turning bright red), RASH ERYTHEMATOUS (Like had a worse sunburn on face), FEELING HOT (face was red hot,extremly hot), SWELLING FACE (Whole face swollen up), EPISTAXIS (Blood out of nose), SKIN EXFOLIATION (face pealed,Top of head pealed,face broke out), TOOTHACHE (Teeth started hurting, every tooth of mouth,Still happening in the back of the teeth), MYALGIA (general aches), HEADACHE (headache) and PYREXIA (little bit of fever) had not resolved and PHARYNGEAL SWELLING (Throat swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There is no concomitant list. Treatment includes a steroid shot from doctor after face broke out.  Company comment: 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, further information has been requested.   Reporter did not allow further contact; Sender'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, further information has been requested.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Swelling face, Toothache
Clinical narrative: diagnosed with Bells palsy; face was red,Face turning bright red; Like had a worse sunburn on face; face was red hot,extremly hot; Whole face swollen up; Blood out of nose; face pealed,Top of head pealed,face broke out; Teeth started hurting, every tooth of mouth,Still happening in the back of the teeth; Throat swelling; general aches; headache; little bit of fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (diagnosed with Bells palsy) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced FACIAL PARALYSIS (diagnosed with Bells palsy) (seriousness criterion medically significant), ERYTHEMA (face was red,Face turning bright red), RASH ERYTHEMATOUS (Like had a worse sunburn on face), FEELING HOT (face was red hot,extremly hot), SWELLING FACE (Whole face swollen up), EPISTAXIS (Blood out of nose), SKIN EXFOLIATION (face pealed,Top of head pealed,face broke out), TOOTHACHE (Teeth started hurting, every tooth of mouth,Still happening in the back of the teeth), PHARYNGEAL SWELLING (Throat swelling), MYALGIA (general aches), HEADACHE (headache) and PYREXIA (little bit of fever). At the time of the report, FACIAL PARALYSIS (diagnosed with Bells palsy), ERYTHEMA (face was red,Face turning bright red), RASH ERYTHEMATOUS (Like had a worse sunburn on face), FEELING HOT (face was red hot,extremly hot), SWELLING FACE (Whole face swollen up), EPISTAXIS (Blood out of nose), SKIN EXFOLIATION (face pealed,Top of head pealed,face broke out), TOOTHACHE (Teeth started hurting, every tooth of mouth,Still happening in the back of the teeth), MYALGIA (general aches), HEADACHE (headache) and PYREXIA (little bit of fever) had not resolved and PHARYNGEAL SWELLING (Throat swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There is no concomitant list. Treatment includes a steroid shot from doctor after face broke out.  Company comment: 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, further information has been requested.   Reporter did not allow further contact; Sender'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, further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Sudden hearing loss, Tinnitus
Clinical narrative: Sudden hearing loss; Ear ringing; This spontaneous case was reported by a consumer and describes the occurrence of SUDDEN HEARING LOSS (Sudden hearing loss) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced TINNITUS (Ear ringing). On 10-Mar-2021, the patient experienced SUDDEN HEARING LOSS (Sudden hearing loss) (seriousness criterion medically significant). At the time of the report, SUDDEN HEARING LOSS (Sudden hearing loss) and TINNITUS (Ear ringing) had not resolved.  Concomitant medications were not reported. Treatment received in response to the events was not reported. Company Comment Based on current available information and the temporal association between product and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product and the start date of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer female, Dyspnoea, Feeling abnormal, Hypoxia, Lung disorder
Clinical narrative: compromised lung function; Diagnosed with breast CA; patient's low oxygen stores; a week later she had shortness of breath; felt bad for a day; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BREAST CANCER (Diagnosed with breast CA) and HYPOXIA (patient's low oxygen stores) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced FEELING ABNORMAL (felt bad for a day). On 17-Mar-2021, the patient experienced HYPOXIA (patient's low oxygen stores) (seriousness criterion medically significant) and DYSPNOEA (a week later she had shortness of breath). On 05-Apr-2021, the patient experienced BREAST CANCER  (Diagnosed with breast CA) (seriousness criterion medically significant). On 08-Apr-2021, the patient experienced LUNG DISORDER (compromised lung function). The patient was treated with Surgery for Breast cancer female. On 11-Mar-2021, FEELING ABNORMAL (felt bad for a day) outcome was unknown. At the time of the report, BREAST CANCER FEMALE (Diagnosed with breast CA), HYPOXIA (patient's low oxygen stores), DYSPNOEA (a week later she had shortness of breath) and LUNG DISORDER (compromised lung function) outcome was unknown.            Treatment for the events included oxygen therapy.  Company Comment: Based on current available information and the temporal association between drug use and the start date of the events a causal relationship cannot be excluded except for the event of Breast cancer as this causality is unlikely.   This case was linked to MOD-2021-031179; Sender's Comments: Based on current available information and the temporal association between drug use and the start date of the events a causal relationship cannot be excluded except for the event of Breast cancer as this causality is unlikely.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Fall, Hip fracture, Incomplete course of vaccination
Clinical narrative: She fell and broke her hip; She fell and broke her hip; Lost balance; Not able to get her second dose bacuse both hospital and rehab center had only Pfizer's vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HIP FRACTURE (She fell and broke her hip), FALL (She fell and broke her hip) and BALANCE DISORDER (Lost balance) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced HIP FRACTURE (She fell and broke her hip) (seriousness criterion hospitalization), FALL (She fell and broke her hip) (seriousness criterion hospitalization), BALANCE DISORDER (Lost balance) (seriousness criterion hospitalization) and INCOMPLETE COURSE OF VACCINATION (Not able to get her second dose bacuse both hospital and rehab center had only Pfizer's vaccine). The patient was treated with Surgery for Hip fracture. On 01-Apr-2021, INCOMPLETE COURSE OF VACCINATION (Not able to get her second dose bacuse both hospital and rehab center had only Pfizer's vaccine) had resolved. At the time of the report, HIP FRACTURE (She fell and broke her hip), FALL (She fell and broke her hip) and BALANCE DISORDER (Lost balance) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Per patient she was working in the garage, "doing something stupid" and lost her balance and fell right on her hip. She had surgery and now is in a rehabilitation center, but doing much better.  Treatment information was not provided.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy to vaccine, Anaphylactic reaction, Decreased appetite, Dizziness, Feeling hot
Clinical narrative: anaphylaxis reaction; severe allergic reaction; throat closing up/throat started swelling; dizzy; lack of appetite; vertigo; headaches; started to feel hot; breaking out in a rash/skin began to break out; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (anaphylaxis reaction) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced ANAPHYLACTIC REACTION (anaphylaxis reaction) (seriousness criterion medically significant), ALLERGY TO VACCINE (severe allergic reaction), PHARYNGEAL SWELLING (throat closing up/throat started swelling), DIZZINESS (dizzy), DECREASED APPETITE (lack of appetite), VERTIGO (vertigo), HEADACHE (headaches), FEELING HOT (started to feel hot) and RASH (breaking out in a rash/skin began to break out). At the time of the report, ANAPHYLACTIC REACTION (anaphylaxis reaction), ALLERGY TO VACCINE (severe allergic reaction), PHARYNGEAL SWELLING (throat closing up/throat started swelling), DIZZINESS (dizzy), DECREASED APPETITE (lack of appetite), HEADACHE (headaches), FEELING HOT (started to feel hot) and RASH (breaking out in a rash/skin began to break out) had resolved and VERTIGO (vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included: Epinephrine given in hospital, Benadryl and Predisone Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pharyngeal swelling, Rash, Vertigo
Clinical narrative: anaphylaxis reaction; severe allergic reaction; throat closing up/throat started swelling; dizzy; lack of appetite; vertigo; headaches; started to feel hot; breaking out in a rash/skin began to break out; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (anaphylaxis reaction) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced ANAPHYLACTIC REACTION (anaphylaxis reaction) (seriousness criterion medically significant), ALLERGY TO VACCINE (severe allergic reaction), PHARYNGEAL SWELLING (throat closing up/throat started swelling), DIZZINESS (dizzy), DECREASED APPETITE (lack of appetite), VERTIGO (vertigo), HEADACHE (headaches), FEELING HOT (started to feel hot) and RASH (breaking out in a rash/skin began to break out). At the time of the report, ANAPHYLACTIC REACTION (anaphylaxis reaction), ALLERGY TO VACCINE (severe allergic reaction), PHARYNGEAL SWELLING (throat closing up/throat started swelling), DIZZINESS (dizzy), DECREASED APPETITE (lack of appetite), HEADACHE (headaches), FEELING HOT (started to feel hot) and RASH (breaking out in a rash/skin began to break out) had resolved and VERTIGO (vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included: Epinephrine given in hospital, Benadryl and Predisone Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Cervix carcinoma, Incomplete course of vaccination
Clinical narrative: Cervical cancer; second dose not given in dosing window; This spontaneous case was reported by a patient and describes the occurrence of CERVIX CARCINOMA (Cervical cancer) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CERVIX CARCINOMA (Cervical cancer) (seriousness criterion medically significant) and INCOMPLETE COURSE OF VACCINATION (second dose not given in dosing window). The patient was treated with Surgery (surgery and four sessions of chemotherapy) for Cervix carcinoma. At the time of the report, CERVIX CARCINOMA (Cervical cancer) and INCOMPLETE COURSE OF VACCINATION (second dose not given in dosing window) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not provided. Treatment not reported.  She has undergone surgery and four sessions of chemotherapy. At the time of her originally scheduled second dose, she was too sick to receive it.   Reporter did not allow further contact; Sender's Comments: Based on current available information and the temporal association between the produce and the start date of the event a causal relationship is unlikely.
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Pericardial effusion, Pyrexia
Clinical narrative: Moderate level of fluid around heart ((baseline/all her life = minimal level of fluid); Temp 103, low grade fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERICARDIAL EFFUSION (Moderate level of fluid around heart ((baseline/all her life = minimal level of fluid)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PERICARDIAL EFFUSION (Moderate level of fluid around heart ((baseline/all her life = minimal level of fluid)) (seriousness criterion medically significant) and PYREXIA (Temp 103, low grade fever). At the time of the report, PERICARDIAL EFFUSION (Moderate level of fluid around heart ((baseline/all her life = minimal level of fluid)) and PYREXIA (Temp 103, low grade fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Electrocardiogram: abnormal had moderate level of fluid around heart (baseline/all her life = minimal level of fluid).         No relevant concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-033237; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Loss of consciousness
Clinical narrative: passed out; sweating profusely; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Apr-2021 and was forwarded to Moderna on 23-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant medical history provided.  Concomitant products included VITAMINS NOS for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant) and HYPERHIDROSIS (sweating profusely). On 13-Apr-2021, LOSS OF CONSCIOUSNESS (passed out) and HYPERHIDROSIS (sweating profusely) had resolved. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided.; Sender'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: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Haematochezia, Pyrexia
Clinical narrative: a lot of blood in his stool twice in the morning; Felt "really bad"; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (a lot of blood in his stool twice in the morning) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced FEELING ABNORMAL (Felt "really bad") and PYREXIA (Fever). On 23-Apr-2021, the patient experienced HAEMATOCHEZIA (a lot of blood in his stool twice in the morning) (seriousness criterion medically significant). At the time of the report, HAEMATOCHEZIA (a lot of blood in his stool twice in the morning), FEELING ABNORMAL (Felt "really bad") and PYREXIA (Fever) outcome was unknown.            Concomitant product use was not provided. Treatment included Ibuprofen and Tylenol.  Action taken with mRNA-1273 in response to the events was not Applicable.  Company comment: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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature increased, Fatigue, Hypertension, Myalgia
Clinical narrative: Blood pressure to be very high (188/100); Elevated temperature; Sleeping a lot; Fatigue; Body aches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (Blood pressure to be very high (188/100)) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included AMLODIPINE and LISINOPRIL for Hypertension.   On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced BODY TEMPERATURE INCREASED (Elevated temperature), SOMNOLENCE (Sleeping a lot), FATIGUE (Fatigue) and MYALGIA (Body aches). On 23-Apr-2021, the patient experienced HYPERTENSION (Blood pressure to be very high (188/100)) (seriousness criterion medically significant). On 24-Apr-2021, HYPERTENSION (Blood pressure to be very high (188/100)), BODY TEMPERATURE INCREASED (Elevated temperature), SOMNOLENCE (Sleeping a lot), FATIGUE (Fatigue) and MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Blood pressure measurement: 188/100 (High) went for a routine health check up and found his blood pressure to be very high (188/100).  Patient reported normally his Blood Pressure is between 120-130.Treatment for the event included ibuprofen. 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. This case concerns a 60-year-old male with a serious unexpected event of hypertension, and nonserious unexpected body temperature increased, somnolence and expected fatigue, myalgia. Event onset 2 days after first dose mRNA-1273. 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.; Sender's Comments: This case concerns a 60-year-old male with a serious unexpected event of hypertension, and nonserious unexpected body temperature increased, somnolence and expected fatigue, myalgia. Event onset 2 days after first dose mRNA-1273. 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.
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Blood pressure to be very high (188/100); Elevated temperature; Sleeping a lot; Fatigue; Body aches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (Blood pressure to be very high (188/100)) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included AMLODIPINE and LISINOPRIL for Hypertension.   On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced BODY TEMPERATURE INCREASED (Elevated temperature), SOMNOLENCE (Sleeping a lot), FATIGUE (Fatigue) and MYALGIA (Body aches). On 23-Apr-2021, the patient experienced HYPERTENSION (Blood pressure to be very high (188/100)) (seriousness criterion medically significant). On 24-Apr-2021, HYPERTENSION (Blood pressure to be very high (188/100)), BODY TEMPERATURE INCREASED (Elevated temperature), SOMNOLENCE (Sleeping a lot), FATIGUE (Fatigue) and MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Blood pressure measurement: 188/100 (High) went for a routine health check up and found his blood pressure to be very high (188/100).  Patient reported normally his Blood Pressure is between 120-130.Treatment for the event included ibuprofen. 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. This case concerns a 60-year-old male with a serious unexpected event of hypertension, and nonserious unexpected body temperature increased, somnolence and expected fatigue, myalgia. Event onset 2 days after first dose mRNA-1273. 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.; Sender's Comments: This case concerns a 60-year-old male with a serious unexpected event of hypertension, and nonserious unexpected body temperature increased, somnolence and expected fatigue, myalgia. Event onset 2 days after first dose mRNA-1273. 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.