chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Fatigue
Clinical narrative: She got her vaccine, told them that she had a lot of reactions to many foods.  The shot area was a little swollen, kept messaging it so that it wouldn't be painful the following day.  She told them that she was feeling a little wheezy but that she would get a reaction within 24 hours.  She did have some dizziness but nothing to complain about.   She went to bed and at 12:35 AM she work up with a high fever, body aches, extreme chills to the point of toes being frozen, extreme headache, excruciating abdominal pain.  Her muscles were sore and swollen.   The chills went away within 24 hours.  Where she received her shot it was about the size of a baseball.  She could not move, she did make it to the restroom and her temp was 104 degrees.  She was able to put water on her body and got it down to 103, which took about 45 minutes and then she passed out.   She thought she was going to die.  She focused on her breathing, lives alone.  She lost her equilibrium, and was not able to get up to get anything to eat or drink anything.   She woke up around 4-5 hours later and she was tired, still in pain muscle wise, abdominal area was very painful and that's when she started calling us.  She took Tylenol for these symptoms.  She did call her doctor and he advised her to call 9-1-1 if her breathing got worse and advised her not to get the 2nd vaccine.  On the 5th day she was okay and back to her baseline.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Headache, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: She got her vaccine, told them that she had a lot of reactions to many foods.  The shot area was a little swollen, kept messaging it so that it wouldn't be painful the following day.  She told them that she was feeling a little wheezy but that she would get a reaction within 24 hours.  She did have some dizziness but nothing to complain about.   She went to bed and at 12:35 AM she work up with a high fever, body aches, extreme chills to the point of toes being frozen, extreme headache, excruciating abdominal pain.  Her muscles were sore and swollen.   The chills went away within 24 hours.  Where she received her shot it was about the size of a baseball.  She could not move, she did make it to the restroom and her temp was 104 degrees.  She was able to put water on her body and got it down to 103, which took about 45 minutes and then she passed out.   She thought she was going to die.  She focused on her breathing, lives alone.  She lost her equilibrium, and was not able to get up to get anything to eat or drink anything.   She woke up around 4-5 hours later and she was tired, still in pain muscle wise, abdominal area was very painful and that's when she started calling us.  She took Tylenol for these symptoms.  She did call her doctor and he advised her to call 9-1-1 if her breathing got worse and advised her not to get the 2nd vaccine.  On the 5th day she was okay and back to her baseline.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pyrexia, Swelling face
Clinical narrative: She got her vaccine, told them that she had a lot of reactions to many foods.  The shot area was a little swollen, kept messaging it so that it wouldn't be painful the following day.  She told them that she was feeling a little wheezy but that she would get a reaction within 24 hours.  She did have some dizziness but nothing to complain about.   She went to bed and at 12:35 AM she work up with a high fever, body aches, extreme chills to the point of toes being frozen, extreme headache, excruciating abdominal pain.  Her muscles were sore and swollen.   The chills went away within 24 hours.  Where she received her shot it was about the size of a baseball.  She could not move, she did make it to the restroom and her temp was 104 degrees.  She was able to put water on her body and got it down to 103, which took about 45 minutes and then she passed out.   She thought she was going to die.  She focused on her breathing, lives alone.  She lost her equilibrium, and was not able to get up to get anything to eat or drink anything.   She woke up around 4-5 hours later and she was tired, still in pain muscle wise, abdominal area was very painful and that's when she started calling us.  She took Tylenol for these symptoms.  She did call her doctor and he advised her to call 9-1-1 if her breathing got worse and advised her not to get the 2nd vaccine.  On the 5th day she was okay and back to her baseline.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Adverse food reaction, Chills, Dizziness, Fatigue
Clinical narrative: She got her vaccine, told them that she had a lot of reactions to many foods.  The shot area was a little swollen, kept messaging it so that it wouldn't be painful the following day.  She told them that she was feeling a little wheezy but that she would get a reaction within 24 hours.  She did have some dizziness but nothing to complain about.   She went to bed and at 12:35 AM she work up with a high fever, body aches, extreme chills to the point of toes being frozen, extreme headache, excruciating abdominal pain.  Her muscles were sore and swollen.   The chills went away within 24 hours.  Where she received her shot it was about the size of a baseball.  She could not move, she did make it to the restroom and her temp was 104 degrees.  She was able to put water on her body and got it down to 103, which took about 45 minutes and then she passed out.   She thought she was going to die.  She focused on her breathing, lives alone.  She lost her equilibrium, and was not able to get up to get anything to eat or drink anything.   She woke up around 4-5 hours later and she was tired, still in pain muscle wise, abdominal area was very painful and that's when she started calling us.  She took Tylenol for these symptoms.  She did call her doctor and he advised her to call 9-1-1 if her breathing got worse and advised her not to get the 2nd vaccine.  On the 5th day she was okay and back to her baseline.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Injection site swelling, Myalgia, Pain, Pyrexia
Clinical narrative: She got her vaccine, told them that she had a lot of reactions to many foods.  The shot area was a little swollen, kept messaging it so that it wouldn't be painful the following day.  She told them that she was feeling a little wheezy but that she would get a reaction within 24 hours.  She did have some dizziness but nothing to complain about.   She went to bed and at 12:35 AM she work up with a high fever, body aches, extreme chills to the point of toes being frozen, extreme headache, excruciating abdominal pain.  Her muscles were sore and swollen.   The chills went away within 24 hours.  Where she received her shot it was about the size of a baseball.  She could not move, she did make it to the restroom and her temp was 104 degrees.  She was able to put water on her body and got it down to 103, which took about 45 minutes and then she passed out.   She thought she was going to die.  She focused on her breathing, lives alone.  She lost her equilibrium, and was not able to get up to get anything to eat or drink anything.   She woke up around 4-5 hours later and she was tired, still in pain muscle wise, abdominal area was very painful and that's when she started calling us.  She took Tylenol for these symptoms.  She did call her doctor and he advised her to call 9-1-1 if her breathing got worse and advised her not to get the 2nd vaccine.  On the 5th day she was okay and back to her baseline.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope, Wheezing
Clinical narrative: She got her vaccine, told them that she had a lot of reactions to many foods.  The shot area was a little swollen, kept messaging it so that it wouldn't be painful the following day.  She told them that she was feeling a little wheezy but that she would get a reaction within 24 hours.  She did have some dizziness but nothing to complain about.   She went to bed and at 12:35 AM she work up with a high fever, body aches, extreme chills to the point of toes being frozen, extreme headache, excruciating abdominal pain.  Her muscles were sore and swollen.   The chills went away within 24 hours.  Where she received her shot it was about the size of a baseball.  She could not move, she did make it to the restroom and her temp was 104 degrees.  She was able to put water on her body and got it down to 103, which took about 45 minutes and then she passed out.   She thought she was going to die.  She focused on her breathing, lives alone.  She lost her equilibrium, and was not able to get up to get anything to eat or drink anything.   She woke up around 4-5 hours later and she was tired, still in pain muscle wise, abdominal area was very painful and that's when she started calling us.  She took Tylenol for these symptoms.  She did call her doctor and he advised her to call 9-1-1 if her breathing got worse and advised her not to get the 2nd vaccine.  On the 5th day she was okay and back to her baseline.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Agitation, Dysphagia, Dysphonia, Nasopharyngitis, Nervousness
Clinical narrative: Tingling sensation and swelling in neck and rash at her chest. Treated as anaphylactic reaction. Epi 0.3 x 2IM with Benadryl 25 mg IM and albuterol inhaler. Rash/symptoms improved after.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal swelling, Rash, Rash erythematous, Wheezing
Clinical narrative: Tingling sensation and swelling in neck and rash at her chest. Treated as anaphylactic reaction. Epi 0.3 x 2IM with Benadryl 25 mg IM and albuterol inhaler. Rash/symptoms improved after.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Dermatitis bullous, Paraesthesia, Swelling
Clinical narrative: Tingling sensation and swelling in neck and rash at her chest. Treated as anaphylactic reaction. Epi 0.3 x 2IM with Benadryl 25 mg IM and albuterol inhaler. Rash/symptoms improved after.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Chills, Decreased appetite, Diarrhoea
Clinical narrative: I got my vaccine and the next day I ran a low-grade fever for 3 hours. On the third day I was very sick and I threw up which is very unusual for me,  on the fourth day in the evening my stomach was burning. The next day I had diarrhea which is not normal for me either. It felt like I had something wrong like I had a rope across my stomach. I thought my Lymph nodes were very enlarged. My doctor gave me Zofran. My second dose just caused me a few hours of discomfort and no stomach symptoms. I had tested positive for Covid-19 in July of last year and I was sick for eleven days.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Nausea, Pyrexia, Vomiting
Clinical narrative: I got my vaccine and the next day I ran a low-grade fever for 3 hours. On the third day I was very sick and I threw up which is very unusual for me,  on the fourth day in the evening my stomach was burning. The next day I had diarrhea which is not normal for me either. It felt like I had something wrong like I had a rope across my stomach. I thought my Lymph nodes were very enlarged. My doctor gave me Zofran. My second dose just caused me a few hours of discomfort and no stomach symptoms. I had tested positive for Covid-19 in July of last year and I was sick for eleven days.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Discomfort
Clinical narrative: I got my vaccine and the next day I ran a low-grade fever for 3 hours. On the third day I was very sick and I threw up which is very unusual for me,  on the fourth day in the evening my stomach was burning. The next day I had diarrhea which is not normal for me either. It felt like I had something wrong like I had a rope across my stomach. I thought my Lymph nodes were very enlarged. My doctor gave me Zofran. My second dose just caused me a few hours of discomfort and no stomach symptoms. I had tested positive for Covid-19 in July of last year and I was sick for eleven days.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus genital, Rash pruritic, Urticaria
Clinical narrative: itchy on my upper torso to groin area; skin was red, hives(welts) itchy; skin was red, hives(welts) itchy; skin was red, hives(welts) itchy; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9266), via an unspecified route of administration, in the left arm on 13Feb2021 13:30 (at the age of 66-years-old) as single dose for COVID-19 immunisation. Medical history included was reported as none. The patient had no allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included benazepril (BENAZEPRIL); ergocalciferol (VIT D); pitavastatin calcium (ALIPZA) and ezetimibe (EZETIMIBE). The patient did not receive any other vaccines within four weeks prior to the vaccination. It was reported that no probs after shot. On 14Feb2021 after 36 hours became itchy on my upper torso to groin area. Skin was red, hives(welts) itchy. No trouble breathing or swallowing. Took Benedryl and all subsided within 2 hours. Outcome of the events were recovered on an unspecified date.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: itchy on my upper torso to groin area; skin was red, hives(welts) itchy; skin was red, hives(welts) itchy; skin was red, hives(welts) itchy; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9266), via an unspecified route of administration, in the left arm on 13Feb2021 13:30 (at the age of 66-years-old) as single dose for COVID-19 immunisation. Medical history included was reported as none. The patient had no allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included benazepril (BENAZEPRIL); ergocalciferol (VIT D); pitavastatin calcium (ALIPZA) and ezetimibe (EZETIMIBE). The patient did not receive any other vaccines within four weeks prior to the vaccination. It was reported that no probs after shot. On 14Feb2021 after 36 hours became itchy on my upper torso to groin area. Skin was red, hives(welts) itchy. No trouble breathing or swallowing. Took Benedryl and all subsided within 2 hours. Outcome of the events were recovered on an unspecified date.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Face oedema, Facial pain, Injection site pain
Clinical narrative: gradual facial pain; mild inflammation on the right side of face; This is a spontaneous report from a contactable healthcare professional (patient). This non-pregnant 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6201) via an unspecified route of administration in the left arm on 19Feb2021 at 08:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfa drug allergy, penicillin allergy, and evergreen allergy, all from unknown dates and unknown if ongoing. Prior to vaccination the patient had not been diagnosed with COVID-19. Concomitant medications included vitamin C and vitamin B complex, both from unknown dates for unknown indications. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that about 30 hours post-injection, she experienced gradual facial pain and mild inflammation on the right side of the face. The pain and inflammation lasted 6 hours and gradually decreased; she reported no droop or numbness. The events were reported as non-serious and did not require hospitalization. No treatment was received for the events. The clinical outcomes of gradual facial pain and mild inflammation on the right side of the face were recovered in Feb2021. It was also reported that since vaccination the patient had been tested for COVID-19 on 23Feb2021 via polymerase chain reaction (PCR) nasal swab, and the results were pending (as of 24Feb2021).
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial pain, Inflammation, SARS-CoV-2 test
Clinical narrative: gradual facial pain; mild inflammation on the right side of face; This is a spontaneous report from a contactable healthcare professional (patient). This non-pregnant 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6201) via an unspecified route of administration in the left arm on 19Feb2021 at 08:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfa drug allergy, penicillin allergy, and evergreen allergy, all from unknown dates and unknown if ongoing. Prior to vaccination the patient had not been diagnosed with COVID-19. Concomitant medications included vitamin C and vitamin B complex, both from unknown dates for unknown indications. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that about 30 hours post-injection, she experienced gradual facial pain and mild inflammation on the right side of the face. The pain and inflammation lasted 6 hours and gradually decreased; she reported no droop or numbness. The events were reported as non-serious and did not require hospitalization. No treatment was received for the events. The clinical outcomes of gradual facial pain and mild inflammation on the right side of the face were recovered in Feb2021. It was also reported that since vaccination the patient had been tested for COVID-19 on 23Feb2021 via polymerase chain reaction (PCR) nasal swab, and the results were pending (as of 24Feb2021).
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Injection site pain, Nausea, Vomiting
Clinical narrative: mild upper arm soreness; nausea; strong diarrhea; vomiting; This is a spontaneous report from a contactable consumer (patient). This 72-year-old male patient received the first dose of BNT162B2 (UNSPECIFIED TRADE NAME; lot number EN6198) via an unspecified route of administration in the left arm on 23Feb2021 at 12:15 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included gastroesophageal reflux disease (GERD), slightly high blood pressure (BP), and slightly high cholesterol all from unknown dates and unknown if ongoing. The patient had no allergies to medications, food or other products, and was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included lisinopril, pravastatin, sildenafil and esomeprazole sodium (NEXIUM), all from unknown dates for unknown indications. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 23Feb2021 at 23:45 the patient experience only mild upper arm soreness for 12 hours; then nausea, strong diarrhea, and vomiting. He reported it stabilized within an hour. He also reported mild nausea continued 24 hours after vaccination. The events were reported as non-serious and did not require hospitalization. No treatment was received for the events. The clinical outcomes of mild upper arm soreness, nausea, strong diarrhea, and vomiting were recovering. It was also reported that the patient had not been tested for COVID-19 since vaccination.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Nausea, Pain in extremity, Vomiting
Clinical narrative: mild upper arm soreness; nausea; strong diarrhea; vomiting; This is a spontaneous report from a contactable consumer (patient). This 72-year-old male patient received the first dose of BNT162B2 (UNSPECIFIED TRADE NAME; lot number EN6198) via an unspecified route of administration in the left arm on 23Feb2021 at 12:15 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included gastroesophageal reflux disease (GERD), slightly high blood pressure (BP), and slightly high cholesterol all from unknown dates and unknown if ongoing. The patient had no allergies to medications, food or other products, and was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included lisinopril, pravastatin, sildenafil and esomeprazole sodium (NEXIUM), all from unknown dates for unknown indications. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 23Feb2021 at 23:45 the patient experience only mild upper arm soreness for 12 hours; then nausea, strong diarrhea, and vomiting. He reported it stabilized within an hour. He also reported mild nausea continued 24 hours after vaccination. The events were reported as non-serious and did not require hospitalization. No treatment was received for the events. The clinical outcomes of mild upper arm soreness, nausea, strong diarrhea, and vomiting were recovering. It was also reported that the patient had not been tested for COVID-19 since vaccination.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Moderate to severe bilateral wrist pain; Moderate to severe bilateral hand pain; This is a spontaneous report from a contactable 78-year-old female consumer reported for herself that: A 78-years-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6198),dose 1 intramuscular, administered in Arm Left on 20Feb2021 13:00  as SINGLE DOSE for covid-19 immunisation .The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced moderate to severe bilateral wrist pain on 21Feb2021 15:00 and, moderate to severe bilateral hand pain on 21Feb2021 15:00 and Day 5 of Moderate to severe bilateral hand and wrist pain following Pfizer 1st COVID-19 injection 0n 21Feb2021. Unable to prepare meals, wash dishes, do laundry or other daily chores. My son is typing this message for me. At this time I do not plan to get the second injection. Am sending this message to the CDC and Pfizer. Two 650MG Tylenol gives me little relief. I'm hopeful that someone might suggest something else. and outcome of the event was not recovered.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Moderate to severe bilateral wrist pain; Moderate to severe bilateral hand pain; This is a spontaneous report from a contactable 78-year-old female consumer reported for herself that: A 78-years-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6198),dose 1 intramuscular, administered in Arm Left on 20Feb2021 13:00  as SINGLE DOSE for covid-19 immunisation .The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced moderate to severe bilateral wrist pain on 21Feb2021 15:00 and, moderate to severe bilateral hand pain on 21Feb2021 15:00 and Day 5 of Moderate to severe bilateral hand and wrist pain following Pfizer 1st COVID-19 injection 0n 21Feb2021. Unable to prepare meals, wash dishes, do laundry or other daily chores. My son is typing this message for me. At this time I do not plan to get the second injection. Am sending this message to the CDC and Pfizer. Two 650MG Tylenol gives me little relief. I'm hopeful that someone might suggest something else. and outcome of the event was not recovered.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: "covid arm" - 2.5 inch diameter redness, swelling, itching, painful, with a couple of hive looking spots at injection site; "covid arm" - 2.5 inch diameter redness, swelling, itching, painful, with a couple of hive looking spots at injection site; "covid arm" - 2.5 inch diameter redness, swelling, itching, painful, with a couple of hive looking spots at injection site; "covid arm" - 2.5 inch diameter redness, swelling, itching, painful, with a couple of hive looking spots at injection site; "covid arm" - 2.5 inch diameter redness, swelling, itching, painful, with a couple of hive looking spots at injection site; headache; slight fever; malaise; This is a spontaneous report from a contactable other health professional (patient herself). A 68-years-old contactable female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA, formulation: solution for injection. lot number: EN6202) vaccine via an unspecified route of administration, in left arm on 23Feb2021 18:45 as single dose for covid-19 immunisation. Medical history included hypersensitivity (allergies) to medications, food, or other products. The patient was not diagnosed with COVID-19 before vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included vitamin D and calcium. On 24Feb2021 at 15:00, the patient experienced "covid arm"-2.5-inch diameter redness, swelling, itching, painful, with a couple of hive looking spots at injection site, headache, slight fever, malaise. The reporter classified the events as non-serious. Treatment received for the adverse event was ibuprofen, ice and Benadryl. The outcome of events was not recovered.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Pyrexia, Urticaria
Clinical narrative: "covid arm" - 2.5 inch diameter redness, swelling, itching, painful, with a couple of hive looking spots at injection site; "covid arm" - 2.5 inch diameter redness, swelling, itching, painful, with a couple of hive looking spots at injection site; "covid arm" - 2.5 inch diameter redness, swelling, itching, painful, with a couple of hive looking spots at injection site; "covid arm" - 2.5 inch diameter redness, swelling, itching, painful, with a couple of hive looking spots at injection site; "covid arm" - 2.5 inch diameter redness, swelling, itching, painful, with a couple of hive looking spots at injection site; headache; slight fever; malaise; This is a spontaneous report from a contactable other health professional (patient herself). A 68-years-old contactable female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA, formulation: solution for injection. lot number: EN6202) vaccine via an unspecified route of administration, in left arm on 23Feb2021 18:45 as single dose for covid-19 immunisation. Medical history included hypersensitivity (allergies) to medications, food, or other products. The patient was not diagnosed with COVID-19 before vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included vitamin D and calcium. On 24Feb2021 at 15:00, the patient experienced "covid arm"-2.5-inch diameter redness, swelling, itching, painful, with a couple of hive looking spots at injection site, headache, slight fever, malaise. The reporter classified the events as non-serious. Treatment received for the adverse event was ibuprofen, ice and Benadryl. The outcome of events was not recovered.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Malaise, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: "covid arm" - 2.5 inch diameter redness, swelling, itching, painful, with a couple of hive looking spots at injection site; "covid arm" - 2.5 inch diameter redness, swelling, itching, painful, with a couple of hive looking spots at injection site; "covid arm" - 2.5 inch diameter redness, swelling, itching, painful, with a couple of hive looking spots at injection site; "covid arm" - 2.5 inch diameter redness, swelling, itching, painful, with a couple of hive looking spots at injection site; "covid arm" - 2.5 inch diameter redness, swelling, itching, painful, with a couple of hive looking spots at injection site; headache; slight fever; malaise; This is a spontaneous report from a contactable other health professional (patient herself). A 68-years-old contactable female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA, formulation: solution for injection. lot number: EN6202) vaccine via an unspecified route of administration, in left arm on 23Feb2021 18:45 as single dose for covid-19 immunisation. Medical history included hypersensitivity (allergies) to medications, food, or other products. The patient was not diagnosed with COVID-19 before vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included vitamin D and calcium. On 24Feb2021 at 15:00, the patient experienced "covid arm"-2.5-inch diameter redness, swelling, itching, painful, with a couple of hive looking spots at injection site, headache, slight fever, malaise. The reporter classified the events as non-serious. Treatment received for the adverse event was ibuprofen, ice and Benadryl. The outcome of events was not recovered.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling, Vaccination site urticaria
Clinical narrative: "covid arm" - 2.5 inch diameter redness, swelling, itching, painful, with a couple of hive looking spots at injection site; "covid arm" - 2.5 inch diameter redness, swelling, itching, painful, with a couple of hive looking spots at injection site; "covid arm" - 2.5 inch diameter redness, swelling, itching, painful, with a couple of hive looking spots at injection site; "covid arm" - 2.5 inch diameter redness, swelling, itching, painful, with a couple of hive looking spots at injection site; "covid arm" - 2.5 inch diameter redness, swelling, itching, painful, with a couple of hive looking spots at injection site; headache; slight fever; malaise; This is a spontaneous report from a contactable other health professional (patient herself). A 68-years-old contactable female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA, formulation: solution for injection. lot number: EN6202) vaccine via an unspecified route of administration, in left arm on 23Feb2021 18:45 as single dose for covid-19 immunisation. Medical history included hypersensitivity (allergies) to medications, food, or other products. The patient was not diagnosed with COVID-19 before vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included vitamin D and calcium. On 24Feb2021 at 15:00, the patient experienced "covid arm"-2.5-inch diameter redness, swelling, itching, painful, with a couple of hive looking spots at injection site, headache, slight fever, malaise. The reporter classified the events as non-serious. Treatment received for the adverse event was ibuprofen, ice and Benadryl. The outcome of events was not recovered.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Fatigue, Headache, Insomnia, Pain in extremity
Clinical narrative: Headache; tightness in chest; legs hurting from knees down; super tired; This is a spontaneous report from a contactable 65-year-old female consumer reported for herself. A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 21Feb2021 16:00 (Batch/Lot Number: EL9266) as single dose (at the age of 65 years old) for covid-19 immunisation. Medical history included osteoarthritis due to car wrecks in younger years, migraine headaches, muscle spasms in back, covid-19 from Jul2020 to an unknown date (still on oxygen from being hospitalized in July with Covid and still get really tired, was home for a week and a half before being transported to hospital for 2 weeks, and received a plasma transfusion). The patient previously took codeine and experienced drug hypersensitivity, hydrocodone and experienced drug hypersensitivity, lisinopril and experienced drug hypersensitivity. On 21Feb2021 17:00, the patient experienced headache, tightness in chest, legs hurting from knees down, super tired (felt almost like he did when she had Covid infection and she was still on oxygen from being hospitalized in July with Covid). The outcome of the reported events was recovered.  There was no treatment reported. Since the vaccination, the patient had not been tested for COVID-19.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Visual impairment
Clinical narrative: Headache; tightness in chest; legs hurting from knees down; super tired; This is a spontaneous report from a contactable 65-year-old female consumer reported for herself. A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 21Feb2021 16:00 (Batch/Lot Number: EL9266) as single dose (at the age of 65 years old) for covid-19 immunisation. Medical history included osteoarthritis due to car wrecks in younger years, migraine headaches, muscle spasms in back, covid-19 from Jul2020 to an unknown date (still on oxygen from being hospitalized in July with Covid and still get really tired, was home for a week and a half before being transported to hospital for 2 weeks, and received a plasma transfusion). The patient previously took codeine and experienced drug hypersensitivity, hydrocodone and experienced drug hypersensitivity, lisinopril and experienced drug hypersensitivity. On 21Feb2021 17:00, the patient experienced headache, tightness in chest, legs hurting from knees down, super tired (felt almost like he did when she had Covid infection and she was still on oxygen from being hospitalized in July with Covid). The outcome of the reported events was recovered.  There was no treatment reported. Since the vaccination, the patient had not been tested for COVID-19.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Fatigue, Headache, Pain in extremity
Clinical narrative: Headache; tightness in chest; legs hurting from knees down; super tired; This is a spontaneous report from a contactable 65-year-old female consumer reported for herself. A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 21Feb2021 16:00 (Batch/Lot Number: EL9266) as single dose (at the age of 65 years old) for covid-19 immunisation. Medical history included osteoarthritis due to car wrecks in younger years, migraine headaches, muscle spasms in back, covid-19 from Jul2020 to an unknown date (still on oxygen from being hospitalized in July with Covid and still get really tired, was home for a week and a half before being transported to hospital for 2 weeks, and received a plasma transfusion). The patient previously took codeine and experienced drug hypersensitivity, hydrocodone and experienced drug hypersensitivity, lisinopril and experienced drug hypersensitivity. On 21Feb2021 17:00, the patient experienced headache, tightness in chest, legs hurting from knees down, super tired (felt almost like he did when she had Covid infection and she was still on oxygen from being hospitalized in July with Covid). The outcome of the reported events was recovered.  There was no treatment reported. Since the vaccination, the patient had not been tested for COVID-19.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Urticaria
Clinical narrative: rash; itchiness; This is a spontaneous report from a contactable consumer.   A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration, in the right arm on 26Feb2021 at 15:45 (at the age of 60-years-old) as single dose for COVID-19 immunisation.  Medical history included cardiac murmur, allergy to walnuts, and shellfish, allergy to penicillin, bilateral stenosis of ureters, and obesity; all from an unknown date and unknown if ongoing. 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 received unspecified concomitant drugs within 2 weeks of the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took morphine and experienced drug hypersensitivity.  On 26Feb2021 at 17:00, the patient experienced rash and itchiness. The patient was given diphenhydramine (BENADRYL) as treatment for the events, rash and itchiness. The patient recovered from the events, rash and itchiness on an unknown date.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: rash; itchiness; This is a spontaneous report from a contactable consumer.   A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration, in the right arm on 26Feb2021 at 15:45 (at the age of 60-years-old) as single dose for COVID-19 immunisation.  Medical history included cardiac murmur, allergy to walnuts, and shellfish, allergy to penicillin, bilateral stenosis of ureters, and obesity; all from an unknown date and unknown if ongoing. 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 received unspecified concomitant drugs within 2 weeks of the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took morphine and experienced drug hypersensitivity.  On 26Feb2021 at 17:00, the patient experienced rash and itchiness. The patient was given diphenhydramine (BENADRYL) as treatment for the events, rash and itchiness. The patient recovered from the events, rash and itchiness on an unknown date.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Angioedema, Erythema, Nausea
Clinical narrative: Hand swelling; Rash on face; lip swelling; received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration in left leg; This is a spontaneous report from a contactable healthcare professional (patient herself). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration in left leg on 20Feb2021 12:45 as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation, chronic urticaria, and known allergies. Concomitant medication in two weeks included cetirizine hydrochloride (ZYRTEC). The patient was not pregnant and did not receive any other vaccine in four weeks. She was not diagnosed with COVID prior to vaccination. On 20Feb2021 01.15 PM, the patient experienced hand swelling, rash on face, and lip swelling. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Hospitalization was also reported. Treatment included diphenhydramine (BENADRYL). Outcome of the events was recovering. Patient had not been COVID tested post vaccination.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Lip swelling, Peripheral swelling, Product administered at inappropriate site, Rash
Clinical narrative: Hand swelling; Rash on face; lip swelling; received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration in left leg; This is a spontaneous report from a contactable healthcare professional (patient herself). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration in left leg on 20Feb2021 12:45 as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation, chronic urticaria, and known allergies. Concomitant medication in two weeks included cetirizine hydrochloride (ZYRTEC). The patient was not pregnant and did not receive any other vaccine in four weeks. She was not diagnosed with COVID prior to vaccination. On 20Feb2021 01.15 PM, the patient experienced hand swelling, rash on face, and lip swelling. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Hospitalization was also reported. Treatment included diphenhydramine (BENADRYL). Outcome of the events was recovering. Patient had not been COVID tested post vaccination.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Audiogram, Deafness, Tinnitus
Clinical narrative: Hand swelling; Rash on face; lip swelling; received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration in left leg; This is a spontaneous report from a contactable healthcare professional (patient herself). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration in left leg on 20Feb2021 12:45 as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation, chronic urticaria, and known allergies. Concomitant medication in two weeks included cetirizine hydrochloride (ZYRTEC). The patient was not pregnant and did not receive any other vaccine in four weeks. She was not diagnosed with COVID prior to vaccination. On 20Feb2021 01.15 PM, the patient experienced hand swelling, rash on face, and lip swelling. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Hospitalization was also reported. Treatment included diphenhydramine (BENADRYL). Outcome of the events was recovering. Patient had not been COVID tested post vaccination.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Throat irritation
Clinical narrative: My throat felt like it was going numb. A nurse gave me an injection of my epi pen, then a shot of Benadryll. I was taken to the ER via ambulance and given two 24 hour steroids.  I was in the ER for about 4.5 hours.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Pharyngeal hypoaesthesia
Clinical narrative: My throat felt like it was going numb. A nurse gave me an injection of my epi pen, then a shot of Benadryll. I was taken to the ER via ambulance and given two 24 hour steroids.  I was in the ER for about 4.5 hours.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray normal, Chest discomfort, Electrocardiogram, Troponin normal
Clinical narrative: 35 yo female with a history of heart failure (EF 35%) dx 2020, reports AE after Covid vaccine #1 (3 MAR 2021) at drivethrough event characterized by onset of dizziness and CP 6/10, feeling cold 10 minutes after vaccine receipt. She denies, pruritis, urticaria, oral/face/throat/tongue swelling, flushing, red/watery eyes, cough, wheeze.  She was transferred to ER with neg eval and released. She states CP continued until that evening, but was consistent with CP she intermittently experiences baseline.  She reports mild dizziness continued for two days. She had mild site pain. She had increased fatigue for a few days and resolved. She reports a history of presyncope after blood draws. She denies previous AE after vaccine. She was treated with IVF, ASA 325, torrodol 30 mgs and zofran 8 mgs. No repeat event with second dose receipt.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dizziness, Electrocardiogram, Fatigue, Feeling cold
Clinical narrative: 35 yo female with a history of heart failure (EF 35%) dx 2020, reports AE after Covid vaccine #1 (3 MAR 2021) at drivethrough event characterized by onset of dizziness and CP 6/10, feeling cold 10 minutes after vaccine receipt. She denies, pruritis, urticaria, oral/face/throat/tongue swelling, flushing, red/watery eyes, cough, wheeze.  She was transferred to ER with neg eval and released. She states CP continued until that evening, but was consistent with CP she intermittently experiences baseline.  She reports mild dizziness continued for two days. She had mild site pain. She had increased fatigue for a few days and resolved. She reports a history of presyncope after blood draws. She denies previous AE after vaccine. She was treated with IVF, ASA 325, torrodol 30 mgs and zofran 8 mgs. No repeat event with second dose receipt.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Metabolic function test, Troponin normal
Clinical narrative: 35 yo female with a history of heart failure (EF 35%) dx 2020, reports AE after Covid vaccine #1 (3 MAR 2021) at drivethrough event characterized by onset of dizziness and CP 6/10, feeling cold 10 minutes after vaccine receipt. She denies, pruritis, urticaria, oral/face/throat/tongue swelling, flushing, red/watery eyes, cough, wheeze.  She was transferred to ER with neg eval and released. She states CP continued until that evening, but was consistent with CP she intermittently experiences baseline.  She reports mild dizziness continued for two days. She had mild site pain. She had increased fatigue for a few days and resolved. She reports a history of presyncope after blood draws. She denies previous AE after vaccine. She was treated with IVF, ASA 325, torrodol 30 mgs and zofran 8 mgs. No repeat event with second dose receipt.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Fatigue, Lethargy, Lymphadenopathy, Throat tightness
Clinical narrative: Swollen throat  after 17 minutes and trouble swallowing  which lasted about 12 hours
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Pharyngeal swelling
Clinical narrative: Swollen throat  after 17 minutes and trouble swallowing  which lasted about 12 hours