chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Muscle spasms, Nausea
Clinical narrative: Very tired; Nauseous; Slight cramp in left thigh or leg; Tiredness and feeling unwell; This is a spontaneous report from a contactable consumer.  A 85-years-old female patient received BNT162B2 (BNT162B2, Formulation: solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration, administered in left arm on 29Jan2021 as single dose for prophylaxis, COVID-19 immunization. the patient does not received other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history was not reported but other relevant medical history including but not limited to these conditions: Diagnosed allergies, compromised immune status, Respiratory illness, Genetic Chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity from unknown. The concomitant medications were not reported. On 04Feb2021 08:00 patient experienced (at the age 0f 86-years-old time of onset reaction or event occurred) very tired (fatigue), nauseous (nausea), slight cramp in left thigh or leg (muscle spams) and tiredness and feeling unwell (malaise). Received call from consumer regarding the Pfizer COVID vaccine.  She was called on behalf of someone else. They received their first vaccination on 29Jan2021, and on page 3, she was reading the side effects.  Patient reports being very tired today.  She also felt nauseous and had a cramp in her leg that disappeared almost as quick as it came. The outcome of the events was recovering.  Information on the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: got sleepy; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received single dose of BNT162B2 on an unknown date for Covid-19 immunization (Lot number: Unknown).On an unknown date the patient stated she got sleepy. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling in my left arm, hand, and foot after vaccine/Tingling in left arm has continued and now I have tingling randomly in other parts of my body. i.e. right hand, cheek; This is a spontaneous report from a contactable consumer (patient). An adult patient of an unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EM9810), via an unspecified route of administration in left arm on 04Feb2021 at 18:30 at a single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication included one a day Women's Vitamin. Other vaccine in four weeks was reported as no. The patient was not diagnosed with COVID-19 prior to vaccination. It was reported that tingling in my left arm, hand, and foot after vaccine on 04Feb2020 at 19:00 and tingling in left arm has continued and now I have tingling randomly in other parts of my body. i.e. right hand, cheek. The patient did not receive any treatment for the event. The outcome of the event was not recovered. It was also reported that post vaccination, the patient had not been tested for COVID-19.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash, Swelling of eyelid
Clinical narrative: her legs were red, the back of neck, stomach and arms; a little swelling under eyes and middle of back; rash all over the body; This is a spontaneous report from a contactable consumer.A 96-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot number: EL9264), via an unspecified route of administration on 02Feb2021, 6PM as single dose at left arm for covid-19 immunisation. The patient medical history included scoliosis, skin problems off and on prior to the vaccine and have dermatitis and other skin issues which had been diagnosed for years. the patient concomitant medication was not reported. on her legs were red, the back of neck, stomach and arms and a little swelling under eyes and middle of back and chest had some rash, states it is a dry rash. States that on Monday prior to the vaccine, one of her cheeks was red, that by yesterday she had a rash all over. the patient was is shrinking from scoliosis. On 03Feb2021, the patient had a rash come over her body . the outcome of event rash was not recovered. outcome of events her legs were red, the back of neck, stomach and arms and a little swelling under eyes and middle of back was unknown.  No follow up attempts are possible. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Sleep disorder, Weight fluctuation
Clinical narrative: nauseous/ queasy/ Terribly nauseous; tired/ fatigue; slept right through the night; This is a spontaneous report from a contactable consumer or other non hcp. A 82-year-old female patient received bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on 31Jan2021 as SINGLE DOSE for covid-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing Verbatim: Diabetic, thyroid disorder from an unknown date and unknown if ongoing Thyroid medication. Concomitant medication included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported; losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported; simvastatin (SIMVASTATIN) taken for an unspecified indication, start and stop date were not reported; (OCUVITE) taken for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient experienced nauseous/ queasy/ terribly nauseous, tired/ fatigue, slept right through the night. The patient underwent lab tests and procedures which included weight fluctuation: 112, 110, 111 on It's about 112 pounds, once day it's 110, 111 it depends on (incomprehensible word). The action taken in response to the event for bnt162b2 was not applicable. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Headache, Vision blurred
Clinical narrative: Headache; vision was unclear; blood pressure was 190/104; This is a spontaneous report from a contactable nurse (patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 04Feb2021 at single dose for covid-19 immunisation. Medical history included History of High blood pressure. The patient's concomitant medications were not reported. The patient reported that she had the vaccine last Thursday, and Friday she woke up with a horrendous headache she also reported that her vision was unclear when she was trying to read. She said that she has a history of high blood pressure, it was well controlled and has been fine and said that her headache lasted all day and she took Motrin and nothing touched it. She took her blood pressure at 15:00 and it was 190/104, which is really high for her. It scared her. Being a cardiac nurse, she knew to take her blood pressure medication early, and she took additional amounts that she knew was safe. She said that within 1.5 hours her headache was gone. That night her blood pressure was back down. She is really concerned about getting the second vaccine. She said that her blood pressure is fine and has been fine since. The seriousness was reported as non-serious. The outcome of the events was resolved.  Information on the lot/batch number has been requested.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Fatigue, Headache, Somnolence
Clinical narrative: severe fatigue; severe sleepiness and sleeping like 20 hours a day; Cough; headache; lack of appetite; This is a spontaneous report from a contactable consumer reported for a male patient (Reporter's husband). A 76-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA) vaccine (Solution for injection, lot number: EN5318, Expiration date; unknown), intramuscular injection in right upper arm on 28Jan2021 05:00, at single dose for COVID-19 immunization. The patient's last weight was 242lbs, but on 07Jan2021 he weighed 257lbs. Reporter said that was considerable weight loss. The patient medical history included ongoing Diabetes, high blood pressure, High cholesterol, Sleep apnea, unspecified Small B Cell Marginal Zone Lymphoma. Concomitant medication included monthly B12 shots ongoing, unspecified route of Administration for underlying conditions such as lymphoma type cancer (Small b cell marginal zone Lymphoma). Patient taken medication for diabetes, high blood pressure, and high cholesterol no further details provided. On 28Jan2021, the patient experienced severe sleepiness, sleeping like 20 hours a day, Cough, Headache, lack of appetite and severe fatigue. The patient was taking treatment Nyquil taken for cough. The outcome of events were not recovered.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising
Clinical narrative: Next morning, bruising (1.5 inches long) on one side of injection site; This is a spontaneous report from a contactable consumer. A 71-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 06Feb2021 16:00 as single dose for covid-19 immunisation. Medical history included none. Concomitant medication included atorvastatin (LIPITOR [ATORVASTATIN]), vitamin d nos (VITAMIN D NOS), ascorbic acid (VIT C) from unspecified date to unspecified date for unknown indication. On 07Feb2021 08:00, The patient experienced next morning, bruising (1.5 inches long) on one side of injection site. The action taken in response to the event for BNT162B2 was not applicable. The outcome of event was recovering.   Information on the Lot/Batch Number has been requested.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Feeling abnormal, Headache
Clinical narrative: I am in bad shape here, I have had everything it's a bad situation; I have been in bed for two days; Swelling; Chills; Headache; Muscle pain; Joint pain; Slight fever; This is a spontaneous report from a contactable consumer (patient reported himself). A 79-year-old male patient received BNT162B2 (Formulation: Solution for injection, NDC number/UPC number: Unknown (there was nothing over here, there was nothing on the card), Expiry Date: Unknown (it was not there)) via an unspecified route of administration on an unspecified date at single dose to his right arm for Covid-19 immunization. The patient's medical history included ongoing blood pressure. Concomitant medication included hydrochlorothiazide (HCT) from an unspecified date and ongoing at 50 mg once a day for blood pressure. Consumer stated, "it was a pill" (not clarified further). It was reported that, about two days ago on 10Feb2021, he was in bad shape here, he have had everything it was a bad situation. He had been in bed for two days. On 10Feb2021, the patient experienced swelling, chills, headache, muscle pain, joint pain and slight fever. Consumer stated "It looked like lot number L8982 and then the next one was, it was two lot number on here, the second dose is 813248." Consumer stated "he just reported all the symptoms that, he took vaccine and he was in bad shape here, he had been in bed for two days. He got swelling, chills, had everything, it was a bad situation, got headaches, muscle pain, joint pain slight fever, right he got all." Consumer confirmed it was Pfizer vaccine, however name was not clarified. When probed for age, consumer stated, "he started feeling the symptoms about two days ago. He did not understand." Consumer stated, "about two days ago 10Feb2021." (not clarified further). When probed for the name of the Centre where patient was administered the vaccine, consumer stated, "The VA, that's the service, he was in the service the (state name) VA." Regarding lot number, consumer stated, "It looked like lot number L8982 and then the next one was, it was two lot number on here, the second dose is 813248." (Not clarified further). Consumer stated, "he did not see dose." When probed if still experiencing the problems (event not specified), consumer stated, "yeah, it was been improving a little bit, not much". (not clarified further). The patient received paracetamol (TYLENOL) as a treatment for the events. Regarding the treatment, consumer stated, "he did not know, he took it over the counter that's all he knew." Outcome of the events was unknown.  Information of lot/batch number has been requested.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Myalgia, Pyrexia, Swelling
Clinical narrative: I am in bad shape here, I have had everything it's a bad situation; I have been in bed for two days; Swelling; Chills; Headache; Muscle pain; Joint pain; Slight fever; This is a spontaneous report from a contactable consumer (patient reported himself). A 79-year-old male patient received BNT162B2 (Formulation: Solution for injection, NDC number/UPC number: Unknown (there was nothing over here, there was nothing on the card), Expiry Date: Unknown (it was not there)) via an unspecified route of administration on an unspecified date at single dose to his right arm for Covid-19 immunization. The patient's medical history included ongoing blood pressure. Concomitant medication included hydrochlorothiazide (HCT) from an unspecified date and ongoing at 50 mg once a day for blood pressure. Consumer stated, "it was a pill" (not clarified further). It was reported that, about two days ago on 10Feb2021, he was in bad shape here, he have had everything it was a bad situation. He had been in bed for two days. On 10Feb2021, the patient experienced swelling, chills, headache, muscle pain, joint pain and slight fever. Consumer stated "It looked like lot number L8982 and then the next one was, it was two lot number on here, the second dose is 813248." Consumer stated "he just reported all the symptoms that, he took vaccine and he was in bad shape here, he had been in bed for two days. He got swelling, chills, had everything, it was a bad situation, got headaches, muscle pain, joint pain slight fever, right he got all." Consumer confirmed it was Pfizer vaccine, however name was not clarified. When probed for age, consumer stated, "he started feeling the symptoms about two days ago. He did not understand." Consumer stated, "about two days ago 10Feb2021." (not clarified further). When probed for the name of the Centre where patient was administered the vaccine, consumer stated, "The VA, that's the service, he was in the service the (state name) VA." Regarding lot number, consumer stated, "It looked like lot number L8982 and then the next one was, it was two lot number on here, the second dose is 813248." (Not clarified further). Consumer stated, "he did not see dose." When probed if still experiencing the problems (event not specified), consumer stated, "yeah, it was been improving a little bit, not much". (not clarified further). The patient received paracetamol (TYLENOL) as a treatment for the events. Regarding the treatment, consumer stated, "he did not know, he took it over the counter that's all he knew." Outcome of the events was unknown.  Information of lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema
Clinical narrative: sore arm; red itchy circle; This is a spontaneous report from a contactable Consumer (self-report). This 71-year-old female consumer patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown, Expiry date: Unknown) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. She received her first dose of the Pfizer covid vaccine 1 1/2 weeks ago (will be 2 weeks on 15Feb2021). She developed a sore arm for a day and a half after the injection but developed a round red itchy circle under the arm on the arm where she didnt receive the injection at all. States it has become smaller in size. She has a doctors appoiment this coming Monday. She found an image on a website of a local reaction to the vaccine that was identical to what she has (doesnt remember the website). Adds that her daughters husbands friend also developed a little lump after receiving the Pfizer covid vaccine. asking for information on this side effect of the vaccine.  Information on the lot/ batch number has been requested.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Blood test, Computerised tomogram, Fall
Clinical narrative: Thigh pain; Hip pain; Vomiting; Shaky/Real shaky; she collapsed because of weakness in her legs/Legs collapsed on her; pain in her legs/Leg pain; weakness/Real weak; fatigue; severe headache; This is a spontaneous report from a contactable consumer received via Medical Information Team. An 87-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 05Feb2021 at 10:00 (Batch/Lot number was not reported) (at the age of 86-year-old) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 for COVID-19 immunisation and experienced urinary tract infection; the patient previously took clindamycin hydrochloride (DYNACIN) and experienced allergy, gabapentin and experienced allergy, doxycycline which made her pass out and lose complete control of muscles and everything and put her in the hospital for 3 days.  The patient experienced severe headache on 14Feb2021; the patient collapsed because of weakness in her legs/ legs collapsed on her and experienced pain in her legs/leg pain, weakness/real weak and fatigue, all on 22Feb2021; shaky/real shaky on 24Feb2021, vomiting on 26Feb2021, thigh pain and hip pain on 27Feb2021. Clinical course: on 22Feb2021 she saw her primary care physician for leg pain, weakness, fatigue and the same severe headache that she was seen for on 14Feb2021. On 22Feb2021 she was prescribed cyclobenzaprine and tramadol as pain medication. Before she took any of the cyclobenzaprine or tramadol on the night of 22Feb2021 her legs collapsed on her. On 24Feb2021 they called the doctor and told them that she had collapsed again, and he said to stop the cyclobenzaprine and changed tramadol dose to half strength. She started being shaky. On 26Feb2021 they called the doctor back because she had the same symptoms with the addition of vomiting. They said to stop the tramadol and start taking TYLENOL. On 27Feb2021 they went back to the urgent care for the same symptoms as well as leg pain, thigh pain, hip pain, being really shaky and real weak.  The patient underwent lab tests and procedures which included blood test: everything was ok (her bloodwork is fine) on an unspecified date, computerized tomogram (CAT scan): everything checked out just fine on 14Feb2021, Urine test: urinary tract infection on 04Feb2021  and worsened urinary tract infection on 16Feb2021.   Therapeutic measures were taken as a result of the events and included treatment with cyclobenzaprine (strength: 5mg) as a muscle relaxer and tramadol (strength: 50 mg) as pain medication both from 22Feb2021, tramadol was stopped on 26Feb2021 and TYLENOL (every 8 hrs. strength: 650 mg, Lot Number: SBA002, Expiry date: Dec2022) was started on the same date. The patient outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Investigation, Nervousness, Pain in extremity
Clinical narrative: Thigh pain; Hip pain; Vomiting; Shaky/Real shaky; she collapsed because of weakness in her legs/Legs collapsed on her; pain in her legs/Leg pain; weakness/Real weak; fatigue; severe headache; This is a spontaneous report from a contactable consumer received via Medical Information Team. An 87-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 05Feb2021 at 10:00 (Batch/Lot number was not reported) (at the age of 86-year-old) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 for COVID-19 immunisation and experienced urinary tract infection; the patient previously took clindamycin hydrochloride (DYNACIN) and experienced allergy, gabapentin and experienced allergy, doxycycline which made her pass out and lose complete control of muscles and everything and put her in the hospital for 3 days.  The patient experienced severe headache on 14Feb2021; the patient collapsed because of weakness in her legs/ legs collapsed on her and experienced pain in her legs/leg pain, weakness/real weak and fatigue, all on 22Feb2021; shaky/real shaky on 24Feb2021, vomiting on 26Feb2021, thigh pain and hip pain on 27Feb2021. Clinical course: on 22Feb2021 she saw her primary care physician for leg pain, weakness, fatigue and the same severe headache that she was seen for on 14Feb2021. On 22Feb2021 she was prescribed cyclobenzaprine and tramadol as pain medication. Before she took any of the cyclobenzaprine or tramadol on the night of 22Feb2021 her legs collapsed on her. On 24Feb2021 they called the doctor and told them that she had collapsed again, and he said to stop the cyclobenzaprine and changed tramadol dose to half strength. She started being shaky. On 26Feb2021 they called the doctor back because she had the same symptoms with the addition of vomiting. They said to stop the tramadol and start taking TYLENOL. On 27Feb2021 they went back to the urgent care for the same symptoms as well as leg pain, thigh pain, hip pain, being really shaky and real weak.  The patient underwent lab tests and procedures which included blood test: everything was ok (her bloodwork is fine) on an unspecified date, computerized tomogram (CAT scan): everything checked out just fine on 14Feb2021, Urine test: urinary tract infection on 04Feb2021  and worsened urinary tract infection on 16Feb2021.   Therapeutic measures were taken as a result of the events and included treatment with cyclobenzaprine (strength: 5mg) as a muscle relaxer and tramadol (strength: 50 mg) as pain medication both from 22Feb2021, tramadol was stopped on 26Feb2021 and TYLENOL (every 8 hrs. strength: 650 mg, Lot Number: SBA002, Expiry date: Dec2022) was started on the same date. The patient outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Thigh pain; Hip pain; Vomiting; Shaky/Real shaky; she collapsed because of weakness in her legs/Legs collapsed on her; pain in her legs/Leg pain; weakness/Real weak; fatigue; severe headache; This is a spontaneous report from a contactable consumer received via Medical Information Team. An 87-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 05Feb2021 at 10:00 (Batch/Lot number was not reported) (at the age of 86-year-old) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 for COVID-19 immunisation and experienced urinary tract infection; the patient previously took clindamycin hydrochloride (DYNACIN) and experienced allergy, gabapentin and experienced allergy, doxycycline which made her pass out and lose complete control of muscles and everything and put her in the hospital for 3 days.  The patient experienced severe headache on 14Feb2021; the patient collapsed because of weakness in her legs/ legs collapsed on her and experienced pain in her legs/leg pain, weakness/real weak and fatigue, all on 22Feb2021; shaky/real shaky on 24Feb2021, vomiting on 26Feb2021, thigh pain and hip pain on 27Feb2021. Clinical course: on 22Feb2021 she saw her primary care physician for leg pain, weakness, fatigue and the same severe headache that she was seen for on 14Feb2021. On 22Feb2021 she was prescribed cyclobenzaprine and tramadol as pain medication. Before she took any of the cyclobenzaprine or tramadol on the night of 22Feb2021 her legs collapsed on her. On 24Feb2021 they called the doctor and told them that she had collapsed again, and he said to stop the cyclobenzaprine and changed tramadol dose to half strength. She started being shaky. On 26Feb2021 they called the doctor back because she had the same symptoms with the addition of vomiting. They said to stop the tramadol and start taking TYLENOL. On 27Feb2021 they went back to the urgent care for the same symptoms as well as leg pain, thigh pain, hip pain, being really shaky and real weak.  The patient underwent lab tests and procedures which included blood test: everything was ok (her bloodwork is fine) on an unspecified date, computerized tomogram (CAT scan): everything checked out just fine on 14Feb2021, Urine test: urinary tract infection on 04Feb2021  and worsened urinary tract infection on 16Feb2021.   Therapeutic measures were taken as a result of the events and included treatment with cyclobenzaprine (strength: 5mg) as a muscle relaxer and tramadol (strength: 50 mg) as pain medication both from 22Feb2021, tramadol was stopped on 26Feb2021 and TYLENOL (every 8 hrs. strength: 650 mg, Lot Number: SBA002, Expiry date: Dec2022) was started on the same date. The patient outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Blood test, Computerised tomogram, Fatigue
Clinical narrative: Thigh pain; Hip pain; Vomiting; Shaky/Real shaky; she collapsed because of weakness in her legs/Legs collapsed on her; pain in her legs/Leg pain; weakness/Real weak; fatigue; severe headache; This is a spontaneous report from a contactable consumer received via Medical Information Team. An 87-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 05Feb2021 at 10:00 (Batch/Lot number was not reported) (at the age of 86-year-old) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 for COVID-19 immunisation and experienced urinary tract infection; the patient previously took clindamycin hydrochloride (DYNACIN) and experienced allergy, gabapentin and experienced allergy, doxycycline which made her pass out and lose complete control of muscles and everything and put her in the hospital for 3 days.  The patient experienced severe headache on 14Feb2021; the patient collapsed because of weakness in her legs/ legs collapsed on her and experienced pain in her legs/leg pain, weakness/real weak and fatigue, all on 22Feb2021; shaky/real shaky on 24Feb2021, vomiting on 26Feb2021, thigh pain and hip pain on 27Feb2021. Clinical course: on 22Feb2021 she saw her primary care physician for leg pain, weakness, fatigue and the same severe headache that she was seen for on 14Feb2021. On 22Feb2021 she was prescribed cyclobenzaprine and tramadol as pain medication. Before she took any of the cyclobenzaprine or tramadol on the night of 22Feb2021 her legs collapsed on her. On 24Feb2021 they called the doctor and told them that she had collapsed again, and he said to stop the cyclobenzaprine and changed tramadol dose to half strength. She started being shaky. On 26Feb2021 they called the doctor back because she had the same symptoms with the addition of vomiting. They said to stop the tramadol and start taking TYLENOL. On 27Feb2021 they went back to the urgent care for the same symptoms as well as leg pain, thigh pain, hip pain, being really shaky and real weak.  The patient underwent lab tests and procedures which included blood test: everything was ok (her bloodwork is fine) on an unspecified date, computerized tomogram (CAT scan): everything checked out just fine on 14Feb2021, Urine test: urinary tract infection on 04Feb2021  and worsened urinary tract infection on 16Feb2021.   Therapeutic measures were taken as a result of the events and included treatment with cyclobenzaprine (strength: 5mg) as a muscle relaxer and tramadol (strength: 50 mg) as pain medication both from 22Feb2021, tramadol was stopped on 26Feb2021 and TYLENOL (every 8 hrs. strength: 650 mg, Lot Number: SBA002, Expiry date: Dec2022) was started on the same date. The patient outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Muscular weakness, Pain in extremity, Tremor, Urinary tract infection
Clinical narrative: Thigh pain; Hip pain; Vomiting; Shaky/Real shaky; she collapsed because of weakness in her legs/Legs collapsed on her; pain in her legs/Leg pain; weakness/Real weak; fatigue; severe headache; This is a spontaneous report from a contactable consumer received via Medical Information Team. An 87-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 05Feb2021 at 10:00 (Batch/Lot number was not reported) (at the age of 86-year-old) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 for COVID-19 immunisation and experienced urinary tract infection; the patient previously took clindamycin hydrochloride (DYNACIN) and experienced allergy, gabapentin and experienced allergy, doxycycline which made her pass out and lose complete control of muscles and everything and put her in the hospital for 3 days.  The patient experienced severe headache on 14Feb2021; the patient collapsed because of weakness in her legs/ legs collapsed on her and experienced pain in her legs/leg pain, weakness/real weak and fatigue, all on 22Feb2021; shaky/real shaky on 24Feb2021, vomiting on 26Feb2021, thigh pain and hip pain on 27Feb2021. Clinical course: on 22Feb2021 she saw her primary care physician for leg pain, weakness, fatigue and the same severe headache that she was seen for on 14Feb2021. On 22Feb2021 she was prescribed cyclobenzaprine and tramadol as pain medication. Before she took any of the cyclobenzaprine or tramadol on the night of 22Feb2021 her legs collapsed on her. On 24Feb2021 they called the doctor and told them that she had collapsed again, and he said to stop the cyclobenzaprine and changed tramadol dose to half strength. She started being shaky. On 26Feb2021 they called the doctor back because she had the same symptoms with the addition of vomiting. They said to stop the tramadol and start taking TYLENOL. On 27Feb2021 they went back to the urgent care for the same symptoms as well as leg pain, thigh pain, hip pain, being really shaky and real weak.  The patient underwent lab tests and procedures which included blood test: everything was ok (her bloodwork is fine) on an unspecified date, computerized tomogram (CAT scan): everything checked out just fine on 14Feb2021, Urine test: urinary tract infection on 04Feb2021  and worsened urinary tract infection on 16Feb2021.   Therapeutic measures were taken as a result of the events and included treatment with cyclobenzaprine (strength: 5mg) as a muscle relaxer and tramadol (strength: 50 mg) as pain medication both from 22Feb2021, tramadol was stopped on 26Feb2021 and TYLENOL (every 8 hrs. strength: 650 mg, Lot Number: SBA002, Expiry date: Dec2022) was started on the same date. The patient outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urine analysis, Vomiting
Clinical narrative: Thigh pain; Hip pain; Vomiting; Shaky/Real shaky; she collapsed because of weakness in her legs/Legs collapsed on her; pain in her legs/Leg pain; weakness/Real weak; fatigue; severe headache; This is a spontaneous report from a contactable consumer received via Medical Information Team. An 87-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 05Feb2021 at 10:00 (Batch/Lot number was not reported) (at the age of 86-year-old) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 for COVID-19 immunisation and experienced urinary tract infection; the patient previously took clindamycin hydrochloride (DYNACIN) and experienced allergy, gabapentin and experienced allergy, doxycycline which made her pass out and lose complete control of muscles and everything and put her in the hospital for 3 days.  The patient experienced severe headache on 14Feb2021; the patient collapsed because of weakness in her legs/ legs collapsed on her and experienced pain in her legs/leg pain, weakness/real weak and fatigue, all on 22Feb2021; shaky/real shaky on 24Feb2021, vomiting on 26Feb2021, thigh pain and hip pain on 27Feb2021. Clinical course: on 22Feb2021 she saw her primary care physician for leg pain, weakness, fatigue and the same severe headache that she was seen for on 14Feb2021. On 22Feb2021 she was prescribed cyclobenzaprine and tramadol as pain medication. Before she took any of the cyclobenzaprine or tramadol on the night of 22Feb2021 her legs collapsed on her. On 24Feb2021 they called the doctor and told them that she had collapsed again, and he said to stop the cyclobenzaprine and changed tramadol dose to half strength. She started being shaky. On 26Feb2021 they called the doctor back because she had the same symptoms with the addition of vomiting. They said to stop the tramadol and start taking TYLENOL. On 27Feb2021 they went back to the urgent care for the same symptoms as well as leg pain, thigh pain, hip pain, being really shaky and real weak.  The patient underwent lab tests and procedures which included blood test: everything was ok (her bloodwork is fine) on an unspecified date, computerized tomogram (CAT scan): everything checked out just fine on 14Feb2021, Urine test: urinary tract infection on 04Feb2021  and worsened urinary tract infection on 16Feb2021.   Therapeutic measures were taken as a result of the events and included treatment with cyclobenzaprine (strength: 5mg) as a muscle relaxer and tramadol (strength: 50 mg) as pain medication both from 22Feb2021, tramadol was stopped on 26Feb2021 and TYLENOL (every 8 hrs. strength: 650 mg, Lot Number: SBA002, Expiry date: Dec2022) was started on the same date. The patient outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19 on 11Feb2021; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection) via an unspecified route of administration on 08Feb2021 as a single dose for COVID-19 immunization. Medical history included lymphedema and cellulitis, both from an unspecified date and unspecified if ongoing. Concomitant medications were not reported. The patient tested positive for COVID-19 on 11Feb2021. The patient stated that this "was a unique situation as she was experiencing a bout of cellulitis because of her lymphedema and she experienced this almost annually." During her COVID-19 diagnosis she was treated with bamlanivimab. The patient was scheduled to receive her second dose of the Pfizer COVID-19 vaccine today and she wanted to know if she was okay to proceed with receiving the second dose considering her recent COVID-19 diagnosis. The patient wanted to know if the bamlanivimab that she received would cause the second dose of the Pfizer COVID-19 vaccine to be less effective. The caller stated that she spoke with the manufacturer of this drug, and they let the caller know that bamlanivimab could potentially decrease the potential for creating antibodies after receiving a COVID-19 vaccine. She also wanted to know if it was possible that the vaccine caused a false positive test result. The clinical outcome of the event tested positive for COVID-19 on 11Feb2021 was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, SARS-CoV-2 antibody test
Clinical narrative: tiredness; This is a spontaneous report from a contactable consumer, the patient, via the sponsored program. A 78-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 immunization. Medical history included multiple myeloma for which the patient had taken a few unspecified immunosuppressant therapies. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date for COVID-19 immunization. On an unspecified date, the patient experienced a little tiredness. The patient underwent laboratory tests on an unspecified date (3 weeks after the second vaccine) which included an antibody test with the following result: no antibodies, thus, the patient stated the vaccine did not work for him. The clinical outcome of tiredness was unknown.  Information about lot/batch has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Insomnia, Pruritus, Rash pruritic, Skin swelling
Clinical narrative: last night she couldn't sleep; Itchy Hives/Welts/welts are annoying; on her inner thighs, groin, waist and arms pits; developed welts and itching; Rash, Hives and welts, and states they are itchy; start with a small regular size and get bigger and elevated on the skin; start with a small regular size and get bigger and elevated on the skin; This is a spontaneous report from a contactable Nurse (patient).  A 69-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration as single dose 1st dose in left arm on 22Jan2021 (Lot # EL9741), 2nd dose in right arm on 12Feb2021 (Lot # EM9809) for COVID-19 immunisation.  Medical history was none. There were no concomitant medications.  On 06Feb2021, 2 weeks after receiving her first dose, the patient experienced itchy hives, welts/welts are annoying; on her inner thighs, groin, waist and arms pits, developed welts and itching, rash, hives and welts, and states they are itchy. Patient also reported she received her 1st Covid dose on 22Jan2021 which is clarified that this is when the hives and welts started (under clarification). On unspecified date the patient experienced start with a small regular size and get bigger and elevated on the skin. On 03Mar2021 she couldn't sleep. The event itchy hives was considered medically significant by reporter.  Course of events: Two weeks after receiving her first dose she developed welts and itching that has persisted through today. She has not changed medicines, foods, soaps or detergents. She has been taking Benadryl for about a month now for the itching. She reported rash, hives and welts, and stated they are itchy.  They started with a small regular size and get bigger and elevated on the skin. The welts are annoying; on her inner thighs, groin, waist and arms pits. She ruled out foods or any products she had, and she wasn't taking anything new. She was using Benadryl Extra Strength Cream on her hives and after a few minutes it resolved, but last night (03Mar23021) she couldn't sleep, it usually resolved after a few minutes, but this time it lasted over an hour, states she had to just keep slathering it on because it wasn't helping.  The outcome of itchy hives, welts/welts are annoying; on her inner thighs, groin, waist and arms pits, welts and itching, rash, hives and welts, and states they are itchy was not recovered, of start with a small regular size and get bigger and elevated on the skin, last night she couldn't sleep was unknown. A Product Complaint was filed. The reporter assessed the events hives and welts as related to the vaccine.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: last night she couldn't sleep; Itchy Hives/Welts/welts are annoying; on her inner thighs, groin, waist and arms pits; developed welts and itching; Rash, Hives and welts, and states they are itchy; start with a small regular size and get bigger and elevated on the skin; start with a small regular size and get bigger and elevated on the skin; This is a spontaneous report from a contactable Nurse (patient).  A 69-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration as single dose 1st dose in left arm on 22Jan2021 (Lot # EL9741), 2nd dose in right arm on 12Feb2021 (Lot # EM9809) for COVID-19 immunisation.  Medical history was none. There were no concomitant medications.  On 06Feb2021, 2 weeks after receiving her first dose, the patient experienced itchy hives, welts/welts are annoying; on her inner thighs, groin, waist and arms pits, developed welts and itching, rash, hives and welts, and states they are itchy. Patient also reported she received her 1st Covid dose on 22Jan2021 which is clarified that this is when the hives and welts started (under clarification). On unspecified date the patient experienced start with a small regular size and get bigger and elevated on the skin. On 03Mar2021 she couldn't sleep. The event itchy hives was considered medically significant by reporter.  Course of events: Two weeks after receiving her first dose she developed welts and itching that has persisted through today. She has not changed medicines, foods, soaps or detergents. She has been taking Benadryl for about a month now for the itching. She reported rash, hives and welts, and stated they are itchy.  They started with a small regular size and get bigger and elevated on the skin. The welts are annoying; on her inner thighs, groin, waist and arms pits. She ruled out foods or any products she had, and she wasn't taking anything new. She was using Benadryl Extra Strength Cream on her hives and after a few minutes it resolved, but last night (03Mar23021) she couldn't sleep, it usually resolved after a few minutes, but this time it lasted over an hour, states she had to just keep slathering it on because it wasn't helping.  The outcome of itchy hives, welts/welts are annoying; on her inner thighs, groin, waist and arms pits, welts and itching, rash, hives and welts, and states they are itchy was not recovered, of start with a small regular size and get bigger and elevated on the skin, last night she couldn't sleep was unknown. A Product Complaint was filed. The reporter assessed the events hives and welts as related to the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test with no symptoms; positive COVID-19 test with no symptoms; This is a spontaneous report from a contactable consumer (reporting for a friend). A female patient (Age: 85, Units: unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration on 11Feb2021 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the Pfizer COVID-19 shot on 11Feb2021. Two weeks later, she got COVID (unspecified date). The test said she was positive (unspecified date). She had no symptoms. She was in contact with a person who had it. Now (hospital name) said the patient can't get the second dose for three months. Every doctor the reporter had talked to said that wasn't true. The reporter asked what was the timing of the second dose, and wouldn't the first one run out? Will she have to get them both if it runs out? The reporter thought that there may have been a misunderstanding, and maybe the person didn't realize the patient had already had the first dose. The patient has been in isolation and her last day of isolation will be tomorrow. The clinical outcome of positive COVID-19 test with no symptoms was unknown.  Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Nasal congestion, Pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: she tested positive for covid; fever/a low grade fever; had congestion; achiness; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age (reported as 42, unit unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 27Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer covid-19 vaccine on Saturday 27Feb2021. She began showing the regular side effects and had congestion, fever and achiness and a low grade fever in 2021. She stated that the fever increased and she tested positive for covid on Tuesday 02Mar2021. She had antigen therapy and wanted to know if it was appropriate for her to get the second dose and what was the timeline. Therapeutic measures were taken as a result of she tested positive for covid. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Pain in extremity, SARS-CoV-2 test
Clinical narrative: I came up positive to Covid-19; positive COVID-19 test with symptoms; arm sore; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer reported for herself.  A female patient of unspecified age received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), at single dose on 23Feb2021 for COVID-19 immunization from lot EN6203, the patient was not sure if it is G or 6. Relevant medical history and concomitant medications were not reported. After the vaccination the patient experienced arm sore only. On 28Feb2021 she was with her girlfriend and had dinner together, were social distancing but no masks and her girlfriend on 04Mar2021 was tested positive for the virus. The patient had runny nose, fever, nasal congestion and coughing. She was scheduled to get her second dose on 16Mar2021 but she tested positive on 11Mar2021, with a rapid COVID-19 antigen test.  She was advised that she can't get the 2nd dose until after 20Mar2021. The outcome of the events was unknown.