chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: received First Covid vaccine- a week later got a positive test; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A female patient of an unspecified age 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 an unspecified date, as a single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient received her first COVID vaccine and a week later the patient got a positive test on unspecified date; the second dose will be rescheduled. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: she felt a little sore in the part of her arm where the vaccine was injected.; This is a spontaneous report from a consumer (patient) via Pfizer sponsored program. A female patient of an unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration on 31Mar2021 as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 09Mar2021 as a single dose for covid-19 immunization. The patient had the 2nd dose on 31Mar2021 and she felt a little sore in the part of her arm where the vaccine was injected. She has more than the usual 21 days interval scheduled date of doses. She also stated that one doctor told her friend not to get the Covid-19 Vaccine because it causes liver cancer and other cancers. So, she was asking if does the doctor have the right to tell other people not to get the Covid-19 Vaccine. She also shared that one of the Doctors in Walgreens agreed with her that a doctor does not have any right to tell something like that especially if the doctor does not know the person or the patient very well. There were some unaddressed medical questions referred or forwarded to medical information. The outcome of the event was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling
Clinical narrative: her arm is sore; her neck is swollen; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (BNT162B2 ; lot number and expiration date were not reported), via an unspecified route of administration on 09Apr2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's arm was sore and neck was swollen after taking first dose in Apr2021. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid worked itself in; covid worked itself in; This is an initial spontaneous report from a contactable consumer. A female patient of unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via unspecified route of administration on 19Feb2021 as a single dose for covid-19 immunization. Patient was weaning of methotrexate for rheumatoid arthritis due to the side effects of the methotrexate. She missed the second dose of the vaccine because she was experiencing things from withdrawing from the methotrexate and covid worked itself in. She is no longer on methotrexate. Second dose of the vaccine was cancelled on 19Mar2021 because of being very sick due to taking Methotrexate and immunosuppressant drugs for Rheumatoid arthritis. She said she was also advised by the Facility that she can get her second dose of the vaccine 40 days after the first dose. The outcome of the events were unknown.  Follow up (13Apr2021): This is a follow up spontaneous report from a Pfizer Sponsored Program COVAX Support. Contactable female consumer (patient) reported treatment details, suspect drug information added clinical information.  Information on the lot/batch number has been requested.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Bradyphrenia, Fatigue, Feeling abnormal, Hypoaesthesia, Monoplegia
Clinical narrative: Leg paralysis 12 hours after.; Slower cognitive functions for 5 days.; Leg numbing for 5 days.; Brain fog and fatigue for 5 days; Brain fog and fatigue for 5 days.; This is a spontaneous report from a contactable consumer. A 36-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6204), via an unspecified route of administration, at the age of 36 years, administered on the left arm on 05Apr2021 12:00 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. On 05Apr2021 23:00, the patient experienced leg paralysis 12 hours after, leg numbing for 5 days, brain fog and fatigue for 5 days and slower cognitive functions for 5 days. No treatment was received for the events. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Influenza like illness, Nausea, Pain
Clinical narrative: Shoulder/arm pain at the injection site; Nausea; headache; general soreness; Shoulder sourness; Flu-like symptoms; This is a spontaneous report from a contactable consumer. This consumer female patient reported that she received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine; Solution for injection) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. The patients past medical history and concomitant medications were not reported. On an unknown date, the patient experienced fatigue, nausea, headache and general soreness. Flu-like symptoms (moderate- described as feeling awful) until 24 hours after the second dose was administered. The reporter mentioned that these symptoms did not require any require any treatment or attention by an HCP. These effects were reported to me at 12 PM and 8 PM today. The patient was presently recovering from the events. Information on lot/batch number has been requested.  Followup(14Apr2021): This is a spontaneous report from a contactable consumer. This consumer (patient) reported that: The report of shoulder soreness was sent via text message.  No follow-up attempts are needed. Information on lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Shoulder/arm pain at the injection site; Nausea; headache; general soreness; Shoulder sourness; Flu-like symptoms; This is a spontaneous report from a contactable consumer. This consumer female patient reported that she received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine; Solution for injection) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. The patients past medical history and concomitant medications were not reported. On an unknown date, the patient experienced fatigue, nausea, headache and general soreness. Flu-like symptoms (moderate- described as feeling awful) until 24 hours after the second dose was administered. The reporter mentioned that these symptoms did not require any require any treatment or attention by an HCP. These effects were reported to me at 12 PM and 8 PM today. The patient was presently recovering from the events. Information on lot/batch number has been requested.  Followup(14Apr2021): This is a spontaneous report from a contactable consumer. This consumer (patient) reported that: The report of shoulder soreness was sent via text message.  No follow-up attempts are needed. Information on lot/batch number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Left side of face (cheek & along jaw) went numb/spread across to right side of my face then under jaw and upper neck.; This is a spontaneous report from a contactable consumer. A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EP6955) via an unspecified route of administration, administered in left arm on 09Apr2021 10:00 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 09-APR-2021 10:45 , the patient experienced left side of face (cheek & along jaw) went numb then spread across to right side of my face then under jaw and upper neck. Outcome of the event was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Feeling hot, Headache, Migraine
Clinical narrative: migraine; headache; tiredness; vomitting; chills; feeling hot; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 10Apr2021 as Single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via unspecified route and date as Single dose for COVID-19 immunization and experienced sore arm. The patient experienced headache, migraine, tiredness, vomiting, chills, and feeling hot on an unspecified date in Apr2021. The outcome of these events at the reporting time was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: migraine; headache; tiredness; vomitting; chills; feeling hot; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 10Apr2021 as Single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via unspecified route and date as Single dose for COVID-19 immunization and experienced sore arm. The patient experienced headache, migraine, tiredness, vomiting, chills, and feeling hot on an unspecified date in Apr2021. The outcome of these events at the reporting time was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax, Eating disorder, Headache, Migraine, Nausea
Clinical narrative: migraine; headache; tiredness; vomitting; chills; feeling hot; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 10Apr2021 as Single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via unspecified route and date as Single dose for COVID-19 immunization and experienced sore arm. The patient experienced headache, migraine, tiredness, vomiting, chills, and feeling hot on an unspecified date in Apr2021. The outcome of these events at the reporting time was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal pain, Myalgia, Pain in extremity
Clinical narrative: Leg pain. Started in calf. Moved to hamstring. Moved to glutes; Leg pain. Started in calf. Moved to hamstring. Moved to glutes; Leg pain. Started in calf. Moved to hamstring. Moved to glutes; This is a spontaneous report received from a Non-contactable consumer (Patient). This 52-year-old female (non-pregnant) consumer reported for herself that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EP7533) via an unspecified route of administration into the left arm on 07Apr2021 09:30 AM (at the age of 52-year-old) at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included allergies to medications, food, or other products. Others included EGPA, asthma, bronchiectasis, vasculitis, eosinophilic granulomatosis with polyangiitis, aspirin [acetylsalicylic acid], iodine and antibiotics all for drug hypersensitivity. The patient concomitant medications included medications that the patient received within two weeks of vaccination which included mepolizumab (NUCALA), prednisolone acetate (PRED+), cetirizine hydrochloride (ZYRTEC ALLERGY), atorvastatin (LIPITOR [ATORVASTATIN]), diltiazem (CARDIZEM [DILTIAZEM]), budesonide, formoterol fumarate (SYMBICORT). On 08Apr2021 05:00 PM, the patient reported of leg pain which started in calf, moved to hamstring and moved to glutes. The patient did not receive treatment nor any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was recovering for all the events.  No follow-up attempts are possible. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased
Clinical narrative: watering eyes; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer, the female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 11Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on 20Mar2021 for covid-19 immunisation. On an unspecified date in Apr2021, the patient experienced watering eyes. The patient wants to know if she can take Benadryl. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: Early, heavy and prolonged menstruation.; Early, heavy and prolonged menstruation.; This is a spontaneous report from a contactable consumer. A 43-year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP6955, Batch no: CCBH 7957), via an unspecified route of administration, administered in Arm Right on 21Mar2021 01:15 PM as single dose for covid-19 immunization. Medical history included Latex Allergy. Concomitant medication included escitalopram oxalate (LEXAPRO) and Vitamin D. Patient was not diagnosed with COVID-19 prior to vaccination. Patient did not receive any other vaccines with 4 weeks prior to COVID vaccine. On 03Apr2021 13:00 the patient experienced early, heavy and prolonged menstruation. Patient had not been tested for COVID-19 since the vaccination. No treatment was received for the events. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Oropharyngeal pain, Pyrexia
Clinical narrative: throat pain; chills; fever; This is a spontaneous report from a non-contactable consumer (patient). This consumer reported events for two patients (himself and partner). This is the first of two reports.   A male patient of unspecified age received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient reported that 24 hours after the application, patient felt throat pain, chills, and fever in the subsequent 18 hours. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021406357 same reporter/drug, different patient/event.
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: patient fainted while driving the car; This is a spontaneous report from a non-contactable consumer reporting for a patient. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, age at vaccination unknown. The patient medical history and patient's concomitant medications were not reported. 40 minutes after the application, patient fainted while driving the car. Outcome of the event was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: felt nausea after the first dose; sore arms; This is a spontaneous report received from a contactable consumer (patient) via Pfizer-sponsored program: 159558. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot# unknown), on 11Mar2021 and second dose on 06Apr2021, both via an unspecified route of administration as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient experienced nausea and sore arms after the first dose. The patient was treated with Tylenol for sore arms. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea
Clinical narrative: migraine; nausea; This is a spontaneous report received from a Pfizer Sponsored Program. A contactable female consumer (patient) reported for herself that, she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: Unknown)  via an unspecified route of administration on 11Apr2021 as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient was currently experiencing migraine. She was asking if she can take Migraine pills for her migraine. Upon follow up received on 11Apr2021: This is a follow up spontaneous report received from a Pfizer Sponsored Program. A contactable female consumer (patient) reported for herself. Upon follow up received on 13Apr2021, patient received Pfizer Covid-19 vaccine first dose 11Apr2021 and experienced migraine and nausea. Wanted to know if she can take Ibuprofen or is there any medication that would affect the effects of the vaccine. The outcome of the evets was reported as unknown. The action taken in response to the events for bnt162b2 was not applicable.   Follow up received on 11Apr2021: This is a follow up spontaneous report received from a Pfizer Sponsored Program. A contactable female consumer (patient) reported for herself. No new information was received.  Follow up received on 13Apr2021: Events was added (nausea). New information was added.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19, UNK, UNK, UNK, COVID19, UNK, UNK, UNK
Symptoms: Arthralgia, Bone pain, Haemorrhage, Irritability, Swelling face
Clinical narrative: I am bleeding heavily because I am getting blood clots and stuff like that; I am bleeding heavily because I am getting blood clots and stuff like that; Right side of face, my tongue inside is very swollen and irritated; Lot of pain in my joints and in my bones; Right side of face, my tongue inside is very swollen and irritated; Right side of face, my tongue inside is very swollen and irritated; Lot of pain in my joints and in my bones; This is a spontaneous report from a contactable consumer (patient)   A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Lot number FN6200) as SINGLE DOSE for covid-19 immunisation; axitinib (INLYTA), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 2 DF, 1x/day (two pills a day ) for renal cancer; pembrolizumab (KEYTRUDA), route of administration, start and stop date, batch/lot number and dose were not reported for renal cancer; zoledronic acid (ZOMETA), route of administration, start and stop date, batch/lot number and dose were not reported for bone disorder  . The patient received the first dose of BNT162B2 on unknown date (Lot number CL9265).  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient stated "I got a clear cell renal cancer. And I am taking a combination Inlyta okay which is your drug and Keytruda and I also have also taken Zometa that is for the bones and I have had two Pfizer Vaccines (Unspecified Vaccines) for it.I am getting terrible side effects from either the Inlyta or the Keytruda. I am bleeding very heavily and the right side of face, my tongue inside is very swollen and irritated. I am getting a lot of pain in my joints and in my bones. I am bleeding heavily because I am getting blood clots and stuff like that. I just wonder if there is anything that I have been taking Inlyta two pills a day and I have taken probably 80 pills from the start. So, if there is anything to mitigate what's going on. The action taken with axitinib , and pzoledronic acid embolizumab was unknown.".The outcome of the event was unknown
Sex: U
Vaccine: COVID19, UNK, UNK, UNK, COVID19, UNK, UNK, UNK
Symptoms: Swollen tongue, Thrombosis
Clinical narrative: I am bleeding heavily because I am getting blood clots and stuff like that; I am bleeding heavily because I am getting blood clots and stuff like that; Right side of face, my tongue inside is very swollen and irritated; Lot of pain in my joints and in my bones; Right side of face, my tongue inside is very swollen and irritated; Right side of face, my tongue inside is very swollen and irritated; Lot of pain in my joints and in my bones; This is a spontaneous report from a contactable consumer (patient)   A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Lot number FN6200) as SINGLE DOSE for covid-19 immunisation; axitinib (INLYTA), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 2 DF, 1x/day (two pills a day ) for renal cancer; pembrolizumab (KEYTRUDA), route of administration, start and stop date, batch/lot number and dose were not reported for renal cancer; zoledronic acid (ZOMETA), route of administration, start and stop date, batch/lot number and dose were not reported for bone disorder  . The patient received the first dose of BNT162B2 on unknown date (Lot number CL9265).  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient stated "I got a clear cell renal cancer. And I am taking a combination Inlyta okay which is your drug and Keytruda and I also have also taken Zometa that is for the bones and I have had two Pfizer Vaccines (Unspecified Vaccines) for it.I am getting terrible side effects from either the Inlyta or the Keytruda. I am bleeding very heavily and the right side of face, my tongue inside is very swollen and irritated. I am getting a lot of pain in my joints and in my bones. I am bleeding heavily because I am getting blood clots and stuff like that. I just wonder if there is anything that I have been taking Inlyta two pills a day and I have taken probably 80 pills from the start. So, if there is anything to mitigate what's going on. The action taken with axitinib , and pzoledronic acid embolizumab was unknown.".The outcome of the event was unknown
Sex: U
Vaccine: COVID19, UNK, UNK, UNK, COVID19, UNK, UNK, UNK
Symptoms: Arthralgia, Bone pain, Glossitis, Haemorrhage, Skin irritation
Clinical narrative: I am bleeding heavily because I am getting blood clots and stuff like that; I am bleeding heavily because I am getting blood clots and stuff like that; Right side of face, my tongue inside is very swollen and irritated; Lot of pain in my joints and in my bones; Right side of face, my tongue inside is very swollen and irritated; Right side of face, my tongue inside is very swollen and irritated; Lot of pain in my joints and in my bones; This is a spontaneous report from a contactable consumer (patient)   A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Lot number FN6200) as SINGLE DOSE for covid-19 immunisation; axitinib (INLYTA), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 2 DF, 1x/day (two pills a day ) for renal cancer; pembrolizumab (KEYTRUDA), route of administration, start and stop date, batch/lot number and dose were not reported for renal cancer; zoledronic acid (ZOMETA), route of administration, start and stop date, batch/lot number and dose were not reported for bone disorder  . The patient received the first dose of BNT162B2 on unknown date (Lot number CL9265).  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient stated "I got a clear cell renal cancer. And I am taking a combination Inlyta okay which is your drug and Keytruda and I also have also taken Zometa that is for the bones and I have had two Pfizer Vaccines (Unspecified Vaccines) for it.I am getting terrible side effects from either the Inlyta or the Keytruda. I am bleeding very heavily and the right side of face, my tongue inside is very swollen and irritated. I am getting a lot of pain in my joints and in my bones. I am bleeding heavily because I am getting blood clots and stuff like that. I just wonder if there is anything that I have been taking Inlyta two pills a day and I have taken probably 80 pills from the start. So, if there is anything to mitigate what's going on. The action taken with axitinib , and pzoledronic acid embolizumab was unknown.".The outcome of the event was unknown
Sex: U
Vaccine: COVID19, UNK, UNK, UNK, COVID19, UNK, UNK, UNK
Symptoms: Swelling face, Swollen tongue, Thrombosis
Clinical narrative: I am bleeding heavily because I am getting blood clots and stuff like that; I am bleeding heavily because I am getting blood clots and stuff like that; Right side of face, my tongue inside is very swollen and irritated; Lot of pain in my joints and in my bones; Right side of face, my tongue inside is very swollen and irritated; Right side of face, my tongue inside is very swollen and irritated; Lot of pain in my joints and in my bones; This is a spontaneous report from a contactable consumer (patient)   A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Lot number FN6200) as SINGLE DOSE for covid-19 immunisation; axitinib (INLYTA), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 2 DF, 1x/day (two pills a day ) for renal cancer; pembrolizumab (KEYTRUDA), route of administration, start and stop date, batch/lot number and dose were not reported for renal cancer; zoledronic acid (ZOMETA), route of administration, start and stop date, batch/lot number and dose were not reported for bone disorder  . The patient received the first dose of BNT162B2 on unknown date (Lot number CL9265).  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient stated "I got a clear cell renal cancer. And I am taking a combination Inlyta okay which is your drug and Keytruda and I also have also taken Zometa that is for the bones and I have had two Pfizer Vaccines (Unspecified Vaccines) for it.I am getting terrible side effects from either the Inlyta or the Keytruda. I am bleeding very heavily and the right side of face, my tongue inside is very swollen and irritated. I am getting a lot of pain in my joints and in my bones. I am bleeding heavily because I am getting blood clots and stuff like that. I just wonder if there is anything that I have been taking Inlyta two pills a day and I have taken probably 80 pills from the start. So, if there is anything to mitigate what's going on. The action taken with axitinib , and pzoledronic acid embolizumab was unknown.".The outcome of the event was unknown
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer (patient's husband). A 65-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not available), via an unspecified route of administration, in left arm on 08Apr2021 at 12:30 or 13:00 (at the age of 65-years-old) as a single dose for COVID-19 immunization. The patient's medical history was reported as none. The patient's concomitant medications were not reported. No other vaccine was given in four weeks. The patient experienced sore arm on 09Apr2021. The patient did not receive any treatment for the event. The outcome of the event was not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: UTI; This is a spontaneous report from a Pfizer sponsored program. The contactable male consumer reported for himself that: an unspecified age of male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown), via unspecified route of administration on 21Feb2021 as a SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Approximately on an unknown date in 2021, the patient he was diagnosed with UTI and will take antibiotics. The patient supposed to received second dose tomorrow (past 21 days). He enquired that, if it was ok to take antibiotics. The outcome of the event was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Broke out in a rash between my legs, that ran down my inner thighs and on my wrists and hands; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE ; lot number and expiration date were not reported), via an unspecified route of administration, in Left arm in Mar2021 at 13:45 (at the age of 42-years-old) at single dose for COVID-19 immunization. Medical history was reported as none. Patient had no allergies to medications, food or other products. The patient did not receive concomitant medications. The patient was not pregnant at the time of vaccination. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient broke out in a rash between legs, that ran down inner thighs and on wrists and hands after the first dose on 16Mar2021. The event resulted in doctor or other healthcare professional office/clinic visit. Steroid treatment was received for the event. The outcome of the event was not recovered. It was also reported the patient received first dose of unspecified Pfizer vaccine in left arm in Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Formication, Vertigo, Vomiting
Clinical narrative: Extreme fatigue; light headed; room spinning; feels like bugs crawling under skin; vomiting lasting 3 days; This is a spontaneous report from a contactable consumer (reported for herself). The non pregnant female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration as a single dose on 30Mar2021 02:45 PM, for Covid-19 immunization. Medical history and concomitant medications were not reported. She did not have known allergies. She received first dose BNT162B2, Lot number: unknown) via an unspecified route of administration as a single dose on an unknown date, for Covid-19 immunization. On an unknown date, the patient experienced extreme fatigue, felt lightheaded, room spinning felt like bugs crawling under skin and vomiting lasting 3days. She did not receive treatment for events. She was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 Since the vaccination. The outcome of the events of extreme fatigue, felt lightheaded, room spinning felt like bugs crawling under skin and vomiting lasting for 3 days was recovering. No follow-up attempts were needed. No further information was expected. Information about lot/batch number could not be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Gastrointestinal pain, Malaise
Clinical narrative: intestinal cramping; gastro-intestinal discomfort; she was not feeling well; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer, the female patient of 59-year-old received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, on 20Mar2021 in between 12:30 to 13:00 in the afternoon (Batch/Lot Number: EP7536), (at the age of 59-years-old) on her right arm as single dose for covid-19 immunisation. The patient medical history included allergy to sulfa from unspecified date and was ongoing. The patient stated that she had her first reaction to sulfa in her 30 or 40 years of age (probably closer to 40) and does not take it anymore. The patient had no family medical history relevant to events. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021, patient experienced intestinal cramping. The patient was not feeling well too and hence missed to take her second dose of Covid vaccine. The patient also reported that both herself and her husband were scheduled for their second dose on 11Apr2021 and were unable to take because she was not feeling well. The patient enquired about how to reschedule appointment and stated that the intestinal cramping had nothing to do with the reaction, that was 3 weeks ago. The patient enquired into appointment scheduling due to missing appointment for second dose of vaccine on 11Apr2021 due to not feeling well, caller clarified that it was gastrointestinal discomfort in 2021. The events did not require a visit to emergency room or physician office. The outcome of the event intestinal cramping was recovered on 11Apr2021 and other events was unknown.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nerve injury, Pain in extremity, Paraesthesia
Clinical narrative: Sore arm; more of a tingle; like a nerve, "maybe she hit a nerve"; This is a spontaneous report received from a contactable consumer. The consumer reporting for his friend's mother-in-law. A female patient of an unspecified age received unspecified dose number of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; 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 sore arm, more of a tingle and like a nerve, "maybe she hit a nerve". It took over 6 weeks to resolve. The outcome of the events was resolved.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021406507 Same reporter/drug, different event/patient;US-PFIZER INC-2021400811 Same reporter/drug, different event/patient
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Dizziness/vertigo lasting over 2 days.; Dizziness/vertigo lasting over 2 days.; This is a spontaneous report from a non-contactable consumer (patient). A 27-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration in Left arm on 09Apr2021 at 12:30 (at the age of 27-year-old) as single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had no known allergies to medications, food or other products. The patient's concomitant medication included sertraline hydrochloride (ZOLOFT). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration in Left arm on 12Mar2021 at 12:15 (at the age of 27-year-old) as single dose for COVID-19 immunization. The patient was not pregnant. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient experienced dizziness/vertigo lasting over 2 days on 11Apr2021 at 11:00. No treatment was received for these events. The outcome of these events was not resolved at reporting time.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Chills, Dizziness, Headache, Loss of consciousness
Clinical narrative: losing vision; almost passing out; After second dose: fever; chills; headache; body ache; pain at injection site; dizziness; This is a spontaneous report from a non-contactable consumer (patient). An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 09Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, at 18 years old. The patient medical history was not reported. There were no concomitant medications. No other vaccines if four weeks. Patient received the first dose of bnt162b2 at 12Mar2021 16:30, arm left for covid-19 immunisation, at 18 years old. Patient is not pregnant. The patient experienced after second dose: losing vision, almost passing out, dizziness, fever, chills, headache, body ache, pain at injection site on 10Apr2021 00:00 (12AM). Treatment was not given. Outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site pain
Clinical narrative: losing vision; almost passing out; After second dose: fever; chills; headache; body ache; pain at injection site; dizziness; This is a spontaneous report from a non-contactable consumer (patient). An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 09Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, at 18 years old. The patient medical history was not reported. There were no concomitant medications. No other vaccines if four weeks. Patient received the first dose of bnt162b2 at 12Mar2021 16:30, arm left for covid-19 immunisation, at 18 years old. Patient is not pregnant. The patient experienced after second dose: losing vision, almost passing out, dizziness, fever, chills, headache, body ache, pain at injection site on 10Apr2021 00:00 (12AM). Treatment was not given. 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: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive with Covid-19 on friday; This is Spontaneous report from a Pfizer Sponsored Program. A contactable male consumer (patient) of an unspecified age received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration on 04Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On Friday 09Apr2021, the patient underwent lab tests and procedures which included sars-cov-2 test and tested positive with Covid-19 (non-serious). It was reported that patient asked what he needs to do with his 2nd dose which is scheduled on 25Apr2021. The outcome of the event was unknown. The action taken in response to the event for bnt162b2 was not applicable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: bad allergies; This is a spontaneous report from a contactable consumer, based on information received by Pfizer the contactable consumer(manufacturer control number: USASL2021048790). This is a split case for BNT162B2 from master case (a non-serious solicited report (USASL2021048790) reported to contactable consumer on 29/MAR/2021 by a consumer from a commercial program (PSP00180b)).  A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization on unknown date. The patient's current medical condition included ongoing rheumatoid arthritis. The patient's concomitant medication included etanercept (ENBREL) weekly for rheumatoid arthritis from 2020, methotrexate. The patient received her COVID-19 injection, and that she had bad allergies. No treatment information was received. The outcome of the event was reported as unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: he started bleeding from the injection site and bled a good amount; This is a spontaneous report from a contactable consumer (patient's spouse). An adult male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown) via an unspecified route of administration administered in the left arm on 10Apr2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. The patient did not have covid prior vaccination. The spouse informed that when the patient got his vaccine today, 10Apr2021, he started bleeding from the injection site and bled a good amount and he was concerned that the vaccine came out with his bleeding. The spouse and the patient wanted to know if the Pfizer covid-19 leaks out of the injection site. They both wanted to know if this was possible and; to let them know how it works to put them at ease or; let them know if the patient needed another first dose. No treatment was received for the adverse event reported. The outcome of the adverse event was unknown. The patient has not been covid-tested post-vaccination.   Information about the batch/lot no has been requested.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness transitory, Tinnitus
Clinical narrative: Experienced momentary loss of hearing (seconds duration) in each ear, which seemed to resolve; have persistent tinnitus in both ears; This is a spontaneous report from a contactable consumer (patient himself).  A 47-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EP7533) via an unspecified route of administration on 05Apr2021 at 11:45 am as a single dose for COVID-19 immunisation. The patient's medical history included Allergy and GERD. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient's 2 weeks prior vaccines included omeprazole, daily vitamin B-12, D3. Prior to vaccination, patient was not diagnosed with COVID-19. COVID vaccination was none. Since the vaccination, patient had not been tested for COVID-19. COVID tested post vaccination was none. On 08Apr2021 at 11pm, the patient reported that she experienced momentary loss of hearing (seconds duration) in each ear, which seemed to resolve, but currently she has persistent tinnitus in both ears. The patient reported that she did not take any treatment for the events and the events led to physician visit. Outcome of events was not resolved.
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Erythema, Skin disorder, Skin warm
Clinical narrative: cellulitis; having a skin reaction the size of a tangerine; Her skin is hot to the touch and red; Her skin is hot to the touch and red; This is a spontaneous report from a contactable consumer or other non hcp.  A female patient of an unspecified age received bnt162b2 (BNT162B2) Solution for injection, dose 2 via an unspecified route of administration on 10Apr2021 (Batch/Lot number was not reported) as Single dose for covid-19 immunisation. The patient medical history and concomitant was not reported. On unknown date, Apr2021, the patient experienced cellulitis, having a skin reaction the size of a tangerine, her skin is hot to the touch and red. The outcome of the events was unknown.  Information about the lot/batch number has been requested
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Reporter mentioned that her son diagnosed with COVID19 virus; This is a spontaneous report from Pfizer-sponsored program Covax Support. A contactable consumer (mother) reported for her son (patient) stating that: A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The reporter stated that her son got the first dose of the vaccine and then the next day, he got sick. She mentioned that her son diagnosed with COVID19 virus and already had it for 6 or 7 days now. She was asking if her son needs to get the 2nd dose or if they should reschedule or cancel it. The seriousness of the event COVID-19 was considered as medically significant. Outcome of the events was unknown.  Information on the lot/batch number has been requested.