chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary thrombosis, Vaccination site pain
Clinical narrative: difficulty breathing; soreness after 1st dose left arm; Clot in Lung; chest pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY THROMBOSIS (Clot in Lung) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Heart disorder.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced PULMONARY THROMBOSIS (Clot in Lung) (seriousness criterion medically significant) and CHEST PAIN (chest pain). On 29-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness after 1st dose left arm). On an unknown date, the patient experienced DYSPNOEA (difficulty breathing). On 30-Mar-2021, VACCINATION SITE PAIN (soreness after 1st dose left arm) had resolved. At the time of the report, PULMONARY THROMBOSIS (Clot in Lung), CHEST PAIN (chest pain) and DYSPNOEA (difficulty breathing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Echocardiogram: normal (normal) Normal. On an unknown date, Computerised tomogram: abnormal (abnormal) Blood clot in Lung. On an unknown date, Pulmonary function test: normal (normal) came back perfect.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 08-Mar-2021 patient had an echocardiogram (results are not provided). Concomitant medications are not reported. No Treatment for events is provided. Based on the current available information which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, causal relationship cannot be excluded. Vaccination site pain is consistent with the known safety profile of the vaccine   This case was linked to MOD-2021-084017 (Patient Link).; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, causal relationship cannot be excluded. Vaccination site pain is consistent with the known safety profile of the vaccine
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Gingival bleeding, Platelet count, Platelet count decreased, Product dose omission issue
Clinical narrative: depleted blood platelets, 0 platelets counts; 2nd dose: did not receive as advised by her HCP; Red spots on her tongue; bleeding around her gums; red dots and purple dots on her legs; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PLATELET COUNT DECREASED (depleted blood platelets, 0 platelets counts) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.  On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced TONGUE PIGMENTATION (Red spots on her tongue), GINGIVAL BLEEDING (bleeding around her gums) and ERYTHEMA (red dots and purple dots on her legs). On 15-Mar-2021, the patient experienced PLATELET COUNT DECREASED (depleted blood platelets, 0 platelets counts) (seriousness criterion hospitalization). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose: did not receive as advised by her HCP). The patient was hospitalized from 15-Mar-2021 to 17-Mar-2021 due to PLATELET COUNT DECREASED. At the time of the report, PLATELET COUNT DECREASED (depleted blood platelets, 0 platelets counts), TONGUE PIGMENTATION (Red spots on her tongue), GINGIVAL BLEEDING (bleeding around her gums) and ERYTHEMA (red dots and purple dots on her legs) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (2nd dose: did not receive as advised by her HCP) had resolved. Related    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Platelet count: 67000 (Inconclusive) 67000. On 23-Mar-2021, Platelet count: 270,000 (Inconclusive) 270,000. On 12-Apr-2021, Platelet count: 200,000 (Inconclusive) 200,000.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were provided Treatment for the events included steroids The patient  visited urgent care on 14Mar2021, and the doctor advised her to go to the ER. The patient went to her primary care provider and her blood work came back and she had 0 platelets counts and depleted blood platelets and the doctor stated that it was due to the Moderna covid vaccine that the patient had received.The patient went to the emergency room immediately and was admitted into hospital on 15Mar2021 and received 2 bags of platelets and steroids to calm her immune system down.The doctor advised patient not to take any vaccines until next year.  Company Comment 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: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue pigmentation
Clinical narrative: depleted blood platelets, 0 platelets counts; 2nd dose: did not receive as advised by her HCP; Red spots on her tongue; bleeding around her gums; red dots and purple dots on her legs; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PLATELET COUNT DECREASED (depleted blood platelets, 0 platelets counts) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.  On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced TONGUE PIGMENTATION (Red spots on her tongue), GINGIVAL BLEEDING (bleeding around her gums) and ERYTHEMA (red dots and purple dots on her legs). On 15-Mar-2021, the patient experienced PLATELET COUNT DECREASED (depleted blood platelets, 0 platelets counts) (seriousness criterion hospitalization). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose: did not receive as advised by her HCP). The patient was hospitalized from 15-Mar-2021 to 17-Mar-2021 due to PLATELET COUNT DECREASED. At the time of the report, PLATELET COUNT DECREASED (depleted blood platelets, 0 platelets counts), TONGUE PIGMENTATION (Red spots on her tongue), GINGIVAL BLEEDING (bleeding around her gums) and ERYTHEMA (red dots and purple dots on her legs) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (2nd dose: did not receive as advised by her HCP) had resolved. Related    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Platelet count: 67000 (Inconclusive) 67000. On 23-Mar-2021, Platelet count: 270,000 (Inconclusive) 270,000. On 12-Apr-2021, Platelet count: 200,000 (Inconclusive) 200,000.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were provided Treatment for the events included steroids The patient  visited urgent care on 14Mar2021, and the doctor advised her to go to the ER. The patient went to her primary care provider and her blood work came back and she had 0 platelets counts and depleted blood platelets and the doctor stated that it was due to the Moderna covid vaccine that the patient had received.The patient went to the emergency room immediately and was admitted into hospital on 15Mar2021 and received 2 bags of platelets and steroids to calm her immune system down.The doctor advised patient not to take any vaccines until next year.  Company Comment Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Completed suicide, Tinnitus
Clinical narrative: committed suicide; ringing in his ears; This spontaneous case was reported by a consumer and describes the occurrence of COMPLETED SUICIDE (committed suicide) 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.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COMPLETED SUICIDE (committed suicide) (seriousness criterion death) and TINNITUS (ringing in his ears). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, TINNITUS (ringing in his ears) outcome was unknown.        Concomitant medications were not reported; Reported Cause(s) of Death: Unknown cause of death
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Hemiplegia, Product dose omission issue
Clinical narrative: missing of scheduled second dose of vaccine / dose omission; stroke; right side of his body paralyzed, from his face to his feet; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) and HEMIPLEGIA (right side of his body paralyzed, from his face to his feet) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke in October 2015.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant) and HEMIPLEGIA (right side of his body paralyzed, from his face to his feet) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missing of scheduled second dose of vaccine / dose omission). The patient was treated with Rehabilitation therapy for Cerebrovascular accident. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke) outcome was unknown, HEMIPLEGIA (right side of his body paralyzed, from his face to his feet) had not resolved and PRODUCT DOSE OMISSION ISSUE (missing of scheduled second dose of vaccine / dose omission) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       After hospitalization, patient was transferred to nursing home, then a rehabilitation facility. The second dose of the Moderna COVID-19 Vaccine was scheduled for an incorrect date of 04-Mar-2021;however the patient did not receive this dose due to hospitalization.  Products known to have been used by the patient, within two weeks prior to the event, included unspecified 15 pills. No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Swelling face, Swollen tongue
Clinical narrative: Tongue swelling; Face swelling; Chest pains left side of chest; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of SWOLLEN TONGUE (Tongue swelling) and SWELLING FACE (Face swelling) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced SWOLLEN TONGUE (Tongue swelling) (seriousness criterion hospitalization), SWELLING FACE (Face swelling) (seriousness criterion hospitalization) and CHEST PAIN (Chest pains left side of chest). At the time of the report, SWOLLEN TONGUE (Tongue swelling), SWELLING FACE (Face swelling) and CHEST PAIN (Chest pains left side of chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment included Benadryl IM and Steroid IV.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pulmonary hypertension
Clinical narrative: Diagnosed with pulmonary hypertension; After two half weeks she started having palpitation; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PULMONARY HYPERTENSION (Diagnosed with pulmonary hypertension) in a 62-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.     The patient's past medical history included No adverse event (No reported medical history).   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced PULMONARY HYPERTENSION (Diagnosed with pulmonary hypertension) (seriousness criterion medically significant) and PALPITATIONS (After two half weeks she started having palpitation). At the time of the report, PULMONARY HYPERTENSION (Diagnosed with pulmonary hypertension) had not resolved and PALPITATIONS (After two half weeks she started having palpitation) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication use was unknown.  Treatment information was not provided.  Company comment: Very limited information regarding these events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Death, Hypotension, Thrombosis
Clinical narrative: Patient passed away; patient had blood clots in his brain/ Legs/ Lungs/ Arms; Severe hypotension; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Patient passed away), THROMBOSIS (patient had blood clots in his brain/ Legs/ Lungs/ Arms) and HYPOTENSION (Severe hypotension) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 DEATH (Patient passed away) (seriousness criterion death), THROMBOSIS (patient had blood clots in his brain/ Legs/ Lungs/ Arms) (seriousness criterion death) and HYPOTENSION (Severe hypotension) (seriousness criterion death). The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.  Company comment: This case concerns the death of a patient of unknown age and gender after administration of mrna-1273 ()LOT  UNKNOWN). Very limited information regarding this event/s has been provided at this time. Further information has been requested. Critical details such as the mRNA-1273 date of administration, onset of any signs an d symptoms, and date of death is lacking.; Sender's Comments: This case concerns the death of a patient of unknown age and gender after administration of mrna-1273 ()LOT UNKNOWN) .  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.  Critical details such as the mRNA-1273 date of administration, onset of any signs an d symptoms, and date of death is lacking.; Reported Cause(s) of Death: Unknown cause of death
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dehydration, Fatigue, Headache, Nausea
Clinical narrative: dehydration; Fatigue; chills; headache; fever; nausea; body ache; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EN5318) via unspecified route of administration in left arm on 26Jan2021 at 11:00 AM (at the age of 78-year-old) for COVID-19 immunization and other unspecified pfizer vaccine (Lot number EN538) in left arm on same date 26Jan2021. Medical history included blood pressure and covid. Patient had no known allergies. Concomitant medications included unspecified blood pressure medications (in two weeks). No other vaccine in four weeks. Patient experienced fatigue, chills, headache, fever, nausea, body ache on 26Jan2021 at 04:00 AM and dehydration on an unknown date. Adverse event resulted in emergency room/department or urgent care. Treatment was received for all events. IV treatment was received for dehydration event. Patient had covid prior vaccination, Patient did not test for covid post vaccination. The outcome of all the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: dehydration; Fatigue; chills; headache; fever; nausea; body ache; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EN5318) via unspecified route of administration in left arm on 26Jan2021 at 11:00 AM (at the age of 78-year-old) for COVID-19 immunization and other unspecified pfizer vaccine (Lot number EN538) in left arm on same date 26Jan2021. Medical history included blood pressure and covid. Patient had no known allergies. Concomitant medications included unspecified blood pressure medications (in two weeks). No other vaccine in four weeks. Patient experienced fatigue, chills, headache, fever, nausea, body ache on 26Jan2021 at 04:00 AM and dehydration on an unknown date. Adverse event resulted in emergency room/department or urgent care. Treatment was received for all events. IV treatment was received for dehydration event. Patient had covid prior vaccination, Patient did not test for covid post vaccination. The outcome of all the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dysgeusia, Heart rate, Oxygen saturation, Paraesthesia
Clinical narrative: mild tingling sensation on the back part of my tongue; metal taste; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EL9264), via an unspecified route of administration, in the left arm on 29Jan2021 at 09:30 (at the age of 58-years-old) as a single dose for covid-19 immunisation. Patient's medical history included cardiovascular disease, 2 stents and hypertension (on medications). The patient was not aware of any allergies to medications, food or other products. Patient did not receive any other vaccines within 4 weeks prior to vaccination. Concomitant medications included (acetylsalicylic acid) LD ASPIRIN, metoprolol succinate (TOPROL), clopidogrel bisulfate (PLAVIX), valsartan (DIOVAN), atorvastatin (LIPITOR) and ergocalciferol (VIT D). Prior to the vaccination the patient was not diagnosed with COVID-19. On 29Jan2021 at 09:30, the patient experienced mild tingling sensation on the back part of my tongue and metal taste. Sensation peaked at approx. 30-40 minutes then started to subside. Fully subsided after approx. 2 hours. Treatment was received. Patient underwent Blood pressure measurement, pulse rate and oxygen saturation on 29Jan2021 and results were unknown. Since the vaccination the patient had not been tested for COVID-19. The outcome of the event paraesthesia was recovered on 29Jan2021 at 11:30 and Dysgeusia was recovered on an unspecified date in 2021.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Inappropriate schedule of product administration, Malaise, Vaccination site pain
Clinical narrative: Injection site pain; tiredness; chills; feeling unwell; administration date=02Feb2021, dose number=2/ administration date=16Jan2021, dose number=1; This is a spontaneous report from a contactable consumer (patient himself). A 81-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: unknown, Expiration date: unknown), via an unspecified route of administration in left arm on 02Feb2021 at 14:30 at 14:00 at single dose for covid-19 immunization. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number unknown, Expiration date unknown), via an unspecified route of administration in left arm on 16Jan2021 at 14:00 as a single dose for covid-19 immunization. Patient's concomitant medications were not reported. Patient was not performed lab test. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. On 02Feb2021, the patient experienced On 02Feb2021, the patient experienced administration date: 02Feb2021, dose number:2/ administration date:16Jan2021, dose number:1 on 02Feb2021 14:00. Also, he had injection site pain, tiredness, chills, and feeling unwell on 03Feb2021. The outcome of event injection site pain, tiredness, chills, and feeling unwell was recovered on an unspecified date while for another event it was unknown.   Information on the lot/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fall, Fatigue, Headache, Influenza like illness
Clinical narrative: got up twice during the middle of the night and fell twice; flu like symptoms; body aches; joint pain; headache; stinging; swelling; redness at injection site; tiredness; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient who received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Batch/lot number unknown, Expiration date unknown), via an unspecified route of administration in right arm on 08Feb2021 at 19:30 at a single dose for covid-19 immunization at Hospital. The patient's medical history and concomitant medications were not reported. NDC number of COVID-19 vaccine was unknown. On 08Feb2021, the patient experienced stinging, swelling, tiredness and redness at injection site. The tiredness started last night at 9pm. She had been sleeping on and off ever since. She took Benadryl at 08 p.m. last night and it went away. On 09Feb2021, she had body aches, headache and joint pain. She has had flu like symptoms since. She has had body aches and tiredness. She hasn't had a high fever. She was in bed. She got up twice during the middle of the night and fell twice because of the joint aches. She lost her balance. Her joints just gave out. She was steady on her feet. She was just slow. She was not taking Benadryl now. She just had ice on the back of her neck, and it was working. The headache was manageable without medication and ice. Therapeutic measures were taken as a result of stinging, swelling, and redness at injection site. The reporter classified the events as non-serious and assessed the causality between the event and the vaccines as related. The outcome of events stinging, swelling, tiredness and redness at injection site was recovered on 08Feb2021, outcome of body aches was recovering and outcome of other events was not recovered.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Pain, Swelling
Clinical narrative: got up twice during the middle of the night and fell twice; flu like symptoms; body aches; joint pain; headache; stinging; swelling; redness at injection site; tiredness; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient who received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Batch/lot number unknown, Expiration date unknown), via an unspecified route of administration in right arm on 08Feb2021 at 19:30 at a single dose for covid-19 immunization at Hospital. The patient's medical history and concomitant medications were not reported. NDC number of COVID-19 vaccine was unknown. On 08Feb2021, the patient experienced stinging, swelling, tiredness and redness at injection site. The tiredness started last night at 9pm. She had been sleeping on and off ever since. She took Benadryl at 08 p.m. last night and it went away. On 09Feb2021, she had body aches, headache and joint pain. She has had flu like symptoms since. She has had body aches and tiredness. She hasn't had a high fever. She was in bed. She got up twice during the middle of the night and fell twice because of the joint aches. She lost her balance. Her joints just gave out. She was steady on her feet. She was just slow. She was not taking Benadryl now. She just had ice on the back of her neck, and it was working. The headache was manageable without medication and ice. Therapeutic measures were taken as a result of stinging, swelling, and redness at injection site. The reporter classified the events as non-serious and assessed the causality between the event and the vaccines as related. The outcome of events stinging, swelling, tiredness and redness at injection site was recovered on 08Feb2021, outcome of body aches was recovering and outcome of other events was not recovered.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy test, Rash erythematous, Rash pruritic
Clinical narrative: red, itchy rash.; itchy rash./broke out in an itchy rash on his waist, back, shoulders, chest, and neck.; This is a spontaneous report from a contactable consumer, caregiver/wife. An 82-year-old male patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 vaccine, solution for injection, Lot Number: EL9263, Expiry Date: Unknown, NDC number: unknown) via an unspecified route of administration on 24Jan2021 at 11:30 on right arm as a single dose (at the age of 82-years) for COVID-19 immunization. Patient's Medical History (including any illness at time of vaccination): None. Family Medical History Relevant to AE(s) was not provided. Patient used no other products. No vaccines administered on same date of the Pfizer suspect. Patient did not receive any prior vaccinations (within 4 weeks). Caller stated that she was calling on behalf of her husband (name) who received the first dose of Pfizer COVID vaccine on 24Jan2021. Caller stated on 02-03Feb2021 (a week and a half later after receiving the vaccine) her husband developed a red, itchy rash on his waist, back, shoulders, chest, and neck. She said her husband did not have a rash on his arms, legs or face. Patient did not require a visit to emergency room but visited physician office (Primary Care Doctor and Allergist). Reported her husband's allergist did a bunch of allergies testing and all the test results were negative. Her husband's doctor gave her husband a couple of injections. She said she knew one of the medications started with "Dexa", saying the medication was something like Dexatrim. She said she did not know what the other medication's name was. Her husband had taken some over-the-counter Benadryl. She said her husband is no longer taking the Benadryl. She did not have the Benadryl UPC/NDC, Lot, and Expiration Date. Reported her husband was using over-the-counter cream, clarified as Sarna cream. She said the Sarna cream was a white cream and was helping her husband's itch and rash. She said she did not have the Sarna cream with her to provide the UPC/NDC, Lot and Expiration Date. Caller stated her husband is due for his second COVID-19 vaccine and wanted to know if Pfizer recommended her husband get the second COVID-19 Vaccine dose. She reported that her husband's primary care doctor and allergist both recommended her husband not take the second COVID-19 Vaccine dose. Outcome of the events was recovering. Investigation Assessment: Yes.  No further details provided.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: she is still experiencing soreness to the injection site in the left arm where she got the shot; This is a spontaneous report from a contactable consumer (patient) via Medical information team.  A 85-years-old female patient received first dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265; Expiration Date: May2021) via an unspecified route of administration, administered in left arm on 29Jan2021 at 13:30 (at the age of 85 years old) as single dose for covid-19 immunisation. The patient's medical history included blood pressure high, A-Fib 3-4 years or longer was diagnosed with A-Fib, thyroid disorder since at least five years. The patient concomitant medications included digoxin 125mg tablet once a day for heart pill, methimazole 5mg once a day for thyroid pill, metoprolol tartrate 25mg tablet twice a day oral, spironolactone 25mg once a day as water pill, magnesium oxide (MAG OXIDE) 400mg tablet oral twice daily, apixaban (ELIQUIS) 5mg twice daily for blood thinner, vitamin d3, cobamamide (VITAMIN B12). The patient's historical vaccine included flu shot, pneumonia shot, and shingles shot. The patient did not receive any other vaccines within four weeks prior to the vaccination. No additional vaccines administered on same date of the suspect pfizer vaccine. On 29Jan2021, the patient experienced soreness at injection site, the upper left arm in the evening of the day she got the vaccine. The patient asked if it was normal, and should she get the second dose of vaccine if she is still sore. The outcome of the event was not recovered.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Headache, Influenza like illness, Nausea
Clinical narrative: Flu like symptoms; Dizziness; Joint Pain; Headache; Nausea; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9269), via an unspecified route of administration in left arm on 09Feb2021 at 13:30 at single dose for COVID-19 immunisation. The patient was allergic to codeine. Concomitant medications were not reported. No covid prior vaccination. No covid tested done post vaccination. The patient was not pregnant at the time of vaccination. On 09Feb2021 at 07:00 PM, the patient experienced flu like symptoms, dizziness, Joint pain, headache and nausea. No treatment was received. The outcome of the events was recovered.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: 10 days after COVID VACCINE had soreness, itching, warmth and red area size of orange at injection site on right arm; 10 days after COVID VACCINE had soreness, itching, warmth and red area size of orange at injection site on right arm; 10 days after COVID VACCINE had soreness, itching, warmth and red area size of orange at injection site on right arm; 10 days after COVID VACCINE had soreness, itching, warmth and red area size of orange at injection site on right arm; This is a spontaneous report from a contactable nurse (patient). A 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Formulation: Solution for injection, Lot: EM9810 Expiration date:unknown) first dose intramuscular on right arm on 05Feb2021 08:30 AM (at age of 81-year-old) at single dose for Covid-19 immunization. Medical history included emphysema, ruptured eardrum partial deafness, arthritis from unspecified date. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient has not tested COVID post vaccination. No other vaccine was taken in four weeks. Patient was allergic to Zyban. Concomitant medications included ASA 81 mg, MVI, Biotin, Vitamin C, Stiolto inhaler from unspecified date and unknown if ongoing. Patient previously 18 months ago got surgical glue in vein procedure,10 days later patient experienced warmth, redness, itching, tenderness at site after COVID VACCINE had soreness, itching, warmth, and red area size of orange at injection site on right arm on 13 Feb2021. No treatment received for the adverse event and the patient asked should I take the second dose of the vaccine. The outcome of events were recovering.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: experience some mild numbing of the pinky on the arm that received the shot; This is a spontaneous report from a contactable consumer reported for a patient. A male patient unspecified age received an unspecified dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown) via an unspecified route of administration, in arm on an unknown date at a single dose for covid-19 immunisation. Patient medical history and concomitant medication were not reported. The patient had not known allergies. On 20Jan2021, the patient experienced some mild numbing of the pinky on the arm that received the shot. The facility where the most recent COVID-19 vaccine was administered was Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post the vaccination, the patient has not been tested for COVID-19. It was unknown whether treatment was received for the adverse event. The outcome of the event was recovering.  Information on the lot/batch number has been requested.  Follow-up (19Apr2021): 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.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Developed symptoms and tested positive for COVID; This is a spontaneous report from a contactable nurse and consumer. A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number: EL9264; expiration date: May2021), dose 1, via an unspecified route of administration, administered in left deltoid on 28Jan2021 08:00 (at the age of 61-year- old) as single dose for COVID-19 immunization. Medical history included type 2 diabetes mellitus diagnosed a couple years ago and total lung capacity decreased from asbestos scarring diagnosed about 15-20 years ago. Concomitant medication included metformin for type 2 diabetes mellitus. The patient received the first dose of the COVID-19 vaccine on 28Jan2021 08:00 AM. The patient developed symptoms on 29Jan2021 and tested positive for COVID on 01Feb2021. The patient mentioned that he has no idea what type of COVID-19 virus test was used when he tested positive. The patient received bamlanivimab (BAM) monoclonal antibody infusion therapy at 700 mg in 270 ml normal saline (lot number: D332489A; expiration date: 08Nov2021) in the infusion clinic of the hospital on 02Feb2021. It was reported that the hospital contacted the patient after he tested positive for the COVID-19 virus to let the patient know he was eligible for the BAM monoclonal antibody therapy based on his past medical history. The BAM therapy would have been physician ordered for the patient. The nurse reported that she looked at the information on the CDC's website for the COVID-19 vaccine, and the CDC website stated people who have the COVID-19 virus antibodies should wait 90 days before getting the COVID-19 vaccine. The nurse was wondering what is the company's guidance is on the patient getting his second COVID-19 vaccine dose, since patient had his first COVID-19 vaccine dose, and then tested positive for the COVID-19 virus, and then had the COVID-19 virus monoclonal antibody therapy. The nurse asked does the CDC's 90-day wait time apply to the patient's situation. The patient also wanted to know how he should go about getting the second dose, should he wait 90 days. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: moderate vaginal bleeding; This is a spontaneous report from a contactable consumer or other non hcp. A 36-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 16Jan2021 13:00 (Batch/Lot Number: EL3248) as single dose, dose 2 via an unspecified route of administration, administered in Arm Right on 06Feb2021 (Batch/Lot Number: EL9269) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously experienced drug hypersensitivity. The patient reported that about 12-18 hours after getting the 1st and 2nd shot she experienced light to moderate vaginal bleeding for 2-3 hours and then it cleared up. Both times she was not near her mensural cycle. The patient did not have any other vaccine in four weeks. The patient was not priorly Covid vaccinated. The patient was not tested Covid post vaccination. The outcome of the event was reported as recovered on an unspecified date 2021.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Influenza like illness, Malaise, Pain, Pyrexia
Clinical narrative: severly ill; fever; achy; flu like symptoms; severe weakness; This is a spontaneous report from a contactable other hcp. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration on 03Feb2021 as SINGLE DOSE for covid-19 immunization. Patient medical history and concomitant medications were not reported. On 04feb2021 the day after vaccination the patient became severly ill including 14.7F fever, achy, flu like symptoms, severe weakness. He was treated with Tylenol but didn't respond. He did not go to the hospital. He called to see if he should receive the second dose scheduled for the 25Feb2021. Therapeutic measures were taken for the events. Outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: blood pressure spikes after her 2nd dose/high blood pressure like 144/70 3 days after the 2nd dose; This is a spontaneous report from a contactable consumer via Pfizer-sponsored program. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunization. Patient medical history and concomitant medications were not reported. On an unspecified date she had some blood pressure spikes after her 2nd dose. Patient was asking if it's normal to have high blood pressure like 144/70 3 days after the 2nd dose. The patient underwent lab tests and procedures which included blood pressure measurement: 144/70. Outcome of the event was unknown.  Information about the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: she had arm soreness; This is a spontaneous report from a contactable nurse (patient) via Pfizer Sales Representative.  A 5-decade-old female patient received first dose of BNT162B2 (solution for injection) via an unspecified route of administration as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced arm soreness after received the Pfizer COVID vaccine and went away next day. The outcome of the event was resolved.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: Fatigue; Fever; Muscle aches; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: E19267), via an unspecified route of administration in right arm on 17Feb2021 at 02:30 PM at single dose for COVID-19 immunisation.The patient's medical history included high BP, high cholesterol and diabetes. The patient was allergic to Mobic. It was reported that prior to vaccination, the patient was diagnosed with COVID-19 and the patient did not get tested for COVID-19, since the vaccination. The patient's concomitant medications included celecoxib (CELEBREX), metformin, allopurinol and pravastatin. On 18Feb2021 at 6:30 AM, the patient experienced fatigue, fever and muscle aches for 36 hours. The patient did not received any treatment. The outcome of the events was recovered.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient) via Pfizer-sponsored program support. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration in left arm on 09Feb2021 as single dose for COVID-19 immunization. Patient medical history and the patient concomitant medications were not reported. It was reported that, just patient got the 1st dose last week 09Feb2021 and she was reporting about the schedule for the second dose that is more than 3 weeks on 09Mar2021. The patient experienced an arm sore on her left arm where the vaccine was administered. The event was considered as a non-serious. The outcome of the event was reported as unknown. Information about lot/batch number has been requested.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Hypoaesthesia, Illness, Nail discolouration
Clinical narrative: numbness in right hand middle finger; the tip of the finger and under nail turning purple; body aches; chills; feeling sick overall; headache; This is a spontaneous report from a contactable consumer. A 64-year-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: El19269; Expiration Date: unknown), dose 2 via an unspecified route of administration, in Arm Left on 08Feb2021 14:30 as single dose, dose 1 on19Jan2021 09:15 AM in left arm for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included atorvastatin, zinc, ascorbic acid. The patient did not had covid prior or post the vaccination. On 08Feb2021, 20:00 the patient experienced numbness in right hand middle finger, the tip of the finger and under nail turning purple, body aches, chills, feeling sick overall, headache. Treatment for the adverse events was not received. The outcome of the event was recovering.  No follow-up attempts are possible, and no information is required.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: numbness in right hand middle finger; the tip of the finger and under nail turning purple; body aches; chills; feeling sick overall; headache; This is a spontaneous report from a contactable consumer. A 64-year-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: El19269; Expiration Date: unknown), dose 2 via an unspecified route of administration, in Arm Left on 08Feb2021 14:30 as single dose, dose 1 on19Jan2021 09:15 AM in left arm for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included atorvastatin, zinc, ascorbic acid. The patient did not had covid prior or post the vaccination. On 08Feb2021, 20:00 the patient experienced numbness in right hand middle finger, the tip of the finger and under nail turning purple, body aches, chills, feeling sick overall, headache. Treatment for the adverse events was not received. The outcome of the event was recovering.  No follow-up attempts are possible, and no information is required.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nasal congestion, Oropharyngeal pain, Somnolence
Clinical narrative: Sore throat; stuffy nose; slight headache; sleepy; This is a spontaneous report from a contactable consumer(patient reported). A 61-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 17Feb2021 as SINGLE DOSE for covid-19 immunization. Patient was 61 years old at the time of vaccination. Patient medical history was not reported. Concomitant medications included hydrochlorothiazide, metoprololon an unspecified date for unknown indication. On 18Feb2021 the patient experienced sore throat, stuffy nose, slight headache and sleepy. The outcome of the events was recovering.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Faeces soft, Fatigue
Clinical narrative: tiredness; mild soft stool; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number:Unknown), via an unspecified route of administration on 17Feb2021 at a single dose for covid-19 immunisation. Medical history included ITP (and would like to measure his immune response. Asking if we have additional test to asses this). The patient's concomitant medications were not reported. The patient experienced tiredness and mild soft stool. His second dose was scheduled on 10Mar2021.The outcome of the events was unknown.