chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Bump at the site of injection/big Walsh looking like bump/ swelling/puffy), VACCINATION SITE PAIN (It hurts) and VACCINATION SITE PRURITUS (Its itching) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. Concurrent medical conditions included Tetanus. Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Bump at the site of injection/big Walsh looking like bump/ swelling/puffy), VACCINATION SITE PAIN (It hurts) and VACCINATION SITE PRURITUS (Its itching). At the time of the report, VACCINATION SITE SWELLING (Bump at the site of injection/big Walsh looking like bump/ swelling/puffy), VACCINATION SITE PAIN (It hurts) and VACCINATION SITE PRURITUS (Its itching) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.Treatment information was not provided by the reporter
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Appendicitis, Influenza like illness
Clinical narrative: Diagnosed with appendicitis; Severe pain in lower right abdomen; Felt like she had the flu; This spontaneous case was reported by an other health care professional and describes the occurrence of APPENDICITIS (Diagnosed with appendicitis) and ABDOMINAL PAIN LOWER (Severe pain in lower right abdomen) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included HRT since an unknown date. Concurrent medical conditions included Asthma chronic (Mild chronic asthma). Concomitant products included FLUTICASONE PROPIONATE (FLOVENT) and ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced APPENDICITIS (Diagnosed with appendicitis) (seriousness criteria hospitalization and medically significant). In 2021, the patient experienced ABDOMINAL PAIN LOWER (Severe pain in lower right abdomen) (seriousness criterion hospitalization) and INFLUENZA LIKE ILLNESS (Felt like she had the flu). The patient was hospitalized on sometime in April 2021 due to APPENDICITIS. The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form and Surgery (Appendectomy) for Appendicitis. At the time of the report, APPENDICITIS (Diagnosed with appendicitis), ABDOMINAL PAIN LOWER (Severe pain in lower right abdomen) and INFLUENZA LIKE ILLNESS (Felt like she had the flu) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant therapy included HRT (Hormone replacement therapy). Patient took Albuterol intermittently.  Patient was diagnosed with appendicitis and had an emergency appendectomy 2 days later.  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. Further information has been requested   This case was linked to MOD-2021-313465 (Patient Link).; 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. Further information has been requested
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: More than 35 days between Moderna Covid-19 vaccinations/ did not get my second Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 35 days between Moderna Covid-19 vaccinations/ did not get my second Moderna Covid-19 vaccine) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B31) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 35 days between Moderna Covid-19 vaccinations/ did not get my second Moderna Covid-19 vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 35 days between Moderna Covid-19 vaccinations/ did not get my second Moderna Covid-19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by reporter. Treatment information was not provided.   Reporter did not allow further contact
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Felt strange; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt strange ) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No medical history information  was reported.     On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced FEELING ABNORMAL (Felt strange ). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Felt strange ) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Relevant concomitant medications were not reported.   This case was linked to MOD-2021-313642 (Patient Link).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Influenza, Pain in jaw
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (noticed a pain in the jaw), INFLUENZA (flu) and CONDITION AGGRAVATED (it was significantly worse than with the second shot) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 010M20A) for COVID-19 vaccination. Concurrent medical conditions included Hashimoto's disease, Hypothyroidism and Asthma. Concomitant products included COLECALCIFEROL (VITAMIN D3), THYROID (ARMOUR THYROID), SERTRALINE, ATOMOXETINE and OMEPRAZOLE for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN JAW (noticed a pain in the jaw), INFLUENZA (flu) and CONDITION AGGRAVATED (it was significantly worst than with the second shot). At the time of the report, PAIN IN JAW (noticed a pain in the jaw), INFLUENZA (flu) and CONDITION AGGRAVATED (it was significantly worst than with the second shot) outcome was unknown. No treatment information was provided. This case was linked to MOD-2021-313599. This case was linked to MOD-2021-307971. See case MOD-2021-313599 for details regarding the child case.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Immunodeficiency, Polymyalgia rheumatica
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica) and IMMUNODEFICIENCY (Immunocompromised) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 029L20A) for COVID-19 vaccination. No Medical History information was reported. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica) and IMMUNODEFICIENCY (Immunocompromised). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency and CELECOXIB (CELEBREX) for Pain, at an unspecified dose and frequency. At the time of the report, POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica) and IMMUNODEFICIENCY (Immunocompromised) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided. Three weeks after the first shot felt strange, and took Advil and felt better. About 4 months after vaccination, patient was diagnosed with Polymyalgia rheumatica. Patient had already started taking Celebrex after vaccination, but it did not alleviate the pain and inflammation. The doctor stopped the Celebrex and gave him Prednisone. The doctor told him to go ahead and take a third shot. Patient has not received a third shot yet. Reported immunocompromise due to Prednisone treatment. This case was linked to MOD-2021-313578 (Patient Link).; 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. Events Polymyalgia rheumatica and immunodeficiency were automatically upgraded as a Serious event as per list. However, based on information available and as per medical criteria was classified as Non-serious.
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fall, Inappropriate schedule of product administration, Injury
Clinical narrative: SECOND SHOT MADE ME EXTREMELY DIZZY; I ABOUT INJURIED MYSELF FALLING SEVERAL TIMES; I ABOUT INJURIED MYSELF FALLING SEVERAL TIMES; doses administered 14 days apart; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (SECOND SHOT MADE ME EXTREMELY DIZZY), INJURY (I ABOUT INJURIED MYSELF FALLING SEVERAL TIMES), FALL (I ABOUT INJURIED MYSELF FALLING SEVERAL TIMES) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (doses administered 14 days apart) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 025J20-2A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Blood pressure high. Concomitant products included INSULIN for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (SECOND SHOT MADE ME EXTREMELY DIZZY), INJURY (I ABOUT INJURIED MYSELF FALLING SEVERAL TIMES), FALL (I ABOUT INJURIED MYSELF FALLING SEVERAL TIMES) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (doses administered 14 days apart). At the time of the report, DIZZINESS (SECOND SHOT MADE ME EXTREMELY DIZZY), INJURY (I ABOUT INJURIED MYSELF FALLING SEVERAL TIMES) and FALL (I ABOUT INJURIED MYSELF FALLING SEVERAL TIMES) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (doses administered 14 days apart) had resolved.            Patient was on cholesterol medication and high blood pressure medication before he received the vaccine. No Treatment medications was provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Followup received on 10-sep-2021, contains about concomitant medication and about dosage details.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects). At the time of the report, VACCINATION COMPLICATION (Side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter. No treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side Effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side Effect) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side Effect). At the time of the report, VACCINATION COMPLICATION (Side Effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Rare side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Rare side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Rare side effects). At the time of the report, VACCINATION COMPLICATION (Rare side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment medication was reported
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: hurts where shot was inserted; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (hurts where shot was inserted) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (hurts where shot was inserted). At the time of the report, VACCINATION SITE PAIN (hurts where shot was inserted) had not resolved.            No concomitant medication was reported by the reporter. No treatment was reported by the reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: Last night I had some bad diarrhea; Today I feel nauseous; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Last night I had some bad diarrhea) and NAUSEA (Today I feel nauseous) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Last night I had some bad diarrhea) and NAUSEA (Today I feel nauseous). At the time of the report, DIARRHOEA (Last night I had some bad diarrhea) and NAUSEA (Today I feel nauseous) outcome was unknown.            Patient stated that the diarrhea may have been caused due to the food and patient was active before the events occurred.  No concomitant information was reported. No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: >35 days since first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (>35 days since first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-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 PRODUCT DOSE OMISSION ISSUE (>35 days since first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (>35 days since first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headaches from the booster shot; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches from the booster shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headaches from the booster shot). At the time of the report, HEADACHE (Headaches from the booster shot) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Off label use, Pain, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous case was reported by a health care professional and describes the occurrence of OFF LABEL USE (not immunocompromised), COVID-19 (Positive for COVID-9), PAIN IN EXTREMITY (Sore arm), PAIN (Achy) and PYREXIA (Fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A, 006B21A and 015M20A) for COVID-19 vaccination. No Medical History information was reported. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 3 dosage form. On 31-Aug-2021, the patient experienced OFF LABEL USE (not immunocompromised). On 08-Sep-2021, the patient experienced COVID-19 (Positive for COVID-9). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), PAIN (Achy) and PYREXIA (Fever). The patient was treated with OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for Head cold, at an unspecified dose and frequency. At the time of the report, OFF LABEL USE (not immunocompromised) and PAIN IN EXTREMITY (Sore arm) had resolved and COVID-19 (Positive for COVID-9), PAIN (Achy) and PYREXIA (Fever) outcome was unknown. Caller is not immunocompromised but got the third dose/ booster. Concomitant medication use was unknown.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: got COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got COVID) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, the patient experienced COVID-19 (got COVID). At the time of the report, COVID-19 (got COVID) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Narcolepsy, Vein collapse
Clinical narrative: Extreame chest pain; Become narcoleptic to the point of not being able to sleep less then 16 hours; I had a vein implode in my leg; This spontaneous case was reported by a consumer and describes the occurrence of NARCOLEPSY (Become narcoleptic to the point of not being able to sleep less then 16 hours) in a  patient of an unknown age and 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 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced NARCOLEPSY (Become narcoleptic to the point of not being able to sleep less then 16 hours) (seriousness criterion medically significant) and VEIN COLLAPSE (I had a vein implode in my leg). On an unknown date, the patient experienced CHEST PAIN (Extreame chest pain). At the time of the report, NARCOLEPSY (Become narcoleptic to the point of not being able to sleep less then 16 hours), VEIN COLLAPSE (I had a vein implode in my leg) and CHEST PAIN (Extreame chest pain) outcome was unknown.            Concomitant medications were not reported. Treatment information was not provided.  Company Comment:  This report concerns a patient who experienced an unexpected serious event of narcolepsy and unexpected non serious events of vein collapse and chest pain unknown duration following vaccination with mRNA-1273. It has been reported that the patient has taken both the doses of the vaccine. Very limited information regarding these events has been provided at this time. However, the benefit-risk relationship of mRNA-1273  is not affected by this report.; Sender's Comments: This report concerns a patient who experienced an unexpected serious event of narcolepsy and unexpected non serious events of vein collapse and chest pain unknown duration following vaccination with mRNA-1273. It has been reported that the patient has taken both the doses of the vaccine. Very limited information regarding these events has been provided at this time. However, the benefit-risk relationship of mRNA-1273  is not affected by this report.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Asthenia, Fatigue, Feeding disorder, Illness
Clinical narrative: She was in bed because she didn't have any energy; couldn't eat or drink anything; She was tired for a while; She was very sick for two days after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (She was in bed because she didn't have any energy), FEEDING DISORDER (couldn't eat or drink anything), ILLNESS (She was very sick for two days after the second dose) and FATIGUE (She was tired for a while) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (Patient has been doing well with Keytruda but she has not eliminated cancer), Celiac disease and Gastrointestinal motility disorder NOS (Motility issues). Concomitant products included PEMBROLIZUMAB (KEYTRUDA) for Cancer.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (She was very sick for two days after the second dose). On an unknown date, the patient experienced ASTHENIA (She was in bed because she didn't have any energy), FEEDING DISORDER (couldn't eat or drink anything) and FATIGUE (She was tired for a while). On 17-Mar-2021, ILLNESS (She was very sick for two days after the second dose) had resolved. At the time of the report, ASTHENIA (She was in bed because she didn't have any energy), FEEDING DISORDER (couldn't eat or drink anything) and FATIGUE (She was tired for a while) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: high (High) She did an antibody test, and she had a higher level than normal people would.         Patient was very sick for two days after the second dose. It started that night on 15Mar2021. It was not surprising that she could not eat or drink anything. She was in bed because she did not have any energy. It lasted for few days. Then she came out of it. She was tired for a while.   Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: lesser known side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (lesser known side effect) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (lesser known side effect). At the time of the report, VACCINATION COMPLICATION (lesser known side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Hypersensitivity, Tachycardia
Clinical narrative: Shortness of breath; Allergic reaction; Rapid heart beat; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), HYPERSENSITIVITY (Allergic reaction) and TACHYCARDIA (Rapid heart beat) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath) (seriousness criterion medically significant), HYPERSENSITIVITY (Allergic reaction) (seriousness criterion medically significant) and TACHYCARDIA (Rapid heart beat) (seriousness criterion medically significant). At the time of the report, DYSPNOEA (Shortness of breath), HYPERSENSITIVITY (Allergic reaction) and TACHYCARDIA (Rapid heart beat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: rapid (High) rapid heart beat.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.  Company Comment: This case concerns a patient of unknown age and gender with serious unexpected events of hypersensitivity, dyspnoea, and tachycardia. Event onset with unknown latency after mRNA-1273. Outcome unknown. Rechallenge not reported. Reporter causality not provided. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a patient of unknown age and gender with serious unexpected events of hypersensitivity, dyspnoea, and tachycardia. Event onset with unknown latency after mRNA-1273. Outcome unknown. Rechallenge not reported. Reporter causality not provided. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 43.0
Sex: U
Vaccine: COVID19
Symptoms: Air embolism, Vaccination site pain
Clinical narrative: sensation of bubbles on the blood vessels of the leg, that later extended to the arm and hand.; pain at the site of the injection (upper right arm); This spontaneous case was reported by a consumer and describes the occurrence of AIR EMBOLISM (sensation of bubbles on the blood vessels of the leg, that later extended to the arm and hand.) in a 43-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, the patient experienced AIR EMBOLISM (sensation of bubbles on the blood vessels of the leg, that later extended to the arm and hand.) (seriousness criterion medically significant) and VACCINATION SITE PAIN (pain at the site of the injection (upper right arm)). At the time of the report, AIR EMBOLISM (sensation of bubbles on the blood vessels of the leg, that later extended to the arm and hand.) and VACCINATION SITE PAIN (pain at the site of the injection (upper right arm)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided  Treatment information included ashubanda to try and alleviate the symptoms.  Company Comment: This case concerns a 43-year-old patient of an unknown gender, who experienced the unexpected event of Air embolism, and expected event of Vaccination site pain. The events occurred approximately 8 days after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The event Vaccination site pain is consistent with the known safety profile. The benefit-risk relationship of drug mRNA-1273 (Moderna COVID-19 Vaccine) in not affected by this report.; Sender's Comments: This case concerns a 43-year-old patient of an unknown gender, who experienced the unexpected event of Air embolism, and expected event of Vaccination site pain. The events occurred approximately 8 days after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The event Vaccination site pain is consistent with the known safety profile. The benefit-risk relationship of drug mRNA-1273 (Moderna COVID-19 Vaccine) in not affected by this report.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Drug abuse
Clinical narrative: Tested positive for cocaine by hair follicle test; This spontaneous case was reported by a nurse and describes the occurrence of DRUG ABUSE (Tested positive for cocaine by hair follicle test) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 010A21A) for COVID-19 vaccination.     Concomitant products included CALCIUM PANTOTHENATE, FOLIC ACID, VITAMINS NOS (MULTI-VITAMINS VITAFIT) for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced DRUG ABUSE (Tested positive for cocaine by hair follicle test) (seriousness criterion medically significant). The patient was treated with TERBINAFINE at an unspecified dose and frequency. At the time of the report, DRUG ABUSE (Tested positive for cocaine by hair follicle test) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications mention were Allmax, Epitome Hard Core.  Company Comment - This case concerns a  36-year-old, male patient with no relevant medical history, who experienced the unexpected events of Cocaine use. The events occurred several months after the second dose of Spikevax. The rechallenge/dechallenge result is not applicable. The reporter assessed the events as related to the product. The benefit-risk relationship of Spikevax in not affected by this report, however there was no information in the source document supporting that the event resulted in a persistent or permanent incapacity, life threatening, prolong hospitalization, or the need of medical intervention.   This case was linked to MOD-2021-057634 (Patient Link).; Sender's Comments: This case concerns a  36-year-old, male patient with no relevant medical history, who experienced the unexpected events of Cocaine use. The events occurred several months after the second dose of Spikevax. The rechallenge/dechallenge result is not applicable. The reporter assessed the events as related to the product. The benefit-risk relationship of Spikevax in not affected by this report, however there was no information in the source document supporting that the event resulted in a persistent or permanent incapacity, life threatening, prolong hospitalization, or the need of medical intervention.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Retracted nipple
Clinical narrative: Retracted nipple; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Sep-2021 and was forwarded to the company on 08-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RETRACTED NIPPLE (Retracted nipple) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (patient is allergic to Dilaudid), Parkinson's disease since 2019, Essential tremor and Bone disorder (NOS). Concomitant products included VITAMIN D NOS for Bone disorder (NOS), PROPRANOLOL for Essential tremor, ETHINYLESTRADIOL, NORETHISTERONE (BALZIVA) for Hormone therapy, MULTIVITAMINS [VITAMINS NOS] and ASCORBIC ACID (VITAMIN C ACID) for Prophylaxis.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced RETRACTED NIPPLE (Retracted nipple). At the time of the report, RETRACTED NIPPLE (Retracted nipple) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided.  Laboratory investigations include ultrasound and mammogram. on an unknown date of Mar-2021 patient nasal swab covid-19 test with unspecified result.   This case was linked to MOD-2021-281250 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Diabetes. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), LISINOPRIL and METFORMIN for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 10-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       A consumer reported no thyroid.   This case was linked to MOD-2021-303744 (Patient Link).
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Henoch-Schonlein purpura
Clinical narrative: / Now he has had a recurrence that has lasted about a month with extrenme pain; This spontaneous case was reported by a consumer and describes the occurrence of HENOCH-SCHONLEIN PURPURA (/ Now he has had a recurrence that has lasted about a month with extrenme pain) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Henoch-Schonlein purpura (Patient had HSP when he was 5 years old with relatively short flare ups about every 10 years.).    In April 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HENOCH-SCHONLEIN PURPURA (Henoch-Schönlein purpura/ Now he has had a recurrence that has lasted about a month with extrenme pain) (seriousness criterion hospitalization). The patient was treated with MORPHINE for Adverse event, at an unspecified dose and frequency. At the time of the report, HENOCH-SCHONLEIN PURPURA (Henoch-Schönlein purpura/ Now he has had a recurrence that has lasted about a month with extrenme pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reportedly did not read the fine print that people that had Henoch-Schonlein purpura (HSP) should not get the vaccine. Patient had HSP when he was 5-years-old with relatively short flare-ups about every 10 years.  Now, he had a recurrence that has lasted about a month and was in the hospital with extreme pain, bleeding and on a feeding tube because of difficulty eating.   No concomitant medications were reported.  Additional reatment included "potent painkillers" as well as corticosteroids.   Company Comment:  This report concerns a case of 42 year old male patient with concurrent medical condition of henoch-schonlein purpura who was hospitalized for the recurrence of henoch-schonlein purpura (serious unexpected event) after unknown duration following vaccination with mRNA-1273. The medical history of henoch-schonlein purpura remains a confounder for the recurrence of the event. The benefit-risk relationship of mRNA-1273  in not affected by this report.; Sender's Comments: This report concerns a case of 42 year old male patient with concurrent medical condition of henoch-schonlein purpura who was hospitalized for the recurrence of henoch-schonlein purpura (serious unexpected event) after unknown duration following vaccination with mRNA-1273. The medical history of henoch-schonlein purpura remains a confounder for the recurrence of the event. The benefit-risk relationship of mRNA-1273  in not affected by this report.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pain in extremity, Vaccination site pain
Clinical narrative: Pain in injection site; states his lower arm and joint are hurting; Last night he turned over and the pain is traveling down into his lower left arm/states his lower arm and joint are hurting; States felt the site was sore and the pain never left, states it has worsened; This is a spontaneous report from a contactable consumer (patient).  A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported, Expiration date: Unknown) via an unspecified route of administration on 15May2021 (60-year-old at vaccination) as Dose 2, single for COVID-19 immunization. The report was not related to a study or programme. Vaccination Facility Type was reported as clinic at school and not military facility. The patient's medical history included blood pressure and he had been on blood pressure medication for years, no further information provided. The patient's family medical history was reported as none. There were no concomitant medications within in 4 weeks prior to vaccination. No additional vaccines was administered on same date of the Pfizer vaccination. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: EW0158) via an unspecified route of administration in Left arm on 24Apr2021 at 10:00 AM (60-year-old at vaccination) as Dose 1, single for COVID-19 immunization. The patient stated that on 16May2021 he was still having pain in the injection site, stated his lower arm and joint are hurting, and now last night he turned over and the pain was traveling down/radiating down into his lower left arm. He stated that he felt the site was sore and the pain never left, stated it had being worsened. The reporter stated that these adverse events did not required an emergency room/ physician office visit. No relevant tests reported. No investigation assessment was reported. He wanted to know if he should be concerned about his blood pressure. The outcome of the events was not recovered. The reporter declined to provide email id and HCP details.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Lip swelling
Clinical narrative: My lips began to swell 30mins after getting the vaccine.; My left arm feeling heavy and strange; This is a spontaneous report from a contactable consumer. This 55-year-old female consumer (patient) reported for herself that:  A 55-years-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot unknown reason=Not available/provided to reporter at the time of report completion) via an unspecified route of administration in arm left on 20Jul2021 12:00 as dose 1, single for COVID-19 immunization. Medical history included   from an unknown date and unknown if ongoing. Patient don't have known allergies. The patient receives other medications within 2 weeks of vaccination: Aleve, melatonin, multivitamin, Allerclear. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Concomitant medications included naproxen sodium (ALEVE) taken for an unspecified indication, start and stop date were not reported; melatonin (MELATONIN) taken for an unspecified indication, start and stop date were not reported; loratadine (ALLERCLEAR) taken for an unspecified indication, start and stop date were not reported. On Jul2021 at 12:30 PM patient lips began to swell 30mins after getting the vaccine, left arm feeling heavy and strange. Patient didn't received treatment for the events. The clinical outcome of the event was unknown.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Pain in extremity, Poor quality product administered, Product temperature excursion issue, Pyrexia
Clinical narrative: patient received the Pfizer Covid-19 vaccine that was diluted and then left on a counter for 2 weeks at room temperature before it was administered to the patient.; patient received the Pfizer Covid-19 vaccine that was diluted and then left on a counter for 2 weeks at room temperature before it was administered to the patient.; patient was administered expired Pfizer COVID 19 vaccine; arm soreness; fever; This is a spontaneous report from a contactable Pharmacist. This pharmacist reported for a male patient that:  A male patient of an unspecified age (Age: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: Unknown, Expiry date: unknown) via unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient received the Pfizer Covid-19 vaccine that was diluted and then left on a counter for 2 weeks at room temperature before it was administered to the patient. Patient had complaints of arm soreness (unknown which arm per HCP) and fever of 102 degrees Fahrenheit after being administered the Pfizer Covid-19 vaccine. HCP looking guidance for revaccination. Additional Context: To get clarification on administration of expired vaccine. Clinical Pharmacist stated, "I do. Yeah, if it feels okay, I will give you a little more detail, ok so we had a situation where one of our patient was administered expired Pfizer COVID 19 vaccine. It had been out of the Refrigerator sitting on a desk for an extended period of time about 2 weeks from 01Jul till 15Jul, so it was administered after 14 days. I am looking at the CDC guidance for deviations for typical COVID 19 vaccination and they do know that if the dose has been administration past the expiration will be on new date to contact them for any guidance and if manufacturer can provide information or support or the dose should be repeated, and repeated dose can be given immediately with no minimal interval of after the arm. So, I am calling to call in terms of what the manufacturer guidance is for this particular case and should the second shot have administered and expelled. Clinical Pharmacist stated, "I do in about half an hour. I just want to make sure, I get them call and gave it wrap. I hope that's okay. Clinical Pharmacist was unwilling to complete the report hence further probing could not be done. Hence, limited information available over the call. The patient underwent lab tests and procedures which included pyrexia: 102 degrees fahrenheit on unspecified date. The clinical outcome of events was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.