chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site reaction, Mobility decreased, Pain in extremity, Rash, Rash macular
Clinical narrative: Several areas where there were red marks and or a slight rash surrounding injection site; Several areas where there were red marks and or a slight rash surrounding injection site; pain in arm and unable to lift it above my head; upper arm was warm to touch; Some were above the site and the rash closer to her chest; This is a spontaneous report from a contactable consumer (patient). A 68-year-old non pregnant female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ELAZ64 and Expiry date was unknown), via an unspecified route of administration in left arm, on 02Feb2021, at 19:15, as 1ST DOSE, SINGLE for COVID-19 immunisation. The age at time of vaccination was 68 years. 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 patient medical history included seasonal allergies and tmj (Temporomandibular joint syndrome). The patient never had allergies to medications, food, or other products. The patient received other medications within 2 weeks of vaccination. The concomitant medications were not reported. On 03Feb2021 at 8:00, patient had several areas where there were red marks and or a slight rash surrounding injection site. the red marks were seen the next morning and the rash later that evening. Some were above the site and the rash closer to her chest. Also, pain in arm and unable to lift it above her head. Also, upper arm was warm to touch. Today, 04Feb2021, (1.5 days since vaccination) the arm is not warm to touch, still slightly sore and redness has diminished but still visible. The events did not receive any treatments. The outcome of the events was recovering.  Upon Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin discolouration
Clinical narrative: Several areas where there were red marks and or a slight rash surrounding injection site; Several areas where there were red marks and or a slight rash surrounding injection site; pain in arm and unable to lift it above my head; upper arm was warm to touch; Some were above the site and the rash closer to her chest; This is a spontaneous report from a contactable consumer (patient). A 68-year-old non pregnant female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ELAZ64 and Expiry date was unknown), via an unspecified route of administration in left arm, on 02Feb2021, at 19:15, as 1ST DOSE, SINGLE for COVID-19 immunisation. The age at time of vaccination was 68 years. 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 patient medical history included seasonal allergies and tmj (Temporomandibular joint syndrome). The patient never had allergies to medications, food, or other products. The patient received other medications within 2 weeks of vaccination. The concomitant medications were not reported. On 03Feb2021 at 8:00, patient had several areas where there were red marks and or a slight rash surrounding injection site. the red marks were seen the next morning and the rash later that evening. Some were above the site and the rash closer to her chest. Also, pain in arm and unable to lift it above her head. Also, upper arm was warm to touch. Today, 04Feb2021, (1.5 days since vaccination) the arm is not warm to touch, still slightly sore and redness has diminished but still visible. The events did not receive any treatments. The outcome of the events was recovering.  Upon Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Rash, Vaccination site erythema, Vaccination site rash, Vaccination site warmth
Clinical narrative: Several areas where there were red marks and or a slight rash surrounding injection site; Several areas where there were red marks and or a slight rash surrounding injection site; pain in arm and unable to lift it above my head; upper arm was warm to touch; Some were above the site and the rash closer to her chest; This is a spontaneous report from a contactable consumer (patient). A 68-year-old non pregnant female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ELAZ64 and Expiry date was unknown), via an unspecified route of administration in left arm, on 02Feb2021, at 19:15, as 1ST DOSE, SINGLE for COVID-19 immunisation. The age at time of vaccination was 68 years. 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 patient medical history included seasonal allergies and tmj (Temporomandibular joint syndrome). The patient never had allergies to medications, food, or other products. The patient received other medications within 2 weeks of vaccination. The concomitant medications were not reported. On 03Feb2021 at 8:00, patient had several areas where there were red marks and or a slight rash surrounding injection site. the red marks were seen the next morning and the rash later that evening. Some were above the site and the rash closer to her chest. Also, pain in arm and unable to lift it above her head. Also, upper arm was warm to touch. Today, 04Feb2021, (1.5 days since vaccination) the arm is not warm to touch, still slightly sore and redness has diminished but still visible. The events did not receive any treatments. The outcome of the events was recovering.  Upon Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness of the face; This is a spontaneous report from a contactable consumer (patient).  A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 26Feb2021 09:00 (Batch/Lot Number: EN6205) as single dose for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient was not pregnant. The patient did not take other vaccine in four weeks. The patient previously took iodine and experienced allergy.  The patient experienced numbness of the face (non-serious) on 26Feb2021 09:05. No treatment was received. The outcome was recovered on 27Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Piloerection
Clinical narrative: Huge Headache; Goosebumps; Dizziness; Fatigue; Soreness in arm; This is a spontaneous report from a contactable consumer.   A 75-years-old non-pregnant female patient received second dose of BNT162B2 (Formulation: Solution for injection; Batch/Lot Number: EN6202), dose 2 via an unspecified route of administration, administered in arm left on 24Feb2021 as 2nd dose, single for covid-19 immunisation. Medical history included allergies with Penicillin, zinc, latex, mango. Triple negative breast cancer from 2014 to an unknown date and back pain. Concomitant medications included other medications in two weeks Levothyroxine, Vit D, Calcium. Not covid-19 prior vaccination and not covid-19 tested post vaccination. The patient received BNT162B2 (Formulation: Solution for injection; Batch/Lot Number: EL9262) dose 1 via an unspecified route of administration, administered in arm left for covid-19 immunisation on 03Feb2021. On 25Feb2021 patient experienced huge headache, goosebumps, dizziness, fatigue, soreness in arm. Patient took Advil and rested all day as treatment. No other vaccine in four weeks. The outcome of the events was recovered on an unspecified date 2021.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Headache, Pain in extremity, Piloerection
Clinical narrative: Huge Headache; Goosebumps; Dizziness; Fatigue; Soreness in arm; This is a spontaneous report from a contactable consumer.   A 75-years-old non-pregnant female patient received second dose of BNT162B2 (Formulation: Solution for injection; Batch/Lot Number: EN6202), dose 2 via an unspecified route of administration, administered in arm left on 24Feb2021 as 2nd dose, single for covid-19 immunisation. Medical history included allergies with Penicillin, zinc, latex, mango. Triple negative breast cancer from 2014 to an unknown date and back pain. Concomitant medications included other medications in two weeks Levothyroxine, Vit D, Calcium. Not covid-19 prior vaccination and not covid-19 tested post vaccination. The patient received BNT162B2 (Formulation: Solution for injection; Batch/Lot Number: EL9262) dose 1 via an unspecified route of administration, administered in arm left for covid-19 immunisation on 03Feb2021. On 25Feb2021 patient experienced huge headache, goosebumps, dizziness, fatigue, soreness in arm. Patient took Advil and rested all day as treatment. No other vaccine in four weeks. The outcome of the events was recovered on an unspecified date 2021.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear pain, Headache, Neck pain
Clinical narrative: 4 of 10 throbbing headache; left ear/lateral neck pain; left ear/lateral neck pain; This is a spontaneous report from a contactable other HCP reported that, A 28-year-old female (Non pregnant) patient received second dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: el3302), via Intramuscular route of administration in left arm on 14Jan2021 at 06:00 PM (at the age of 28-years-old) at Public Health Clinic/(Name) facility as a single dose for COVID-19immunisation. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: el1284), via Intramuscular route of administration in left arm on 23Dec2020 at 05:30 PM as a single dose for COVID-19immunisation.Patient medical history of the patient was not reported. The patient allergy history was not reported. Patient concomitant medications of the patient include ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL MULTIVITAMINS) taken by mouth, once a day. It was not reported whether the patient was diagnosed covid-19 before vaccination and if tested covid-19 after vaccination. On 14Jan2021, 45 minutes after receiving her second dose of covered vaccine, presents to urgent care complaining of a 4 of 10 throbbing headache and left ear/lateral neck pain. She has not taken anything for pain, having come straight from work/vaccination clinic. She tolerated her first dose of vaccine well. Ae resulted in [Emergency room/department or urgent care]. The patient underwent lab tests and procedures which included pain assessment: 4, on 14Jan2021. Therapeutic methods were taken that include tylenol 1000mg by mouth once, patient monitoring. The outcome of all the events was recovered.  No follow up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear pain, Headache, Neck pain, Pain assessment
Clinical narrative: 4 of 10 throbbing headache; left ear/lateral neck pain; left ear/lateral neck pain; This is a spontaneous report from a contactable other HCP reported that, A 28-year-old female (Non pregnant) patient received second dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: el3302), via Intramuscular route of administration in left arm on 14Jan2021 at 06:00 PM (at the age of 28-years-old) at Public Health Clinic/(Name) facility as a single dose for COVID-19immunisation. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: el1284), via Intramuscular route of administration in left arm on 23Dec2020 at 05:30 PM as a single dose for COVID-19immunisation.Patient medical history of the patient was not reported. The patient allergy history was not reported. Patient concomitant medications of the patient include ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL MULTIVITAMINS) taken by mouth, once a day. It was not reported whether the patient was diagnosed covid-19 before vaccination and if tested covid-19 after vaccination. On 14Jan2021, 45 minutes after receiving her second dose of covered vaccine, presents to urgent care complaining of a 4 of 10 throbbing headache and left ear/lateral neck pain. She has not taken anything for pain, having come straight from work/vaccination clinic. She tolerated her first dose of vaccine well. Ae resulted in [Emergency room/department or urgent care]. The patient underwent lab tests and procedures which included pain assessment: 4, on 14Jan2021. Therapeutic methods were taken that include tylenol 1000mg by mouth once, patient monitoring. The outcome of all the events was recovered.  No follow up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient herself). A 70-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation solution for injection; Lot number: EN6203), via an unspecified route of administration, on 28Feb2021 17:15 (at the age of 70-year-old) in Arm Right as single dose for COVID-19 immunization. The patient medical history included sleep apnoea, COVID-19 (prior to vaccination); and patient was using continuous positive airway pressure. The patient's concomitant medications included apixaban (ELIQUIS) and metoprolol succinate (METOPROLOL SUCCINATE). On 01Mar2021 17:15, the patient experienced headache, fever (over 100F), chills, tiredness, and pain in arm. On 01Mar2021, the patient underwent laboratory test included body temperature which showed 100 Fahrenheit. The patient received treatment with Tylenol. The outcome of the reported events was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer (patient herself). A 70-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation solution for injection; Lot number: EN6203), via an unspecified route of administration, on 28Feb2021 17:15 (at the age of 70-year-old) in Arm Right as single dose for COVID-19 immunization. The patient medical history included sleep apnoea, COVID-19 (prior to vaccination); and patient was using continuous positive airway pressure. The patient's concomitant medications included apixaban (ELIQUIS) and metoprolol succinate (METOPROLOL SUCCINATE). On 01Mar2021 17:15, the patient experienced headache, fever (over 100F), chills, tiredness, and pain in arm. On 01Mar2021, the patient underwent laboratory test included body temperature which showed 100 Fahrenheit. The patient received treatment with Tylenol. The outcome of the reported events was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient herself). A 70-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation solution for injection; Lot number: EN6203), via an unspecified route of administration, on 28Feb2021 17:15 (at the age of 70-year-old) in Arm Right as single dose for COVID-19 immunization. The patient medical history included sleep apnoea, COVID-19 (prior to vaccination); and patient was using continuous positive airway pressure. The patient's concomitant medications included apixaban (ELIQUIS) and metoprolol succinate (METOPROLOL SUCCINATE). On 01Mar2021 17:15, the patient experienced headache, fever (over 100F), chills, tiredness, and pain in arm. On 01Mar2021, the patient underwent laboratory test included body temperature which showed 100 Fahrenheit. The patient received treatment with Tylenol. The outcome of the reported events was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Disorientation, Fatigue, Headache
Clinical narrative: Full blown flu symptoms; Severe headache; Random sharp muscle pain; Fatigue; Joint pain; Chills; Feverish; Sore arm; This is a spontaneous report received from a contactable consumer. A 52-years-old male patient received first dose of bnt162b2 (BNT162B2,Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration (at the age of 52-year-old), administered in right arm on 02Mar2021 10:15 at a single dose (1ST DOSE, SINGLE) for covid-19 immunisation. Medical history included hypertension and gerd. Concomitant medications included daily multivitamin, atenolol, chlortalidone and lansoprazole (PREVACID). The patient had known allergies chantix and prozac. Patient not diagnosed with COVID-19, prior to vaccination. Patient not tested for COVID-19, since the vaccination. The patient experienced severe headache, random sharp muscle pain, fatigue, joint pain, chills and feverish on 03Mar2021 10:30. On 02Mar2021, the patient had sore arm. On 04Mar2021, patient had full blown flu symptoms. No other vaccines within 4 weeks prior to the COVID vaccine. He returned to work on 05Mar2021 with just minor fatigue. The outcome of the events was recovered with sequelae while sore arm and full blown flu symptoms were unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Full blown flu symptoms; Severe headache; Random sharp muscle pain; Fatigue; Joint pain; Chills; Feverish; Sore arm; This is a spontaneous report received from a contactable consumer. A 52-years-old male patient received first dose of bnt162b2 (BNT162B2,Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration (at the age of 52-year-old), administered in right arm on 02Mar2021 10:15 at a single dose (1ST DOSE, SINGLE) for covid-19 immunisation. Medical history included hypertension and gerd. Concomitant medications included daily multivitamin, atenolol, chlortalidone and lansoprazole (PREVACID). The patient had known allergies chantix and prozac. Patient not diagnosed with COVID-19, prior to vaccination. Patient not tested for COVID-19, since the vaccination. The patient experienced severe headache, random sharp muscle pain, fatigue, joint pain, chills and feverish on 03Mar2021 10:30. On 02Mar2021, the patient had sore arm. On 04Mar2021, patient had full blown flu symptoms. No other vaccines within 4 weeks prior to the COVID vaccine. He returned to work on 05Mar2021 with just minor fatigue. The outcome of the events was recovered with sequelae while sore arm and full blown flu symptoms were unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Influenza
Clinical narrative: Full blown flu symptoms; Severe headache; Random sharp muscle pain; Fatigue; Joint pain; Chills; Feverish; Sore arm; This is a spontaneous report received from a contactable consumer. A 52-years-old male patient received first dose of bnt162b2 (BNT162B2,Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration (at the age of 52-year-old), administered in right arm on 02Mar2021 10:15 at a single dose (1ST DOSE, SINGLE) for covid-19 immunisation. Medical history included hypertension and gerd. Concomitant medications included daily multivitamin, atenolol, chlortalidone and lansoprazole (PREVACID). The patient had known allergies chantix and prozac. Patient not diagnosed with COVID-19, prior to vaccination. Patient not tested for COVID-19, since the vaccination. The patient experienced severe headache, random sharp muscle pain, fatigue, joint pain, chills and feverish on 03Mar2021 10:30. On 02Mar2021, the patient had sore arm. On 04Mar2021, patient had full blown flu symptoms. No other vaccines within 4 weeks prior to the COVID vaccine. He returned to work on 05Mar2021 with just minor fatigue. The outcome of the events was recovered with sequelae while sore arm and full blown flu symptoms were unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Full blown flu symptoms; Severe headache; Random sharp muscle pain; Fatigue; Joint pain; Chills; Feverish; Sore arm; This is a spontaneous report received from a contactable consumer. A 52-years-old male patient received first dose of bnt162b2 (BNT162B2,Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration (at the age of 52-year-old), administered in right arm on 02Mar2021 10:15 at a single dose (1ST DOSE, SINGLE) for covid-19 immunisation. Medical history included hypertension and gerd. Concomitant medications included daily multivitamin, atenolol, chlortalidone and lansoprazole (PREVACID). The patient had known allergies chantix and prozac. Patient not diagnosed with COVID-19, prior to vaccination. Patient not tested for COVID-19, since the vaccination. The patient experienced severe headache, random sharp muscle pain, fatigue, joint pain, chills and feverish on 03Mar2021 10:30. On 02Mar2021, the patient had sore arm. On 04Mar2021, patient had full blown flu symptoms. No other vaccines within 4 weeks prior to the COVID vaccine. He returned to work on 05Mar2021 with just minor fatigue. The outcome of the events was recovered with sequelae while sore arm and full blown flu symptoms were unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Ear discomfort, Hyperhidrosis, Tinnitus
Clinical narrative: Tinnitus got worse; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199], via an unspecified route of administration, in the right arm on 06Mar2021 at 10:45 (at the age of 69-years-old) as single dose for COVID-19 immunisation. Medical history includes osteoporosis and recovering from a broken arm. The patient had allergy to Ibuprofen, mold and cats. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included Imodium (MANUFACTURER UNKNOWN) taken for unknown indication from unknown date. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 08Mar2021, the patient reported her tinnitus got worse. The patient did not received any treatment for the event. The clinical outcome of the tinnitus got worse was not recovered. No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus got worse; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199], via an unspecified route of administration, in the right arm on 06Mar2021 at 10:45 (at the age of 69-years-old) as single dose for COVID-19 immunisation. Medical history includes osteoporosis and recovering from a broken arm. The patient had allergy to Ibuprofen, mold and cats. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included Imodium (MANUFACTURER UNKNOWN) taken for unknown indication from unknown date. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 08Mar2021, the patient reported her tinnitus got worse. The patient did not received any treatment for the event. The clinical outcome of the tinnitus got worse was not recovered. No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Fatigue, Vaccination site pain
Clinical narrative: fatigue; This is a spontaneous report from a contactable Other-HCP. A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expire Date: unknown), via unspecified route of administration, on an unknown date, as single dose, for Covid-19 immunisation. Medical history and concomitant medications were not reported. After vaccination, patient stated that she was having occasional fatigue. Patient did have a Covid Vaccine and the first injection she took during her on week and just had fatigue. The outcome of event was unknown.    No follow-up attempts are possible. Information on Lot/Batch number has been requested. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This is a spontaneous report from a contactable Other-HCP. A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expire Date: unknown), via unspecified route of administration, on an unknown date, as single dose, for Covid-19 immunisation. Medical history and concomitant medications were not reported. After vaccination, patient stated that she was having occasional fatigue. Patient did have a Covid Vaccine and the first injection she took during her on week and just had fatigue. The outcome of event was unknown.    No follow-up attempts are possible. Information on Lot/Batch number has been requested. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Amylase increased, Blood creatinine increased, Blood potassium increased, Blood sodium increased
Clinical narrative: Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe, Additional Details: Daughter states patient did not feel well in the days after his vaccine. He was weak, had nausea/vomiting, and was unable to eat/drink. About a week later, patient was hospitalized with acute renal failure, likely due to excessive loss of volume. Daughter states that his doctors believe he had underlying renal issues and because he wasn't able to eat or drink for several days, this led to the renal failure. Daughter says that 2 months later, patient is on dialysis.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood urea increased, Glomerular filtration rate increased, Lipase increased, Pancreatitis
Clinical narrative: Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe, Additional Details: Daughter states patient did not feel well in the days after his vaccine. He was weak, had nausea/vomiting, and was unable to eat/drink. About a week later, patient was hospitalized with acute renal failure, likely due to excessive loss of volume. Daughter states that his doctors believe he had underlying renal issues and because he wasn't able to eat or drink for several days, this led to the renal failure. Daughter says that 2 months later, patient is on dialysis.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Asthenia, Dialysis, Dysphagia, Fatigue
Clinical narrative: Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe, Additional Details: Daughter states patient did not feel well in the days after his vaccine. He was weak, had nausea/vomiting, and was unable to eat/drink. About a week later, patient was hospitalized with acute renal failure, likely due to excessive loss of volume. Daughter states that his doctors believe he had underlying renal issues and because he wasn't able to eat or drink for several days, this led to the renal failure. Daughter says that 2 months later, patient is on dialysis.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lethargy, Malaise, Nausea, Pyrexia, Vomiting
Clinical narrative: Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe, Additional Details: Daughter states patient did not feel well in the days after his vaccine. He was weak, had nausea/vomiting, and was unable to eat/drink. About a week later, patient was hospitalized with acute renal failure, likely due to excessive loss of volume. Daughter states that his doctors believe he had underlying renal issues and because he wasn't able to eat or drink for several days, this led to the renal failure. Daughter says that 2 months later, patient is on dialysis.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blister
Clinical narrative: Blister under true breast leaking fluid hurting; Blister under true breast leaking fluid hurting; Started itching and might have scratched it; This is a spontaneous report from a contactable consumer. A 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3249), via an unspecified route of administration, on 24Jan2021 at 09:30 (at the age of 83-year-old) as 1st dose, single dose in left arm for COVID-19 immunisation at Hospital. The patient's medical history was not reported. Concomitant medications included lovastatin 10mg, and Amigo stone hcl 200mg. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Jan2021, the patient experienced blister under true breast leaking fluid hurting. Patient noticed blister on lower right abdomen, did not bother and went to bed, and later it popped out. Patient started itching and might have scratched it. Patient never had this before, until after the COVID-19 shot. It was a three-quarter inch line. When the blister popped it leaked over on the skin and another blister appeared, and stated there were about 5 blisters. It was real sore. Patient used Calamine lotion on it and it was great after that. Calamine lotion dried it fast, stopped itching and got good relief. Patient enquired what else he needs to do. The clinical outcome of the events was recovering.  Follow-up (29Jan2021): This follow-up is being submitted to notify that new event Started itching and might have scratched it' added, updated onset date of all events.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blister, Pain, Pruritus
Clinical narrative: Blister under true breast leaking fluid hurting; Blister under true breast leaking fluid hurting; Started itching and might have scratched it; This is a spontaneous report from a contactable consumer. A 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3249), via an unspecified route of administration, on 24Jan2021 at 09:30 (at the age of 83-year-old) as 1st dose, single dose in left arm for COVID-19 immunisation at Hospital. The patient's medical history was not reported. Concomitant medications included lovastatin 10mg, and Amigo stone hcl 200mg. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Jan2021, the patient experienced blister under true breast leaking fluid hurting. Patient noticed blister on lower right abdomen, did not bother and went to bed, and later it popped out. Patient started itching and might have scratched it. Patient never had this before, until after the COVID-19 shot. It was a three-quarter inch line. When the blister popped it leaked over on the skin and another blister appeared, and stated there were about 5 blisters. It was real sore. Patient used Calamine lotion on it and it was great after that. Calamine lotion dried it fast, stopped itching and got good relief. Patient enquired what else he needs to do. The clinical outcome of the events was recovering.  Follow-up (29Jan2021): This follow-up is being submitted to notify that new event Started itching and might have scratched it' added, updated onset date of all events.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature increased, Dizziness, Dry mouth, Heart rate increased
Clinical narrative: next night I couldn't sleep because I was itchy and feeling ticking all over my body; next night I couldn't sleep because I was itchy and feeling ticking all over my body; next night I couldn't sleep because I was itchy and feeling ticking all over my body; Hearing loss; tunnel vision; After a couple of minutes, started feeling faint/dizziness; weakness; nausea; got hot; started sweating excessively; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in arm left on 07Apr2021 20:15 at age of 43-year-old (Batch/Lot Number: Ew0151) at single dose for COVID-19 immunization. Medical history included know allergies to wheat. The patient is not pregnant at the time of report. Prior to vaccination, the patient was not diagnosed with COVID-19. There was no other vaccine in four weeks or other medications in two weeks. After a couple of minutes on 07Apr2021 at 20: 30, the patient started feeling faint. Hearing loss, tunnel vision, dizziness, weakness, nausea, got hot and started sweating excessively. The patient was able to walk with assistance after 20-25 minutes. The patient also developed sore arm on 07Apr2021, then the next night of 08Apr2021, she couldn't sleep because she was itchy and feeling ticking all over her body. The events did not result in emergency room visit or physician office visit. There was no treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was resolved in Apr2021.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Deafness, Dizziness, Feeling abnormal, Feeling hot
Clinical narrative: next night I couldn't sleep because I was itchy and feeling ticking all over my body; next night I couldn't sleep because I was itchy and feeling ticking all over my body; next night I couldn't sleep because I was itchy and feeling ticking all over my body; Hearing loss; tunnel vision; After a couple of minutes, started feeling faint/dizziness; weakness; nausea; got hot; started sweating excessively; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in arm left on 07Apr2021 20:15 at age of 43-year-old (Batch/Lot Number: Ew0151) at single dose for COVID-19 immunization. Medical history included know allergies to wheat. The patient is not pregnant at the time of report. Prior to vaccination, the patient was not diagnosed with COVID-19. There was no other vaccine in four weeks or other medications in two weeks. After a couple of minutes on 07Apr2021 at 20: 30, the patient started feeling faint. Hearing loss, tunnel vision, dizziness, weakness, nausea, got hot and started sweating excessively. The patient was able to walk with assistance after 20-25 minutes. The patient also developed sore arm on 07Apr2021, then the next night of 08Apr2021, she couldn't sleep because she was itchy and feeling ticking all over her body. The events did not result in emergency room visit or physician office visit. There was no treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was resolved in Apr2021.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Insomnia, Nausea, Pain in extremity, Pruritus
Clinical narrative: next night I couldn't sleep because I was itchy and feeling ticking all over my body; next night I couldn't sleep because I was itchy and feeling ticking all over my body; next night I couldn't sleep because I was itchy and feeling ticking all over my body; Hearing loss; tunnel vision; After a couple of minutes, started feeling faint/dizziness; weakness; nausea; got hot; started sweating excessively; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in arm left on 07Apr2021 20:15 at age of 43-year-old (Batch/Lot Number: Ew0151) at single dose for COVID-19 immunization. Medical history included know allergies to wheat. The patient is not pregnant at the time of report. Prior to vaccination, the patient was not diagnosed with COVID-19. There was no other vaccine in four weeks or other medications in two weeks. After a couple of minutes on 07Apr2021 at 20: 30, the patient started feeling faint. Hearing loss, tunnel vision, dizziness, weakness, nausea, got hot and started sweating excessively. The patient was able to walk with assistance after 20-25 minutes. The patient also developed sore arm on 07Apr2021, then the next night of 08Apr2021, she couldn't sleep because she was itchy and feeling ticking all over her body. The events did not result in emergency room visit or physician office visit. There was no treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was resolved in Apr2021.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tunnel vision
Clinical narrative: next night I couldn't sleep because I was itchy and feeling ticking all over my body; next night I couldn't sleep because I was itchy and feeling ticking all over my body; next night I couldn't sleep because I was itchy and feeling ticking all over my body; Hearing loss; tunnel vision; After a couple of minutes, started feeling faint/dizziness; weakness; nausea; got hot; started sweating excessively; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in arm left on 07Apr2021 20:15 at age of 43-year-old (Batch/Lot Number: Ew0151) at single dose for COVID-19 immunization. Medical history included know allergies to wheat. The patient is not pregnant at the time of report. Prior to vaccination, the patient was not diagnosed with COVID-19. There was no other vaccine in four weeks or other medications in two weeks. After a couple of minutes on 07Apr2021 at 20: 30, the patient started feeling faint. Hearing loss, tunnel vision, dizziness, weakness, nausea, got hot and started sweating excessively. The patient was able to walk with assistance after 20-25 minutes. The patient also developed sore arm on 07Apr2021, then the next night of 08Apr2021, she couldn't sleep because she was itchy and feeling ticking all over her body. The events did not result in emergency room visit or physician office visit. There was no treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was resolved in Apr2021.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-HCP. A seventy-six-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9809) (At the age of seventy-six-years-old) via an unspecified route of administration, administered in left arm on 13Feb2021 at 09:45 as 1ST DOSE, SINGLE for COVID-19 Immunization. Patient did not receive any other vaccine in four weeks. Patient did not experience COVID-19 Infection prior vaccination. The patient medical history Includes known allergies: Sulfa drugs, Amoxicillin. Concomitant medications included Simvastatin, Levothyroxine Sodium and Alendronate Sodium taken for an unspecified indication, start and stop date were not reported. On 16, Feb2021 at 05:00 PM, the patient experienced headache and chills developed 3rd day. severe headache for seven days, mild headache for four days She was worried about 2nd dose. The patient underwent lab tests and procedures which included Nasal swab and CVS swab post vaccination and showed negative Sars-Cov-2 test on 18, Feb2021. The outcome of the events was not recovered. No follow up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dermatitis atopic, Fungal infection, Fungal skin infection, Pruritus, Rash
Clinical narrative: rash all over her body; Itching; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot Number: EW0153) on 07Apr2021, at 10:30, at single dose, in the left arm, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history and concomitant medications were unknown. She had her first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot Number: EN6207) vaccine on 04Mar2021, for COVID-19 immunisation. On 18Apr2021, at 14:00, the patient experienced rash all over her body, and itching. The patient went to dermatologists and doctors and got steroid shots, oral steroids, creams and lotions. For rash, itching, the patient received steroid shots (unspecified) from 20Apr2021 (ongoing) and triamcinolone acetonide cream 0.1% (Expiration date: Nov2023) from 20Apr2021. It was reported that steroid shots and cream did not work. Patient stated that the rash is starting to disappear but the itching is not gone away. Clarified that the rash went away about 4 days before this report. Stated that the steroid shots and the cream were not working for the itching. Then, the patient stated that the Triamcinolone Acetonide Cream USP 0.1% was used for 5 days and she recovered with lasting effects of itching.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sleep disorder
Clinical narrative: rash all over her body; Itching; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot Number: EW0153) on 07Apr2021, at 10:30, at single dose, in the left arm, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history and concomitant medications were unknown. She had her first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot Number: EN6207) vaccine on 04Mar2021, for COVID-19 immunisation. On 18Apr2021, at 14:00, the patient experienced rash all over her body, and itching. The patient went to dermatologists and doctors and got steroid shots, oral steroids, creams and lotions. For rash, itching, the patient received steroid shots (unspecified) from 20Apr2021 (ongoing) and triamcinolone acetonide cream 0.1% (Expiration date: Nov2023) from 20Apr2021. It was reported that steroid shots and cream did not work. Patient stated that the rash is starting to disappear but the itching is not gone away. Clarified that the rash went away about 4 days before this report. Stated that the steroid shots and the cream were not working for the itching. Then, the patient stated that the Triamcinolone Acetonide Cream USP 0.1% was used for 5 days and she recovered with lasting effects of itching.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: rash all over her body; Itching; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot Number: EW0153) on 07Apr2021, at 10:30, at single dose, in the left arm, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history and concomitant medications were unknown. She had her first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot Number: EN6207) vaccine on 04Mar2021, for COVID-19 immunisation. On 18Apr2021, at 14:00, the patient experienced rash all over her body, and itching. The patient went to dermatologists and doctors and got steroid shots, oral steroids, creams and lotions. For rash, itching, the patient received steroid shots (unspecified) from 20Apr2021 (ongoing) and triamcinolone acetonide cream 0.1% (Expiration date: Nov2023) from 20Apr2021. It was reported that steroid shots and cream did not work. Patient stated that the rash is starting to disappear but the itching is not gone away. Clarified that the rash went away about 4 days before this report. Stated that the steroid shots and the cream were not working for the itching. Then, the patient stated that the Triamcinolone Acetonide Cream USP 0.1% was used for 5 days and she recovered with lasting effects of itching.   No follow-up attempts are needed. No further information is expected.