chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: Very sore at injection site; very large red area at injection site; Very itchy area at injection site; Large knot at injection site; Swollen Lymph nodes; Severe headaches; Severe fatigue; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the arm left on 29Apr2021 at 13:15 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient received other unspecified medications within 2 weeks of vaccination. The patient previously received levofloxacin (LEVAQUIN) and cinnamon. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021 at 14:00, the patient experienced very sore, very large red area and large knot at the injection site, swollen lymph nodes, severe headaches and severe fatigue for 4 days and very itchy area at injection site. The clinical outcome of events very sore, very large red area and large knot at the injection site, swollen lymph nodes, severe headaches and severe fatigue were resolved on 03May2021 while the event very itchy area at injection site was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pruritus, Lymphadenopathy
Clinical narrative: Very sore at injection site; very large red area at injection site; Very itchy area at injection site; Large knot at injection site; Swollen Lymph nodes; Severe headaches; Severe fatigue; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the arm left on 29Apr2021 at 13:15 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient received other unspecified medications within 2 weeks of vaccination. The patient previously received levofloxacin (LEVAQUIN) and cinnamon. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021 at 14:00, the patient experienced very sore, very large red area and large knot at the injection site, swollen lymph nodes, severe headaches and severe fatigue for 4 days and very itchy area at injection site. The clinical outcome of events very sore, very large red area and large knot at the injection site, swollen lymph nodes, severe headaches and severe fatigue were resolved on 03May2021 while the event very itchy area at injection site was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Vaccination site erythema, Vaccination site mass
Clinical narrative: Very sore at injection site; very large red area at injection site; Very itchy area at injection site; Large knot at injection site; Swollen Lymph nodes; Severe headaches; Severe fatigue; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the arm left on 29Apr2021 at 13:15 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient received other unspecified medications within 2 weeks of vaccination. The patient previously received levofloxacin (LEVAQUIN) and cinnamon. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021 at 14:00, the patient experienced very sore, very large red area and large knot at the injection site, swollen lymph nodes, severe headaches and severe fatigue for 4 days and very itchy area at injection site. The clinical outcome of events very sore, very large red area and large knot at the injection site, swollen lymph nodes, severe headaches and severe fatigue were resolved on 03May2021 while the event very itchy area at injection site was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: Very sore at injection site; very large red area at injection site; Very itchy area at injection site; Large knot at injection site; Swollen Lymph nodes; Severe headaches; Severe fatigue; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the arm left on 29Apr2021 at 13:15 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient received other unspecified medications within 2 weeks of vaccination. The patient previously received levofloxacin (LEVAQUIN) and cinnamon. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021 at 14:00, the patient experienced very sore, very large red area and large knot at the injection site, swollen lymph nodes, severe headaches and severe fatigue for 4 days and very itchy area at injection site. The clinical outcome of events very sore, very large red area and large knot at the injection site, swollen lymph nodes, severe headaches and severe fatigue were resolved on 03May2021 while the event very itchy area at injection site was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: Annoying continuous sound in both of the ears and was diagnosed with tinnitus; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810) via an unspecified route of administration in the right arm on 22Feb2021 at 10:30 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. The patient had unspecified medical history. The patient received other unspecified medications within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EM9810) via an unspecified route of administration in the left arm on 04Feb2021 at 17:30 (at the age of 76-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 08Apr2021 at 17:00, the patient experienced annoying continuous sound in both of the ears and was diagnosed with tinnitus. It was reported that, this situation was very difficult to put up with and the patient needed help to overcome this annoying situation. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event annoying continuous sound in both of the ears and was diagnosed with tinnitus was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Annoying continuous sound in both of the ears and was diagnosed with tinnitus; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810) via an unspecified route of administration in the right arm on 22Feb2021 at 10:30 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. The patient had unspecified medical history. The patient received other unspecified medications within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EM9810) via an unspecified route of administration in the left arm on 04Feb2021 at 17:30 (at the age of 76-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 08Apr2021 at 17:00, the patient experienced annoying continuous sound in both of the ears and was diagnosed with tinnitus. It was reported that, this situation was very difficult to put up with and the patient needed help to overcome this annoying situation. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event annoying continuous sound in both of the ears and was diagnosed with tinnitus was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chills, Cough, Influenza, Influenza virus test
Clinical narrative: Patient hospitalized and died due to COVID after being vaccinated.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Respiratory syncytial virus test, SARS-CoV-2 test positive
Clinical narrative: Patient hospitalized and died due to COVID after being vaccinated.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death
Clinical narrative: Patient hospitalized and died due to COVID after being vaccinated.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Lymphadenopathy
Clinical narrative: Enlarged lymph nodes in neck and shoulder on the left side.; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 16Apr2021 at 12:15 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. Medical history included cancer and blood pressure high. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and hydrochlorothiazide (MANUFACTURER UNKNOWN), both taken from unknown dates for unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Apr2021 at 14:00, the patient experienced enlarged lymph nodes in neck and shoulder on the left side. The event resulted in doctor or other healthcare professional office/clinic visit. On an unknown date, the patient underwent CT scan and the result was unknown. The clinical outcome of the event enlarged lymph nodes in neck and shoulder on the left side was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breast pain, Hypersomnia, Lethargy, Loss of personal independence in daily activities, Lymph node pain
Clinical narrative: Fully bed ridden; Extreme fatigue; fever/ fever averaged at 100.9; Extreme swelling under arm by armpit; Pain continues below armpit; severe congestion; Dizzy and lightheaded; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 13Apr2021 at 08:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19, herpes simplex (HSV), asthma, obesity, high cholesterol and had allergies to sulfates, shell fish, seasonal allergies. Concomitant medications included quetiapine fumarate (SEROQUEL) and valaciclovir (MANUFACTURER UNKNOWN); all from an unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 13Apr2021 at 09:15, the patient experienced dizzy and lightheaded after 30 minutes of dose. On 13Apr2021 at 17:15 the patient experienced extreme swelling under arm by armpit for a total of 10 days, pain continues below armpit 20 days after initial dose, severe congestion continues 20 days after initial dose, fever averaged at 100.9 for 8 consecutive days, starting at 8.5 hours after dose. On 14Apr2021 at 08:45 the patient experienced extreme fatigue and fully bed ridden starting 24 hours after dose for a total of 4 days. The events resulted in doctor or other healthcare professional office/clinic visit. On 30Apr2021, the patient underwent nasal swab and the result was negative. The clinical outcomes of dizzy, lightheaded, extreme swelling under arm by armpit, pain continues below armpit, severe congestion, fever averaged at 100.9, extreme fatigue and fully bed ridden were not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Nasal congestion, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Fully bed ridden; Extreme fatigue; fever/ fever averaged at 100.9; Extreme swelling under arm by armpit; Pain continues below armpit; severe congestion; Dizzy and lightheaded; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 13Apr2021 at 08:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19, herpes simplex (HSV), asthma, obesity, high cholesterol and had allergies to sulfates, shell fish, seasonal allergies. Concomitant medications included quetiapine fumarate (SEROQUEL) and valaciclovir (MANUFACTURER UNKNOWN); all from an unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 13Apr2021 at 09:15, the patient experienced dizzy and lightheaded after 30 minutes of dose. On 13Apr2021 at 17:15 the patient experienced extreme swelling under arm by armpit for a total of 10 days, pain continues below armpit 20 days after initial dose, severe congestion continues 20 days after initial dose, fever averaged at 100.9 for 8 consecutive days, starting at 8.5 hours after dose. On 14Apr2021 at 08:45 the patient experienced extreme fatigue and fully bed ridden starting 24 hours after dose for a total of 4 days. The events resulted in doctor or other healthcare professional office/clinic visit. On 30Apr2021, the patient underwent nasal swab and the result was negative. The clinical outcomes of dizzy, lightheaded, extreme swelling under arm by armpit, pain continues below armpit, severe congestion, fever averaged at 100.9, extreme fatigue and fully bed ridden were not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bedridden, Body temperature, Dizziness, Fatigue, Lymph node pain
Clinical narrative: Fully bed ridden; Extreme fatigue; fever/ fever averaged at 100.9; Extreme swelling under arm by armpit; Pain continues below armpit; severe congestion; Dizzy and lightheaded; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 13Apr2021 at 08:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19, herpes simplex (HSV), asthma, obesity, high cholesterol and had allergies to sulfates, shell fish, seasonal allergies. Concomitant medications included quetiapine fumarate (SEROQUEL) and valaciclovir (MANUFACTURER UNKNOWN); all from an unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 13Apr2021 at 09:15, the patient experienced dizzy and lightheaded after 30 minutes of dose. On 13Apr2021 at 17:15 the patient experienced extreme swelling under arm by armpit for a total of 10 days, pain continues below armpit 20 days after initial dose, severe congestion continues 20 days after initial dose, fever averaged at 100.9 for 8 consecutive days, starting at 8.5 hours after dose. On 14Apr2021 at 08:45 the patient experienced extreme fatigue and fully bed ridden starting 24 hours after dose for a total of 4 days. The events resulted in doctor or other healthcare professional office/clinic visit. On 30Apr2021, the patient underwent nasal swab and the result was negative. The clinical outcomes of dizzy, lightheaded, extreme swelling under arm by armpit, pain continues below armpit, severe congestion, fever averaged at 100.9, extreme fatigue and fully bed ridden were not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Nasal congestion, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fully bed ridden; Extreme fatigue; fever/ fever averaged at 100.9; Extreme swelling under arm by armpit; Pain continues below armpit; severe congestion; Dizzy and lightheaded; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 13Apr2021 at 08:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19, herpes simplex (HSV), asthma, obesity, high cholesterol and had allergies to sulfates, shell fish, seasonal allergies. Concomitant medications included quetiapine fumarate (SEROQUEL) and valaciclovir (MANUFACTURER UNKNOWN); all from an unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 13Apr2021 at 09:15, the patient experienced dizzy and lightheaded after 30 minutes of dose. On 13Apr2021 at 17:15 the patient experienced extreme swelling under arm by armpit for a total of 10 days, pain continues below armpit 20 days after initial dose, severe congestion continues 20 days after initial dose, fever averaged at 100.9 for 8 consecutive days, starting at 8.5 hours after dose. On 14Apr2021 at 08:45 the patient experienced extreme fatigue and fully bed ridden starting 24 hours after dose for a total of 4 days. The events resulted in doctor or other healthcare professional office/clinic visit. On 30Apr2021, the patient underwent nasal swab and the result was negative. The clinical outcomes of dizzy, lightheaded, extreme swelling under arm by armpit, pain continues below armpit, severe congestion, fever averaged at 100.9, extreme fatigue and fully bed ridden were not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Heparin-induced thrombocytopenia test, Myalgia, Syncope, Venogram normal
Clinical narrative: From 4/20/21 hospital report: This is a 52-year-old female with diabetes, "irregular heartbeat," also on hormone replacement therapy, who received the Johnson & Johnson Covid vaccine 4/9/2021 and presented to outside facility with several days of headache and an episode of syncope. The day after her vaccine she felt under the weather with some aches and chills. The next day, she developed a headache that she thought was a sinus headache. It was above her eyes in the middle of her forehead and also behind her left ear. She does get sinus issues when it is windy because she has allergies, so she took some Claritin without significant improvement. She was not having her other usual allergy symptoms such as runny nose or postnasal drip. A few days ago she developed sensitivity to light but her headache actually got better. This morning she went outside to take out the trash and lost consciousness, falling onto her left hand. She did not strike her head. She went to outside facility urgent care.  There is report that her x-ray of her left hand was normal although the read is not available. CT head without contrast was read as unremarkable. EKG was unremarkable. Here she has had normal vital signs. Labs including platelet and HIT antibody were negative. MR venogram showed thrombosis of right transverse and sigmoid sinuses and right internal jugular vein. Teleneurology recommends MRI and low molecular weight heparin. Patient was given aspirin. -Patient reports a headache for a week prior to her syncopal episode. The headache was at its worst last week, but has since improved. At this time, the pain is located in the occipital region and is described as constant, dull, is rated as moderate in severity, non-radiating, and has no exacerbating or alleviating factors. She states that after taking out the trash, patient "felt like I was hit in the head" then woke up on the floor looking at her fence. She denies any head strike during the episode.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Angiogram cerebral abnormal, Anticoagulant therapy, Cerebral venous sinus thrombosis, Chills
Clinical narrative: From 4/20/21 hospital report: This is a 52-year-old female with diabetes, "irregular heartbeat," also on hormone replacement therapy, who received the Johnson & Johnson Covid vaccine 4/9/2021 and presented to outside facility with several days of headache and an episode of syncope. The day after her vaccine she felt under the weather with some aches and chills. The next day, she developed a headache that she thought was a sinus headache. It was above her eyes in the middle of her forehead and also behind her left ear. She does get sinus issues when it is windy because she has allergies, so she took some Claritin without significant improvement. She was not having her other usual allergy symptoms such as runny nose or postnasal drip. A few days ago she developed sensitivity to light but her headache actually got better. This morning she went outside to take out the trash and lost consciousness, falling onto her left hand. She did not strike her head. She went to outside facility urgent care.  There is report that her x-ray of her left hand was normal although the read is not available. CT head without contrast was read as unremarkable. EKG was unremarkable. Here she has had normal vital signs. Labs including platelet and HIT antibody were negative. MR venogram showed thrombosis of right transverse and sigmoid sinuses and right internal jugular vein. Teleneurology recommends MRI and low molecular weight heparin. Patient was given aspirin. -Patient reports a headache for a week prior to her syncopal episode. The headache was at its worst last week, but has since improved. At this time, the pain is located in the occipital region and is described as constant, dull, is rated as moderate in severity, non-radiating, and has no exacerbating or alleviating factors. She states that after taking out the trash, patient "felt like I was hit in the head" then woke up on the floor looking at her fence. She denies any head strike during the episode.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head normal, Electrocardiogram normal, Fall, Feeling abnormal, Headache
Clinical narrative: From 4/20/21 hospital report: This is a 52-year-old female with diabetes, "irregular heartbeat," also on hormone replacement therapy, who received the Johnson & Johnson Covid vaccine 4/9/2021 and presented to outside facility with several days of headache and an episode of syncope. The day after her vaccine she felt under the weather with some aches and chills. The next day, she developed a headache that she thought was a sinus headache. It was above her eyes in the middle of her forehead and also behind her left ear. She does get sinus issues when it is windy because she has allergies, so she took some Claritin without significant improvement. She was not having her other usual allergy symptoms such as runny nose or postnasal drip. A few days ago she developed sensitivity to light but her headache actually got better. This morning she went outside to take out the trash and lost consciousness, falling onto her left hand. She did not strike her head. She went to outside facility urgent care.  There is report that her x-ray of her left hand was normal although the read is not available. CT head without contrast was read as unremarkable. EKG was unremarkable. Here she has had normal vital signs. Labs including platelet and HIT antibody were negative. MR venogram showed thrombosis of right transverse and sigmoid sinuses and right internal jugular vein. Teleneurology recommends MRI and low molecular weight heparin. Patient was given aspirin. -Patient reports a headache for a week prior to her syncopal episode. The headache was at its worst last week, but has since improved. At this time, the pain is located in the occipital region and is described as constant, dull, is rated as moderate in severity, non-radiating, and has no exacerbating or alleviating factors. She states that after taking out the trash, patient "felt like I was hit in the head" then woke up on the floor looking at her fence. She denies any head strike during the episode.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heparin-induced thrombocytopenia test, Jugular vein thrombosis, Limb injury, Loss of consciousness, Magnetic resonance imaging head abnormal
Clinical narrative: From 4/20/21 hospital report: This is a 52-year-old female with diabetes, "irregular heartbeat," also on hormone replacement therapy, who received the Johnson & Johnson Covid vaccine 4/9/2021 and presented to outside facility with several days of headache and an episode of syncope. The day after her vaccine she felt under the weather with some aches and chills. The next day, she developed a headache that she thought was a sinus headache. It was above her eyes in the middle of her forehead and also behind her left ear. She does get sinus issues when it is windy because she has allergies, so she took some Claritin without significant improvement. She was not having her other usual allergy symptoms such as runny nose or postnasal drip. A few days ago she developed sensitivity to light but her headache actually got better. This morning she went outside to take out the trash and lost consciousness, falling onto her left hand. She did not strike her head. She went to outside facility urgent care.  There is report that her x-ray of her left hand was normal although the read is not available. CT head without contrast was read as unremarkable. EKG was unremarkable. Here she has had normal vital signs. Labs including platelet and HIT antibody were negative. MR venogram showed thrombosis of right transverse and sigmoid sinuses and right internal jugular vein. Teleneurology recommends MRI and low molecular weight heparin. Patient was given aspirin. -Patient reports a headache for a week prior to her syncopal episode. The headache was at its worst last week, but has since improved. At this time, the pain is located in the occipital region and is described as constant, dull, is rated as moderate in severity, non-radiating, and has no exacerbating or alleviating factors. She states that after taking out the trash, patient "felt like I was hit in the head" then woke up on the floor looking at her fence. She denies any head strike during the episode.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head normal, Pain, Photophobia, Platelet count normal, Sinus headache
Clinical narrative: From 4/20/21 hospital report: This is a 52-year-old female with diabetes, "irregular heartbeat," also on hormone replacement therapy, who received the Johnson & Johnson Covid vaccine 4/9/2021 and presented to outside facility with several days of headache and an episode of syncope. The day after her vaccine she felt under the weather with some aches and chills. The next day, she developed a headache that she thought was a sinus headache. It was above her eyes in the middle of her forehead and also behind her left ear. She does get sinus issues when it is windy because she has allergies, so she took some Claritin without significant improvement. She was not having her other usual allergy symptoms such as runny nose or postnasal drip. A few days ago she developed sensitivity to light but her headache actually got better. This morning she went outside to take out the trash and lost consciousness, falling onto her left hand. She did not strike her head. She went to outside facility urgent care.  There is report that her x-ray of her left hand was normal although the read is not available. CT head without contrast was read as unremarkable. EKG was unremarkable. Here she has had normal vital signs. Labs including platelet and HIT antibody were negative. MR venogram showed thrombosis of right transverse and sigmoid sinuses and right internal jugular vein. Teleneurology recommends MRI and low molecular weight heparin. Patient was given aspirin. -Patient reports a headache for a week prior to her syncopal episode. The headache was at its worst last week, but has since improved. At this time, the pain is located in the occipital region and is described as constant, dull, is rated as moderate in severity, non-radiating, and has no exacerbating or alleviating factors. She states that after taking out the trash, patient "felt like I was hit in the head" then woke up on the floor looking at her fence. She denies any head strike during the episode.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope, Transverse sinus thrombosis, Ultrasound Doppler normal, Venogram abnormal
Clinical narrative: From 4/20/21 hospital report: This is a 52-year-old female with diabetes, "irregular heartbeat," also on hormone replacement therapy, who received the Johnson & Johnson Covid vaccine 4/9/2021 and presented to outside facility with several days of headache and an episode of syncope. The day after her vaccine she felt under the weather with some aches and chills. The next day, she developed a headache that she thought was a sinus headache. It was above her eyes in the middle of her forehead and also behind her left ear. She does get sinus issues when it is windy because she has allergies, so she took some Claritin without significant improvement. She was not having her other usual allergy symptoms such as runny nose or postnasal drip. A few days ago she developed sensitivity to light but her headache actually got better. This morning she went outside to take out the trash and lost consciousness, falling onto her left hand. She did not strike her head. She went to outside facility urgent care.  There is report that her x-ray of her left hand was normal although the read is not available. CT head without contrast was read as unremarkable. EKG was unremarkable. Here she has had normal vital signs. Labs including platelet and HIT antibody were negative. MR venogram showed thrombosis of right transverse and sigmoid sinuses and right internal jugular vein. Teleneurology recommends MRI and low molecular weight heparin. Patient was given aspirin. -Patient reports a headache for a week prior to her syncopal episode. The headache was at its worst last week, but has since improved. At this time, the pain is located in the occipital region and is described as constant, dull, is rated as moderate in severity, non-radiating, and has no exacerbating or alleviating factors. She states that after taking out the trash, patient "felt like I was hit in the head" then woke up on the floor looking at her fence. She denies any head strike during the episode.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable consumer (patient, self-reported). A female patient of an unspecified age received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated she had surgery on 08Apr2021 and woke up with complications from intubation- mouth sores and a lip sore. She got the first dose of the vaccine 2 weeks later on 23Apr2021 and was cleared to get that. The day after the vaccine she started getting a mouth infection and horrible pain on the left side which was where the other sores were from. The pain was horrendous and lasted all week and through the weekend she used some Oxy from surgery. That bad pain lasted a couple days. She saw the dentist on "the 26th" and he thought it was a mouth infection and gave her antibiotics and it started decreasing through the weekend. On the left arm, not far from where she got the vaccine, she had weird blisters that started Sunday or Monday of this week and started spreading quickly last night to this morning. She went to the doctor this morning and the doctor said it looks like shingles and started her on antiviral today. The doctor said that the pain was the initial start of the shingles. She has never had shingles. She is supposed to get the second shot next Friday. She asked if this was related to the vaccine and if she should get the second dose. She stated there were some reports in the news from 21Apr2021 and 22Apr2021 about 6 women (out of 491 patients) that got shingles between day 3-14 after the vaccine. This came from the journal of rheumatology. There was not a product complaint to report. There was not a medical information request. Outcome of the event was unknown.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blister, Diarrhoea, Facial pain, Fatigue, Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable consumer (patient, self-reported). A female patient of an unspecified age received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated she had surgery on 08Apr2021 and woke up with complications from intubation- mouth sores and a lip sore. She got the first dose of the vaccine 2 weeks later on 23Apr2021 and was cleared to get that. The day after the vaccine she started getting a mouth infection and horrible pain on the left side which was where the other sores were from. The pain was horrendous and lasted all week and through the weekend she used some Oxy from surgery. That bad pain lasted a couple days. She saw the dentist on "the 26th" and he thought it was a mouth infection and gave her antibiotics and it started decreasing through the weekend. On the left arm, not far from where she got the vaccine, she had weird blisters that started Sunday or Monday of this week and started spreading quickly last night to this morning. She went to the doctor this morning and the doctor said it looks like shingles and started her on antiviral today. The doctor said that the pain was the initial start of the shingles. She has never had shingles. She is supposed to get the second shot next Friday. She asked if this was related to the vaccine and if she should get the second dose. She stated there were some reports in the news from 21Apr2021 and 22Apr2021 about 6 women (out of 491 patients) that got shingles between day 3-14 after the vaccine. This came from the journal of rheumatology. There was not a product complaint to report. There was not a medical information request. Outcome of the event was unknown.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Neck pain, Oral infection, Oral pain, Pain in extremity, Pyrexia
Clinical narrative: shingles; This is a spontaneous report from a contactable consumer (patient, self-reported). A female patient of an unspecified age received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated she had surgery on 08Apr2021 and woke up with complications from intubation- mouth sores and a lip sore. She got the first dose of the vaccine 2 weeks later on 23Apr2021 and was cleared to get that. The day after the vaccine she started getting a mouth infection and horrible pain on the left side which was where the other sores were from. The pain was horrendous and lasted all week and through the weekend she used some Oxy from surgery. That bad pain lasted a couple days. She saw the dentist on "the 26th" and he thought it was a mouth infection and gave her antibiotics and it started decreasing through the weekend. On the left arm, not far from where she got the vaccine, she had weird blisters that started Sunday or Monday of this week and started spreading quickly last night to this morning. She went to the doctor this morning and the doctor said it looks like shingles and started her on antiviral today. The doctor said that the pain was the initial start of the shingles. She has never had shingles. She is supposed to get the second shot next Friday. She asked if this was related to the vaccine and if she should get the second dose. She stated there were some reports in the news from 21Apr2021 and 22Apr2021 about 6 women (out of 491 patients) that got shingles between day 3-14 after the vaccine. This came from the journal of rheumatology. There was not a product complaint to report. There was not a medical information request. Outcome of the event was unknown.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Computerised tomogram, Culture, Dyspnoea, Herpes zoster
Clinical narrative: Rash; Warmth; sensation of the burning and stinging on his skin; sensation of the burning and stinging on his skin; This is a spontaneous report from a contactable nurse who reported events after first and second dose of the vaccine. This case is for event after the first dose.  A 72-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EM9809), intramuscular in Deltoid Left on 04Feb2021 at 14:30 (at 72 years) as single dose for covid-19 immunisation . Medical history included hypertension from 30Apr2013 and ongoing , diabetes from 16May2013 and ongoing , Atherosclerotic cardiovascular disease (ASCVD) from 30Apr2013 and ongoing , cardiomyopathy from 03Oct2012 and ongoing  and shingles from an unknown date. There were no concomitant medications. On 05Feb2021 the patient experienced rash and warmth, both serious due to disability and medically significant. Treatment included increased O2 use to full time (as reported). It was reported that patient did not have shingles. He was relating the sensation of the burning and stinging on his skin (unspecified date in 2021) to the feeling of shingles (which he has had before). Outcome of rash and warmth was not recovered, outcome of the other events was unknown.; Sender's Comments: Based on the available information in the case, the causal association between the events rash, feeling hot and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021167847 Same patient and drug, different AE and dose
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypogeusia, Pruritus, Rash
Clinical narrative: Rash; Warmth; sensation of the burning and stinging on his skin; sensation of the burning and stinging on his skin; This is a spontaneous report from a contactable nurse who reported events after first and second dose of the vaccine. This case is for event after the first dose.  A 72-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EM9809), intramuscular in Deltoid Left on 04Feb2021 at 14:30 (at 72 years) as single dose for covid-19 immunisation . Medical history included hypertension from 30Apr2013 and ongoing , diabetes from 16May2013 and ongoing , Atherosclerotic cardiovascular disease (ASCVD) from 30Apr2013 and ongoing , cardiomyopathy from 03Oct2012 and ongoing  and shingles from an unknown date. There were no concomitant medications. On 05Feb2021 the patient experienced rash and warmth, both serious due to disability and medically significant. Treatment included increased O2 use to full time (as reported). It was reported that patient did not have shingles. He was relating the sensation of the burning and stinging on his skin (unspecified date in 2021) to the feeling of shingles (which he has had before). Outcome of rash and warmth was not recovered, outcome of the other events was unknown.; Sender's Comments: Based on the available information in the case, the causal association between the events rash, feeling hot and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021167847 Same patient and drug, different AE and dose
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Pain of skin, Rash, Skin burning sensation
Clinical narrative: Rash; Warmth; sensation of the burning and stinging on his skin; sensation of the burning and stinging on his skin; This is a spontaneous report from a contactable nurse who reported events after first and second dose of the vaccine. This case is for event after the first dose.  A 72-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EM9809), intramuscular in Deltoid Left on 04Feb2021 at 14:30 (at 72 years) as single dose for covid-19 immunisation . Medical history included hypertension from 30Apr2013 and ongoing , diabetes from 16May2013 and ongoing , Atherosclerotic cardiovascular disease (ASCVD) from 30Apr2013 and ongoing , cardiomyopathy from 03Oct2012 and ongoing  and shingles from an unknown date. There were no concomitant medications. On 05Feb2021 the patient experienced rash and warmth, both serious due to disability and medically significant. Treatment included increased O2 use to full time (as reported). It was reported that patient did not have shingles. He was relating the sensation of the burning and stinging on his skin (unspecified date in 2021) to the feeling of shingles (which he has had before). Outcome of rash and warmth was not recovered, outcome of the other events was unknown.; Sender's Comments: Based on the available information in the case, the causal association between the events rash, feeling hot and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021167847 Same patient and drug, different AE and dose