chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Somnolence, Unevaluable event
Clinical narrative: STRONG COUGH WITH PHLEGM; DIARRHEA; SHIVERS; FEVER; HEADACHE; CHEST HURT; STOMACH HURT; NASAL SECRETION; VACCINE ALMOST KILLED ME; UNKNOWN SIDE EFFECTS; IN BED ALL THE TIME; COUGH FOR 10 DAYS AND NOW WITH BLOOD; This spontaneous report received from a patient concerned a 22 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was healthy young man with no previous health conditions. the patient was taking antibiotics, inhalers and expectorants. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 07-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On JUL-2021, the subject experienced cough for 10 days and now with blood. On JUL-2021, the subject experienced chest hurt. On JUL-2021, the subject experienced stomach hurt. On JUL-2021, the subject experienced nasal secretion. On JUL-2021, the subject experienced vaccine almost killed me. On JUL-2021, the subject experienced unknown side effects. On JUL-2021, the subject experienced in bed all the time. On JUL-2021, the subject experienced headache. On 08-JUL-2021, the subject experienced strong cough with phlegm. On 08-JUL-2021, the subject experienced diarrhea. On 08-JUL-2021, the subject experienced shivers. On 08-JUL-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, shivers, diarrhea, strong cough with phlegm, cough for 10 days and now with blood, chest hurt, stomach hurt, nasal secretion, headache, vaccine almost killed me, unknown side effects and in bed all the time was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Feeling hot, Pain, Pain in extremity
Clinical narrative: ARM FEELS A LITTLE WARM; REDNESS; SORE ARM; BODY ACHES; CHILLS; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 14-SEP-2021) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021, the subject experienced body aches. On 30-JUL-2021, the subject experienced chills. On 01-AUG-2021, the subject experienced sore arm. On 02-AUG-2021, the subject experienced redness. On an unspecified date, the subject experienced arm feels a little warm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and chills on 31-JUL-2021, had not recovered from sore arm, and the outcome of redness and arm feels a little warm was not reported. This report was non-serious.
Age: 73.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Colitis
Clinical narrative: COLITIS SYMPTOMS DID CAME BACK AFTER GOT THE COVID VACCINE; This spontaneous report received from a patient concerned a 73 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included moderate to severe adult crohn's disease, and moderate to severe ulcerative colitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers.   Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported, and dose, frequency, and therapy dates were not reported for moderate to severe adult crohn's disease, and moderate to severe ulcerative colitis. No concomitant medications were reported. On an unspecified date, the subject experienced colitis symptoms did came back after got the covid vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from colitis symptoms did came back after got the covid vaccine. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: Heart trouble; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (Heart trouble) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cardiac ablation.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (Heart trouble). At the time of the report, CARDIAC DISORDER (Heart trouble) was resolving.            No concomitant products were provided by the reporter. The reporter stated that after second vaccine dose the patient started having heart trouble for which the patient underwent heart ablation in the hospital. The patient currently is doing well. No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Non-significant follow up received, Patient requested follow up form via mail address.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Blood blister, Bullous haemorrhagic dermatosis
Clinical narrative: hemorrhagic bullous; she had a blister in her leg the size of 3or 4cm dose; haemorrhagic blisters in legs/ skin blisters with blood; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (she had a blister in her leg the size of 3or 4cm dose), BLOOD BLISTER (haemorrhagic blisters in legs/ skin blisters with blood) and BULLOUS HAEMORRHAGIC DERMATOSIS (hemorrhagic bullous) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Anaphylaxis (Iodine), Drug allergy (patient allergic to iodine.  DNA filaxis (contrast materisLXCT)) on 03-May-1999, Depression and Dementia. Concomitant products included DONEPEZIL HYDROCHLORIDE (ARICEPT) from 01-Oct-2015 to an unknown date and MEMANTINE HYDROCHLORIDE (NAMENDA) from 01-Oct-2015 to an unknown date for Dementia, SERTRALINE from 01-Oct-2015 to an unknown date and BUPROPION from 01-Oct-2015 to an unknown date for Depression, ASA from 01-Oct-2015 to an unknown date for an unknown indication.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, the patient experienced BLISTER (she had a blister in her leg the size of 3or 4cm dose) (seriousness criterion hospitalization) and BLOOD BLISTER (haemorrhagic blisters in legs/ skin blisters with blood) (seriousness criterion hospitalization). On 22-Jul-2021 at 7:00 AM, the patient experienced BULLOUS HAEMORRHAGIC DERMATOSIS (hemorrhagic bullous) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 22-Jul-2021 to 28-Jul-2021 due to BLISTER and BLOOD BLISTER, and then on 22-Jul-2021 due to BULLOUS HAEMORRHAGIC DERMATOSIS. At the time of the report, BLISTER (she had a blister in her leg the size of 3or 4cm dose) and BLOOD BLISTER (haemorrhagic blisters in legs/ skin blisters with blood) had not resolved and BULLOUS HAEMORRHAGIC DERMATOSIS (hemorrhagic bullous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up received on 28-JUL-2021 contains Significant information that includes, Event update, Seriousness criteria update.; 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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Pain in extremity, Product dose omission issue, Thrombosis
Clinical narrative: Clot; big lump/almost like 3 inches diameter round/very hard lump; Pain in both arms at the deltoid/pain in legs; Lower legs and arm were weak/weakness in muscle; Headache in the left side of her head; Patient has not received the second dose; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Clot) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMIN [VITAMINS NOS], VITAMIN D [VITAMIN D NOS], FISH OIL and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Clot) (seriousness criterion medically significant), VACCINATION SITE MASS (big lump/almost like 3 inches diameter round/very hard lump), PAIN IN EXTREMITY (Pain in both arms at the deltoid/pain in legs), ASTHENIA (Lower legs and arm were weak/weakness in muscle), HEADACHE (Headache in the left side of her head) and PRODUCT DOSE OMISSION ISSUE (Patient has not received the second dose). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (Clot), VACCINATION SITE MASS (big lump/almost like 3 inches diameter round/very hard lump), PAIN IN EXTREMITY (Pain in both arms at the deltoid/pain in legs), ASTHENIA (Lower legs and arm were weak/weakness in muscle) and HEADACHE (Headache in the left side of her head) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient has not received the second dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was delayed on an unknown date.       Patient had to shower with hot but tolerated water to make sure the clot doesn't form all over.  Company comment: Very limited information regarding these events have been provided at this time. Further information is requested.; Sender's Comments: Very limited information regarding these events have been provided at this time. Further information is requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: Clot; big lump/almost like 3 inches diameter round/very hard lump; Pain in both arms at the deltoid/pain in legs; Lower legs and arm were weak/weakness in muscle; Headache in the left side of her head; Patient has not received the second dose; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Clot) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMIN [VITAMINS NOS], VITAMIN D [VITAMIN D NOS], FISH OIL and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Clot) (seriousness criterion medically significant), VACCINATION SITE MASS (big lump/almost like 3 inches diameter round/very hard lump), PAIN IN EXTREMITY (Pain in both arms at the deltoid/pain in legs), ASTHENIA (Lower legs and arm were weak/weakness in muscle), HEADACHE (Headache in the left side of her head) and PRODUCT DOSE OMISSION ISSUE (Patient has not received the second dose). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (Clot), VACCINATION SITE MASS (big lump/almost like 3 inches diameter round/very hard lump), PAIN IN EXTREMITY (Pain in both arms at the deltoid/pain in legs), ASTHENIA (Lower legs and arm were weak/weakness in muscle) and HEADACHE (Headache in the left side of her head) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient has not received the second dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was delayed on an unknown date.       Patient had to shower with hot but tolerated water to make sure the clot doesn't form all over.  Company comment: Very limited information regarding these events have been provided at this time. Further information is requested.; Sender's Comments: Very limited information regarding these events have been provided at this time. Further information is requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Concussion, Haemorrhage, Headache, Loss of consciousness, Skeletal injury
Clinical narrative: She had hit the bone under the eye brow on left side.; she had a black out for 5-10 minutes while walking; She lost lots of blood; She had concussion; She had constant headache.; This spontaneous case was reported by a consumer and describes the occurrence of SKELETAL INJURY (She had hit the bone under the eye brow on left side.), LOSS OF CONSCIOUSNESS (she had a black out for 5-10 minutes while walking), HAEMORRHAGE (She lost lots of blood), CONCUSSION (She had concussion) and HEADACHE (She had constant headache.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS and ACETYLCYSTEINE, CALCIUM LEVOMEFOLATE, MECOBALAMIN (CEREFOLIN NAC [ACETYLCYSTEINE;CALCIUM LEVOMEFOLATE;MECOBALAMIN]) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced SKELETAL INJURY (She had hit the bone under the eye brow on left side.) (seriousness criterion hospitalization), LOSS OF CONSCIOUSNESS (she had a black out for 5-10 minutes while walking) (seriousness criteria hospitalization and medically significant), HAEMORRHAGE (She lost lots of blood) (seriousness criteria hospitalization and medically significant), CONCUSSION (She had concussion) (seriousness criterion hospitalization) and HEADACHE (She had constant headache.) (seriousness criterion hospitalization). The patient was hospitalized on 12-Mar-2021 due to CONCUSSION, HAEMORRHAGE, HEADACHE, LOSS OF CONSCIOUSNESS and SKELETAL INJURY. The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, SKELETAL INJURY (She had hit the bone under the eye brow on left side.), LOSS OF CONSCIOUSNESS (she had a black out for 5-10 minutes while walking), HAEMORRHAGE (She lost lots of blood), CONCUSSION (She had concussion) and HEADACHE (She had constant headache.) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.       Patient received her 1st dose on 02Mar2021 on her left arm. On 12Mar2021, she had a black out for 5-10 minutes while walking. She had hit the bone under the eye brow on left side. She ended up in hospital on same day. She had lost lots of blood. She had concussion. She had constant headache. Concomitant product included as Cerefolin Nac.  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.   This case was linked to MOD-2021-269924 (Patient Link).   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.
Sex: U
Vaccine: COVID19
Symptoms: Coronavirus test positive, Influenza like illness
Clinical narrative: Flu like symptoms; Positive for COVID; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and CORONAVIRUS TEST POSITIVE (Positive for COVID) 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 January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 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 INFLUENZA LIKE ILLNESS (Flu like symptoms) (seriousness criterion hospitalization) and CORONAVIRUS TEST POSITIVE (Positive for COVID) (seriousness criterion hospitalization). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) and CORONAVIRUS TEST POSITIVE (Positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Coronavirus test positive: positive (Positive) Positive.         No concomitant Medications were provided. No treatment Medications were provided.  The patient received two doses of moderna vaccine in January 2021 and had been doing ok. The patient was nowin the hospital with positive covid and flu like symptoms.  The patient got COVID After the Vaccine.  Very limited information regarding these events has been provided at this time. This Spontaneous report also states that two doses are given on the same month with no specified day (unknown batch lot#). No further information is expected.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding these events has been provided at this time. This Spontaneous report also states that two doses are given on the same month with no specified day (unknown batch lot#). No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Thrombosis
Clinical narrative: on his other arm he noticed blood clots; he noticed a bruise on his arm; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (on his other arm he noticed blood clots) in a male 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.     Concurrent medical conditions included Diabetic.   On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-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 THROMBOSIS (on his other arm he noticed blood clots) (seriousness criterion medically significant) and CONTUSION (he noticed a bruise on his arm). At the time of the report, THROMBOSIS (on his other arm he noticed blood clots) and CONTUSION (he noticed a bruise on his arm) outcome was unknown.            No concomitant medication was not reported. No treatment medication was not reported  Action taken with mRNA-1273 in response to the event was not applicable.  Very limited information regarding these events has been provided at this time. This Spontaneous report states that two doses are given on the same date (unknown batch lot#). Information needs to be clarified.  Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. This Spontaenous report states that two doses are given on the same date (unknown batch lot#). Information needs to be clarified.  Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Hyperthyroidism, Vaccination complication
Clinical narrative: was diagnosed with disease hyperthyroidism; Feeling symptoms but I just thought it was a side effect of the shot; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTHYROIDISM (was diagnosed with disease hyperthyroidism) 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 28-Apr-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERTHYROIDISM (was diagnosed with disease hyperthyroidism) (seriousness criterion medically significant) and VACCINATION COMPLICATION (Feeling symptoms but I just thought it was a side effect of the shot). At the time of the report, HYPERTHYROIDISM (was diagnosed with disease hyperthyroidism) and VACCINATION COMPLICATION (Feeling symptoms but I just thought it was a side effect of the shot) outcome was unknown.           Concomitant medications were not reported. Treatment information was not provided.  Very limited information regarding these events has been provided at this time. No further information is expected.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding these events has been provided at this time. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Breast cancer
Clinical narrative: Breast Cancer Scare; This spontaneous case was reported by an other health care professional and describes the occurrence of BREAST CANCER (Breast Cancer Scare) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided.     On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BREAST CANCER (Breast Cancer Scare) (seriousness criterion medically significant). At the time of the report, BREAST CANCER (Breast Cancer Scare) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Very limited information regarding this event has been provided at this time.; Sender's Comments: Very limited information regarding this event has been provided at this time.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Biopsy, Extranodal marginal zone B-cell lymphoma (MALT type), Mammogram, Pain in extremity, Positron emission tomogram
Clinical narrative: Low grade Malt B-cell lymphoma; Arm soreness; This spontaneous case was reported by a patient and describes the occurrence of EXTRANODAL MARGINAL ZONE B-CELL LYMPHOMA (MALT TYPE) (Low grade Malt B-cell lymphoma) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044321A and 0311321A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anxiety and Cholesterol. Concomitant products included SERTRALINE for Anxiety, ATORVASTATIN for Cholesterol.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). In June 2021, the patient experienced EXTRANODAL MARGINAL ZONE B-CELL LYMPHOMA (MALT TYPE) (Low grade Malt B-cell lymphoma) (seriousness criterion medically significant). On 04-May-2021, PAIN IN EXTREMITY (Arm soreness) had resolved. At the time of the report, EXTRANODAL MARGINAL ZONE B-CELL LYMPHOMA (MALT TYPE) (Low grade Malt B-cell lymphoma) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jul-2021, Mammogram: abnormal (abnormal) low grade Malt B-cell lymphoma. On 09-Jul-2021, Biopsy: abnormal (abnormal) low grade Malt B-cell lymphoma. On 28-Jul-2021, Positron emission tomogram: abnormal (abnormal) Abnormal.         The patient stated not experiencing any side effects after the first dose. The patient has not taken anything to help with the symptoms of arm soreness. The first week of June the patient found a lump just above the left breast. The patient went in the last week of June to see their health care provider for the lump. On 14-Jul-2021, the results of laboratory came back as low grade Malt B-cell lymphoma.   Action taken with mRNA-1273 in response to the event was Not Applicable  Company's 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.  There is a short time between the administration of vaccine and the development of breast tumor. Unlikely, that the events are related to the vaccine. Very limited information has been provided at this time.  Further information is expected.; 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.  There is a short time between the administration of vaccine and the development of breast tumor. Unlikely, that the events are related to the vaccine.Very limited information has been provided at this time.  Further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Premature delivery, Premature separation of placenta
Clinical narrative: placenta separate after the vaccine (unconfirmed vaccine); baby was delivered at 32 weeks; pregnancy; This spontaneous retrospective pregnancy case was reported by an other health care professional and describes the occurrence of PREMATURE SEPARATION OF PLACENTA (placenta separate after the vaccine (unconfirmed vaccine)), PREMATURE DELIVERY (baby was delivered at 32 weeks) and MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced PREMATURE SEPARATION OF PLACENTA (placenta separate after the vaccine (unconfirmed vaccine)) (seriousness criteria hospitalization and medically significant), PREMATURE DELIVERY (baby was delivered at 32 weeks) (seriousness criterion hospitalization) and MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) (seriousness criterion hospitalization). The delivery occurred on an unknown date, which was reported as Premature. For neonate 1, The outcome was reported as Pre-Term Birth NOS. At the time of the report, PREMATURE SEPARATION OF PLACENTA (placenta separate after the vaccine (unconfirmed vaccine)), PREMATURE DELIVERY (baby was delivered at 32 weeks) and MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) had resolved.        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 provided. No treatment information mentioned.  This is a case of product exposure during pregnancy with associated AEs. Very limited information regarding this event/s has been provided at this time. Further information has been requested.; Sender's Comments: This is a case of product exposure during pregnancy with associated AEs. Very limited information regarding this event/s has been provided at this time. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Neoplasm malignant, Positron emission tomogram
Clinical narrative: third patient they have seen that has received the COVID-19 vaccine and now has cancer; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (third patient they have seen that has received the COVID-19 vaccine and now has cancer) 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) at an unspecified dose. On an unknown date, the patient experienced NEOPLASM MALIGNANT (third patient they have seen that has received the COVID-19 vaccine and now has cancer) (seriousness criterion medically significant). At the time of the report, NEOPLASM MALIGNANT (third patient they have seen that has received the COVID-19 vaccine and now has cancer) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jul-2021, Positron emission tomogram: abnormal (abnormal) Cancer.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  The patient explained they found a lump just above the left breast. The patient went and had a few test done.  Treatment information was also not reported.  Company comment: Very limited information regarding this event has been provided at this time. Details including patient demographics, medical history, concomitant medications, date of vaccine administration, details of the tests/diagnostics and final diagnosis is required for further assessment.; Sender's Comments: Very limited information regarding this event has been provided at this time. Details including patient demographics, medical history, concomitant medications, date of vaccine administration, details of the tests/diagnostics and final diagnosis is required for further assessment.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Diagnosed with 2 blood clots; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Diagnosed with 2 blood clots) in a male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Diagnosed with 2 blood clots) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Diagnosed with 2 blood clots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Facial paralysis, Fatigue, Vaccination site pain
Clinical narrative: her eye hurts and bothers her too much; facial paralysis on the left side of her face; pain in the injection site; tiredness; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (facial paralysis on the left side of her face) in a 51-year-old female patient 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 01-May-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced VACCINATION SITE PAIN (pain in the injection site) and FATIGUE (tiredness). On 07-May-2021, the patient experienced FACIAL PARALYSIS (facial paralysis on the left side of her face) (seriousness criterion medically significant). On an unknown date, the patient experienced EYE PAIN (her eye hurts and bothers her too much). The patient was treated with Manual therapy (Accupunture) for Facial paralysis. At the time of the report, FACIAL PARALYSIS (facial paralysis on the left side of her face), EYE PAIN (her eye hurts and bothers her too much), VACCINATION SITE PAIN (pain in the injection site) and FATIGUE (tiredness) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient stated that she did not take any concomitant medications.  Patient's recovery was moderate and not complete.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Very limited information has been provided at this time. Further information is expected; 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.  Very limited information has been provided at this time. Further information is expected
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: TIA Mini stroke; This spontaneous case was reported by a consumer and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (TIA Mini stroke) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 037B21A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, LISINOPRIL, HYDROCHLOROTHIAZIDE and SIMVASTATIN for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (TIA Mini stroke) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 27-Mar-2021 to 29-Mar-2021 due to TRANSIENT ISCHAEMIC ATTACK. On 29-Mar-2021, TRANSIENT ISCHAEMIC ATTACK (TIA Mini stroke) had resolved.            Treatment was not reported.  Very limited information regarding this events has been provided at this time.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.   This case was linked to MOD-2021-272348 (Patient Link).   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this events has been provided at this time.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Appendicitis, Erythema, Incision site pain, Vaccination site pain
Clinical narrative: Appendicitis; pain from my incisions; terrible stomach aches/pains; vomiting; soreness and redness, but it wasn't intense; barely felt any soreness; This spontaneous case was reported by a consumer and describes the occurrence of APPENDICITIS (Appendicitis) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078C21A and 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jul-2021, the patient experienced VACCINATION SITE PAIN (barely felt any soreness). On 17-Jul-2021, the patient experienced ERYTHEMA (soreness and redness, but it wasn't intense). On 19-Jul-2021, the patient experienced ABDOMINAL PAIN UPPER (terrible stomach aches/pains) and VOMITING (vomiting). On 20-Jul-2021, the patient experienced INCISION SITE PAIN (pain from my incisions). On an unknown date, the patient experienced APPENDICITIS (Appendicitis) (seriousness criteria hospitalization prolonged and medically significant). The patient was treated with OXYCODONE at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and Surgery (to remove appendix) for Appendicitis. On 16-Jul-2021, VACCINATION SITE PAIN (barely felt any soreness) had resolved. On 20-Jul-2021, ABDOMINAL PAIN UPPER (terrible stomach aches/pains) and VOMITING (vomiting) had resolved. On 22-Jul-2021, ERYTHEMA (soreness and redness, but it wasn't intense) had resolved. At the time of the report, APPENDICITIS (Appendicitis) and INCISION SITE PAIN (pain from my incisions) outcome was unknown.            No concomitant medication information was provided. she was given blood work, urine tests, an EKG, a CT scan, and an Ultrasound. Then she was diagnosed with appendicitis and admitted around 4:30 PM. She given medicines in preparation for surgery including IV antibiotics, and oxycodone. Then had surgery to remove her appendix. After the surgery she has not had the same pain as prior, but has had pain from her incisions.  Company comment-Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Appendicitis; pain from my incisions; terrible stomach aches/pains; vomiting; soreness and redness, but it wasn't intense; barely felt any soreness; This spontaneous case was reported by a consumer and describes the occurrence of APPENDICITIS (Appendicitis) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078C21A and 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jul-2021, the patient experienced VACCINATION SITE PAIN (barely felt any soreness). On 17-Jul-2021, the patient experienced ERYTHEMA (soreness and redness, but it wasn't intense). On 19-Jul-2021, the patient experienced ABDOMINAL PAIN UPPER (terrible stomach aches/pains) and VOMITING (vomiting). On 20-Jul-2021, the patient experienced INCISION SITE PAIN (pain from my incisions). On an unknown date, the patient experienced APPENDICITIS (Appendicitis) (seriousness criteria hospitalization prolonged and medically significant). The patient was treated with OXYCODONE at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and Surgery (to remove appendix) for Appendicitis. On 16-Jul-2021, VACCINATION SITE PAIN (barely felt any soreness) had resolved. On 20-Jul-2021, ABDOMINAL PAIN UPPER (terrible stomach aches/pains) and VOMITING (vomiting) had resolved. On 22-Jul-2021, ERYTHEMA (soreness and redness, but it wasn't intense) had resolved. At the time of the report, APPENDICITIS (Appendicitis) and INCISION SITE PAIN (pain from my incisions) outcome was unknown.            No concomitant medication information was provided. she was given blood work, urine tests, an EKG, a CT scan, and an Ultrasound. Then she was diagnosed with appendicitis and admitted around 4:30 PM. She given medicines in preparation for surgery including IV antibiotics, and oxycodone. Then had surgery to remove her appendix. After the surgery she has not had the same pain as prior, but has had pain from her incisions.  Company comment-Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: got sore in the arm where he got the shot in/mild-to-moderate pain and soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0196; Expiration Date: Sep2021), via an unspecified route of administration, administered in Arm Left on 27Jun2021 around lunchtime, 11:00-11:30 (at the age of 42-year-old) as dose 1, single for COVID-19 immunisation. Medical history was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included ongoing phentermine as diet pill.  The patient received the first dose of the Pfizer Covid-19 vaccine in his left arm and had been experiencing mild-to-moderate pain and soreness at injection site on 28Jun2021 that continued to 19Jul2021. The patient stated he got received his first vaccine on 27Jun2021 and he was concerned about taking his second vaccine shot, clarifying the reason why he was concerned about taking the second vaccine shot was due to the side effect that he was experiencing from the first vaccine shot which was normal. The patient had got sore in the arm where he got the shot in but his side effect had extended a week and his arm had been sore every day since. The patient further stated he experienced the side effects that's soreness in his arm and soreness had continued for the past three weeks, just pain aching pain in his arm. The patient reported that it had been 3 weeks and he continued to have the same level of pain in his arm each day unless he took a muscle relaxer or over the counter pain medication. The patient reported that he was calling to see if the soreness in his arm for 3 weeks was normal, if it had been reported before, and if it was safe for him to take the second shot of the Covid-19 vaccine. The patient was supposed to get the second dose of the Pfizer Covid-19 vaccine on 18Jul2021. The patient reported that he did not go to the emergency room or physician's office because he knew that a sore arm was a normal side effect of the Covid-19 vaccine. There was no investigation assessment. The event outcome was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Cold; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 16May2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated because she got the first dose for the Pfizer Covid 19 Vaccine on the 16May and she was supposed to be scheduled for the second dose on the 07Jun but she was unable to take it because she said she had cold in 2021 and she wanted to know if she could receive the second dose or she would start with the first dose again. The event outcome was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Palpitations, Peripheral swelling, SARS-CoV-2 test
Clinical narrative: I also got palpitations and chest tightness; I also got palpitations and chest tightness; My left hand got swollen in the afternoon and it lasted all night; This is a spontaneous report from a contactable consumer (patient). A 27-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCIN, Lot Number: EW0181), via an unspecified route of administration, administered in arm left on 05Jul2021 09:30 (at the age of 27-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included pantoprazole. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took carbamazepine and experienced drug allergy. The patient stated her left hand got swollen in the afternoon and it lasted all night, the day after she got the vaccine on 06Jul2021 19:00. She also got palpitations and chest tightness on 06Jul2021 19:00. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 (PCR and RDT): Negative on 02Jul2021 (Nasal Swab). No treatment was received as a result of the events. The event outcome was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: cold sores/had an outbreak/not just a single sore, it was her entire mouth; This is a spontaneous report from a contactable consumer (patient). A 36-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCIN, Lot Number: eW0167), via an unspecified route of administration, administered in arm left on 03May2021 10:00 (at the age of 36-year-old) as dose 2, single for COVID-19 immunisation. Medical history included currently undergoing in vitro fertilisation (IVF) (so hormones also playing a role), allergies: Sulfa drugs (hives) and ongoing cold sores. Concomitant medications included clobetasol for poison ivy (topical) and levocetirizine for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCIN, Lot Number: ER8730), via an unspecified route of administration, administered in arm left on 12Apr2021 10:00 (at the age of 36-year-old) as dose 1, single for COVID-19 immunisation. The patient stated she had cold sores, which had been under control for a decade with 1-2 outbreaks a year. She stated starting 6 weeks after her vaccine on 13Jun2021, she had an outbreak that did not go away for more than a few days before returning again. She stated her immune system just didn't seem able to suppress it, clarifying it was extremely aggressive (not just a single sore, it was her entire mouth) and didn't respond as well to antivirals as past out breaks. The patient went to doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the event and included Valtrex prescription. The event outcome was not recovered.