chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Headache, Hypoaesthesia, Muscular weakness
Clinical narrative: Chills; Muscle and joint ache; Muscle and joint ache; Headache; Injection site pain; Tingling; Numbness; Muscle weakness; Swelling and pain in left arm; Swelling and pain in left arm - all the way down to hand; Swelling and pain in left arm - all the way down to hand; This is a spontaneous report from a contactable consumer (patient).   A 58-year-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EL3248) at single dose, in the left arm, on 21Jan2021, at 11:45 AM, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Relevant medical history included allergies to sulfa drugs and to wasps, fibromyalgia (autoimmune issues), rosacea, rheumatoid arthritis (RA) and frozen shoulder (L). Concomitant medications, received within 2 weeks of vaccination, included cannabidiol (CBD OIL), vitamin D (ergocalciferol), biotin and meloxicam (MEL). On 21Jan2021, at 03:00 PM, the patient experienced chills, muscle and joint aches, headache, injection site pain, tingling and numbness, muscle weakness, swelling and pain in left arm - all the way down to hand. No treatment was received. The patient did not recover from the events at time of this report. The case was assessed as non-serious (seriousness criteria-results in death: no, seriousness criteria-life threatening: no, seriousness criteria-caused/prolonged hospitalization: no, seriousness criteria-disabling/incapacitating: no and seriousness criteria-congenital anomaly/birth defect: no). Post the vaccination, the patient has not been tested for COVID-19.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pain in extremity, Paraesthesia, Peripheral swelling, Vaccination site pain
Clinical narrative: Chills; Muscle and joint ache; Muscle and joint ache; Headache; Injection site pain; Tingling; Numbness; Muscle weakness; Swelling and pain in left arm; Swelling and pain in left arm - all the way down to hand; Swelling and pain in left arm - all the way down to hand; This is a spontaneous report from a contactable consumer (patient).   A 58-year-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EL3248) at single dose, in the left arm, on 21Jan2021, at 11:45 AM, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Relevant medical history included allergies to sulfa drugs and to wasps, fibromyalgia (autoimmune issues), rosacea, rheumatoid arthritis (RA) and frozen shoulder (L). Concomitant medications, received within 2 weeks of vaccination, included cannabidiol (CBD OIL), vitamin D (ergocalciferol), biotin and meloxicam (MEL). On 21Jan2021, at 03:00 PM, the patient experienced chills, muscle and joint aches, headache, injection site pain, tingling and numbness, muscle weakness, swelling and pain in left arm - all the way down to hand. No treatment was received. The patient did not recover from the events at time of this report. The case was assessed as non-serious (seriousness criteria-results in death: no, seriousness criteria-life threatening: no, seriousness criteria-caused/prolonged hospitalization: no, seriousness criteria-disabling/incapacitating: no and seriousness criteria-congenital anomaly/birth defect: no). Post the vaccination, the patient has not been tested for COVID-19.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Chills; Muscle and joint ache; Muscle and joint ache; Headache; Injection site pain; Tingling; Numbness; Muscle weakness; Swelling and pain in left arm; Swelling and pain in left arm - all the way down to hand; Swelling and pain in left arm - all the way down to hand; This is a spontaneous report from a contactable consumer (patient).   A 58-year-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EL3248) at single dose, in the left arm, on 21Jan2021, at 11:45 AM, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Relevant medical history included allergies to sulfa drugs and to wasps, fibromyalgia (autoimmune issues), rosacea, rheumatoid arthritis (RA) and frozen shoulder (L). Concomitant medications, received within 2 weeks of vaccination, included cannabidiol (CBD OIL), vitamin D (ergocalciferol), biotin and meloxicam (MEL). On 21Jan2021, at 03:00 PM, the patient experienced chills, muscle and joint aches, headache, injection site pain, tingling and numbness, muscle weakness, swelling and pain in left arm - all the way down to hand. No treatment was received. The patient did not recover from the events at time of this report. The case was assessed as non-serious (seriousness criteria-results in death: no, seriousness criteria-life threatening: no, seriousness criteria-caused/prolonged hospitalization: no, seriousness criteria-disabling/incapacitating: no and seriousness criteria-congenital anomaly/birth defect: no). Post the vaccination, the patient has not been tested for COVID-19.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Headache, Hypoaesthesia, Joint swelling
Clinical narrative: Chills; Muscle and joint ache; Muscle and joint ache; Headache; Injection site pain; Tingling; Numbness; Muscle weakness; Swelling and pain in left arm; Swelling and pain in left arm - all the way down to hand; Swelling and pain in left arm - all the way down to hand; This is a spontaneous report from a contactable consumer (patient).   A 58-year-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EL3248) at single dose, in the left arm, on 21Jan2021, at 11:45 AM, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Relevant medical history included allergies to sulfa drugs and to wasps, fibromyalgia (autoimmune issues), rosacea, rheumatoid arthritis (RA) and frozen shoulder (L). Concomitant medications, received within 2 weeks of vaccination, included cannabidiol (CBD OIL), vitamin D (ergocalciferol), biotin and meloxicam (MEL). On 21Jan2021, at 03:00 PM, the patient experienced chills, muscle and joint aches, headache, injection site pain, tingling and numbness, muscle weakness, swelling and pain in left arm - all the way down to hand. No treatment was received. The patient did not recover from the events at time of this report. The case was assessed as non-serious (seriousness criteria-results in death: no, seriousness criteria-life threatening: no, seriousness criteria-caused/prolonged hospitalization: no, seriousness criteria-disabling/incapacitating: no and seriousness criteria-congenital anomaly/birth defect: no). Post the vaccination, the patient has not been tested for COVID-19.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Off label use, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Chills; Muscle and joint ache; Muscle and joint ache; Headache; Injection site pain; Tingling; Numbness; Muscle weakness; Swelling and pain in left arm; Swelling and pain in left arm - all the way down to hand; Swelling and pain in left arm - all the way down to hand; This is a spontaneous report from a contactable consumer (patient).   A 58-year-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EL3248) at single dose, in the left arm, on 21Jan2021, at 11:45 AM, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Relevant medical history included allergies to sulfa drugs and to wasps, fibromyalgia (autoimmune issues), rosacea, rheumatoid arthritis (RA) and frozen shoulder (L). Concomitant medications, received within 2 weeks of vaccination, included cannabidiol (CBD OIL), vitamin D (ergocalciferol), biotin and meloxicam (MEL). On 21Jan2021, at 03:00 PM, the patient experienced chills, muscle and joint aches, headache, injection site pain, tingling and numbness, muscle weakness, swelling and pain in left arm - all the way down to hand. No treatment was received. The patient did not recover from the events at time of this report. The case was assessed as non-serious (seriousness criteria-results in death: no, seriousness criteria-life threatening: no, seriousness criteria-caused/prolonged hospitalization: no, seriousness criteria-disabling/incapacitating: no and seriousness criteria-congenital anomaly/birth defect: no). Post the vaccination, the patient has not been tested for COVID-19.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product use issue, Pyrexia, Vaccination site movement impairment, Vaccination site pain, Vaccination site swelling
Clinical narrative: Chills; Muscle and joint ache; Muscle and joint ache; Headache; Injection site pain; Tingling; Numbness; Muscle weakness; Swelling and pain in left arm; Swelling and pain in left arm - all the way down to hand; Swelling and pain in left arm - all the way down to hand; This is a spontaneous report from a contactable consumer (patient).   A 58-year-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EL3248) at single dose, in the left arm, on 21Jan2021, at 11:45 AM, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Relevant medical history included allergies to sulfa drugs and to wasps, fibromyalgia (autoimmune issues), rosacea, rheumatoid arthritis (RA) and frozen shoulder (L). Concomitant medications, received within 2 weeks of vaccination, included cannabidiol (CBD OIL), vitamin D (ergocalciferol), biotin and meloxicam (MEL). On 21Jan2021, at 03:00 PM, the patient experienced chills, muscle and joint aches, headache, injection site pain, tingling and numbness, muscle weakness, swelling and pain in left arm - all the way down to hand. No treatment was received. The patient did not recover from the events at time of this report. The case was assessed as non-serious (seriousness criteria-results in death: no, seriousness criteria-life threatening: no, seriousness criteria-caused/prolonged hospitalization: no, seriousness criteria-disabling/incapacitating: no and seriousness criteria-congenital anomaly/birth defect: no). Post the vaccination, the patient has not been tested for COVID-19.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Malaise
Clinical narrative: Injection site pain; Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever; Injection site swelling; Injection site redness; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH 9899), via an unspecified route of administration on 21Dec2020 09:00 at a single dose for COVID-19 immunization. The patient's medical history included achondroplasia. The patient have no known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Concomitant medication included drospirenone, ethinylestradiol betadex clathrate (YAZ). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 21Dec2020, the patient experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, and feeling unwell. Outcome of the events was recovered. The events were considered non-serious.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Injection site pain; Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever; Injection site swelling; Injection site redness; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH 9899), via an unspecified route of administration on 21Dec2020 09:00 at a single dose for COVID-19 immunization. The patient's medical history included achondroplasia. The patient have no known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Concomitant medication included drospirenone, ethinylestradiol betadex clathrate (YAZ). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 21Dec2020, the patient experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, and feeling unwell. Outcome of the events was recovered. The events were considered non-serious.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Injection site pain; Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever; Injection site swelling; Injection site redness; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH 9899), via an unspecified route of administration on 21Dec2020 09:00 at a single dose for COVID-19 immunization. The patient's medical history included achondroplasia. The patient have no known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Concomitant medication included drospirenone, ethinylestradiol betadex clathrate (YAZ). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 21Dec2020, the patient experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, and feeling unwell. Outcome of the events was recovered. The events were considered non-serious.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable 36-year-old female healthcare professional reported for herself that she received bnt162b2 (BNT162B2) on 23Jan2021 02:45 PM for COVID-19 immunization Medical history was not provided. Patient was not diagnosed with COVID-19 prior to vaccination. Patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Concomitant drugs were reported as none. The patient experienced diarrhea on 24Jan2021. Event was reported non-serious and no treatment was received for it. The patient has not tested for COVID-19. Outcome of the event was resolving.  Information on the lot/batch number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Chest pain, Pain in extremity
Clinical narrative: Left arm has been sore/ soreness that runs from my shoulder all the way to my hand; Soreness that runs from my shoulder all the way to my hand; Burning inside my upper left arm to my shoulder and chest; Burning inside my upper left arm to my shoulder and chest; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 24-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via intramuscular route of administration, on 11Jan2021 (at the age of 24 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history was none. The patient previously received the first dose of BNT162B2 (lot number/expiration date: not provided) on 23Dec2020 (at the age of 24 years old) at 07:45 PM via intramuscular route of administration as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication (other medications taken in two weeks) were none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks (other than the first dose of BNT162B2) prior to the COVID vaccine. On 18Jan2021 at 07:30, the patient experienced left arm has been sore. The patient described it as "my left arm had been sore this past week of 18Jan2021, it is a soreness that runs from my shoulder all the way to my hand, then goes up again and concentrates from my upper left arm it starts burning inside my upper left arm to my shoulder and chest and stays the burning for a few seconds to a minute". The events were reported as non-serious. The patient did not receive any treatment for these events. The outcome of the events left arm sore, shoulder sore, and burning inside upper left arm to shoulder and chest was unknown. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Myalgia, Nasal congestion
Clinical narrative: Fatigue; Headache; Muscle aches; Runny nose; Nasal congestion; Low fever; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received the first dose of bnt162b2 (Lot number: E13247), via an unspecified route of administration in left arm on 21Jan2021 16:30 at single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included fluoxetine hydrochloride (PROZAC). The patient experienced fatigue, headache, muscle aches, runny nose, nasal congestion and wondering if its a sinus infection, low fever (highest temp recorded was 99.9 F) on 24Jan2021 06:00. It was unknown if treatment received for the adverse event. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient was no pregnant. The outcome of events was not recovered.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Fatigue; Headache; Muscle aches; Runny nose; Nasal congestion; Low fever; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received the first dose of bnt162b2 (Lot number: E13247), via an unspecified route of administration in left arm on 21Jan2021 16:30 at single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included fluoxetine hydrochloride (PROZAC). The patient experienced fatigue, headache, muscle aches, runny nose, nasal congestion and wondering if its a sinus infection, low fever (highest temp recorded was 99.9 F) on 24Jan2021 06:00. It was unknown if treatment received for the adverse event. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient was no pregnant. The outcome of events was not recovered.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Feeling hot, Headache
Clinical narrative: headache; pain in arm; Aches/pain; Pain injection site; feeling like her whole body is burning up, hot feeling; could not sleep all night/did not sleep last night; tired; feeling like she has a fever/felt warm and feverish/temperature it was 98; chills; This is a spontaneous report from a contactable consumer (patient). A 93-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1283) intramuscular injection in right upper arm, near her shoulder on 21Jan2021 10:00 AM at single dose for preventative. Medical history and concomitant medication were none. patient reported side effects to the pfizer vaccine after the first dose last Thursday 21Jan2021. Caller reported headache, chills, pain in arm and feeling like she has a fever. Caller stated pfizer should have two dose, one for small people and one for large people. Reporter asked what the timing of the second dose of Pfizer-BioNTech COVID-19 vaccine is and if she could receive it earlier or later than 3 weeks.  Caller stated she received the first Pfizer dose on 21Jan2021 and her second dose is on 18Feb2021. She is calling about the Pfizer BioNtech Covid vaccine. She had the vaccine last Thursday on 21Jan2021. She started having the usual aches, headaches, and pain. On Saturday (23Jan2021) she started getting chills and by the evening she felt warm and feverish, when she checked her temperature it was 98. Last night, she felt like her body was burning up but her temperature was 98. She felt miserable and could not sleep all night. States she attributed it to the vaccine since she was feeling ok prior to the vaccine. She is asking if she should get the second dose. Weight: 95 to 98 pounds, she suggests that those that are smaller like her be given a smaller dose since she weighs so little. She is nervous about getting the second dose which is scheduled on 18Feb2021. She felt like she was burning up and it drained her. She keeps taking her temperature but she does not have a fever. She did not sleep last night. She feels better today. She is aching a bit today but not as much as she did. She is tired since she did not sleep last night. She still has the chills. States it is weird since she feels like she has a high temperature but does not have a high temperature or fever. She hears that there is usually not side effects with the first injection and usually there are side effects with the second injection. She did not feel the vaccine when it was administered. Her chills on Sunday was really bad and today it is better. The burning up/ hot feeling started gradually on Saturday and then on Sunday it got worse. She does not feel as hot and it has improved right now. it was also reported pain in injection site. Relevant Tests was none. no AEs following prior vaccinations. The last outcome of did not sleep last night and tired was unknown, of the events was recovering. It was a non-serious report. Event were not required a visit to Emergency Room nor Physician Office.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain, Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: headache; pain in arm; Aches/pain; Pain injection site; feeling like her whole body is burning up, hot feeling; could not sleep all night/did not sleep last night; tired; feeling like she has a fever/felt warm and feverish/temperature it was 98; chills; This is a spontaneous report from a contactable consumer (patient). A 93-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1283) intramuscular injection in right upper arm, near her shoulder on 21Jan2021 10:00 AM at single dose for preventative. Medical history and concomitant medication were none. patient reported side effects to the pfizer vaccine after the first dose last Thursday 21Jan2021. Caller reported headache, chills, pain in arm and feeling like she has a fever. Caller stated pfizer should have two dose, one for small people and one for large people. Reporter asked what the timing of the second dose of Pfizer-BioNTech COVID-19 vaccine is and if she could receive it earlier or later than 3 weeks.  Caller stated she received the first Pfizer dose on 21Jan2021 and her second dose is on 18Feb2021. She is calling about the Pfizer BioNtech Covid vaccine. She had the vaccine last Thursday on 21Jan2021. She started having the usual aches, headaches, and pain. On Saturday (23Jan2021) she started getting chills and by the evening she felt warm and feverish, when she checked her temperature it was 98. Last night, she felt like her body was burning up but her temperature was 98. She felt miserable and could not sleep all night. States she attributed it to the vaccine since she was feeling ok prior to the vaccine. She is asking if she should get the second dose. Weight: 95 to 98 pounds, she suggests that those that are smaller like her be given a smaller dose since she weighs so little. She is nervous about getting the second dose which is scheduled on 18Feb2021. She felt like she was burning up and it drained her. She keeps taking her temperature but she does not have a fever. She did not sleep last night. She feels better today. She is aching a bit today but not as much as she did. She is tired since she did not sleep last night. She still has the chills. States it is weird since she feels like she has a high temperature but does not have a high temperature or fever. She hears that there is usually not side effects with the first injection and usually there are side effects with the second injection. She did not feel the vaccine when it was administered. Her chills on Sunday was really bad and today it is better. The burning up/ hot feeling started gradually on Saturday and then on Sunday it got worse. She does not feel as hot and it has improved right now. it was also reported pain in injection site. Relevant Tests was none. no AEs following prior vaccinations. The last outcome of did not sleep last night and tired was unknown, of the events was recovering. It was a non-serious report. Event were not required a visit to Emergency Room nor Physician Office.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Weight
Clinical narrative: headache; pain in arm; Aches/pain; Pain injection site; feeling like her whole body is burning up, hot feeling; could not sleep all night/did not sleep last night; tired; feeling like she has a fever/felt warm and feverish/temperature it was 98; chills; This is a spontaneous report from a contactable consumer (patient). A 93-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1283) intramuscular injection in right upper arm, near her shoulder on 21Jan2021 10:00 AM at single dose for preventative. Medical history and concomitant medication were none. patient reported side effects to the pfizer vaccine after the first dose last Thursday 21Jan2021. Caller reported headache, chills, pain in arm and feeling like she has a fever. Caller stated pfizer should have two dose, one for small people and one for large people. Reporter asked what the timing of the second dose of Pfizer-BioNTech COVID-19 vaccine is and if she could receive it earlier or later than 3 weeks.  Caller stated she received the first Pfizer dose on 21Jan2021 and her second dose is on 18Feb2021. She is calling about the Pfizer BioNtech Covid vaccine. She had the vaccine last Thursday on 21Jan2021. She started having the usual aches, headaches, and pain. On Saturday (23Jan2021) she started getting chills and by the evening she felt warm and feverish, when she checked her temperature it was 98. Last night, she felt like her body was burning up but her temperature was 98. She felt miserable and could not sleep all night. States she attributed it to the vaccine since she was feeling ok prior to the vaccine. She is asking if she should get the second dose. Weight: 95 to 98 pounds, she suggests that those that are smaller like her be given a smaller dose since she weighs so little. She is nervous about getting the second dose which is scheduled on 18Feb2021. She felt like she was burning up and it drained her. She keeps taking her temperature but she does not have a fever. She did not sleep last night. She feels better today. She is aching a bit today but not as much as she did. She is tired since she did not sleep last night. She still has the chills. States it is weird since she feels like she has a high temperature but does not have a high temperature or fever. She hears that there is usually not side effects with the first injection and usually there are side effects with the second injection. She did not feel the vaccine when it was administered. Her chills on Sunday was really bad and today it is better. The burning up/ hot feeling started gradually on Saturday and then on Sunday it got worse. She does not feel as hot and it has improved right now. it was also reported pain in injection site. Relevant Tests was none. no AEs following prior vaccinations. The last outcome of did not sleep last night and tired was unknown, of the events was recovering. It was a non-serious report. Event were not required a visit to Emergency Room nor Physician Office.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Fatigue, Hypotension
Clinical narrative: Low blood pressure; Extreme fatigue; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient (not pregnant at the time of vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 20Jan2021 at 16:00 at single dose for COVID-19 immunization. The patient medical history was not reported. Prior to vaccination, patient was not diagnosed with COVID-19. No allergies to medications, food, or other products. Concomitant medications included duloxetine and ergocalciferol (VIT D). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Extreme fatigue for 5 days with low blood pressure on 21Jan2021 at 12:00 AM. Events were resulted in Doctor or other healthcare professional office/clinic visit. Since the vaccination, patient had not been tested for COVID-19. It was unknown if any treatment was received for the events. The outcome of the events was not recovered. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Fever; Headache; This is a spontaneous report from a contactable consumer (patient).  A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number and expiration date unknown), via an unspecified route of administration on an unspecified date in Jan2021 (on Friday) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient developed a headache and fever afterward that she was still somewhat experiencing. Currently taking Tylenol for the events. The outcome of the events was not recovered.  Information on the Lot/Batch Number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Constipation, Lymphadenopathy, Muscle spasms, Nausea
Clinical narrative: Nausea; vomiting; body aches; chills; constipation; cramping; swollen lymph nodes in neck and under arms; This is a spontaneous report from a contactable healthcare professional (patient). A 51-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), intramuscular in the left arm on 22Jan2021 09:30 at a single dose for COVID-19 immunization. The patient's medical history included allergies to IV dye. The patient was not pregnant at the time of vaccination. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730), intramuscular in the left arm on 31Dec2020 09:30 at the age of 51 years old for COVID-19 immunization and codeine and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 22Jan2021 10:00, the patient experienced nausea, vomiting, body aches, chills, constipation, cramping, swollen lymph nodes in neck and under arms. No treatment was received for the adverse events. Outcome of the events was recovering. The events were considered non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vomiting
Clinical narrative: Nausea; vomiting; body aches; chills; constipation; cramping; swollen lymph nodes in neck and under arms; This is a spontaneous report from a contactable healthcare professional (patient). A 51-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), intramuscular in the left arm on 22Jan2021 09:30 at a single dose for COVID-19 immunization. The patient's medical history included allergies to IV dye. The patient was not pregnant at the time of vaccination. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730), intramuscular in the left arm on 31Dec2020 09:30 at the age of 51 years old for COVID-19 immunization and codeine and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 22Jan2021 10:00, the patient experienced nausea, vomiting, body aches, chills, constipation, cramping, swollen lymph nodes in neck and under arms. No treatment was received for the adverse events. Outcome of the events was recovering. The events were considered non-serious.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Breast pain, Flank pain, Lymphadenopathy
Clinical narrative: Swollen and tender axillary and pec lymph nodes; sore arm, R breast and R scapular area; sore arm, R breast and R scapular area; sore arm, R breast and R scapular area; R abdominal/flank pain; R abdominal/flank pain; mild fever; This is a spontaneous report from a contactable health professional, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the right arm on 20Jan2021 at 10:15 (at the age of 36-years-old) as a single dose for COVID-19 immunization. Medical history included hypertension and COVID-19 (diagnosed prior to vaccination), as of unknown dates. The patient had no known allergies. Concomitant medications included olmesartan, fish oil (OMEGA 3) and unspecified CLARITIN. The patient did not receive any other vaccines within 4 weeks of the vaccination. On 21Jan2021 at 16:00, the patient experienced swollen and tender axillary and pec lymph nodes, sore arm, right breast and right scapular area, right abdominal/flank pain and mild fever. The patient was treated for the events with acetaminophen (TYLENOL) and ibuprofen (ADVIL). Since the vaccination, the patient was tested for COVID-19 via nasal swab on 20Jan2021 with a negative result. The clinical outcome of swollen and tender axillary and pec lymph nodes, sore arm, right breast and right scapular area, right abdominal/flank pain and mild fever was resolving.   Information on the Batch/Lot number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: Swollen and tender axillary and pec lymph nodes; sore arm, R breast and R scapular area; sore arm, R breast and R scapular area; sore arm, R breast and R scapular area; R abdominal/flank pain; R abdominal/flank pain; mild fever; This is a spontaneous report from a contactable health professional, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the right arm on 20Jan2021 at 10:15 (at the age of 36-years-old) as a single dose for COVID-19 immunization. Medical history included hypertension and COVID-19 (diagnosed prior to vaccination), as of unknown dates. The patient had no known allergies. Concomitant medications included olmesartan, fish oil (OMEGA 3) and unspecified CLARITIN. The patient did not receive any other vaccines within 4 weeks of the vaccination. On 21Jan2021 at 16:00, the patient experienced swollen and tender axillary and pec lymph nodes, sore arm, right breast and right scapular area, right abdominal/flank pain and mild fever. The patient was treated for the events with acetaminophen (TYLENOL) and ibuprofen (ADVIL). Since the vaccination, the patient was tested for COVID-19 via nasal swab on 20Jan2021 with a negative result. The clinical outcome of swollen and tender axillary and pec lymph nodes, sore arm, right breast and right scapular area, right abdominal/flank pain and mild fever was resolving.   Information on the Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain
Clinical narrative: tiredness; nausea; body ache; This is a spontaneous report from a contactable consumer. This female consumer (patient) with unspecified age reported that she received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. Historical vaccine included she experienced a similar reaction (unspecified) to the influenza vaccine for immunization in the past. In Jan2021, few days later the BNT162B2 vaccine, the patient experienced tiredness with outcome of recovered in Jan2021, nausea with outcome of recovered in Jan2021; a few weeks after the vaccine body ache with outcome of unknown.  Information on the lot/batch number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Vaccination site pain
Clinical narrative: Fatigue; headache; pain at injection site; shortness of breath; This is a spontaneous report from a contactable other health professional (patient). A 25-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly in right arm on 22Jan2021 10:00 at single dose for COVID-19 immunization. Medical history included Lyme disease, early onset arthritis, allergy to latex. Concomitant medication included diclofenac (VOLTAREN). The patient experienced fatigue, headache, pain at injection site for 2 days, shortness of breath for 20 minutes on day 2 afternoon, all on 23Jan2021 13:30. No treatment received. The reporter considered the events as non-serious. The patient was not pregnant at the time of vaccination. 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 event pain at injection site was recovered on 25Jan2021 13:30, of the event shortness of breath was recovered on 23Jan2021 13:50, of the other events was recovered in Jan2021.   Information on the lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Diarrhoea, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer reported for herself.   A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot# EL3249, exp.date May2021 on 15Jan2021 16:00 at single dose for COVID-19 immunization, via unspecified route of administration at the left arm. The patient had get earlier in January a DPT (diphtheria, pertussis, and tetanus) vaccine in the left arm. The patient had have a Pneumonia and Shingles vaccines in the last 2 years and she had no problems in past with vaccines, but stated she did get a little bit of swelling and had to put heat to the area with vaccines, but never had a fever afterwards. The patient had not medical history. Concomitant medications were not reported.  No other vaccines given the same day. Since 16Jan2021, he started having symptoms, fever, cough and Diarrhea. On 17Jan2021 the patient was positive to SARS-CoV-2 test. On 19Jan2021 she received monoclonal antibody therapy. The outcome of the event was not recovered.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer reported for herself.   A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot# EL3249, exp.date May2021 on 15Jan2021 16:00 at single dose for COVID-19 immunization, via unspecified route of administration at the left arm. The patient had get earlier in January a DPT (diphtheria, pertussis, and tetanus) vaccine in the left arm. The patient had have a Pneumonia and Shingles vaccines in the last 2 years and she had no problems in past with vaccines, but stated she did get a little bit of swelling and had to put heat to the area with vaccines, but never had a fever afterwards. The patient had not medical history. Concomitant medications were not reported.  No other vaccines given the same day. Since 16Jan2021, he started having symptoms, fever, cough and Diarrhea. On 17Jan2021 the patient was positive to SARS-CoV-2 test. On 19Jan2021 she received monoclonal antibody therapy. The outcome of the event was not recovered.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Liver tenderness, Lymphadenopathy, Malaise
Clinical narrative: This is a spontaneous report from a contactable physician . A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EL3249) intramuscular in Right arm on 20Jan2021 at 10:45 at single dose for covid-19 immunisation .  Medical history included attention deficit hyperactivity disorder (ADD) and hypertension (HTN). Patient had iodine allergy. Patient was not pregnant.Concomitant medication included methylphenidate hydrochloride (CONCERTA); amlodipine; calcium/vitamin D NOS ; omeprazole (PROTONIX); meloxicam and medroxyprogesterone acetate (DEPO-PROVERA). The patient previously on 30Dec2020 at 10:45 took the first dose of BNT162B2 (PFIZER-BIONTECH COVID19 VACCINE;lot EK9231) intramuscular in Right arm for covid-19 immunisation.  On 22Jan2021 at 09:00 the patient experienced joint pain, malaise, R axillary lymphadenopathy, enlarged and tender spleen, tender liver, all non serious.No treatment given for the adverse events.The final outcome of the events was reported as not recovered
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Splenomegaly
Clinical narrative: This is a spontaneous report from a contactable physician . A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EL3249) intramuscular in Right arm on 20Jan2021 at 10:45 at single dose for covid-19 immunisation .  Medical history included attention deficit hyperactivity disorder (ADD) and hypertension (HTN). Patient had iodine allergy. Patient was not pregnant.Concomitant medication included methylphenidate hydrochloride (CONCERTA); amlodipine; calcium/vitamin D NOS ; omeprazole (PROTONIX); meloxicam and medroxyprogesterone acetate (DEPO-PROVERA). The patient previously on 30Dec2020 at 10:45 took the first dose of BNT162B2 (PFIZER-BIONTECH COVID19 VACCINE;lot EK9231) intramuscular in Right arm for covid-19 immunisation.  On 22Jan2021 at 09:00 the patient experienced joint pain, malaise, R axillary lymphadenopathy, enlarged and tender spleen, tender liver, all non serious.No treatment given for the adverse events.The final outcome of the events was reported as not recovered
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site bruising, Vaccination site pain
Clinical narrative: Pain at injection site; muscle pain below injection site; severe bruising below injection site; This is a spontaneous report from a contactable consumer reporting for himself. An 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL8982, expiry date unknown) on 16Jan2021 15:30 at a single dose via an unspecified route of administration in his left arm for COVID-19 immunization. Medical history included diabetes, heart disease and arthritis, from unknown date and unspecified if ongoing. The patient had known allergies to penicillin and tramadol hydrochloride (ULTRAM). The patient's concomitant drug included apixaban (ELIQUIS), no other vaccine received in four weeks. The patient had not had COVID prior the vaccination and no COVID tested post the vaccination. On 16Jan2021 (time provided as 22:00), the patient experienced pain at injection site, muscle pain below injection site, severe bruising below injection site. The patient took apixaban and he believed the injection caused severe bruising. The patient received home remedy: elevated arm applied warm compress, as treatment for the events. The patient was recovering from the events.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Blood test, Cough, Dry throat, Myalgia
Clinical narrative: sore throat; pain/aches; he said he had a loss of taste that started yesterday, 24Jan2021, but he did not have a complete loss of taste; Coughing; Dry throat; Muscle pain; This is a spontaneous report from a contactable consumer reported for himself. A 74-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246 and expiry date: Apr2021), via an unspecified route of administration on left arm on 18Jan2021 (11:00-11:10 AM) at SINGLE DOSE for covid-19 immunisation. Medical history included none. The patient's concomitant medications were not reported. The patient previously took flu shot on 06Jan2021 with no adverse event. The patient received 1st dose on 18Jan2021, unknown date the patient started experiencing "what sounded like flu": sore throat, pain/aches. He said 2 days ago on 23Jan2021, he had developed a dry throat, coughing, and muscle pain. He said everything else is easing up (clarified as his dry throat and muscle pain), except for his cough. He said he is supposed to have a procedure tomorrow to replace his defibrillator and is wondering if it is OK for him to go ahead with the procedure. Reported he had a loss of taste that started yesterday on 24Jan2021. He said he did not have a complete loss of taste. He said he does not have a strong sense of taste now. He said he could barely taste his coffee this morning, clarifying that his coffee tasted like he was drinking hot water. Declined any reported he had taken some over-thecounter pain killers, like Ibuprofen, in the past couple of weeks. He said he is not a big medication person, except for his heart medication, and the Ibuprofen is something he previously had in his house. The caller clarified his doctor stated he would test him for the COVID-19 Virus tomorrow on 26Jan2021 before his surgery. Reported he had blood work done on 06Jan2021, the same day he had a flu shot. He clarified he did not have any side effects from the flu vaccine on 06Jan2021. He said he never has side effects when he gets vaccines. Reported he had blood work done again on Friday, 22Jan2021, when he went for his preregistration for his surgery that is scheduled on 26Jan2021. Outcome of the events dry throat, and muscle pain was recovering, outcome of the event loss of taste and coughing was not recovered, outcome of the other events was unknown.