chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Head discomfort, Headache, Hypoaesthesia, Limb discomfort
Clinical narrative: painful, jolts through head on left side, behind eye, temples, lots of pressure; throat swelling; Lots of pressure behind ears; headache; flushing of cheeks, chin, forehead; heavy / sinking feeling; heavy / sinking feeling; difficult to swallow; tight sensation in throat; throat hurts; allergic reaction to vaccine; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot/Batch number: not reported, expiry date: not reported) via an unspecified route of administration on 14Apr2021 13:00 (at age of 37-years-old) as dose 1, single for covid-19 immunisation. The medical history included PCOS and there was no known allergies (allergies to medications, food, or other products: no). The patient concomitant medication was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Patient did not receive any other medication within 2 weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19.On 14Apr2021 13:05, 5 minutes after vaccine, patient experienced flushing of cheeks, chin, forehead and heavy / sinking feeling. Therapeutic measures were taken as a result of the events which included treatment with Zyrtec provided by nurse and seemed to have resolved. On 16Apr2021, 28 hours post vaccine patient has experienced throat swelling developed tight sensation in throat, felt like throat was swelling. took Zyrtec which helps stop it from getting worse, but it remained difficult to swallow. The next day patient went to doctor and has been advised to take Zyrtec twice a day as he had allergic reaction to vaccine Apr2021. In Apr 2021,55 hours after vaccine the throat still hurts and was hard to swallow. The patient was hoping this will go away soon and not get worse. On 14Apr2021, headache began a few hours after vaccine. Continued for days and then on 24Apr2021, 9 day after vaccine became very painful, jolts through head on left side, behind eye, temples, lots of pressure. Now 14 days out from vaccine and still have headache. Lots of pressure behind ears. The patient was very scared and inquired would this go a way soon. The patient never had headaches before The adverse event resulted in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The reporter assessed case as non serious. The patient received treatment for the events. The outcome of events was not recovered. Outcome of allergic to vaccine is unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Muscle spasms, Ocular discomfort, Pain, Pharyngeal swelling
Clinical narrative: painful, jolts through head on left side, behind eye, temples, lots of pressure; throat swelling; Lots of pressure behind ears; headache; flushing of cheeks, chin, forehead; heavy / sinking feeling; heavy / sinking feeling; difficult to swallow; tight sensation in throat; throat hurts; allergic reaction to vaccine; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot/Batch number: not reported, expiry date: not reported) via an unspecified route of administration on 14Apr2021 13:00 (at age of 37-years-old) as dose 1, single for covid-19 immunisation. The medical history included PCOS and there was no known allergies (allergies to medications, food, or other products: no). The patient concomitant medication was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Patient did not receive any other medication within 2 weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19.On 14Apr2021 13:05, 5 minutes after vaccine, patient experienced flushing of cheeks, chin, forehead and heavy / sinking feeling. Therapeutic measures were taken as a result of the events which included treatment with Zyrtec provided by nurse and seemed to have resolved. On 16Apr2021, 28 hours post vaccine patient has experienced throat swelling developed tight sensation in throat, felt like throat was swelling. took Zyrtec which helps stop it from getting worse, but it remained difficult to swallow. The next day patient went to doctor and has been advised to take Zyrtec twice a day as he had allergic reaction to vaccine Apr2021. In Apr 2021,55 hours after vaccine the throat still hurts and was hard to swallow. The patient was hoping this will go away soon and not get worse. On 14Apr2021, headache began a few hours after vaccine. Continued for days and then on 24Apr2021, 9 day after vaccine became very painful, jolts through head on left side, behind eye, temples, lots of pressure. Now 14 days out from vaccine and still have headache. Lots of pressure behind ears. The patient was very scared and inquired would this go a way soon. The patient never had headaches before The adverse event resulted in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The reporter assessed case as non serious. The patient received treatment for the events. The outcome of events was not recovered. Outcome of allergic to vaccine is unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: painful, jolts through head on left side, behind eye, temples, lots of pressure; throat swelling; Lots of pressure behind ears; headache; flushing of cheeks, chin, forehead; heavy / sinking feeling; heavy / sinking feeling; difficult to swallow; tight sensation in throat; throat hurts; allergic reaction to vaccine; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot/Batch number: not reported, expiry date: not reported) via an unspecified route of administration on 14Apr2021 13:00 (at age of 37-years-old) as dose 1, single for covid-19 immunisation. The medical history included PCOS and there was no known allergies (allergies to medications, food, or other products: no). The patient concomitant medication was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Patient did not receive any other medication within 2 weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19.On 14Apr2021 13:05, 5 minutes after vaccine, patient experienced flushing of cheeks, chin, forehead and heavy / sinking feeling. Therapeutic measures were taken as a result of the events which included treatment with Zyrtec provided by nurse and seemed to have resolved. On 16Apr2021, 28 hours post vaccine patient has experienced throat swelling developed tight sensation in throat, felt like throat was swelling. took Zyrtec which helps stop it from getting worse, but it remained difficult to swallow. The next day patient went to doctor and has been advised to take Zyrtec twice a day as he had allergic reaction to vaccine Apr2021. In Apr 2021,55 hours after vaccine the throat still hurts and was hard to swallow. The patient was hoping this will go away soon and not get worse. On 14Apr2021, headache began a few hours after vaccine. Continued for days and then on 24Apr2021, 9 day after vaccine became very painful, jolts through head on left side, behind eye, temples, lots of pressure. Now 14 days out from vaccine and still have headache. Lots of pressure behind ears. The patient was very scared and inquired would this go a way soon. The patient never had headaches before The adverse event resulted in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The reporter assessed case as non serious. The patient received treatment for the events. The outcome of events was not recovered. Outcome of allergic to vaccine is unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy to vaccine, Depressed mood, Discomfort, Dysphagia, Ear discomfort
Clinical narrative: painful, jolts through head on left side, behind eye, temples, lots of pressure; throat swelling; Lots of pressure behind ears; headache; flushing of cheeks, chin, forehead; heavy / sinking feeling; heavy / sinking feeling; difficult to swallow; tight sensation in throat; throat hurts; allergic reaction to vaccine; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot/Batch number: not reported, expiry date: not reported) via an unspecified route of administration on 14Apr2021 13:00 (at age of 37-years-old) as dose 1, single for covid-19 immunisation. The medical history included PCOS and there was no known allergies (allergies to medications, food, or other products: no). The patient concomitant medication was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Patient did not receive any other medication within 2 weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19.On 14Apr2021 13:05, 5 minutes after vaccine, patient experienced flushing of cheeks, chin, forehead and heavy / sinking feeling. Therapeutic measures were taken as a result of the events which included treatment with Zyrtec provided by nurse and seemed to have resolved. On 16Apr2021, 28 hours post vaccine patient has experienced throat swelling developed tight sensation in throat, felt like throat was swelling. took Zyrtec which helps stop it from getting worse, but it remained difficult to swallow. The next day patient went to doctor and has been advised to take Zyrtec twice a day as he had allergic reaction to vaccine Apr2021. In Apr 2021,55 hours after vaccine the throat still hurts and was hard to swallow. The patient was hoping this will go away soon and not get worse. On 14Apr2021, headache began a few hours after vaccine. Continued for days and then on 24Apr2021, 9 day after vaccine became very painful, jolts through head on left side, behind eye, temples, lots of pressure. Now 14 days out from vaccine and still have headache. Lots of pressure behind ears. The patient was very scared and inquired would this go a way soon. The patient never had headaches before The adverse event resulted in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The reporter assessed case as non serious. The patient received treatment for the events. The outcome of events was not recovered. Outcome of allergic to vaccine is unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Head discomfort, Headache, Oropharyngeal pain, Pharyngeal swelling
Clinical narrative: painful, jolts through head on left side, behind eye, temples, lots of pressure; throat swelling; Lots of pressure behind ears; headache; flushing of cheeks, chin, forehead; heavy / sinking feeling; heavy / sinking feeling; difficult to swallow; tight sensation in throat; throat hurts; allergic reaction to vaccine; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot/Batch number: not reported, expiry date: not reported) via an unspecified route of administration on 14Apr2021 13:00 (at age of 37-years-old) as dose 1, single for covid-19 immunisation. The medical history included PCOS and there was no known allergies (allergies to medications, food, or other products: no). The patient concomitant medication was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Patient did not receive any other medication within 2 weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19.On 14Apr2021 13:05, 5 minutes after vaccine, patient experienced flushing of cheeks, chin, forehead and heavy / sinking feeling. Therapeutic measures were taken as a result of the events which included treatment with Zyrtec provided by nurse and seemed to have resolved. On 16Apr2021, 28 hours post vaccine patient has experienced throat swelling developed tight sensation in throat, felt like throat was swelling. took Zyrtec which helps stop it from getting worse, but it remained difficult to swallow. The next day patient went to doctor and has been advised to take Zyrtec twice a day as he had allergic reaction to vaccine Apr2021. In Apr 2021,55 hours after vaccine the throat still hurts and was hard to swallow. The patient was hoping this will go away soon and not get worse. On 14Apr2021, headache began a few hours after vaccine. Continued for days and then on 24Apr2021, 9 day after vaccine became very painful, jolts through head on left side, behind eye, temples, lots of pressure. Now 14 days out from vaccine and still have headache. Lots of pressure behind ears. The patient was very scared and inquired would this go a way soon. The patient never had headaches before The adverse event resulted in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The reporter assessed case as non serious. The patient received treatment for the events. The outcome of events was not recovered. Outcome of allergic to vaccine is unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness
Clinical narrative: painful, jolts through head on left side, behind eye, temples, lots of pressure; throat swelling; Lots of pressure behind ears; headache; flushing of cheeks, chin, forehead; heavy / sinking feeling; heavy / sinking feeling; difficult to swallow; tight sensation in throat; throat hurts; allergic reaction to vaccine; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot/Batch number: not reported, expiry date: not reported) via an unspecified route of administration on 14Apr2021 13:00 (at age of 37-years-old) as dose 1, single for covid-19 immunisation. The medical history included PCOS and there was no known allergies (allergies to medications, food, or other products: no). The patient concomitant medication was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Patient did not receive any other medication within 2 weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19.On 14Apr2021 13:05, 5 minutes after vaccine, patient experienced flushing of cheeks, chin, forehead and heavy / sinking feeling. Therapeutic measures were taken as a result of the events which included treatment with Zyrtec provided by nurse and seemed to have resolved. On 16Apr2021, 28 hours post vaccine patient has experienced throat swelling developed tight sensation in throat, felt like throat was swelling. took Zyrtec which helps stop it from getting worse, but it remained difficult to swallow. The next day patient went to doctor and has been advised to take Zyrtec twice a day as he had allergic reaction to vaccine Apr2021. In Apr 2021,55 hours after vaccine the throat still hurts and was hard to swallow. The patient was hoping this will go away soon and not get worse. On 14Apr2021, headache began a few hours after vaccine. Continued for days and then on 24Apr2021, 9 day after vaccine became very painful, jolts through head on left side, behind eye, temples, lots of pressure. Now 14 days out from vaccine and still have headache. Lots of pressure behind ears. The patient was very scared and inquired would this go a way soon. The patient never had headaches before The adverse event resulted in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The reporter assessed case as non serious. The patient received treatment for the events. The outcome of events was not recovered. Outcome of allergic to vaccine is unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, Insomnia, Nausea, Pyrexia, Rash
Clinical narrative: rash on her back; Fever; the rash got worse, the rash went over the caller's body and came to her neck; This is a spontaneous report received from a contactable physician from a Pfizer sponsored program. A 53-years-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8729ABG, Expiration date was not reported), via an unspecified route of administration in arm right on 16Apr2021 at 10:00 AM (at the age of 53-years-old) as a dose 2, single for COVID-19 immunization. The patient's medical history included breast cancer with radiation on an unspecified date in 2009, nuts allergy and shingles. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date in Mar2021 at 10:00 AM as a dose 1, single for COVID-19 immunization. It was reported that, the patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as no. Stated that, the caller was called about the Pfizer covid vaccine. Stated that, the caller had the second dose on 16Apr2021, on the third day, the caller started to have a rash on her back and it comes and goes, this lasted for 2 days. Stated that, then on last night on an unspecified date in 2021, the rash got worse, the rash went over the caller's body and came to her neck. Stated that, the caller started to have a fever on 19Apr2021 but didn't take any medication. Stated that, the caller was calling to see if the rash gets worse should she take Benadryl or what she should she do. Stated that, the caller had breast cancer and had radiation on an unspecified date in 2009, when she had radiation she had shingles, so this time after the second dose, the symptoms sort of reminded her, when she had shingles which was why she decided to call Pfizer. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment was not received for the events. The outcome of the events rash in her back was recovered on 21Apr2021 while for the other events was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Pyrexia, Rash
Clinical narrative: rash on her back; Fever; the rash got worse, the rash went over the caller's body and came to her neck; This is a spontaneous report received from a contactable physician from a Pfizer sponsored program. A 53-years-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8729ABG, Expiration date was not reported), via an unspecified route of administration in arm right on 16Apr2021 at 10:00 AM (at the age of 53-years-old) as a dose 2, single for COVID-19 immunization. The patient's medical history included breast cancer with radiation on an unspecified date in 2009, nuts allergy and shingles. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date in Mar2021 at 10:00 AM as a dose 1, single for COVID-19 immunization. It was reported that, the patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as no. Stated that, the caller was called about the Pfizer covid vaccine. Stated that, the caller had the second dose on 16Apr2021, on the third day, the caller started to have a rash on her back and it comes and goes, this lasted for 2 days. Stated that, then on last night on an unspecified date in 2021, the rash got worse, the rash went over the caller's body and came to her neck. Stated that, the caller started to have a fever on 19Apr2021 but didn't take any medication. Stated that, the caller was calling to see if the rash gets worse should she take Benadryl or what she should she do. Stated that, the caller had breast cancer and had radiation on an unspecified date in 2009, when she had radiation she had shingles, so this time after the second dose, the symptoms sort of reminded her, when she had shingles which was why she decided to call Pfizer. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment was not received for the events. The outcome of the events rash in her back was recovered on 21Apr2021 while for the other events was unknown.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test normal, Chest X-ray normal, Computerised tomogram neck, Computerised tomogram thorax normal, Lymphadenopathy
Clinical narrative: Swollen supraclavicular lymph node on left; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 26Feb2021 at 15:45 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any other medications within two weeks of vaccination. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 05Feb2021 at 15:45 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. On 27Feb2021 at 15:00, the patient experienced swollen supraclavicular lymph node on left. The event resulted in doctor or other healthcare professional office or clinic visit. Therapeutic measures were taken as a result of the reported event and included treatment with antibiotics. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen supraclavicular lymph node on left was recovering at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Spinal X-ray normal, Ultrasound scan normal
Clinical narrative: Swollen supraclavicular lymph node on left; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 26Feb2021 at 15:45 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any other medications within two weeks of vaccination. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 05Feb2021 at 15:45 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. On 27Feb2021 at 15:00, the patient experienced swollen supraclavicular lymph node on left. The event resulted in doctor or other healthcare professional office or clinic visit. Therapeutic measures were taken as a result of the reported event and included treatment with antibiotics. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen supraclavicular lymph node on left was recovering at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen supraclavicular lymph node on left; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 26Feb2021 at 15:45 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any other medications within two weeks of vaccination. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 05Feb2021 at 15:45 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. On 27Feb2021 at 15:00, the patient experienced swollen supraclavicular lymph node on left. The event resulted in doctor or other healthcare professional office or clinic visit. Therapeutic measures were taken as a result of the reported event and included treatment with antibiotics. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen supraclavicular lymph node on left was recovering at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Movement disorder, Neck pain
Clinical narrative: She has slight pain at the injection site.; The ER said she is having muscle spasms from the shot; much terrible pain; Shoulder pain; Neck pain; arm pain; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8736), dose 2 via an unspecified route of administration, administered in arm right on 25Apr2021 (at the age of 45-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8733), dose 1 via an unspecified route of administration, administered in arm right on 04Apr2021 as dose 1, single for COVID-19 immunization (at the age of 45-year-old). She received no other vaccines that day or 4 weeks prior. On an unspecified date, she has went to the doctor 3 times, and she went to the ER. The ER said she had muscle spasms from the shot and has slight pain at the injection site. She was in so much terrible pain. She has missed work for about 2 weeks now. She was tired of hearing this was normal. She doesn't understand what is happening to her. She had physical therapy. She doesn't have a prescribing doctor. On 27Apr2021, the patient experienced shoulder pain, neck pain and arm pain. It was hard to lift her arm. The patient was treated with Cyclobenzaprine 10 mg and Aleve as a therapeutic measure of shoulder pain, neck pain, arm pain, the ER said she is having muscle spasms from the shot and has slight pain at the injection site. The outcome of the events shoulder pain, neck pain and arm pain was not recovered and other events outcome was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Muscle spasms, Neck pain, Pain, Pain in extremity
Clinical narrative: She has slight pain at the injection site.; The ER said she is having muscle spasms from the shot; much terrible pain; Shoulder pain; Neck pain; arm pain; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8736), dose 2 via an unspecified route of administration, administered in arm right on 25Apr2021 (at the age of 45-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8733), dose 1 via an unspecified route of administration, administered in arm right on 04Apr2021 as dose 1, single for COVID-19 immunization (at the age of 45-year-old). She received no other vaccines that day or 4 weeks prior. On an unspecified date, she has went to the doctor 3 times, and she went to the ER. The ER said she had muscle spasms from the shot and has slight pain at the injection site. She was in so much terrible pain. She has missed work for about 2 weeks now. She was tired of hearing this was normal. She doesn't understand what is happening to her. She had physical therapy. She doesn't have a prescribing doctor. On 27Apr2021, the patient experienced shoulder pain, neck pain and arm pain. It was hard to lift her arm. The patient was treated with Cyclobenzaprine 10 mg and Aleve as a therapeutic measure of shoulder pain, neck pain, arm pain, the ER said she is having muscle spasms from the shot and has slight pain at the injection site. The outcome of the events shoulder pain, neck pain and arm pain was not recovered and other events outcome was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: She has slight pain at the injection site.; The ER said she is having muscle spasms from the shot; much terrible pain; Shoulder pain; Neck pain; arm pain; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8736), dose 2 via an unspecified route of administration, administered in arm right on 25Apr2021 (at the age of 45-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8733), dose 1 via an unspecified route of administration, administered in arm right on 04Apr2021 as dose 1, single for COVID-19 immunization (at the age of 45-year-old). She received no other vaccines that day or 4 weeks prior. On an unspecified date, she has went to the doctor 3 times, and she went to the ER. The ER said she had muscle spasms from the shot and has slight pain at the injection site. She was in so much terrible pain. She has missed work for about 2 weeks now. She was tired of hearing this was normal. She doesn't understand what is happening to her. She had physical therapy. She doesn't have a prescribing doctor. On 27Apr2021, the patient experienced shoulder pain, neck pain and arm pain. It was hard to lift her arm. The patient was treated with Cyclobenzaprine 10 mg and Aleve as a therapeutic measure of shoulder pain, neck pain, arm pain, the ER said she is having muscle spasms from the shot and has slight pain at the injection site. The outcome of the events shoulder pain, neck pain and arm pain was not recovered and other events outcome was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Off label use, Rash, Swelling, Weight decreased
Clinical narrative: The worst part was that my groin swelled up to about the size of a Cantaloupe. (This also happened to another vet who had his second shot around the same time as I did, within a few days); Rash on arms, hands, legs, feet, and a little bit on chest; fisrt dose on 20Jan2021/second dose on 06Feb2021; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm on 06Feb2021 15:00 (at the age of 61-year-old) (Lot Number: EL9261) as single dose for COVID-19 immunisation. Relevant medical history included diabetes, hypertension, obesity and known allergies to lithium. Concomitant medications were not reported (the patient was receiving 17 unspecified concomitant medications). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in the left arm on 20Jan2021 (at the age of 61-year-old) (Lot Number: EL3249) for COVID-19 immunisation (inappropriate schedule of vaccine administered). On 07Feb2021, the patient experienced rash on arms, hands, legs, feet, and a little bit on chest. The worst part was that his groin swelled up to about the size of a Cantaloupe. The patient was catheterized in the hospital and over a period of about two weeks he lost about 60-70 pounds in water weight. The patient was hospitalized for 14 days. The adverse events resulted also in Emergency room/department or urgent care. Treatment received for the adverse events included catheterization and furosemide. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered with sequel from the events on an unspecified date.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Rash, Swelling
Clinical narrative: The worst part was that my groin swelled up to about the size of a Cantaloupe. (This also happened to another vet who had his second shot around the same time as I did, within a few days); Rash on arms, hands, legs, feet, and a little bit on chest; fisrt dose on 20Jan2021/second dose on 06Feb2021; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm on 06Feb2021 15:00 (at the age of 61-year-old) (Lot Number: EL9261) as single dose for COVID-19 immunisation. Relevant medical history included diabetes, hypertension, obesity and known allergies to lithium. Concomitant medications were not reported (the patient was receiving 17 unspecified concomitant medications). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in the left arm on 20Jan2021 (at the age of 61-year-old) (Lot Number: EL3249) for COVID-19 immunisation (inappropriate schedule of vaccine administered). On 07Feb2021, the patient experienced rash on arms, hands, legs, feet, and a little bit on chest. The worst part was that his groin swelled up to about the size of a Cantaloupe. The patient was catheterized in the hospital and over a period of about two weeks he lost about 60-70 pounds in water weight. The patient was hospitalized for 14 days. The adverse events resulted also in Emergency room/department or urgent care. Treatment received for the adverse events included catheterization and furosemide. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered with sequel from the events on an unspecified date.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Coxsackie virus test, Cytomegalovirus test negative, Echocardiogram, Ejection fraction normal
Clinical narrative: Myocarditis; This is a spontaneous report from a contactable nurse.   A 19-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date, as single dose (unspecified if 1st or 2nd), for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The nurse stated that the patient was admitted to hospital on an unspecified date where he was diagnosed with myocarditis in Jun2021. The nurse believed the patient was still hospitalised. The outcome of the event was not provided.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the known safety profile, a possible contributory role of BNT162B2 to the development of myocarditis cannot be excluded.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram Q waves, Electrocardiogram T wave abnormal, Electrocardiogram abnormal, Enterovirus test negative, Epstein-Barr virus antibody positive
Clinical narrative: Myocarditis; This is a spontaneous report from a contactable nurse.   A 19-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date, as single dose (unspecified if 1st or 2nd), for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The nurse stated that the patient was admitted to hospital on an unspecified date where he was diagnosed with myocarditis in Jun2021. The nurse believed the patient was still hospitalised. The outcome of the event was not provided.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the known safety profile, a possible contributory role of BNT162B2 to the development of myocarditis cannot be excluded.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging heart, Myocarditis, Parvovirus B19 test negative, SARS-CoV-2 antibody test positive, Sinus tachycardia
Clinical narrative: Myocarditis; This is a spontaneous report from a contactable nurse.   A 19-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date, as single dose (unspecified if 1st or 2nd), for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The nurse stated that the patient was admitted to hospital on an unspecified date where he was diagnosed with myocarditis in Jun2021. The nurse believed the patient was still hospitalised. The outcome of the event was not provided.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the known safety profile, a possible contributory role of BNT162B2 to the development of myocarditis cannot be excluded.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Troponin increased
Clinical narrative: Myocarditis; This is a spontaneous report from a contactable nurse.   A 19-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date, as single dose (unspecified if 1st or 2nd), for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The nurse stated that the patient was admitted to hospital on an unspecified date where he was diagnosed with myocarditis in Jun2021. The nurse believed the patient was still hospitalised. The outcome of the event was not provided.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the known safety profile, a possible contributory role of BNT162B2 to the development of myocarditis cannot be excluded.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis; This is a spontaneous report from a contactable nurse.   A 19-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date, as single dose (unspecified if 1st or 2nd), for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The nurse stated that the patient was admitted to hospital on an unspecified date where he was diagnosed with myocarditis in Jun2021. The nurse believed the patient was still hospitalised. The outcome of the event was not provided.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the known safety profile, a possible contributory role of BNT162B2 to the development of myocarditis cannot be excluded.
Age: 65.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Chest pain, Coronary artery bypass, Immediate post-injection reaction, Myocardial infarction
Clinical narrative: 4 blockages; heart attack; chest pain; left arm was hurting; This is a spontaneous report from a contactable consumer (patient). This consumer reported events after two doses of the vaccine. This is the first of two reports. This report is for the first dose. This 65-year-old male patient received first dose of BNT162B2 (COMIRNATY, Batch/lot number: EN6198), via unspecified route of administration in left shoulder (arm) on 27Feb2021 14:00-15:00 at patient age of 65-year-old as single dose for COVID-19 immunisation. Medical history included blood pressure (abnormal), diabetes diagnosed 12 years ago, and on Cpap breathing machine for 7-8 years. Family history included father died of diabetes 20 years ago. Concomitant medications included blood pressure and diabetes medication, prostate medication. None prior vaccinations within 4 weeks. None event following prior vaccinations. On 28Feb2021, he began having chest pain when woke up and left arm was hurting something awful. He went to the ER in Feb2021 at 1:00 AM, after 5.5 hours he saw a doctor, got checked and got a blood test. They said he was not having a heart attack and it was probably indigestion. Three weeks later in Mar2021, he turned around and his chest was bothering him. He went to hospital and was there from 10:00 AM-7 PM. They drew blood and said he was not having a heart attack. He left and by 9:00 PM, his heart was beating out of his chest and he went back to ER. He passed out and he was in the ER and about 30 minutes he was coming to. They did not have equipment or personnel to treat him in ER. They said he was having a heart attack. The patient was transported to hospital. They did a catheter and found he had 4 blockages and spent 10 days (22Mar2021-01Apr2021) in the hospital with a quadruple bypass. The patient stated that prior to getting the vaccine, he had no chest pain or any heart issues. The patient stated that the vaccine might be triggering heart attack from blockages. The outcome of the event chest pain was not resolved. The outcome of the event heart blockages was recovered/resolved with sequel. The outcome of the other events was unknown.   ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101318800 same patient, same drug (different dose), different event
Age: 65.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Atrioventricular block, Blood test, Catheterisation cardiac, Chest pain, Myocardial infarction
Clinical narrative: 4 blockages; heart attack; chest pain; left arm was hurting; This is a spontaneous report from a contactable consumer (patient). This consumer reported events after two doses of the vaccine. This is the first of two reports. This report is for the first dose. This 65-year-old male patient received first dose of BNT162B2 (COMIRNATY, Batch/lot number: EN6198), via unspecified route of administration in left shoulder (arm) on 27Feb2021 14:00-15:00 at patient age of 65-year-old as single dose for COVID-19 immunisation. Medical history included blood pressure (abnormal), diabetes diagnosed 12 years ago, and on Cpap breathing machine for 7-8 years. Family history included father died of diabetes 20 years ago. Concomitant medications included blood pressure and diabetes medication, prostate medication. None prior vaccinations within 4 weeks. None event following prior vaccinations. On 28Feb2021, he began having chest pain when woke up and left arm was hurting something awful. He went to the ER in Feb2021 at 1:00 AM, after 5.5 hours he saw a doctor, got checked and got a blood test. They said he was not having a heart attack and it was probably indigestion. Three weeks later in Mar2021, he turned around and his chest was bothering him. He went to hospital and was there from 10:00 AM-7 PM. They drew blood and said he was not having a heart attack. He left and by 9:00 PM, his heart was beating out of his chest and he went back to ER. He passed out and he was in the ER and about 30 minutes he was coming to. They did not have equipment or personnel to treat him in ER. They said he was having a heart attack. The patient was transported to hospital. They did a catheter and found he had 4 blockages and spent 10 days (22Mar2021-01Apr2021) in the hospital with a quadruple bypass. The patient stated that prior to getting the vaccine, he had no chest pain or any heart issues. The patient stated that the vaccine might be triggering heart attack from blockages. The outcome of the event chest pain was not resolved. The outcome of the event heart blockages was recovered/resolved with sequel. The outcome of the other events was unknown.   ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101318800 same patient, same drug (different dose), different event