chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Visual impairment
Clinical narrative: NEUROLOGIC ISSUES; DYSTONIC REACTIONS; DIFFICULTY IN BREATHING; CHEST TIGHTNESS; SEEING ISSUES; BRAIN FOG; SWEATING UNCONTROLLABLY; CONVULSIONS; FLU-LIKE SYMPTOMS; PAIN IN ARM; STOMACH PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. Immediately after vaccination on 08-APR-2021 the patient felt arm pain, felt okay when she got home and was able to take care of family. Woke up with a fever the next day and body aches with flu-like symptoms. The next morning she felt okay, by the next day she felt something was really wrong, she started sweating uncontrollably and she collapsed on her bedroom floor and started shaking uncontrollably and could not breathe/see very well. Patient was able to get to the entrance of the house and lost control of her bladder and continued to have convulsions. On 08-APR-2021, the patient was hospitalized. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating uncontrollably on APR-2021, flu-like symptoms/fever/body ache on 09-APR-2021, and pain in arm on 07-APR-2021, was recovering from dystonic reaction, difficulty breathing, and convulsions/collapsed on bedroom floor/shaking uncontrollably/lost control of bladder, had not recovered from neurologic issues, seeing issues, brain fog, and chest tightness, and the outcome of stomach pain was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210429120- covid-19 vaccine ad26.cov2.s-Convulsions,dystonic reaction, difficulty breathing, chest tightness, neurologic issues, seeing issue, brain fog, sweating uncontrollably. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Herpes zoster, Hypoaesthesia, Magnetic resonance imaging spinal abnormal, Sensory loss, Spinal cord disorder
Clinical narrative: Shingles outbreak; This is a spontaneous report from a contactable consumer. A 40-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 40 years, via an unspecified route of administration, administered in Arm Left on 01Mar2021 09:00 (Batch/Lot Number: EN6200) as a single dose for covid-19 immunization. The patient's medical history included known allergies to Penicillin. Concomitant medication included doxycycline monohydrate (DOXYCYCLINE MONOHYDRATE) taken for an unspecified indication, start and stop date were not reported. The patient experienced shingles outbreak on 07Mar2021 06:00 which she never had before. It was unknown if patient was treated for the event. She was advised by her doctor to still proceed with the second shot which she got on 25Mar2021. Patient would be speaking with a neurologist week and doing additional test/scans. The patient was tested negative for Covid-19 on 07Apr2021. The outcome of the event  was not recovered
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Herpes zoster, SARS-CoV-2 test
Clinical narrative: Shingles outbreak; This is a spontaneous report from a contactable consumer. A 40-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 40 years, via an unspecified route of administration, administered in Arm Left on 01Mar2021 09:00 (Batch/Lot Number: EN6200) as a single dose for covid-19 immunization. The patient's medical history included known allergies to Penicillin. Concomitant medication included doxycycline monohydrate (DOXYCYCLINE MONOHYDRATE) taken for an unspecified indication, start and stop date were not reported. The patient experienced shingles outbreak on 07Mar2021 06:00 which she never had before. It was unknown if patient was treated for the event. She was advised by her doctor to still proceed with the second shot which she got on 25Mar2021. Patient would be speaking with a neurologist week and doing additional test/scans. The patient was tested negative for Covid-19 on 07Apr2021. The outcome of the event  was not recovered
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Demyelination, Herpes zoster, Hypoaesthesia, Magnetic resonance imaging spinal abnormal, Myelitis transverse
Clinical narrative: Shingles outbreak; This is a spontaneous report from a contactable consumer. A 40-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 40 years, via an unspecified route of administration, administered in Arm Left on 01Mar2021 09:00 (Batch/Lot Number: EN6200) as a single dose for covid-19 immunization. The patient's medical history included known allergies to Penicillin. Concomitant medication included doxycycline monohydrate (DOXYCYCLINE MONOHYDRATE) taken for an unspecified indication, start and stop date were not reported. The patient experienced shingles outbreak on 07Mar2021 06:00 which she never had before. It was unknown if patient was treated for the event. She was advised by her doctor to still proceed with the second shot which she got on 25Mar2021. Patient would be speaking with a neurologist week and doing additional test/scans. The patient was tested negative for Covid-19 on 07Apr2021. The outcome of the event  was not recovered
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: Shingles outbreak; This is a spontaneous report from a contactable consumer. A 40-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 40 years, via an unspecified route of administration, administered in Arm Left on 01Mar2021 09:00 (Batch/Lot Number: EN6200) as a single dose for covid-19 immunization. The patient's medical history included known allergies to Penicillin. Concomitant medication included doxycycline monohydrate (DOXYCYCLINE MONOHYDRATE) taken for an unspecified indication, start and stop date were not reported. The patient experienced shingles outbreak on 07Mar2021 06:00 which she never had before. It was unknown if patient was treated for the event. She was advised by her doctor to still proceed with the second shot which she got on 25Mar2021. Patient would be speaking with a neurologist week and doing additional test/scans. The patient was tested negative for Covid-19 on 07Apr2021. The outcome of the event  was not recovered
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood glucose, Herpes simplex test negative, Herpes zoster, Lumbar puncture, Magnetic resonance imaging head abnormal
Clinical narrative: Shingles outbreak; This is a spontaneous report from a contactable consumer. A 40-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 40 years, via an unspecified route of administration, administered in Arm Left on 01Mar2021 09:00 (Batch/Lot Number: EN6200) as a single dose for covid-19 immunization. The patient's medical history included known allergies to Penicillin. Concomitant medication included doxycycline monohydrate (DOXYCYCLINE MONOHYDRATE) taken for an unspecified indication, start and stop date were not reported. The patient experienced shingles outbreak on 07Mar2021 06:00 which she never had before. It was unknown if patient was treated for the event. She was advised by her doctor to still proceed with the second shot which she got on 25Mar2021. Patient would be speaking with a neurologist week and doing additional test/scans. The patient was tested negative for Covid-19 on 07Apr2021. The outcome of the event  was not recovered
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging spinal abnormal, Paraesthesia, Protein total, Rash vesicular, Scab
Clinical narrative: Shingles outbreak; This is a spontaneous report from a contactable consumer. A 40-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 40 years, via an unspecified route of administration, administered in Arm Left on 01Mar2021 09:00 (Batch/Lot Number: EN6200) as a single dose for covid-19 immunization. The patient's medical history included known allergies to Penicillin. Concomitant medication included doxycycline monohydrate (DOXYCYCLINE MONOHYDRATE) taken for an unspecified indication, start and stop date were not reported. The patient experienced shingles outbreak on 07Mar2021 06:00 which she never had before. It was unknown if patient was treated for the event. She was advised by her doctor to still proceed with the second shot which she got on 25Mar2021. Patient would be speaking with a neurologist week and doing additional test/scans. The patient was tested negative for Covid-19 on 07Apr2021. The outcome of the event  was not recovered
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Skin tightness, Varicella virus test negative, Vertebral lesion
Clinical narrative: Shingles outbreak; This is a spontaneous report from a contactable consumer. A 40-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 40 years, via an unspecified route of administration, administered in Arm Left on 01Mar2021 09:00 (Batch/Lot Number: EN6200) as a single dose for covid-19 immunization. The patient's medical history included known allergies to Penicillin. Concomitant medication included doxycycline monohydrate (DOXYCYCLINE MONOHYDRATE) taken for an unspecified indication, start and stop date were not reported. The patient experienced shingles outbreak on 07Mar2021 06:00 which she never had before. It was unknown if patient was treated for the event. She was advised by her doctor to still proceed with the second shot which she got on 25Mar2021. Patient would be speaking with a neurologist week and doing additional test/scans. The patient was tested negative for Covid-19 on 07Apr2021. The outcome of the event  was not recovered
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear discomfort, Erythema, Headache, Muscle spasms, Muscle tightness
Clinical narrative: this feels like an auto immune thyroid attack; headache/pain in back of head; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area/ The area is also really red and warm to the touch; frontal neck muscles are contracting under chin and on the sides; throat is burning; The area is also really red and warm to the touch; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 03Apr2021 at 14:15 (02:15 PM) (at the age of 55 years old) (Batch/Lot number was not reported) as a single dose for COVID-19 immunization; and thyroid (ARMOUR THYROID) via unspecified route of administration on unspecified date at 15mg for unspecified indication. Medical history included hypothyroidism and known allergies to sulfa drugs.  The patient previously took quinolines and experienced allergies. On 04Apr2021 at 10:00 AM, the patient experienced headache/pain in back of head, but also serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area. This began on day 2 and increased days 3,4,5,6, it became very pronounced after taking Armor Thyroid 15mg medication. It also feels like her frontal neck muscles are contracting under chin and on the sides and throat is burning. The patient called her doctor but no return call yet. She had normal labs several weeks ago for thyroid. She went today again as this feels like an auto immune thyroid attack. The area is also really red and warm to the touch. The patient did not receive other vaccine in four weeks. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination.  The patient did not received treatment for the events. The events resulted in doctor or other healthcare professional office/clinic visit. The action taken in response to the events for ARMOUR THYROID was unknown. The patient had not yet recovered from the events.    Information on the lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neck pain, Skin burning sensation, Thyroid function test, Tongue discomfort
Clinical narrative: this feels like an auto immune thyroid attack; headache/pain in back of head; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area/ The area is also really red and warm to the touch; frontal neck muscles are contracting under chin and on the sides; throat is burning; The area is also really red and warm to the touch; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 03Apr2021 at 14:15 (02:15 PM) (at the age of 55 years old) (Batch/Lot number was not reported) as a single dose for COVID-19 immunization; and thyroid (ARMOUR THYROID) via unspecified route of administration on unspecified date at 15mg for unspecified indication. Medical history included hypothyroidism and known allergies to sulfa drugs.  The patient previously took quinolines and experienced allergies. On 04Apr2021 at 10:00 AM, the patient experienced headache/pain in back of head, but also serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area. This began on day 2 and increased days 3,4,5,6, it became very pronounced after taking Armor Thyroid 15mg medication. It also feels like her frontal neck muscles are contracting under chin and on the sides and throat is burning. The patient called her doctor but no return call yet. She had normal labs several weeks ago for thyroid. She went today again as this feels like an auto immune thyroid attack. The area is also really red and warm to the touch. The patient did not receive other vaccine in four weeks. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination.  The patient did not received treatment for the events. The events resulted in doctor or other healthcare professional office/clinic visit. The action taken in response to the events for ARMOUR THYROID was unknown. The patient had not yet recovered from the events.    Information on the lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Autoimmune thyroid disorder, Burning sensation, Chest pain, Erythema, Feeling hot
Clinical narrative: this feels like an auto immune thyroid attack; headache/pain in back of head; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area/ The area is also really red and warm to the touch; frontal neck muscles are contracting under chin and on the sides; throat is burning; The area is also really red and warm to the touch; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 03Apr2021 at 14:15 (02:15 PM) (at the age of 55 years old) (Batch/Lot number was not reported) as a single dose for COVID-19 immunization; and thyroid (ARMOUR THYROID) via unspecified route of administration on unspecified date at 15mg for unspecified indication. Medical history included hypothyroidism and known allergies to sulfa drugs.  The patient previously took quinolines and experienced allergies. On 04Apr2021 at 10:00 AM, the patient experienced headache/pain in back of head, but also serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area. This began on day 2 and increased days 3,4,5,6, it became very pronounced after taking Armor Thyroid 15mg medication. It also feels like her frontal neck muscles are contracting under chin and on the sides and throat is burning. The patient called her doctor but no return call yet. She had normal labs several weeks ago for thyroid. She went today again as this feels like an auto immune thyroid attack. The area is also really red and warm to the touch. The patient did not receive other vaccine in four weeks. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination.  The patient did not received treatment for the events. The events resulted in doctor or other healthcare professional office/clinic visit. The action taken in response to the events for ARMOUR THYROID was unknown. The patient had not yet recovered from the events.    Information on the lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Muscle contractions involuntary, Neck pain, Throat irritation, Thyroid function test
Clinical narrative: this feels like an auto immune thyroid attack; headache/pain in back of head; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area/ The area is also really red and warm to the touch; frontal neck muscles are contracting under chin and on the sides; throat is burning; The area is also really red and warm to the touch; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 03Apr2021 at 14:15 (02:15 PM) (at the age of 55 years old) (Batch/Lot number was not reported) as a single dose for COVID-19 immunization; and thyroid (ARMOUR THYROID) via unspecified route of administration on unspecified date at 15mg for unspecified indication. Medical history included hypothyroidism and known allergies to sulfa drugs.  The patient previously took quinolines and experienced allergies. On 04Apr2021 at 10:00 AM, the patient experienced headache/pain in back of head, but also serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area. This began on day 2 and increased days 3,4,5,6, it became very pronounced after taking Armor Thyroid 15mg medication. It also feels like her frontal neck muscles are contracting under chin and on the sides and throat is burning. The patient called her doctor but no return call yet. She had normal labs several weeks ago for thyroid. She went today again as this feels like an auto immune thyroid attack. The area is also really red and warm to the touch. The patient did not receive other vaccine in four weeks. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination.  The patient did not received treatment for the events. The events resulted in doctor or other healthcare professional office/clinic visit. The action taken in response to the events for ARMOUR THYROID was unknown. The patient had not yet recovered from the events.    Information on the lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thyroid pain
Clinical narrative: this feels like an auto immune thyroid attack; headache/pain in back of head; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area; serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area/ The area is also really red and warm to the touch; frontal neck muscles are contracting under chin and on the sides; throat is burning; The area is also really red and warm to the touch; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 03Apr2021 at 14:15 (02:15 PM) (at the age of 55 years old) (Batch/Lot number was not reported) as a single dose for COVID-19 immunization; and thyroid (ARMOUR THYROID) via unspecified route of administration on unspecified date at 15mg for unspecified indication. Medical history included hypothyroidism and known allergies to sulfa drugs.  The patient previously took quinolines and experienced allergies. On 04Apr2021 at 10:00 AM, the patient experienced headache/pain in back of head, but also serious pain heat burning and redness in front of neck and sides of neck thyroid and chest area. This began on day 2 and increased days 3,4,5,6, it became very pronounced after taking Armor Thyroid 15mg medication. It also feels like her frontal neck muscles are contracting under chin and on the sides and throat is burning. The patient called her doctor but no return call yet. She had normal labs several weeks ago for thyroid. She went today again as this feels like an auto immune thyroid attack. The area is also really red and warm to the touch. The patient did not receive other vaccine in four weeks. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination.  The patient did not received treatment for the events. The events resulted in doctor or other healthcare professional office/clinic visit. The action taken in response to the events for ARMOUR THYROID was unknown. The patient had not yet recovered from the events.    Information on the lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dysstasia, Erythema, Feeling hot
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for herself, a 60-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Ew0158), via an unspecified route of administration, administered in right arm on 08Apr2021 at 16:00 (at the age of 60 years old) at a single dose for COVID-19 immunization. Medical history included overactive immune system, valley fever, Lyme disease, and known allergies to penicillin and morphine. The patient was not pregnant at the time of vaccination. Patient had no COVID prior to vaccination and was not COVID tested post vaccination. Concomitant medications included supplements. Patient had no other vaccines in four weeks. On 09Apr2021, patient experienced very sore arm and vertigo. Then 24 hours later, on 10Apr2021, a feeling of dizziness/severe dizziness and nausea that comes and goes - which has been going on for days. It felt like patient was about to pass out. The patient was not able to stand, she can't stand up. Her body suddenly got hot then followed by feeling chills, but no fever. She was feeling so odd and severe brain fog. The patient was feeling so ill. She tried to call Pfizer because she wanted to know how long this will be going on. She didn't know whether to take the second dose. She felt so sick she couldn't drive or work. The events resulted in doctor or other healthcare professional office/clinic visit. Unspecified treatment was received for the events vertigo, dizziness, nausea, "Not able to stand/can't stand up" and "feeling so ill/feel so sick". The outcome of the events was not recovered.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Dysstasia, Feeling abnormal, Feeling hot
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for herself, a 60-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Ew0158), via an unspecified route of administration, administered in right arm on 08Apr2021 at 16:00 (at the age of 60 years old) at a single dose for COVID-19 immunization. Medical history included overactive immune system, valley fever, Lyme disease, and known allergies to penicillin and morphine. The patient was not pregnant at the time of vaccination. Patient had no COVID prior to vaccination and was not COVID tested post vaccination. Concomitant medications included supplements. Patient had no other vaccines in four weeks. On 09Apr2021, patient experienced very sore arm and vertigo. Then 24 hours later, on 10Apr2021, a feeling of dizziness/severe dizziness and nausea that comes and goes - which has been going on for days. It felt like patient was about to pass out. The patient was not able to stand, she can't stand up. Her body suddenly got hot then followed by feeling chills, but no fever. She was feeling so odd and severe brain fog. The patient was feeling so ill. She tried to call Pfizer because she wanted to know how long this will be going on. She didn't know whether to take the second dose. She felt so sick she couldn't drive or work. The events resulted in doctor or other healthcare professional office/clinic visit. Unspecified treatment was received for the events vertigo, dizziness, nausea, "Not able to stand/can't stand up" and "feeling so ill/feel so sick". The outcome of the events was not recovered.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Nausea, Pain in extremity, Presyncope, Vertigo
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for herself, a 60-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Ew0158), via an unspecified route of administration, administered in right arm on 08Apr2021 at 16:00 (at the age of 60 years old) at a single dose for COVID-19 immunization. Medical history included overactive immune system, valley fever, Lyme disease, and known allergies to penicillin and morphine. The patient was not pregnant at the time of vaccination. Patient had no COVID prior to vaccination and was not COVID tested post vaccination. Concomitant medications included supplements. Patient had no other vaccines in four weeks. On 09Apr2021, patient experienced very sore arm and vertigo. Then 24 hours later, on 10Apr2021, a feeling of dizziness/severe dizziness and nausea that comes and goes - which has been going on for days. It felt like patient was about to pass out. The patient was not able to stand, she can't stand up. Her body suddenly got hot then followed by feeling chills, but no fever. She was feeling so odd and severe brain fog. The patient was feeling so ill. She tried to call Pfizer because she wanted to know how long this will be going on. She didn't know whether to take the second dose. She felt so sick she couldn't drive or work. The events resulted in doctor or other healthcare professional office/clinic visit. Unspecified treatment was received for the events vertigo, dizziness, nausea, "Not able to stand/can't stand up" and "feeling so ill/feel so sick". The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram head, Computerised tomogram thorax, Electrocardiogram, Pain in extremity, Pneumonia
Clinical narrative: LEFT LOWER LEG PAIN; BLOOD CLOT IN THE LEG; This spontaneous report received from a patient concerned female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: 06-SEP-2021) dose was not reported,1 total administered on 24-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the patient experienced severe pain in the left lower leg and received medical care and then she went to the hospital. The patient had a CT scan (Computerized tomography) of the lungs and head along with Doppler scan.  The patient experienced blood clot in the leg. The patient was treated with Xarelto. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood clot in the leg, and had not recovered from left lower leg pain. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 This report concerns concerned a female patient with unspecified age who had a blood clot in the leg, after unknown days of receiving Jansen vaccine. On an unspecified date, the patient experienced severe pain in the left lower leg. A CT scan of the lungs and head along with Doppler scan revealed a blood clot in the leg. The patient was treated with Xarelto and recovering from the events. This case has insufficient information to make a meaningful medical assessment. Additional information has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test, Scan with contrast, Ultrasound Doppler abnormal
Clinical narrative: LEFT LOWER LEG PAIN; BLOOD CLOT IN THE LEG; This spontaneous report received from a patient concerned female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: 06-SEP-2021) dose was not reported,1 total administered on 24-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the patient experienced severe pain in the left lower leg and received medical care and then she went to the hospital. The patient had a CT scan (Computerized tomography) of the lungs and head along with Doppler scan.  The patient experienced blood clot in the leg. The patient was treated with Xarelto. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood clot in the leg, and had not recovered from left lower leg pain. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 This report concerns concerned a female patient with unspecified age who had a blood clot in the leg, after unknown days of receiving Jansen vaccine. On an unspecified date, the patient experienced severe pain in the left lower leg. A CT scan of the lungs and head along with Doppler scan revealed a blood clot in the leg. The patient was treated with Xarelto and recovering from the events. This case has insufficient information to make a meaningful medical assessment. Additional information has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Pain in extremity, Thrombosis, Ultrasound Doppler
Clinical narrative: LEFT LOWER LEG PAIN; BLOOD CLOT IN THE LEG; This spontaneous report received from a patient concerned female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: 06-SEP-2021) dose was not reported,1 total administered on 24-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the patient experienced severe pain in the left lower leg and received medical care and then she went to the hospital. The patient had a CT scan (Computerized tomography) of the lungs and head along with Doppler scan.  The patient experienced blood clot in the leg. The patient was treated with Xarelto. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood clot in the leg, and had not recovered from left lower leg pain. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 This report concerns concerned a female patient with unspecified age who had a blood clot in the leg, after unknown days of receiving Jansen vaccine. On an unspecified date, the patient experienced severe pain in the left lower leg. A CT scan of the lungs and head along with Doppler scan revealed a blood clot in the leg. The patient was treated with Xarelto and recovering from the events. This case has insufficient information to make a meaningful medical assessment. Additional information has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling cold, Pain, Pain in extremity, Thrombosis, Ventilation/perfusion scan
Clinical narrative: LEFT LOWER LEG PAIN; BLOOD CLOT IN THE LEG; This spontaneous report received from a patient concerned female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: 06-SEP-2021) dose was not reported,1 total administered on 24-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the patient experienced severe pain in the left lower leg and received medical care and then she went to the hospital. The patient had a CT scan (Computerized tomography) of the lungs and head along with Doppler scan.  The patient experienced blood clot in the leg. The patient was treated with Xarelto. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood clot in the leg, and had not recovered from left lower leg pain. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 This report concerns concerned a female patient with unspecified age who had a blood clot in the leg, after unknown days of receiving Jansen vaccine. On an unspecified date, the patient experienced severe pain in the left lower leg. A CT scan of the lungs and head along with Doppler scan revealed a blood clot in the leg. The patient was treated with Xarelto and recovering from the events. This case has insufficient information to make a meaningful medical assessment. Additional information has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Weight bearing difficulty
Clinical narrative: LEFT LOWER LEG PAIN; BLOOD CLOT IN THE LEG; This spontaneous report received from a patient concerned female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: 06-SEP-2021) dose was not reported,1 total administered on 24-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the patient experienced severe pain in the left lower leg and received medical care and then she went to the hospital. The patient had a CT scan (Computerized tomography) of the lungs and head along with Doppler scan.  The patient experienced blood clot in the leg. The patient was treated with Xarelto. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood clot in the leg, and had not recovered from left lower leg pain. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 This report concerns concerned a female patient with unspecified age who had a blood clot in the leg, after unknown days of receiving Jansen vaccine. On an unspecified date, the patient experienced severe pain in the left lower leg. A CT scan of the lungs and head along with Doppler scan revealed a blood clot in the leg. The patient was treated with Xarelto and recovering from the events. This case has insufficient information to make a meaningful medical assessment. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Colitis ischaemic, Colonoscopy, Computerised tomogram abnormal, Diarrhoea
Clinical narrative: portal vein thrombosis; ischemic colitis; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in the left arm, on 07Apr2021 at 09:30 AM at the age of 51-years-old as single dose for COVID-19 immunization. The vaccination facility type was pharmacy or drug store. The patient was not pregnant. The patient had no other vaccine in four weeks. The patient had no medical history and had no known allergies. Concomitant medications included estradiol patch and cyanocobalamin (VIT B12); both taken for unspecified indications, start and stop dates were not reported (reported as other medications in two weeks). The patient previously received the first dose of BNT162B2, administered in the left arm on 10Mar2021 at 08:45 AM at the age of 51-years-old for COVID-19 immunization. The patient reported that at 11:30 pm on 07Apr2021, she had extreme, spontaneous, stomach cramps that was so bad she thought she was going to pass out. That lasted for one hour, then diarrhea. A few hours later, she started blood red rectal bleeding. At the hospital (on Apr2021), she was diagnosed with Ishemic colitis (from colonoscopy) and a blood clot was also found, portal vein thrombosis. She was 100% certain the extreme stomach cramps were brought on by the vaccine and that in turn caused the ishemic colitis; the blood clot may or may not have already been there. The patient reported that the doctors at the hospital were quite put off to try to tie any relation to this episode with the vaccine which was quite frustrating to the patient as it was quite obvious (as reported). The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization. The patient was hospitalized for 2 days in Apr2021. On treatment for the events, the patient reported that the colitis healed on its own, and she was on blood thinners. The patient had no COVID prior the vaccination. The patient was test for COVID post vaccination which was a nasal swab with a negative result on 08Apr2021. The outcome of the events was recovering.   Information on the lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Portal vein thrombosis, Rectal haemorrhage
Clinical narrative: portal vein thrombosis; ischemic colitis; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in the left arm, on 07Apr2021 at 09:30 AM at the age of 51-years-old as single dose for COVID-19 immunization. The vaccination facility type was pharmacy or drug store. The patient was not pregnant. The patient had no other vaccine in four weeks. The patient had no medical history and had no known allergies. Concomitant medications included estradiol patch and cyanocobalamin (VIT B12); both taken for unspecified indications, start and stop dates were not reported (reported as other medications in two weeks). The patient previously received the first dose of BNT162B2, administered in the left arm on 10Mar2021 at 08:45 AM at the age of 51-years-old for COVID-19 immunization. The patient reported that at 11:30 pm on 07Apr2021, she had extreme, spontaneous, stomach cramps that was so bad she thought she was going to pass out. That lasted for one hour, then diarrhea. A few hours later, she started blood red rectal bleeding. At the hospital (on Apr2021), she was diagnosed with Ishemic colitis (from colonoscopy) and a blood clot was also found, portal vein thrombosis. She was 100% certain the extreme stomach cramps were brought on by the vaccine and that in turn caused the ishemic colitis; the blood clot may or may not have already been there. The patient reported that the doctors at the hospital were quite put off to try to tie any relation to this episode with the vaccine which was quite frustrating to the patient as it was quite obvious (as reported). The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization. The patient was hospitalized for 2 days in Apr2021. On treatment for the events, the patient reported that the colitis healed on its own, and she was on blood thinners. The patient had no COVID prior the vaccination. The patient was test for COVID post vaccination which was a nasal swab with a negative result on 08Apr2021. The outcome of the events was recovering.   Information on the lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Colitis ischaemic, Colonoscopy, Portal vein thrombosis, SARS-CoV-2 test
Clinical narrative: portal vein thrombosis; ischemic colitis; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in the left arm, on 07Apr2021 at 09:30 AM at the age of 51-years-old as single dose for COVID-19 immunization. The vaccination facility type was pharmacy or drug store. The patient was not pregnant. The patient had no other vaccine in four weeks. The patient had no medical history and had no known allergies. Concomitant medications included estradiol patch and cyanocobalamin (VIT B12); both taken for unspecified indications, start and stop dates were not reported (reported as other medications in two weeks). The patient previously received the first dose of BNT162B2, administered in the left arm on 10Mar2021 at 08:45 AM at the age of 51-years-old for COVID-19 immunization. The patient reported that at 11:30 pm on 07Apr2021, she had extreme, spontaneous, stomach cramps that was so bad she thought she was going to pass out. That lasted for one hour, then diarrhea. A few hours later, she started blood red rectal bleeding. At the hospital (on Apr2021), she was diagnosed with Ishemic colitis (from colonoscopy) and a blood clot was also found, portal vein thrombosis. She was 100% certain the extreme stomach cramps were brought on by the vaccine and that in turn caused the ishemic colitis; the blood clot may or may not have already been there. The patient reported that the doctors at the hospital were quite put off to try to tie any relation to this episode with the vaccine which was quite frustrating to the patient as it was quite obvious (as reported). The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization. The patient was hospitalized for 2 days in Apr2021. On treatment for the events, the patient reported that the colitis healed on its own, and she was on blood thinners. The patient had no COVID prior the vaccination. The patient was test for COVID post vaccination which was a nasal swab with a negative result on 08Apr2021. The outcome of the events was recovering.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea
Clinical narrative: ALL THE SIDE EFFECTS; STILL DON'T FEEL WELL; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced all the side effects. On APR-2021, the subject experienced still don't feel well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from still don't feel well, and the outcome of all the side effects was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Adverse event, Malaise
Clinical narrative: ALL THE SIDE EFFECTS; STILL DON'T FEEL WELL; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced all the side effects. On APR-2021, the subject experienced still don't feel well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from still don't feel well, and the outcome of all the side effects was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism
Clinical narrative: AE = PE/DVT.  Difficult to say if vaccine played an ancillary role (very short time course).  Treatment = anticoagulation with apixaban.  Outcome = patient discharged from hospital in good condition after 2 days.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anticoagulant therapy, Computerised tomogram thorax abnormal, Deep vein thrombosis, Pulmonary embolism, Pulmonary infarction
Clinical narrative: AE = PE/DVT.  Difficult to say if vaccine played an ancillary role (very short time course).  Treatment = anticoagulation with apixaban.  Outcome = patient discharged from hospital in good condition after 2 days.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ultrasound Doppler abnormal
Clinical narrative: AE = PE/DVT.  Difficult to say if vaccine played an ancillary role (very short time course).  Treatment = anticoagulation with apixaban.  Outcome = patient discharged from hospital in good condition after 2 days.
Age: 95.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Pt had an ED visit and/or hospitalization within 6 weeks of COVID vaccine
Age: 95.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Pt had an ED visit and/or hospitalization within 6 weeks of COVID vaccine