chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dizziness, Flushing, Malaise, Pallor
Clinical narrative: intermittent dizziness; felt a "closing in" sensation/brain fog; pulse and blood pressure went up; pulse and blood pressure went up; severe headache; hot flushing; chest tightness; started getting pale; sweating; peripheral perfusion worsened; palpitations; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), intramuscular in left arm on 31Dec2020 at 08:15 AM at a single dose for COVID-19 immunization in a workplace clinic.  Medical history included mild asthma and known allergies to bee stings.  There were no concomitant medications.  Within a few minutes of the vaccine on 31Dec2020, the patient felt a "closing in" sensation and then her pulse and blood pressure went up. She developed a severe headache and hot flushing with chest tightness. The medical team gave her epinephrine in right thigh and she felt a bit better. Then she started getting pale, sweating, and peripheral perfusion worsened so she was given a second dose of epi. She started feeling better, but had a headache, palpitations and "brain fog" for about 5 days after and she still having intermittent dizziness (unspecified date). The patient received epinephrine IM and benadryl IV push for the events. The events resulted in emergency room/department or urgent care visit. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks and other medications in two weeks. The patient recovered from the events with lasting effects. The patient had not yet recovered from the event dizziness, while the patient recovered with sequelae for the remaining events.   Information on the lot/batch number has been requested.; Sender's Comments: The reported events were likely related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship.  The case will be reassessed should additional information become 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.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations
Clinical narrative: intermittent dizziness; felt a "closing in" sensation/brain fog; pulse and blood pressure went up; pulse and blood pressure went up; severe headache; hot flushing; chest tightness; started getting pale; sweating; peripheral perfusion worsened; palpitations; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), intramuscular in left arm on 31Dec2020 at 08:15 AM at a single dose for COVID-19 immunization in a workplace clinic.  Medical history included mild asthma and known allergies to bee stings.  There were no concomitant medications.  Within a few minutes of the vaccine on 31Dec2020, the patient felt a "closing in" sensation and then her pulse and blood pressure went up. She developed a severe headache and hot flushing with chest tightness. The medical team gave her epinephrine in right thigh and she felt a bit better. Then she started getting pale, sweating, and peripheral perfusion worsened so she was given a second dose of epi. She started feeling better, but had a headache, palpitations and "brain fog" for about 5 days after and she still having intermittent dizziness (unspecified date). The patient received epinephrine IM and benadryl IV push for the events. The events resulted in emergency room/department or urgent care visit. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks and other medications in two weeks. The patient recovered from the events with lasting effects. The patient had not yet recovered from the event dizziness, while the patient recovered with sequelae for the remaining events.   Information on the lot/batch number has been requested.; Sender's Comments: The reported events were likely related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship.  The case will be reassessed should additional information become 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.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Chest discomfort, Dizziness, Feeling abnormal, Headache
Clinical narrative: intermittent dizziness; felt a "closing in" sensation/brain fog; pulse and blood pressure went up; pulse and blood pressure went up; severe headache; hot flushing; chest tightness; started getting pale; sweating; peripheral perfusion worsened; palpitations; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), intramuscular in left arm on 31Dec2020 at 08:15 AM at a single dose for COVID-19 immunization in a workplace clinic.  Medical history included mild asthma and known allergies to bee stings.  There were no concomitant medications.  Within a few minutes of the vaccine on 31Dec2020, the patient felt a "closing in" sensation and then her pulse and blood pressure went up. She developed a severe headache and hot flushing with chest tightness. The medical team gave her epinephrine in right thigh and she felt a bit better. Then she started getting pale, sweating, and peripheral perfusion worsened so she was given a second dose of epi. She started feeling better, but had a headache, palpitations and "brain fog" for about 5 days after and she still having intermittent dizziness (unspecified date). The patient received epinephrine IM and benadryl IV push for the events. The events resulted in emergency room/department or urgent care visit. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks and other medications in two weeks. The patient recovered from the events with lasting effects. The patient had not yet recovered from the event dizziness, while the patient recovered with sequelae for the remaining events.   Information on the lot/batch number has been requested.; Sender's Comments: The reported events were likely related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship.  The case will be reassessed should additional information become 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.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Hot flush, Hyperhidrosis, Pallor, Palpitations
Clinical narrative: intermittent dizziness; felt a "closing in" sensation/brain fog; pulse and blood pressure went up; pulse and blood pressure went up; severe headache; hot flushing; chest tightness; started getting pale; sweating; peripheral perfusion worsened; palpitations; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), intramuscular in left arm on 31Dec2020 at 08:15 AM at a single dose for COVID-19 immunization in a workplace clinic.  Medical history included mild asthma and known allergies to bee stings.  There were no concomitant medications.  Within a few minutes of the vaccine on 31Dec2020, the patient felt a "closing in" sensation and then her pulse and blood pressure went up. She developed a severe headache and hot flushing with chest tightness. The medical team gave her epinephrine in right thigh and she felt a bit better. Then she started getting pale, sweating, and peripheral perfusion worsened so she was given a second dose of epi. She started feeling better, but had a headache, palpitations and "brain fog" for about 5 days after and she still having intermittent dizziness (unspecified date). The patient received epinephrine IM and benadryl IV push for the events. The events resulted in emergency room/department or urgent care visit. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks and other medications in two weeks. The patient recovered from the events with lasting effects. The patient had not yet recovered from the event dizziness, while the patient recovered with sequelae for the remaining events.   Information on the lot/batch number has been requested.; Sender's Comments: The reported events were likely related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship.  The case will be reassessed should additional information become 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.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Poor peripheral circulation
Clinical narrative: intermittent dizziness; felt a "closing in" sensation/brain fog; pulse and blood pressure went up; pulse and blood pressure went up; severe headache; hot flushing; chest tightness; started getting pale; sweating; peripheral perfusion worsened; palpitations; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), intramuscular in left arm on 31Dec2020 at 08:15 AM at a single dose for COVID-19 immunization in a workplace clinic.  Medical history included mild asthma and known allergies to bee stings.  There were no concomitant medications.  Within a few minutes of the vaccine on 31Dec2020, the patient felt a "closing in" sensation and then her pulse and blood pressure went up. She developed a severe headache and hot flushing with chest tightness. The medical team gave her epinephrine in right thigh and she felt a bit better. Then she started getting pale, sweating, and peripheral perfusion worsened so she was given a second dose of epi. She started feeling better, but had a headache, palpitations and "brain fog" for about 5 days after and she still having intermittent dizziness (unspecified date). The patient received epinephrine IM and benadryl IV push for the events. The events resulted in emergency room/department or urgent care visit. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks and other medications in two weeks. The patient recovered from the events with lasting effects. The patient had not yet recovered from the event dizziness, while the patient recovered with sequelae for the remaining events.   Information on the lot/batch number has been requested.; Sender's Comments: The reported events were likely related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship.  The case will be reassessed should additional information become 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.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic shock, Throat tightness, Urticaria
Clinical narrative: Rash; Hives; Throat started to close up; Voice changed/ Functional dysphonia; This is a spontaneous report from a contactable other health professional reporting for herself. A 43-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL1284), intramuscular in the right arm, on 29Dec2020 at 16:42, at single dose, for COVID-19 immunisation. Medical history included diabetes from an unknown date and unknown if ongoing, blood pressure high from an unknown date and unknown if ongoing, anxiety from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing, migraine from an unknown date and unknown if ongoing, drug allergy to triptans from an unknown date and unknown if ongoing. Past drug event included drug allergy to Topamax and Rocephin both from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient experienced rash on 29Dec2020 at 16:45 with outcome of not recovered, hives on 29Dec2020 at 16:45 with outcome of not recovered, throat started to close up on 29Dec2020 at 16:45 with outcome of not recovered. The patient was given Benadryl and EpiPen and was rushed to the emergency room (ER). The events needed emergency room visit and physician office visit. She was admitted into the hospital for 3 days and received Solu-Medrol and intravenous Benadryl every 6 hours until discharge. The reporter stated that after the reaction her voice changed. She was visited by an otorhinolaryngology (ENT) doctor on 19Jan2021 and she had functional dysphonia. Therapeutic measure included speech therapy. Outcome was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination the patient has not been tested for COVID-19.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for reported events rash, hives and throat tightness. 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.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphonia, Rash, Throat tightness, Urticaria
Clinical narrative: Rash; Hives; Throat started to close up; Voice changed/ Functional dysphonia; This is a spontaneous report from a contactable other health professional reporting for herself. A 43-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL1284), intramuscular in the right arm, on 29Dec2020 at 16:42, at single dose, for COVID-19 immunisation. Medical history included diabetes from an unknown date and unknown if ongoing, blood pressure high from an unknown date and unknown if ongoing, anxiety from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing, migraine from an unknown date and unknown if ongoing, drug allergy to triptans from an unknown date and unknown if ongoing. Past drug event included drug allergy to Topamax and Rocephin both from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient experienced rash on 29Dec2020 at 16:45 with outcome of not recovered, hives on 29Dec2020 at 16:45 with outcome of not recovered, throat started to close up on 29Dec2020 at 16:45 with outcome of not recovered. The patient was given Benadryl and EpiPen and was rushed to the emergency room (ER). The events needed emergency room visit and physician office visit. She was admitted into the hospital for 3 days and received Solu-Medrol and intravenous Benadryl every 6 hours until discharge. The reporter stated that after the reaction her voice changed. She was visited by an otorhinolaryngology (ENT) doctor on 19Jan2021 and she had functional dysphonia. Therapeutic measure included speech therapy. Outcome was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination the patient has not been tested for COVID-19.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for reported events rash, hives and throat tightness. 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.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Chills, Nausea, Poor quality sleep, Tremor
Clinical narrative: nause, stomach cramps, fever blisters, lethargic, weakness
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Asthenia, Lethargy, Nausea, Oral herpes
Clinical narrative: nause, stomach cramps, fever blisters, lethargic, weakness
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Hypoaesthesia, Laboratory test normal, Lymphadenopathy, Perfusion brain scan
Clinical narrative: severe left axillary, supraclavicular and anterior cervical lymphadenopathy; left hand numbness/left facial numbness; tongue numbness; This is a spontaneous report from a contactable physician (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in left arm on 11Jan2021 at 09:45 at a single dose for COVID-19 immunization in a hospital. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Unknown lot number and expiration) on 21Dec2020 at 09:30 AM in left arm for COVID-19 immunization.  Medical history reported as none.  The patient has no allergies to medications, food, or other products. There were no concomitant medications.  48hrs post second dose, the patient woke up with severe left axillary, supraclavicular and anterior cervical lymphadenopathy on 13Jan2021 at 06:15 AM. She also woke up with left hand numbness which she initially attributed to the degree of axillary lymphadenopathy bug 2 hours after waking. The patient also experienced left facial and tongue numbness.  She went to ER and was evaluated for stroke (all studies normal including labs, CT angio/perfusion and MRI brain) in Jan2021. Facial numbness resolved in about 12 hours, left hand sensory issue is lingering but improving. All lymphadenopathy is ongoing and quite significant. The events resulted in emergency room/department or urgent care. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. The patient had not yet recovered from the events severe left axillary, supraclavicular and anterior cervical lymphadenopathy as well as tongue numbness; while recovering from the event left hand numbness/left facial numbness. The events were assessed as non-serious.   Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sensory loss
Clinical narrative: severe left axillary, supraclavicular and anterior cervical lymphadenopathy; left hand numbness/left facial numbness; tongue numbness; This is a spontaneous report from a contactable physician (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in left arm on 11Jan2021 at 09:45 at a single dose for COVID-19 immunization in a hospital. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Unknown lot number and expiration) on 21Dec2020 at 09:30 AM in left arm for COVID-19 immunization.  Medical history reported as none.  The patient has no allergies to medications, food, or other products. There were no concomitant medications.  48hrs post second dose, the patient woke up with severe left axillary, supraclavicular and anterior cervical lymphadenopathy on 13Jan2021 at 06:15 AM. She also woke up with left hand numbness which she initially attributed to the degree of axillary lymphadenopathy bug 2 hours after waking. The patient also experienced left facial and tongue numbness.  She went to ER and was evaluated for stroke (all studies normal including labs, CT angio/perfusion and MRI brain) in Jan2021. Facial numbness resolved in about 12 hours, left hand sensory issue is lingering but improving. All lymphadenopathy is ongoing and quite significant. The events resulted in emergency room/department or urgent care. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. The patient had not yet recovered from the events severe left axillary, supraclavicular and anterior cervical lymphadenopathy as well as tongue numbness; while recovering from the event left hand numbness/left facial numbness. The events were assessed as non-serious.   Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram cerebral, Computerised tomogram head, Hypoaesthesia, Hypoaesthesia oral, Laboratory test
Clinical narrative: severe left axillary, supraclavicular and anterior cervical lymphadenopathy; left hand numbness/left facial numbness; tongue numbness; This is a spontaneous report from a contactable physician (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in left arm on 11Jan2021 at 09:45 at a single dose for COVID-19 immunization in a hospital. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Unknown lot number and expiration) on 21Dec2020 at 09:30 AM in left arm for COVID-19 immunization.  Medical history reported as none.  The patient has no allergies to medications, food, or other products. There were no concomitant medications.  48hrs post second dose, the patient woke up with severe left axillary, supraclavicular and anterior cervical lymphadenopathy on 13Jan2021 at 06:15 AM. She also woke up with left hand numbness which she initially attributed to the degree of axillary lymphadenopathy bug 2 hours after waking. The patient also experienced left facial and tongue numbness.  She went to ER and was evaluated for stroke (all studies normal including labs, CT angio/perfusion and MRI brain) in Jan2021. Facial numbness resolved in about 12 hours, left hand sensory issue is lingering but improving. All lymphadenopathy is ongoing and quite significant. The events resulted in emergency room/department or urgent care. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. The patient had not yet recovered from the events severe left axillary, supraclavicular and anterior cervical lymphadenopathy as well as tongue numbness; while recovering from the event left hand numbness/left facial numbness. The events were assessed as non-serious.   Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Magnetic resonance imaging brain
Clinical narrative: severe left axillary, supraclavicular and anterior cervical lymphadenopathy; left hand numbness/left facial numbness; tongue numbness; This is a spontaneous report from a contactable physician (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in left arm on 11Jan2021 at 09:45 at a single dose for COVID-19 immunization in a hospital. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Unknown lot number and expiration) on 21Dec2020 at 09:30 AM in left arm for COVID-19 immunization.  Medical history reported as none.  The patient has no allergies to medications, food, or other products. There were no concomitant medications.  48hrs post second dose, the patient woke up with severe left axillary, supraclavicular and anterior cervical lymphadenopathy on 13Jan2021 at 06:15 AM. She also woke up with left hand numbness which she initially attributed to the degree of axillary lymphadenopathy bug 2 hours after waking. The patient also experienced left facial and tongue numbness.  She went to ER and was evaluated for stroke (all studies normal including labs, CT angio/perfusion and MRI brain) in Jan2021. Facial numbness resolved in about 12 hours, left hand sensory issue is lingering but improving. All lymphadenopathy is ongoing and quite significant. The events resulted in emergency room/department or urgent care. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. The patient had not yet recovered from the events severe left axillary, supraclavicular and anterior cervical lymphadenopathy as well as tongue numbness; while recovering from the event left hand numbness/left facial numbness. The events were assessed as non-serious.   Information on the lot/batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Chills, Erythema, Eye pain, Headache
Clinical narrative: itching; frontal headache; eye pain on movement; sensitivity to light; arthralgias (wrists, ankles); nausea; chills; fever/chills (up to 39 C); myalgias in the back and contralateral arm; left arm soreness; Redness and swelling at injection site; Redness and swelling at injection site; Lower back pain; This is a spontaneous report from a contactable physician (patient).  A 37-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Lot: EK9231) on 13Jan2021 11:45 at a single dose for covid-19 immunization. Medical history included GERD (gastrooesophageal reflux disease), environmental allergies, Penicillin (but not augmentin) allergies and sulfa allergy.   Concomitant medications included cetirizine hydrochloride (ZYRTEC), esomeprazole, and vitamin d. Histrical vaccine included the first dose of BNT162B2 (lot number: EJI685) on 23Dec2020 12:15 in the left arm, for covid-19 immunization. On 13Jan2021 20:00, patient experienced left arm soreness. Then at 21:00, she experienced myalgias in the back and contralateral arm. At 23:00, she had fever/chills (up to 39 C). The next day (14Jan2021) at 2:30, she had frontal headache, eye pain on movement, sensitivity to light, arthralgias (wrists, ankles), persistent fever and nausea. All these symptoms persisted until exactly 11:48 on 14Jan2021, when everything suddenly got better. Still occasional chills but no fever for the rest of the day, left arm pain persists into 15Jan2021. Redness and swelling at injection site are worse. There was also now itching. Lower back pain persists. The outcome of events left arm soreness, "Redness and swelling at injection site" and lower back pain was not recovering. She was recovering from " myalgias in the back and contralateral arm", fever/chills (up to 39 C), frontal headache, eye pain on movement, sensitivity to light, arthralgias (wrists, ankles), nausea, chills Patient did not receive any treatment for the events.  No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Injection site pruritus, Myalgia, Neck pain, Pain in extremity
Clinical narrative: itching; frontal headache; eye pain on movement; sensitivity to light; arthralgias (wrists, ankles); nausea; chills; fever/chills (up to 39 C); myalgias in the back and contralateral arm; left arm soreness; Redness and swelling at injection site; Redness and swelling at injection site; Lower back pain; This is a spontaneous report from a contactable physician (patient).  A 37-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Lot: EK9231) on 13Jan2021 11:45 at a single dose for covid-19 immunization. Medical history included GERD (gastrooesophageal reflux disease), environmental allergies, Penicillin (but not augmentin) allergies and sulfa allergy.   Concomitant medications included cetirizine hydrochloride (ZYRTEC), esomeprazole, and vitamin d. Histrical vaccine included the first dose of BNT162B2 (lot number: EJI685) on 23Dec2020 12:15 in the left arm, for covid-19 immunization. On 13Jan2021 20:00, patient experienced left arm soreness. Then at 21:00, she experienced myalgias in the back and contralateral arm. At 23:00, she had fever/chills (up to 39 C). The next day (14Jan2021) at 2:30, she had frontal headache, eye pain on movement, sensitivity to light, arthralgias (wrists, ankles), persistent fever and nausea. All these symptoms persisted until exactly 11:48 on 14Jan2021, when everything suddenly got better. Still occasional chills but no fever for the rest of the day, left arm pain persists into 15Jan2021. Redness and swelling at injection site are worse. There was also now itching. Lower back pain persists. The outcome of events left arm soreness, "Redness and swelling at injection site" and lower back pain was not recovering. She was recovering from " myalgias in the back and contralateral arm", fever/chills (up to 39 C), frontal headache, eye pain on movement, sensitivity to light, arthralgias (wrists, ankles), nausea, chills Patient did not receive any treatment for the events.  No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Photophobia, Pyrexia, Sleep disorder
Clinical narrative: itching; frontal headache; eye pain on movement; sensitivity to light; arthralgias (wrists, ankles); nausea; chills; fever/chills (up to 39 C); myalgias in the back and contralateral arm; left arm soreness; Redness and swelling at injection site; Redness and swelling at injection site; Lower back pain; This is a spontaneous report from a contactable physician (patient).  A 37-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Lot: EK9231) on 13Jan2021 11:45 at a single dose for covid-19 immunization. Medical history included GERD (gastrooesophageal reflux disease), environmental allergies, Penicillin (but not augmentin) allergies and sulfa allergy.   Concomitant medications included cetirizine hydrochloride (ZYRTEC), esomeprazole, and vitamin d. Histrical vaccine included the first dose of BNT162B2 (lot number: EJI685) on 23Dec2020 12:15 in the left arm, for covid-19 immunization. On 13Jan2021 20:00, patient experienced left arm soreness. Then at 21:00, she experienced myalgias in the back and contralateral arm. At 23:00, she had fever/chills (up to 39 C). The next day (14Jan2021) at 2:30, she had frontal headache, eye pain on movement, sensitivity to light, arthralgias (wrists, ankles), persistent fever and nausea. All these symptoms persisted until exactly 11:48 on 14Jan2021, when everything suddenly got better. Still occasional chills but no fever for the rest of the day, left arm pain persists into 15Jan2021. Redness and swelling at injection site are worse. There was also now itching. Lower back pain persists. The outcome of events left arm soreness, "Redness and swelling at injection site" and lower back pain was not recovering. She was recovering from " myalgias in the back and contralateral arm", fever/chills (up to 39 C), frontal headache, eye pain on movement, sensitivity to light, arthralgias (wrists, ankles), nausea, chills Patient did not receive any treatment for the events.  No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Body temperature, Chills, Eye pain
Clinical narrative: itching; frontal headache; eye pain on movement; sensitivity to light; arthralgias (wrists, ankles); nausea; chills; fever/chills (up to 39 C); myalgias in the back and contralateral arm; left arm soreness; Redness and swelling at injection site; Redness and swelling at injection site; Lower back pain; This is a spontaneous report from a contactable physician (patient).  A 37-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Lot: EK9231) on 13Jan2021 11:45 at a single dose for covid-19 immunization. Medical history included GERD (gastrooesophageal reflux disease), environmental allergies, Penicillin (but not augmentin) allergies and sulfa allergy.   Concomitant medications included cetirizine hydrochloride (ZYRTEC), esomeprazole, and vitamin d. Histrical vaccine included the first dose of BNT162B2 (lot number: EJI685) on 23Dec2020 12:15 in the left arm, for covid-19 immunization. On 13Jan2021 20:00, patient experienced left arm soreness. Then at 21:00, she experienced myalgias in the back and contralateral arm. At 23:00, she had fever/chills (up to 39 C). The next day (14Jan2021) at 2:30, she had frontal headache, eye pain on movement, sensitivity to light, arthralgias (wrists, ankles), persistent fever and nausea. All these symptoms persisted until exactly 11:48 on 14Jan2021, when everything suddenly got better. Still occasional chills but no fever for the rest of the day, left arm pain persists into 15Jan2021. Redness and swelling at injection site are worse. There was also now itching. Lower back pain persists. The outcome of events left arm soreness, "Redness and swelling at injection site" and lower back pain was not recovering. She was recovering from " myalgias in the back and contralateral arm", fever/chills (up to 39 C), frontal headache, eye pain on movement, sensitivity to light, arthralgias (wrists, ankles), nausea, chills Patient did not receive any treatment for the events.  No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Myalgia, Nausea, Pain in extremity, Photosensitivity reaction
Clinical narrative: itching; frontal headache; eye pain on movement; sensitivity to light; arthralgias (wrists, ankles); nausea; chills; fever/chills (up to 39 C); myalgias in the back and contralateral arm; left arm soreness; Redness and swelling at injection site; Redness and swelling at injection site; Lower back pain; This is a spontaneous report from a contactable physician (patient).  A 37-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Lot: EK9231) on 13Jan2021 11:45 at a single dose for covid-19 immunization. Medical history included GERD (gastrooesophageal reflux disease), environmental allergies, Penicillin (but not augmentin) allergies and sulfa allergy.   Concomitant medications included cetirizine hydrochloride (ZYRTEC), esomeprazole, and vitamin d. Histrical vaccine included the first dose of BNT162B2 (lot number: EJI685) on 23Dec2020 12:15 in the left arm, for covid-19 immunization. On 13Jan2021 20:00, patient experienced left arm soreness. Then at 21:00, she experienced myalgias in the back and contralateral arm. At 23:00, she had fever/chills (up to 39 C). The next day (14Jan2021) at 2:30, she had frontal headache, eye pain on movement, sensitivity to light, arthralgias (wrists, ankles), persistent fever and nausea. All these symptoms persisted until exactly 11:48 on 14Jan2021, when everything suddenly got better. Still occasional chills but no fever for the rest of the day, left arm pain persists into 15Jan2021. Redness and swelling at injection site are worse. There was also now itching. Lower back pain persists. The outcome of events left arm soreness, "Redness and swelling at injection site" and lower back pain was not recovering. She was recovering from " myalgias in the back and contralateral arm", fever/chills (up to 39 C), frontal headache, eye pain on movement, sensitivity to light, arthralgias (wrists, ankles), nausea, chills Patient did not receive any treatment for the events.  No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Pyrexia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: itching; frontal headache; eye pain on movement; sensitivity to light; arthralgias (wrists, ankles); nausea; chills; fever/chills (up to 39 C); myalgias in the back and contralateral arm; left arm soreness; Redness and swelling at injection site; Redness and swelling at injection site; Lower back pain; This is a spontaneous report from a contactable physician (patient).  A 37-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Lot: EK9231) on 13Jan2021 11:45 at a single dose for covid-19 immunization. Medical history included GERD (gastrooesophageal reflux disease), environmental allergies, Penicillin (but not augmentin) allergies and sulfa allergy.   Concomitant medications included cetirizine hydrochloride (ZYRTEC), esomeprazole, and vitamin d. Histrical vaccine included the first dose of BNT162B2 (lot number: EJI685) on 23Dec2020 12:15 in the left arm, for covid-19 immunization. On 13Jan2021 20:00, patient experienced left arm soreness. Then at 21:00, she experienced myalgias in the back and contralateral arm. At 23:00, she had fever/chills (up to 39 C). The next day (14Jan2021) at 2:30, she had frontal headache, eye pain on movement, sensitivity to light, arthralgias (wrists, ankles), persistent fever and nausea. All these symptoms persisted until exactly 11:48 on 14Jan2021, when everything suddenly got better. Still occasional chills but no fever for the rest of the day, left arm pain persists into 15Jan2021. Redness and swelling at injection site are worse. There was also now itching. Lower back pain persists. The outcome of events left arm soreness, "Redness and swelling at injection site" and lower back pain was not recovering. She was recovering from " myalgias in the back and contralateral arm", fever/chills (up to 39 C), frontal headache, eye pain on movement, sensitivity to light, arthralgias (wrists, ankles), nausea, chills Patient did not receive any treatment for the events.  No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Blister rupture, Incorrect route of product administration, Product administered at inappropriate site
Clinical narrative: Received the first vaccination and they put into the subcutaneous tissue instead of into the muscle.; I don't think I got the full vaccination; Hearing impaired; Made a blister and it burst and little fluid also came; This is a spontaneous report from a contactable nurse (patient). A 70-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EJ1686) on an unspecified date at SINGLE DOSE for COVID-19 immunisation. Medical history was none. Concomitant medication included omeprazole. The patient received the first vaccination and they put into the subcutaneous tissue instead of into the muscle. It made a blister and it burst and little fluid also came. The patient did not think she got the full vaccination. The patient needed to know as she was going to go ahead and get the second dose which for her is really the first dose but she need to know how to proceed with and she wanted to make sure that she get her second one, her real second one. Nurse stated, "I need you to talk a little slower, I am hearing impaired and I can't understand you, just a little bit slower." No Treatment received. The outcome was unknown.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Hypoacusis, Incorrect route of product administration, Underdose
Clinical narrative: Received the first vaccination and they put into the subcutaneous tissue instead of into the muscle.; I don't think I got the full vaccination; Hearing impaired; Made a blister and it burst and little fluid also came; This is a spontaneous report from a contactable nurse (patient). A 70-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EJ1686) on an unspecified date at SINGLE DOSE for COVID-19 immunisation. Medical history was none. Concomitant medication included omeprazole. The patient received the first vaccination and they put into the subcutaneous tissue instead of into the muscle. It made a blister and it burst and little fluid also came. The patient did not think she got the full vaccination. The patient needed to know as she was going to go ahead and get the second dose which for her is really the first dose but she need to know how to proceed with and she wanted to make sure that she get her second one, her real second one. Nurse stated, "I need you to talk a little slower, I am hearing impaired and I can't understand you, just a little bit slower." No Treatment received. The outcome was unknown.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Blood pressure increased, Dyspnoea, Heart rate increased, Lip swelling
Clinical narrative: Extremely high blood pressure and heart rate, dizziness, numbness in my face, lips and tongue, tingling and numbness in my fingers  I subsequently chewed three Benadryl tablets; symptoms began to resolve after about 1.5 hrs;  fully resolved approximately 48 hours later
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Swollen tongue
Clinical narrative: Extremely high blood pressure and heart rate, dizziness, numbness in my face, lips and tongue, tingling and numbness in my fingers  I subsequently chewed three Benadryl tablets; symptoms began to resolve after about 1.5 hrs;  fully resolved approximately 48 hours later
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate abnormal, Hypertension, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Extremely high blood pressure and heart rate, dizziness, numbness in my face, lips and tongue, tingling and numbness in my fingers  I subsequently chewed three Benadryl tablets; symptoms began to resolve after about 1.5 hrs;  fully resolved approximately 48 hours later
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Nausea, Pain in extremity, Vomiting
Clinical narrative: rec'd covid vaccine on 1/14, reports symptoms of vertigo, vomiting began on 1/15, on 1/27 still having symptoms of vertigo with some improvement, has been seen by PCP and urgent care, wondering if he should get the second dose of the covid vaccine.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: rec'd covid vaccine on 1/14, reports symptoms of vertigo, vomiting began on 1/15, on 1/27 still having symptoms of vertigo with some improvement, has been seen by PCP and urgent care, wondering if he should get the second dose of the covid vaccine.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Electroencephalogram, Magnetic resonance imaging, Muscle spasms
Clinical narrative: Pressured Speech; Weakness and tremors to both limbs; Weakness and tremors to both limbs; muscle spasm; This is a spontaneous report from a contactable Other HCP (patient).  This 49-year-old male patient received his first dose of intramuscular BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Dec202 at 17:30 in left arm at single dose for COVID-19 immunisation at the age of 49-year-old. Lot number was EK9231. Medical history included gout. Concomitant medications were unknown. On 10Jan2021, the patient experienced Pressured Speech, weakness and tremors to both limbs and muscle spasm. The events resulted in Emergency room/ department or urgent care and Hospitalization for one day. The patient was not treated for the events. COVID was tested post vaccination on 13Jan2021, Nasal Swab, polymerase chain reaction (PCR) and it resulted negative. The patient did not recover from the events.; Sender's Comments: The events pressured speech, weakness and tremors to both limbs ,muscle spasm are less likely related to suspect BNT162B2 administration given the weak time association. The available examination results would be helpful for further assessment. 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.