chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: weakness; diarrhea; Dizziness; Really Bad Tiredness; Swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient's wife). A 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at 77-year-old on 11Mar2021 12:00 (lot number: EN6199) at single dose for COVID-19 immunization. Vaccine was received in pharmacy, not at military facility. The patient medical history was reported as none. Family medical history relevant to the events was none. The patient's concomitant medications were not reported. No history of all previous immunization with the BNT162B2 considered as suspect. No additional vaccines were administered on same date of BNT162B2. No other products. No prior vaccinations within 4 weeks. No events following prior vaccinations. The patient experienced diarrhea (hospitalization) on 18Mar2021, weakness (hospitalization) on 22Mar2021, swollen lymph nodes on 18Mar2021, really bad tiredness on 19Mar2021, dizziness on 26Mar2021. Dizziness occurred when he stood up. The patient was hospitalized for diarrhea and weakness from 22Mar2021 to 24Mar2021. The patient was getting weak and they got worried and went to the ER (Emergency Room); he was admitted on 22Mar2021, observed on 23Mar2021 and came out on 24Mar2021. He was "Out of It" and on that Monday he was feeling so tired and weak and he had problems all last year and they were alarmed so they went to be checked out and the patient was released without finding anything. The events resulted in emergency room visit on 22Mar2021. No visit to physician office. Therapeutic measures were taken as a result of events included loperamide hydrochloride (IMODIUM). The outcome of events diarrhea, weakness, swollen lymph nodes, really bad tiredness was recovering, outcome of event dizziness was recovered on 26Mar2021. No medications, medical conditions, or tests relevant to this report. Consumer mentioned that the patient has an appointment to get the second dose of the BNT162B2 on 01Apr2021 and wanted to know if there were reports about getting the second dose will make the side effects stronger.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Dizziness, Ear pain, Epistaxis, Hypoaesthesia
Clinical narrative: She experienced Bell's Palsy; dizzy; bleeding out of my nose; earache; eyes are kinda blurry; My face went numb; This is a spontaneous report received from a Pfizer Sponsored Program. A contactable consumer, the patient reported for herself that a 50-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 08Mar2021 (at the age of 50-years-old) as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included prednisone (MANUFACTURER UNKNOWN); valaciclovir hydrochloride (VALTREX) (MANUFACTURER UNKNOWN). On an unknown date, the patient experienced bell's palsy but upon contacting her physician she was prescribed an immunosuppressant which is Prednisone. She was asking if she can take the second dose. Patient stated, after about a week of first dose on an unspecified date in Mar2021, she got dizzy and started bleeding out of nose. On an unpecified date in Mar2021, 2 weeks in, she thought she had an earache. It started on Sunday, Monday and Tuesday. On an unspecified date in Mar2021 (Wednesday), the first thing she noticed while driving was eyes were kinda blurry and her face went numb and she couldn't close eye. Within 2 hours of numbness she saw the doctor who put her on Valtrex and later her doctor put her on prednisone. She has the 2nd dose scheduled for Monday 05Apr2021 and she is worried about taking it. The clinical outcomes of the she experienced bell's palsy, dizzy, bleeding out of my nose, earache, eyes are kinda blurry, my face went numb were unknown.  Information about lot number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: She experienced Bell's Palsy; dizzy; bleeding out of my nose; earache; eyes are kinda blurry; My face went numb; This is a spontaneous report received from a Pfizer Sponsored Program. A contactable consumer, the patient reported for herself that a 50-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 08Mar2021 (at the age of 50-years-old) as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included prednisone (MANUFACTURER UNKNOWN); valaciclovir hydrochloride (VALTREX) (MANUFACTURER UNKNOWN). On an unknown date, the patient experienced bell's palsy but upon contacting her physician she was prescribed an immunosuppressant which is Prednisone. She was asking if she can take the second dose. Patient stated, after about a week of first dose on an unspecified date in Mar2021, she got dizzy and started bleeding out of nose. On an unpecified date in Mar2021, 2 weeks in, she thought she had an earache. It started on Sunday, Monday and Tuesday. On an unspecified date in Mar2021 (Wednesday), the first thing she noticed while driving was eyes were kinda blurry and her face went numb and she couldn't close eye. Within 2 hours of numbness she saw the doctor who put her on Valtrex and later her doctor put her on prednisone. She has the 2nd dose scheduled for Monday 05Apr2021 and she is worried about taking it. The clinical outcomes of the she experienced bell's palsy, dizzy, bleeding out of my nose, earache, eyes are kinda blurry, my face went numb were unknown.  Information about lot number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Chills, Diarrhoea, Hallucination
Clinical narrative: low grade fever; bad chills; Hallucinations through fever and chills all night; bad stomach pain; headache; horrible diahrrea; Dose Number: 1, Date of start of drug: 9-MAR-2021/Dose Number: 2, Date of start of drug: 23-MAR-2021; Dose Number: 1, Date of start of drug: 9-MAR-2021/Dose Number: 2, Date of start of drug: 23-MAR-2021; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female non pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 23Mar2021 09:00 (Batch/Lot Number: Unknown) as single dose for covid-19 immunization.  Medical history included none. No allergies to medications, food, or other product. Concomitant medication included paracetamol (TYLENOL 8 HOUR) taken for an unspecified indication, start and stop date were not reported. No other vaccines received within 4 weeks prior to the COVID vaccine. The patient previously received dose 1 via an unspecified route of administration, administered in Arm Right on 09Mar2021 09:30 (Batch/Lot Number: unknown) as SINGLE DOSE for covid-19 immunization. The patient experienced bad stomach pain and 12 hours later low-grade fever bad chills on 24Mar2021 04:00, hallucinations through fever and chills all night, headache and horrible diarrhea. Adverse events start time was reported as 16:00 on 23Mar2021. It was unknown if the patient received treatment for the events stomach pain, fever, chills, Hallucinations, headache and diarrhea. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events stomach pain, fever, chills, Hallucinations, headache and diarrhea were recovering, of other event as unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Off label use, Product use issue, Pyrexia
Clinical narrative: low grade fever; bad chills; Hallucinations through fever and chills all night; bad stomach pain; headache; horrible diahrrea; Dose Number: 1, Date of start of drug: 9-MAR-2021/Dose Number: 2, Date of start of drug: 23-MAR-2021; Dose Number: 1, Date of start of drug: 9-MAR-2021/Dose Number: 2, Date of start of drug: 23-MAR-2021; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female non pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 23Mar2021 09:00 (Batch/Lot Number: Unknown) as single dose for covid-19 immunization.  Medical history included none. No allergies to medications, food, or other product. Concomitant medication included paracetamol (TYLENOL 8 HOUR) taken for an unspecified indication, start and stop date were not reported. No other vaccines received within 4 weeks prior to the COVID vaccine. The patient previously received dose 1 via an unspecified route of administration, administered in Arm Right on 09Mar2021 09:30 (Batch/Lot Number: unknown) as SINGLE DOSE for covid-19 immunization. The patient experienced bad stomach pain and 12 hours later low-grade fever bad chills on 24Mar2021 04:00, hallucinations through fever and chills all night, headache and horrible diarrhea. Adverse events start time was reported as 16:00 on 23Mar2021. It was unknown if the patient received treatment for the events stomach pain, fever, chills, Hallucinations, headache and diarrhea. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events stomach pain, fever, chills, Hallucinations, headache and diarrhea were recovering, of other event as unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: nausea; Vomiting; This is a spontaneous report from a contactable other health professional (also reported as a consumer; patient); via specialty pharmacy. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization; treprostinil sodium (REMODULIN 5 mg/ml), intravenously from 10Mar2017 (Batch/Lot number was not reported) to an unspecified date, at 0.094 ug/kg, continuous for primary pulmonary arterial hypertension.  Medical history included primary pulmonary arterial hypertension from an unknown date and unknown if ongoing. Concomitant medications included macitentan (OPSUMIT) taken for an unspecified indication, start and stop date were not reported. On 21Mar2021, the patient experienced nausea and vomiting.  The patient was hospitalized for nausea and vomiting from 21Mar2021 to an unknown date. The patient began therapy with treprostinil sodium (REMODULIN, concentration of 5 mg/ml), on 10Mar2017 for primary pulmonary arterial hypertension. The current dose was reported as 0.094 ug/kg, continuous via intravenous (IV) route. On 21Mar2021, the patient was hospitalized due to nausea and vomiting after getting the COVID vaccine. The action taken in response to the events for treprostinil sodium was unknown. The clinical outcome of the events was unknown. The reporter did not provide causality for the events of nausea and vomiting.  Case Comment/Senders Comment: The company has assessed the serious adverse events of nausea and vomiting as possibly related to IV treprostinil based on the known safety profile of the suspect drug even though there was a lack of temporal relationship. The events could also have been caused by the recent administration of the COVID vaccine.  The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of nausea and vomiting due to temporal relationship and current known drug safety profile.  Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Illness, Pain
Clinical narrative: COVID symptoms after first vaccine/had COVID tested and it was positive; was very weak, achy, and could not get out of bed on 16 MAR 2021 to get the second shot; could not get out of bed; was very weak, achy, and could not get out of bed on 16 MAR 2021 to get the second shot; This is a spontaneous report received from a contactable consumer. A 85-year-old female patient had received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201), via an unspecified route of administration on 23Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that 2 days after her first dose on 25Feb2021, the patient started with COVID symptoms, very weak, achy, and could not get out of bed and was hospitalized, and it was unsure if patient had COVID when she got the vaccine. On 01Mar2021 her mother tested positive for Covid. Patient experienced. The patient was scheduled to have her second dose on 16Mar2021. But patient tested positive again on 16Mar2021 and did not receive her second Pfizer Covid vaccine. Outcome of events was not reported.  Additional information has been requested.; Sender's Comments: Linked Report(s) : PFIZER-2021347468 same reporter/ product, different patient
Sex: M
Vaccine: COVID19
Symptoms: Blood urine present, Body temperature, Culture, Kidney infection, Pain in extremity
Clinical narrative: they did a culture and do not know if he has a kidney infection or urinary infection.; they did a culture and do not know if he has a kidney infection or urinary infection.; He stated running a fever yesterday (100.3 degrees last night); he has a lot of blood in his urine; he had a sore arm for a couple of hours; This is a spontaneous report from a contactable consumer non health care professional via Medical Information team. A patient of 63-year male received of (BNT162B2) (solution for injection/Lot/Batch number not provided, via unspecified route of administration on 10Mar2021 at a single dose of COVID-19 immunization. The patient's relevant medical history included kidney stones, he is on blood thinners because in 2019 he had blood clots in his lungs and was diagnosed with a pulmonary embolism and thrombosis. Laboratory data included body temperature(fever) 100 degrees centigrade, Concomitant medications were not provided. It was reported that the patient had taken covid vaccine, for first shot the patient had experienced a sore arm for a couple of hours that night but no other issues. He took Tylenol after the shot that day and evening, running a fever yesterday (100.3 degrees last night), lot of blood in his urine, He started antibiotics, Macrobid. He is having some difficulty taking it so they gave another prescription, Augmentin, and he is going to call today to see if he should start taking this and stop taking the Macrobid. He is scheduled for his second dose tomorrow on 31Mar2021. He has a history of kidney stones and is not sure if that is what this is because he has a lot of blood in his urine. The only day he knows they give the vaccines is on Wednesday so if he waits he may have to wait a week. He stated he feels a little better at this moment since he has been awake since 7:00 this morning. He asked if he is still able to get his second dose tomorrow while he has a fever and patient stated some people say they have a rough time on the second shot and these are relatively young, healthy people, they did a culture and do not know if he has a kidney infection or urinary infection. For the kidney infection event was medically significant, Outcome of the events was unknown and He stated running a fever yesterday (100.3 degrees last night) was not recovered.  Lot/Batch number has been requested. No further information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Urinary tract infection
Clinical narrative: they did a culture and do not know if he has a kidney infection or urinary infection.; they did a culture and do not know if he has a kidney infection or urinary infection.; He stated running a fever yesterday (100.3 degrees last night); he has a lot of blood in his urine; he had a sore arm for a couple of hours; This is a spontaneous report from a contactable consumer non health care professional via Medical Information team. A patient of 63-year male received of (BNT162B2) (solution for injection/Lot/Batch number not provided, via unspecified route of administration on 10Mar2021 at a single dose of COVID-19 immunization. The patient's relevant medical history included kidney stones, he is on blood thinners because in 2019 he had blood clots in his lungs and was diagnosed with a pulmonary embolism and thrombosis. Laboratory data included body temperature(fever) 100 degrees centigrade, Concomitant medications were not provided. It was reported that the patient had taken covid vaccine, for first shot the patient had experienced a sore arm for a couple of hours that night but no other issues. He took Tylenol after the shot that day and evening, running a fever yesterday (100.3 degrees last night), lot of blood in his urine, He started antibiotics, Macrobid. He is having some difficulty taking it so they gave another prescription, Augmentin, and he is going to call today to see if he should start taking this and stop taking the Macrobid. He is scheduled for his second dose tomorrow on 31Mar2021. He has a history of kidney stones and is not sure if that is what this is because he has a lot of blood in his urine. The only day he knows they give the vaccines is on Wednesday so if he waits he may have to wait a week. He stated he feels a little better at this moment since he has been awake since 7:00 this morning. He asked if he is still able to get his second dose tomorrow while he has a fever and patient stated some people say they have a rough time on the second shot and these are relatively young, healthy people, they did a culture and do not know if he has a kidney infection or urinary infection. For the kidney infection event was medically significant, Outcome of the events was unknown and He stated running a fever yesterday (100.3 degrees last night) was not recovered.  Lot/Batch number has been requested. No further information was reported.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: who received the first dose of the Pfizer vaccine on 3Mar2021 and since tested positive for covid; This is a spontaneous report received from a contactable pharmacist. A 17-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an un-specified route of administration on 03Mar2021 (Batch/Lot number was not re-ported) at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient underwent lab tests and procedures which includes COVID test and resulted a week later as positive for COVID. On unspecified date patient tested negative to COVID. Therapeutic measures were taken as a result of who received the first dose of the Pfizer vaccine on 3Mar2021 and since tested positive for COVID. It was reported that patient had not received any antivirals therapies. States the patient has been riding it out with Tylenol. Reporter declines to complete a safety report at this time. The outcome of the event was recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis
Clinical narrative: bronchitis; This is a spontaneous report received from a contactable consumer (patient) to a Pfizer sponsored program.   A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Unknown; Expiration Date: Unknown) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced bronchitis on an unspecified date. Caller has received first Covid vaccination and now has possible bronchitis. Put on a steroid. Inquiring if that would affect the covid vaccine. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: symptoms of covid-19 5 days after the vaccine; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported for himself that the male patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Pfizer Covid-19 Vaccine), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced symptoms of covid-19 5 days after the vaccine (medically significant) on an unspecified date with outcome of unknown. The patient already taken the 1st dose of the Covid-19 vaccine, had some symptoms of covid-19 5 days after the vaccine. He is about to take the 2nd dose on Monday, and he would like to confirm whether to still take the 2nd dose or not.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died approximately one week after receiving the Pfizer vaccine; This is a spontaneous report from a non-contactable consumer. A 94-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history included cardiovascular disease and other conditions (could not name). The patient's concomitant medications were not reported. The patient was ill but was able to walk around on own and found pretty weak for age. It was reported that the patient died approximately one week after receiving the vaccine on an unspecified date. It was unknown if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: died approximately one week after receiving the Pfizer vaccine
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Myalgia, Nausea
Clinical narrative: Severe Nausea; Fatigue; Muscle and body aches; Muscle and body aches; headache; low grade fever; malaise; severe Tremor; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient (not pregnant at time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Mar2021 at 15:15 on the left arm as single dose for COVID-19 immunization. Medical history included bipolar disorder type 2, known allergies to sulfa. Concomitant medications included taking unspecified other medications in two weeks. The patient did not receive other vaccine in four weeks. The patient previously took prochlorperazine maleate (COMPAZINE) and experienced allergies. The patient did not have covid prior vaccination and there was unknown if the patient had covid tested post vaccination. On 13Mar2021 at 12:00 PM, the patient experienced severe nausea, fatigue, muscle and body aches, headache, low grade fever, malaise 3 days after vaccine since then patient had developed a severe tremor; that all events resulted in disability or permanent damage. Patient received a positive result from a serum antibody test for covid 19 on 29Mar2021 (reported as two days ago, as of 31Mar2021). Patient cancelled her second vaccination appointment. Lab data included serum antibody test was positive on 29Mar2021. There was no treatment received for the adverse events. The outcome of events was not recovered.   Information about Batch/Lot number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 antibody test, Tremor
Clinical narrative: Severe Nausea; Fatigue; Muscle and body aches; Muscle and body aches; headache; low grade fever; malaise; severe Tremor; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient (not pregnant at time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Mar2021 at 15:15 on the left arm as single dose for COVID-19 immunization. Medical history included bipolar disorder type 2, known allergies to sulfa. Concomitant medications included taking unspecified other medications in two weeks. The patient did not receive other vaccine in four weeks. The patient previously took prochlorperazine maleate (COMPAZINE) and experienced allergies. The patient did not have covid prior vaccination and there was unknown if the patient had covid tested post vaccination. On 13Mar2021 at 12:00 PM, the patient experienced severe nausea, fatigue, muscle and body aches, headache, low grade fever, malaise 3 days after vaccine since then patient had developed a severe tremor; that all events resulted in disability or permanent damage. Patient received a positive result from a serum antibody test for covid 19 on 29Mar2021 (reported as two days ago, as of 31Mar2021). Patient cancelled her second vaccination appointment. Lab data included serum antibody test was positive on 29Mar2021. There was no treatment received for the adverse events. The outcome of events was not recovered.   Information about Batch/Lot number has been requested.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Coagulopathy, Gangrene, Hypoaesthesia, Pain in extremity, Skin discolouration
Clinical narrative: Middle finger tip became numb; black spots on finger nail edge and grew into black dead finger tips on three fingers of left hand. Then spread to two middle fingers on left hand; Pain in intense and at times unbearable/finger pain on the tips of my fingers/unbearably painful; The ends of my fingers are gangrenous and now the skin and dead material is sluffing off; Micro clotting; This is a spontaneous report from a contactable consumer (reporting for himself) via a Pfizer-sponsored program. A 71-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Jan2021 at 05:30 (Batch/Lot Number: EN5318) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. On 24Jan2021, the patient reported that his middle fingertip became numb two days after the injection. Progressed from minor numbness to black spots on fingernail edge and grew into black dead finger tips on three fingers of left hand. Then spread to two middle fingers on left hand. Hand specialist, vascular surgeon and rumatologist are shocked at the damage being caused. Now on blood thinners which seems to have reduced spread. Pain in intense and at times unbearable. The ends of my fingers were gangrenous and now the skin and dead material was sluffing off. Micro clotting was the cause as per 4 of the doctors treating him. The patient received blood thinners, Eliquis as treatment for the events. The events were assessed as serious with life-threatening and disabling/incapacitating as seriousness criteria. The outcome of the events was recovered with sequel. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine.  Information on the lot/batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Haemorrhagic urticaria, Rash, Vaccination site rash, Vaccination site urticaria
Clinical narrative: spreading rash and hives starting at injection site; spreading rash and hives starting at injection site; spreading rash and hives starting at injection site and spreading to all arms  and legs within 20 minutes; hives spread over entire body/Hives were breaking open and leaking pus and blood.; having trouble breathing; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 30Mar2021 09:30 (Batch/Lot Number: EP6955) as single dose, for covid-19 immunization at Doctor's office/urgent care. Medical history included asthma, heart (disorder) and known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included aciclovir (ACLOVIR), sucralfate (CARAFATE) and asthma medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EN6203) on 08Mar2021 at 09:00 in the left arm for COVID-19 immunization at a Doctor's office/urgent care. On 30Mar2021 at 19:30, the patient experienced rapidly spreading rash and hives starting at injection site and spreading to all arms and legs within 20 minutes, hives spread over entire body and began having trouble breathing. Hives were breaking open and leaking pus and blood. The hives were size of a dime rash started approx. 11 hours after injection. The patient was given IV steroids and antihistamines and 2 breathing treatments. The patient has not been tested for COVID-19 since the vaccination. The events resulted in Emergency room/department or urgent care visit and assessed as life threatening illness with immediate risk of death from the events. The outcome of the events was recovering.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; This is a spontaneous report from a contactable pharmacist. A 48-year-old female patient received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 48-year-old, intramuscular, administered in right arm on 24Mar2021 13:00 (Lot Number: EL9262) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient was previously vaccinated with the first dose of BNT162B2 (lot number: EN6202) at the age of 48-year-old, on 03Mar2021 at 12:00 PM intramuscularly administered as the left arm for COVID-19 immunization. The patient experienced stroke on 25Mar2021 15:00. The event resulted in emergency room visit and the patient was hospitalized on an unspecified date for 6 days. It was unknown if treatment was given. The event was also reported as life-threatening and disabling/incapacitating. The outcome of the event not recovered.; Sender's Comments: A causal relationship between the event stroke and suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) is possible based on the information provided, drug profile and a temporal association in this 48-year-old female patient. This case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Lyme disease, Swelling, Swelling face, Tongue disorder
Clinical narrative: facial drooping/ Right Sided Bell's Palsy/ All the right side of his face is not moving; swollen face; his tongue feeling fat; sore and swollen area behind his left ear on his neck; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received first dose of the Pfizer Covid19 Vaccine, (Formulation: Solution for injection, Batch/Lot number were UNKNOWN) via an unspecified route of administration on 13Mar2021 as a single a dose for covid-19 vaccination. Patient medical history included, Right Sided Bell's Palsy. Concomitant medications were unknown.  On 15Mar2021, the patient was sent to the ER. Monday morning after experiencing symptoms the night before and the morning of such as his tongue feeling fat. He was tested for Lyme's disease which came back negative and was diagnosed with Right Sided Bell's Palsy. The patient was discharged that day after 3 hours and was prescribed with prescribed with Prednisone and Valtrex. Up until now, the patient still has symptoms such as numbness, tingling, blurry vision, on and off headaches, a swollen face, facial drooping, his tongue feeling fat, difficulty in swallowing and talking, drooling, and a sore and swollen area behind his left ear on his neck. All the right side of his face was not moving. The patient received physical therapy 3 times as of calling. He was supposed to receive his second dose this Saturday and is contemplating as their doctors have not given them a straight answer. The outcome of the events were unknown.  Information on the lot/batch number has been requested.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary embolism, Thrombosis
Clinical narrative: Massive blood clot in left calf leading to pulmonary embolisms in both lungs (multiple clots in each lung); Massive blood clot in left calf leading to pulmonary embolisms in both lungs (multiple clots in each lung); This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm on 21Feb2021 14:00 (at the age of 58-year-old) as SINGLE DOSE for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and it was unknown if the patient has been tested for COVID-19 since the vaccination. The patient's medical history was not reported. The patient had no allergies to medications, food, or other products. The patient had no concomitant medications received within 2 weeks of vaccination. On 10Mar2021 at 11:30 AM, the patient experienced massive blood clot in left calf leading to pulmonary embolisms in both lungs (multiple clots in each lung). The patient was hospitalized for the events for 4 days. The events were also considered as life-threatening. Therapeutic measures were taken as a result of massive blood clot in left calf leading to pulmonary embolisms in both lungs (multiple clots in each lung) which included intravenous anticoagulants and injected anticoagulant. The patient was recovering from the events.  Information about the lot/batch number has been requested.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram pulmonary abnormal, Coagulation factor V level normal, Deep vein thrombosis, Echocardiogram abnormal, Factor II mutation
Clinical narrative: Massive blood clot in left calf leading to pulmonary embolisms in both lungs (multiple clots in each lung); Massive blood clot in left calf leading to pulmonary embolisms in both lungs (multiple clots in each lung); This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm on 21Feb2021 14:00 (at the age of 58-year-old) as SINGLE DOSE for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and it was unknown if the patient has been tested for COVID-19 since the vaccination. The patient's medical history was not reported. The patient had no allergies to medications, food, or other products. The patient had no concomitant medications received within 2 weeks of vaccination. On 10Mar2021 at 11:30 AM, the patient experienced massive blood clot in left calf leading to pulmonary embolisms in both lungs (multiple clots in each lung). The patient was hospitalized for the events for 4 days. The events were also considered as life-threatening. Therapeutic measures were taken as a result of massive blood clot in left calf leading to pulmonary embolisms in both lungs (multiple clots in each lung) which included intravenous anticoagulants and injected anticoagulant. The patient was recovering from the events.  Information about the lot/batch number has been requested.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fibrin D dimer increased, Platelet count decreased, Pulmonary embolism, Right ventricular dysfunction, Thrombocytopenia
Clinical narrative: Massive blood clot in left calf leading to pulmonary embolisms in both lungs (multiple clots in each lung); Massive blood clot in left calf leading to pulmonary embolisms in both lungs (multiple clots in each lung); This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm on 21Feb2021 14:00 (at the age of 58-year-old) as SINGLE DOSE for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and it was unknown if the patient has been tested for COVID-19 since the vaccination. The patient's medical history was not reported. The patient had no allergies to medications, food, or other products. The patient had no concomitant medications received within 2 weeks of vaccination. On 10Mar2021 at 11:30 AM, the patient experienced massive blood clot in left calf leading to pulmonary embolisms in both lungs (multiple clots in each lung). The patient was hospitalized for the events for 4 days. The events were also considered as life-threatening. Therapeutic measures were taken as a result of massive blood clot in left calf leading to pulmonary embolisms in both lungs (multiple clots in each lung) which included intravenous anticoagulants and injected anticoagulant. The patient was recovering from the events.  Information about the lot/batch number has been requested.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Troponin increased, Tumour marker test, Ultrasound Doppler abnormal
Clinical narrative: Massive blood clot in left calf leading to pulmonary embolisms in both lungs (multiple clots in each lung); Massive blood clot in left calf leading to pulmonary embolisms in both lungs (multiple clots in each lung); This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm on 21Feb2021 14:00 (at the age of 58-year-old) as SINGLE DOSE for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and it was unknown if the patient has been tested for COVID-19 since the vaccination. The patient's medical history was not reported. The patient had no allergies to medications, food, or other products. The patient had no concomitant medications received within 2 weeks of vaccination. On 10Mar2021 at 11:30 AM, the patient experienced massive blood clot in left calf leading to pulmonary embolisms in both lungs (multiple clots in each lung). The patient was hospitalized for the events for 4 days. The events were also considered as life-threatening. Therapeutic measures were taken as a result of massive blood clot in left calf leading to pulmonary embolisms in both lungs (multiple clots in each lung) which included intravenous anticoagulants and injected anticoagulant. The patient was recovering from the events.  Information about the lot/batch number has been requested.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Gallbladder disorder, White blood cell count, White blood cell count decreased
Clinical narrative: issue with her gallbladder; about 2 days after receiving the second dose of the vaccine the patient was hospitalized for dangerously low white blood cell counts. It resulted in multiple blood transfusions and a week long hospita; This is a spontaneous report from a contactable consumer (patient). A 94-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on Feb2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no known allergies, The patient was hospitalized for dangerously low white blood cell counts about 2 days after receiving the second dose of the vaccine. It resulted in multiple blood transfusions and a week long hospital visit. The patient returned home for about 2 months on an oxygen tank and was taken to the hospital again for low white blood cell counts and an issue with her gallbladder. She is still currently in the hospital. AE resulted in hospitalization, disability or permanent damage. Adverse event start date was on Feb2021. The patient recovered with lasting effects. treatment was received with AE. No Covid tested prior and post vaccination. No other vaccine received in four weeks. The patient underwent lab tests and procedures which included low white blood cell count dangerously on Feb2021.    Information on the lot/batch number has been requested.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: expired Menactra was administered to a patient (with no reported adverse event); Initial information regarding an unsolicited valid non-serious case was received from Other Health Care Professional via Agency (Reference number- 00533762) and transmitted to Sanofi on 24-Mar-2021.  This case involves a 16 years old female patient who received 0.5 mL expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot number lot U6486AC expiry date- 10-Jan-2021 via intramuscular route in unknown administration site for prophylactic vaccination on 24-Mar-2021.  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   It was a case of actual medication error due to expired vaccine used (latency same day).  The caller would like to know if the patient must be revaccinated.  At the time of report there was no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Neck pain, Pruritus, Rash pruritic
Clinical narrative: Two days after the injection I had a series of bumps that looked like bug bites all over both of my arms and even onto my fingers. They were itchy and I applied topical antihistamines and also had (1) 24 hr over-the-counter antihistamine.  Now, exactly one week later, I am having difficulty breathing. It feels like someone jumped on my chest. This pain started around noon and is still continuing now (7:00 PM). When I turn my head to the right, it seems to get worse; I have pain also in my neck and down my spine until equivalent to my chest.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal discomfort, Throat irritation, Throat tightness
Clinical narrative: Patient felt  itchiness and throat discomfort. No respiratory distress. Patient stated it felt like throat was tightening. She brought her own Epi Pen (Seafood anaphylaxis) and was instructed to self administer. 911 / EMS took her to nearest hospital
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Dysphonia, Pharyngeal paraesthesia, Throat tightness
Clinical narrative: Patient felt  itchiness and throat discomfort. No respiratory distress. Patient stated it felt like throat was tightening. She brought her own Epi Pen (Seafood anaphylaxis) and was instructed to self administer. 911 / EMS took her to nearest hospital
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: received Janssen covid vaccine as 2nd dose of Pfizer covid vaccine,
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Pain, Vertical infection transmission
Clinical narrative: Dizzy and symptoms of Vertigo with severe exhaustion and body aches . It lasted 2 days and I still don?t feel right.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Erythema, Muscle spasms, Muscle twitching
Clinical narrative: 1 hr after shot (tuesday 0831 hrs), right bicep was twitching. Next morning (wedenesday 0700 hrs) pain an redness in Right shoulder.  Most importantly pain in the spine from middle to lower back..  (Thursday 0510 hrs) while brushing teeth, a sharp pain put me to my knees..  1200 hrs pain was still there... Went to urgent care.. Doctor said it was back spasms.. Said he didn't know if it was related to the vaccine. Then also said nobody knows.  I have not worked out nor have I lifted anything heavy in 2 weeks prior to receiving the covid vaccine.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: 1 hr after shot (tuesday 0831 hrs), right bicep was twitching. Next morning (wedenesday 0700 hrs) pain an redness in Right shoulder.  Most importantly pain in the spine from middle to lower back..  (Thursday 0510 hrs) while brushing teeth, a sharp pain put me to my knees..  1200 hrs pain was still there... Went to urgent care.. Doctor said it was back spasms.. Said he didn't know if it was related to the vaccine. Then also said nobody knows.  I have not worked out nor have I lifted anything heavy in 2 weeks prior to receiving the covid vaccine.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 2" x 3" welt near injection site. Area is swollen, raised, warm, and itchy.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Dyspnoea, Vital signs measurement
Clinical narrative: After giving the patient the first dose of Covid vaccine, she started having anxiety attack and then shortness of breath. The patient is on clonazepam, she took a pill, but she insisted on getting the Epipen as well as she was getting worse and worse. I had to give her a dose of IM Epinephrine. Few minutes later, she started breathing normally again. I monitored her for two hours at the pharmacy and I was checking her vitals and heart rate. Everything was back to normal by 11 am. She went home safe afterwards.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Dizziness, Dry mouth, Dry throat, Dyspnoea
Clinical narrative: After giving the patient the first dose of Covid vaccine, she started having anxiety attack and then shortness of breath. The patient is on clonazepam, she took a pill, but she insisted on getting the Epipen as well as she was getting worse and worse. I had to give her a dose of IM Epinephrine. Few minutes later, she started breathing normally again. I monitored her for two hours at the pharmacy and I was checking her vitals and heart rate. Everything was back to normal by 11 am. She went home safe afterwards.