chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Oral pruritus, Oropharyngeal pain, Pain, Throat irritation
Clinical narrative: I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; This is a spontaneous report from a contactable consumer (patient).  A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration into the left arm on 30Dec2020 at 11:00 as single dose for an unspecified indication.  Medical history included penicillin allergy, sulfa allergy and allergy to nuts from an unspecified date. There were no concomitant medications.  The patient experienced allergic reaction, throat pain, swollen uvula, itching in mouth and throat and shaking that was reported as "had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula" on 30Dec2020, at 11:15.  The events were reported to have resulted in emergency room/department or urgent care.  The events were reported as non-serious. Therapeutic measures were taken as a result of the events: treatment included antihistamine and steroids. Prior to vaccination, the patient had not  diagnosed with COVID-19, not had she been tested for COVID-19 since the vaccination.  The outcome of events was recovering.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up .
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug hypersensitivity, Enlarged uvula, Oral pruritus, Oropharyngeal pain, Throat irritation
Clinical narrative: I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; This is a spontaneous report from a contactable consumer (patient).  A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration into the left arm on 30Dec2020 at 11:00 as single dose for an unspecified indication.  Medical history included penicillin allergy, sulfa allergy and allergy to nuts from an unspecified date. There were no concomitant medications.  The patient experienced allergic reaction, throat pain, swollen uvula, itching in mouth and throat and shaking that was reported as "had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula" on 30Dec2020, at 11:15.  The events were reported to have resulted in emergency room/department or urgent care.  The events were reported as non-serious. Therapeutic measures were taken as a result of the events: treatment included antihistamine and steroids. Prior to vaccination, the patient had not  diagnosed with COVID-19, not had she been tested for COVID-19 since the vaccination.  The outcome of events was recovering.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up .
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; This is a spontaneous report from a contactable consumer (patient).  A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration into the left arm on 30Dec2020 at 11:00 as single dose for an unspecified indication.  Medical history included penicillin allergy, sulfa allergy and allergy to nuts from an unspecified date. There were no concomitant medications.  The patient experienced allergic reaction, throat pain, swollen uvula, itching in mouth and throat and shaking that was reported as "had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula" on 30Dec2020, at 11:15.  The events were reported to have resulted in emergency room/department or urgent care.  The events were reported as non-serious. Therapeutic measures were taken as a result of the events: treatment included antihistamine and steroids. Prior to vaccination, the patient had not  diagnosed with COVID-19, not had she been tested for COVID-19 since the vaccination.  The outcome of events was recovering.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up .
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, C-reactive protein, Chills, Computerised tomogram abdomen, Culture stool
Clinical narrative: blood in the stool; fevers; night sweats; chills; aches; This is a spontaneous report from a contactable Physician reporting for herself. A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. She experienced chills and aches after 24 hours (on 31Dec2020) and experienced significant fevers that wouldn't break and cycles of chills and fevers that would last for 2 hours each cycle over the next 24 hours. She also experienced night sweats and blood in the stool and mentioned it was the first time that happened to a healthy 30 year old like her. She is asking for reports of these side effects, especially blood in the stool and for recommendations regarding taking the 2nd dose as she is still not sure on whether to take it due to hearing that the 2nd dose side effects were worse. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of blood in the stool. 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.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Full blood count, Haematochezia, Hyperhidrosis, Metabolic function test, Night sweats
Clinical narrative: blood in the stool; fevers; night sweats; chills; aches; This is a spontaneous report from a contactable Physician reporting for herself. A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. She experienced chills and aches after 24 hours (on 31Dec2020) and experienced significant fevers that wouldn't break and cycles of chills and fevers that would last for 2 hours each cycle over the next 24 hours. She also experienced night sweats and blood in the stool and mentioned it was the first time that happened to a healthy 30 year old like her. She is asking for reports of these side effects, especially blood in the stool and for recommendations regarding taking the 2nd dose as she is still not sure on whether to take it due to hearing that the 2nd dose side effects were worse. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of blood in the stool. 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.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, Red blood cell sedimentation rate, SARS-CoV-2 test
Clinical narrative: blood in the stool; fevers; night sweats; chills; aches; This is a spontaneous report from a contactable Physician reporting for herself. A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. She experienced chills and aches after 24 hours (on 31Dec2020) and experienced significant fevers that wouldn't break and cycles of chills and fevers that would last for 2 hours each cycle over the next 24 hours. She also experienced night sweats and blood in the stool and mentioned it was the first time that happened to a healthy 30 year old like her. She is asking for reports of these side effects, especially blood in the stool and for recommendations regarding taking the 2nd dose as she is still not sure on whether to take it due to hearing that the 2nd dose side effects were worse. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of blood in the stool. 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.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Haematochezia, Night sweats, Pain, Pyrexia
Clinical narrative: blood in the stool; fevers; night sweats; chills; aches; This is a spontaneous report from a contactable Physician reporting for herself. A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. She experienced chills and aches after 24 hours (on 31Dec2020) and experienced significant fevers that wouldn't break and cycles of chills and fevers that would last for 2 hours each cycle over the next 24 hours. She also experienced night sweats and blood in the stool and mentioned it was the first time that happened to a healthy 30 year old like her. She is asking for reports of these side effects, especially blood in the stool and for recommendations regarding taking the 2nd dose as she is still not sure on whether to take it due to hearing that the 2nd dose side effects were worse. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of blood in the stool. 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: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: rash on her belly and torso area; Left arm soreness; This is a spontaneous report from a contactable nurse (patient). A 54-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EJ1686) via an unspecified route of administration in left arm on 28Dec2020 11:15 at single dose for COVID-19 immunisation. There was no medical history. The patient only takes vitamins; has no underlying conditions. There were no concomitant medications. 20 years ago, the patient had flu like symptoms after the Flu vaccine. Last vaccine was a Tetanus shot 8-10 years ago. The patient received COVID-19 vaccine through hospital on 28Dec2020 at 11:15 in left arm. Left arm soreness noticed in morning on 29Dec2020. Forty-eight hours later (15:00 on 30Dec2020) had a rash on her belly and torso area. Rash was no where else. Is due to get second dose on 18Jan2021. She wants to know if it is OK to receive second dose. Clarified she is referring to the Pfizer COVID-19 Vaccine. Clarified soreness was noticed only in the injection arm. Was noticed in morning. Noticed rash at 15:00 on 30Dec2020. She took benedryl x 3 doses and the rash and symptoms were gone on 31Dec2020. Event outcome of rash on her belly and torso area was recovered on 31Dec2020, while for others was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: rash on her belly and torso area; Left arm soreness; This is a spontaneous report from a contactable nurse (patient). A 54-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EJ1686) via an unspecified route of administration in left arm on 28Dec2020 11:15 at single dose for COVID-19 immunisation. There was no medical history. The patient only takes vitamins; has no underlying conditions. There were no concomitant medications. 20 years ago, the patient had flu like symptoms after the Flu vaccine. Last vaccine was a Tetanus shot 8-10 years ago. The patient received COVID-19 vaccine through hospital on 28Dec2020 at 11:15 in left arm. Left arm soreness noticed in morning on 29Dec2020. Forty-eight hours later (15:00 on 30Dec2020) had a rash on her belly and torso area. Rash was no where else. Is due to get second dose on 18Jan2021. She wants to know if it is OK to receive second dose. Clarified she is referring to the Pfizer COVID-19 Vaccine. Clarified soreness was noticed only in the injection arm. Was noticed in morning. Noticed rash at 15:00 on 30Dec2020. She took benedryl x 3 doses and the rash and symptoms were gone on 31Dec2020. Event outcome of rash on her belly and torso area was recovered on 31Dec2020, while for others was unknown.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis, Facial paresis, Hypoaesthesia, Hypoaesthesia oral, Paraesthesia
Clinical narrative: Left Bell's palsy/left side of face, inability to raise left eyebrow; numbness and paresthesia of tongue; numbness and paresthesia of tongue; pain in left upper arm between elbow and shoulder; tachycardia; elevated blood pressure; This is a spontaneous report from a contactable physician. A 35-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), intramuscular at arm left on 31Dec2020 at single dose for covid-19 immunization. The vaccine was administered at other (as reported). Medical history included asthma (Allergy induced asthma). Concomitant medication within 2 weeks of vaccination included cetirizine hydrochloride (ZYRTEC) from Dec2020 at 10mg daily.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Dec2020, the patient experienced Left Bell's palsy, numbness and paresthesia of tongue, left side of face, inability to raise left eyebrow, pain in left upper arm between elbow and shoulder, tachycardia, elevated blood pressure.  The adverse events result in emergency room/department or urgent care. The patient received treatment for the adverse events which included Prednisone 20mg daily, Valacyclovir 1000mg twice a day. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of events was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the Bell's palsy and other reported events due to temporal relationship.  However, the Bell's palsy may possibly represent a concurrent medical condition.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including viral serologies, and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral
Clinical narrative: Left Bell's palsy/left side of face, inability to raise left eyebrow; numbness and paresthesia of tongue; numbness and paresthesia of tongue; pain in left upper arm between elbow and shoulder; tachycardia; elevated blood pressure; This is a spontaneous report from a contactable physician. A 35-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), intramuscular at arm left on 31Dec2020 at single dose for covid-19 immunization. The vaccine was administered at other (as reported). Medical history included asthma (Allergy induced asthma). Concomitant medication within 2 weeks of vaccination included cetirizine hydrochloride (ZYRTEC) from Dec2020 at 10mg daily.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Dec2020, the patient experienced Left Bell's palsy, numbness and paresthesia of tongue, left side of face, inability to raise left eyebrow, pain in left upper arm between elbow and shoulder, tachycardia, elevated blood pressure.  The adverse events result in emergency room/department or urgent care. The patient received treatment for the adverse events which included Prednisone 20mg daily, Valacyclovir 1000mg twice a day. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of events was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the Bell's palsy and other reported events due to temporal relationship.  However, the Bell's palsy may possibly represent a concurrent medical condition.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including viral serologies, and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Facial paralysis, Hypoaesthesia, Hypoaesthesia oral, Injection site pain
Clinical narrative: Left Bell's palsy/left side of face, inability to raise left eyebrow; numbness and paresthesia of tongue; numbness and paresthesia of tongue; pain in left upper arm between elbow and shoulder; tachycardia; elevated blood pressure; This is a spontaneous report from a contactable physician. A 35-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), intramuscular at arm left on 31Dec2020 at single dose for covid-19 immunization. The vaccine was administered at other (as reported). Medical history included asthma (Allergy induced asthma). Concomitant medication within 2 weeks of vaccination included cetirizine hydrochloride (ZYRTEC) from Dec2020 at 10mg daily.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Dec2020, the patient experienced Left Bell's palsy, numbness and paresthesia of tongue, left side of face, inability to raise left eyebrow, pain in left upper arm between elbow and shoulder, tachycardia, elevated blood pressure.  The adverse events result in emergency room/department or urgent care. The patient received treatment for the adverse events which included Prednisone 20mg daily, Valacyclovir 1000mg twice a day. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of events was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the Bell's palsy and other reported events due to temporal relationship.  However, the Bell's palsy may possibly represent a concurrent medical condition.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including viral serologies, and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mobility decreased, Paraesthesia, Paraesthesia oral, Tachycardia
Clinical narrative: Left Bell's palsy/left side of face, inability to raise left eyebrow; numbness and paresthesia of tongue; numbness and paresthesia of tongue; pain in left upper arm between elbow and shoulder; tachycardia; elevated blood pressure; This is a spontaneous report from a contactable physician. A 35-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), intramuscular at arm left on 31Dec2020 at single dose for covid-19 immunization. The vaccine was administered at other (as reported). Medical history included asthma (Allergy induced asthma). Concomitant medication within 2 weeks of vaccination included cetirizine hydrochloride (ZYRTEC) from Dec2020 at 10mg daily.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Dec2020, the patient experienced Left Bell's palsy, numbness and paresthesia of tongue, left side of face, inability to raise left eyebrow, pain in left upper arm between elbow and shoulder, tachycardia, elevated blood pressure.  The adverse events result in emergency room/department or urgent care. The patient received treatment for the adverse events which included Prednisone 20mg daily, Valacyclovir 1000mg twice a day. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of events was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the Bell's palsy and other reported events due to temporal relationship.  However, the Bell's palsy may possibly represent a concurrent medical condition.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including viral serologies, and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Arm swelling, hot and reddened below injection site, started one week post injection
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site warmth, Peripheral swelling
Clinical narrative: Arm swelling, hot and reddened below injection site, started one week post injection
Age: 25.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Chills, Nausea, Pain, Pyrexia, Tachycardia
Clinical narrative: Fever, chills, nausea, body aches, tachycardia; Fever, chills, nausea, body aches, tachycardia; Fever, chills, nausea, body aches, tachycardia; Fever, chills, nausea, body aches, tachycardia; Fever, chills, nausea, body aches, tachycardia; This is a spontaneous report from a contactable nurse (patient).   This 25-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose in the right arm on 04Jan2021 08:30 for Covid-19 immunisation. Medical history included Covid-19 on an unknown date. The patient's concomitant medications were not reported. The patient experienced fever, chills, nausea, body aches, tachycardia on 04Jan2021 20:30 with outcome of unknown. Therapeutic measures were taken as a result of fever, chills, nausea, body aches, tachycardia included Tylenol, Ibuprofen, Benadryl. The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: hives all over her body; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 29Dec2020 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced hives all over her body on 02Jan2021 with outcome of unknown.    Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 5-6 days after my shot I had a allergic reaction. Anaphylaxis.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19 prophylaxis, Electrocardiogram, Full blood count, Laboratory test
Clinical narrative: 5-6 days after my shot I had a allergic reaction. Anaphylaxis.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Thermal burn
Clinical narrative: shoulder turned black/Shoulder blade and whole shoulder turned black; blistered; This is a spontaneous report from a contactable consumer (patient).  A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in deltoid left on 04Jan2021 at single dose for COVID-19 immunization. There were no medical history or concomitant medications.  The patient experienced his whole shoulder turned black/ shoulder blade and whole shoulder turned black and is blistering on 05Jan2021 12:00.  Caller also took the shingles shot 3 weeks prior to getting the COVID-19 vaccine. Confirmed no testing was done. When he went to the doctor they just peeled the scab off, placed ointment on, bandaged him up. He was also provided with a prescription. The outcome of the events was unknown. Information about Lot/Batch number has been requested.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blister, Skin discolouration
Clinical narrative: shoulder turned black/Shoulder blade and whole shoulder turned black; blistered; This is a spontaneous report from a contactable consumer (patient).  A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in deltoid left on 04Jan2021 at single dose for COVID-19 immunization. There were no medical history or concomitant medications.  The patient experienced his whole shoulder turned black/ shoulder blade and whole shoulder turned black and is blistering on 05Jan2021 12:00.  Caller also took the shingles shot 3 weeks prior to getting the COVID-19 vaccine. Confirmed no testing was done. When he went to the doctor they just peeled the scab off, placed ointment on, bandaged him up. He was also provided with a prescription. The outcome of the events was unknown. Information about Lot/Batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Paraesthesia oral, Pruritus, Rash macular
Clinical narrative: I had light itching of my extremeties, red blotches on my face, bottom lip tingling.  Nothing major
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral, Pruritus, Rash macular
Clinical narrative: I had light itching of my extremeties, red blotches on my face, bottom lip tingling.  Nothing major
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Neurological examination
Clinical narrative: developed right forearm numbness; intermittent bilat lower leg numbness / bilat lower leg numbness was constant all day; This is a spontaneous report from a contactable nurse (patient herself). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number EL1284, expiry date was unknown) via an unspecified route of administration at the left arm on 30Dec2020 09:30 AM at a single dose. for COVID-19 immunization. The patient had no medical history and no known allergies. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient did not receive other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Jan2021, 6:30 pm and on 03Jan2021, the patient developed intermittent bilat lower leg numbness. On 04Jan2021, bilat lower leg numbness was constant all day and at 4pm that same day, she developed right forearm numbness. No weakness, just numbness. On 05Jan2021, leg numbness has resolved but still having slight right forearm numbness. On 06Jan2021, still no leg numbness but still having slight right forearm numbness. The events resulted in emergency room/department or urgent care. The patient recovered from the event "intermittent bilat lower leg numbness / bilat lower leg numbness was constant all day" on 05Jan2021. Outcome of the event "developed right forearm numbness" was recovering. No treatment was performed in response to the adverse events. The events were assessed as Non-serious; the events did not result in death, were not life threatening, did not caused/prolonged hospitalization, were not disabling/ incapacitating, and did not caused any congenital anomaly/birth defect.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia
Clinical narrative: developed right forearm numbness; intermittent bilat lower leg numbness / bilat lower leg numbness was constant all day; This is a spontaneous report from a contactable nurse (patient herself). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number EL1284, expiry date was unknown) via an unspecified route of administration at the left arm on 30Dec2020 09:30 AM at a single dose. for COVID-19 immunization. The patient had no medical history and no known allergies. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient did not receive other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Jan2021, 6:30 pm and on 03Jan2021, the patient developed intermittent bilat lower leg numbness. On 04Jan2021, bilat lower leg numbness was constant all day and at 4pm that same day, she developed right forearm numbness. No weakness, just numbness. On 05Jan2021, leg numbness has resolved but still having slight right forearm numbness. On 06Jan2021, still no leg numbness but still having slight right forearm numbness. The events resulted in emergency room/department or urgent care. The patient recovered from the event "intermittent bilat lower leg numbness / bilat lower leg numbness was constant all day" on 05Jan2021. Outcome of the event "developed right forearm numbness" was recovering. No treatment was performed in response to the adverse events. The events were assessed as Non-serious; the events did not result in death, were not life threatening, did not caused/prolonged hospitalization, were not disabling/ incapacitating, and did not caused any congenital anomaly/birth defect.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Breast pain, Cellulitis, Injected limb mobility decreased, Injection site erythema
Clinical narrative: Patient experienced redness, swelling, and pain at injection site that started approximately 10 days after injection.  She was seen in care clinic and required treatment with antihistamine and prescription for keflex for 7 days for treatment of cellulitis.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site rash, Injection site warmth, Neck pain, Oedema peripheral, Pain in extremity
Clinical narrative: Patient experienced redness, swelling, and pain at injection site that started approximately 10 days after injection.  She was seen in care clinic and required treatment with antihistamine and prescription for keflex for 7 days for treatment of cellulitis.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling
Clinical narrative: Patient experienced redness, swelling, and pain at injection site that started approximately 10 days after injection.  She was seen in care clinic and required treatment with antihistamine and prescription for keflex for 7 days for treatment of cellulitis.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient experienced redness, swelling, and pain at injection site that started approximately 10 days after injection.  She was seen in care clinic and required treatment with antihistamine and prescription for keflex for 7 days for treatment of cellulitis.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Diarrhoea, Headache, Pain in extremity, Vomiting
Clinical narrative: Headache; Sore arm; Vomiting; Diarrhea; Chills; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female (non-pregnant) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ELO142), via an unspecified route of administration in left arm, on 04Jan2021 at 10:45, at a single dose, for COVID-19 immunization. The patient's medical history included arrhythmia, right shoulder reverse replacement, and fusion at L5S4. The patient's concomitant medications included metoprolol tartrate, digoxin, levothyroxine, and montelukast sodium (MONTEL). The patient previously took codeine and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered in a hospital. On 04Jan2021 at 3:30 PM, the patient experienced headache, sore arm, vomiting, diarrhea, and chills. The events were considered non-serious. No treatment received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events in Jan2021.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Feeling abnormal, Gait disturbance, Head discomfort, Headache
Clinical narrative: severe dizziness; nausea; vomiting; headache; Vertigo type symptoms; This is a spontaneous report from a contactable nurse. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELU140), via an unspecified route of administration on 21Dec2020 11:00 in right arm at single dose for COVID-19 immunization. Medical history included vertigo from 2015 to an unknown date. There were no concomitant medications. On 29Dec2020 19:00, one week after vaccination, the patient experienced severe dizziness, nausea, vomiting and headache that continues and seemed to be severe vertigo type symptoms. No treatment was given to the patient for the events. The facility where the most recent COVID-19 vaccine was administered was in a Public Health Clinic/Administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. The events was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Nausea, Retching, Vertigo, Visual impairment
Clinical narrative: severe dizziness; nausea; vomiting; headache; Vertigo type symptoms; This is a spontaneous report from a contactable nurse. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELU140), via an unspecified route of administration on 21Dec2020 11:00 in right arm at single dose for COVID-19 immunization. Medical history included vertigo from 2015 to an unknown date. There were no concomitant medications. On 29Dec2020 19:00, one week after vaccination, the patient experienced severe dizziness, nausea, vomiting and headache that continues and seemed to be severe vertigo type symptoms. No treatment was given to the patient for the events. The facility where the most recent COVID-19 vaccine was administered was in a Public Health Clinic/Administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. The events was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: severe dizziness; nausea; vomiting; headache; Vertigo type symptoms; This is a spontaneous report from a contactable nurse. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELU140), via an unspecified route of administration on 21Dec2020 11:00 in right arm at single dose for COVID-19 immunization. Medical history included vertigo from 2015 to an unknown date. There were no concomitant medications. On 29Dec2020 19:00, one week after vaccination, the patient experienced severe dizziness, nausea, vomiting and headache that continues and seemed to be severe vertigo type symptoms. No treatment was given to the patient for the events. The facility where the most recent COVID-19 vaccine was administered was in a Public Health Clinic/Administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. The events was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Headache, Nausea, Vertigo, Vomiting
Clinical narrative: severe dizziness; nausea; vomiting; headache; Vertigo type symptoms; This is a spontaneous report from a contactable nurse. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELU140), via an unspecified route of administration on 21Dec2020 11:00 in right arm at single dose for COVID-19 immunization. Medical history included vertigo from 2015 to an unknown date. There were no concomitant medications. On 29Dec2020 19:00, one week after vaccination, the patient experienced severe dizziness, nausea, vomiting and headache that continues and seemed to be severe vertigo type symptoms. No treatment was given to the patient for the events. The facility where the most recent COVID-19 vaccine was administered was in a Public Health Clinic/Administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. The events was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Palpitations
Clinical narrative: Increased heart rate/palpitations  (up to 108) within 2 minutes of receiving vaccine lasting approximately 20 minutes; Increased heart rate/palpitations  (up to 108) within 2 minutes of receiving vaccine lasting approximately 20 minutes; This is a spontaneous report from a contactable other healthcare professional (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El0142 and expiration date not provided), intramuscular at the left arm on 29Dec2020 17:30 at a single dose for COVID-19 immunization in the hospital. The patient has no relevant medical history.  The patient had no known allergies to medications, food, or other products. The patient has not had any vaccine in four weeks and did not take any medications in two weeks. The patient is not pregnant. There were no concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 29Dec2020, the patient experienced increased heart rate/palpitations (up to 108) within 2 minutes of receiving vaccine lasting approximately 20 minutes. No treatment was administered in response to the events. The patient assessed the events as non-serious. Since the vaccination the patient has not tested for COVID-19. The outcome of the events was recovered on 29Dec2020 17:52.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate, Heart rate increased, Palpitations
Clinical narrative: Increased heart rate/palpitations  (up to 108) within 2 minutes of receiving vaccine lasting approximately 20 minutes; Increased heart rate/palpitations  (up to 108) within 2 minutes of receiving vaccine lasting approximately 20 minutes; This is a spontaneous report from a contactable other healthcare professional (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El0142 and expiration date not provided), intramuscular at the left arm on 29Dec2020 17:30 at a single dose for COVID-19 immunization in the hospital. The patient has no relevant medical history.  The patient had no known allergies to medications, food, or other products. The patient has not had any vaccine in four weeks and did not take any medications in two weeks. The patient is not pregnant. There were no concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 29Dec2020, the patient experienced increased heart rate/palpitations (up to 108) within 2 minutes of receiving vaccine lasting approximately 20 minutes. No treatment was administered in response to the events. The patient assessed the events as non-serious. Since the vaccination the patient has not tested for COVID-19. The outcome of the events was recovered on 29Dec2020 17:52.