chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: Tested positive for COVID-19 virus; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 29Jan2021 at a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 05Feb2021, the patient had tested positive for COVID-19 virus. The outcome of the event, 'tested positive for COVID-19 virus', was unknown. The patient would like to know if she could get the second dose on 19Feb2021 as scheduled.  Information of lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Ageusia, Anosmia, COVID-19, Chest X-ray
Clinical narrative: COVID-19; COVID-19; Fatigue; general achiness; respiratory symptoms; loss of taster intermittent loss of smell; loss of taster intermittent loss of smell; coughing; congestion; sore throat; headache; Exposure to SARS-CoV-2; Nausea; injection site pain; lightheadedness; Stomach pain; extreme exhaustion; This is a spontaneous report received by Pfizer from Agency, (Mfr. Control No: 2020US004529) through a contactable physician.  A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 29Dec2020 (at the age of 65-year-old) as a single dose for Covid-19 immunisation and also started to receive abaloparatide (TYMLOS, Formulation: injection, Lot number: RT01102, Expiration date: Dec2022) via subcutaneous from 20Dec2020 to an unknown date, at 80 ug, once a day for osteoporosis. The patient medical history, included autoimmune disease-Behcet's disease causing ulcers, osteoporosis and constipation, and all were ongoing. The patient concomitant medication was not reported. On 29Dec2020, the patient experienced injection site pain, fatigue, nausea, Stomach pain and Light headness and the patient believed these symptoms were due to the vaccine. On 04Jan2021, the patient was Exposure to SARS-CoV-2. It was also reported that on 16Jan2021, the patient experienced coughing, fatigue, lost taste/smell, congestion, sore throat, headache, respiratory symptoms, general achiness and also had COVID-19 on an unknown date. It was reported that general achiness and respiratory symptoms possibly related to Covid-19 which resulted in emergency room visit on 16Jan2021. The cough was treated with benzonatate pearls. The following relevant laboratory tests were performed: Rapid COVID-19 (12Jan2021), negative, COVID 19 PCR test (15Jan2021), negative, and chest x-ray (16Jan2021), clear, negative. The action taken in response to the events for abaloparatide was unknown. The outcome of the events COVID-19, light headedness, stomach pain, exposure to sars-cov-2 was unknown, for the events nausea, general achiness, respiratory symptoms, loss of taster intermittent loss of smell, coughing, congestion, sore throat, fatigue, headache was not recovered and for the events injection site pain, extreme exhaustion was recovered on 31Dec2020.  Information on batch/lot number was requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 29Dec2020, and contracted COVID on an unspecified date.  No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.  Further information like COVID infection date needed for a full meaningful medical assessment.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Drug ineffective, Exposure to SARS-CoV-2, Fatigue
Clinical narrative: COVID-19; COVID-19; Fatigue; general achiness; respiratory symptoms; loss of taster intermittent loss of smell; loss of taster intermittent loss of smell; coughing; congestion; sore throat; headache; Exposure to SARS-CoV-2; Nausea; injection site pain; lightheadedness; Stomach pain; extreme exhaustion; This is a spontaneous report received by Pfizer from Agency, (Mfr. Control No: 2020US004529) through a contactable physician.  A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 29Dec2020 (at the age of 65-year-old) as a single dose for Covid-19 immunisation and also started to receive abaloparatide (TYMLOS, Formulation: injection, Lot number: RT01102, Expiration date: Dec2022) via subcutaneous from 20Dec2020 to an unknown date, at 80 ug, once a day for osteoporosis. The patient medical history, included autoimmune disease-Behcet's disease causing ulcers, osteoporosis and constipation, and all were ongoing. The patient concomitant medication was not reported. On 29Dec2020, the patient experienced injection site pain, fatigue, nausea, Stomach pain and Light headness and the patient believed these symptoms were due to the vaccine. On 04Jan2021, the patient was Exposure to SARS-CoV-2. It was also reported that on 16Jan2021, the patient experienced coughing, fatigue, lost taste/smell, congestion, sore throat, headache, respiratory symptoms, general achiness and also had COVID-19 on an unknown date. It was reported that general achiness and respiratory symptoms possibly related to Covid-19 which resulted in emergency room visit on 16Jan2021. The cough was treated with benzonatate pearls. The following relevant laboratory tests were performed: Rapid COVID-19 (12Jan2021), negative, COVID 19 PCR test (15Jan2021), negative, and chest x-ray (16Jan2021), clear, negative. The action taken in response to the events for abaloparatide was unknown. The outcome of the events COVID-19, light headedness, stomach pain, exposure to sars-cov-2 was unknown, for the events nausea, general achiness, respiratory symptoms, loss of taster intermittent loss of smell, coughing, congestion, sore throat, fatigue, headache was not recovered and for the events injection site pain, extreme exhaustion was recovered on 31Dec2020.  Information on batch/lot number was requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 29Dec2020, and contracted COVID on an unspecified date.  No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.  Further information like COVID infection date needed for a full meaningful medical assessment.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasal congestion, Nausea, Oropharyngeal pain, Pain
Clinical narrative: COVID-19; COVID-19; Fatigue; general achiness; respiratory symptoms; loss of taster intermittent loss of smell; loss of taster intermittent loss of smell; coughing; congestion; sore throat; headache; Exposure to SARS-CoV-2; Nausea; injection site pain; lightheadedness; Stomach pain; extreme exhaustion; This is a spontaneous report received by Pfizer from Agency, (Mfr. Control No: 2020US004529) through a contactable physician.  A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 29Dec2020 (at the age of 65-year-old) as a single dose for Covid-19 immunisation and also started to receive abaloparatide (TYMLOS, Formulation: injection, Lot number: RT01102, Expiration date: Dec2022) via subcutaneous from 20Dec2020 to an unknown date, at 80 ug, once a day for osteoporosis. The patient medical history, included autoimmune disease-Behcet's disease causing ulcers, osteoporosis and constipation, and all were ongoing. The patient concomitant medication was not reported. On 29Dec2020, the patient experienced injection site pain, fatigue, nausea, Stomach pain and Light headness and the patient believed these symptoms were due to the vaccine. On 04Jan2021, the patient was Exposure to SARS-CoV-2. It was also reported that on 16Jan2021, the patient experienced coughing, fatigue, lost taste/smell, congestion, sore throat, headache, respiratory symptoms, general achiness and also had COVID-19 on an unknown date. It was reported that general achiness and respiratory symptoms possibly related to Covid-19 which resulted in emergency room visit on 16Jan2021. The cough was treated with benzonatate pearls. The following relevant laboratory tests were performed: Rapid COVID-19 (12Jan2021), negative, COVID 19 PCR test (15Jan2021), negative, and chest x-ray (16Jan2021), clear, negative. The action taken in response to the events for abaloparatide was unknown. The outcome of the events COVID-19, light headedness, stomach pain, exposure to sars-cov-2 was unknown, for the events nausea, general achiness, respiratory symptoms, loss of taster intermittent loss of smell, coughing, congestion, sore throat, fatigue, headache was not recovered and for the events injection site pain, extreme exhaustion was recovered on 31Dec2020.  Information on batch/lot number was requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 29Dec2020, and contracted COVID on an unspecified date.  No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.  Further information like COVID infection date needed for a full meaningful medical assessment.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory disorder, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: COVID-19; COVID-19; Fatigue; general achiness; respiratory symptoms; loss of taster intermittent loss of smell; loss of taster intermittent loss of smell; coughing; congestion; sore throat; headache; Exposure to SARS-CoV-2; Nausea; injection site pain; lightheadedness; Stomach pain; extreme exhaustion; This is a spontaneous report received by Pfizer from Agency, (Mfr. Control No: 2020US004529) through a contactable physician.  A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 29Dec2020 (at the age of 65-year-old) as a single dose for Covid-19 immunisation and also started to receive abaloparatide (TYMLOS, Formulation: injection, Lot number: RT01102, Expiration date: Dec2022) via subcutaneous from 20Dec2020 to an unknown date, at 80 ug, once a day for osteoporosis. The patient medical history, included autoimmune disease-Behcet's disease causing ulcers, osteoporosis and constipation, and all were ongoing. The patient concomitant medication was not reported. On 29Dec2020, the patient experienced injection site pain, fatigue, nausea, Stomach pain and Light headness and the patient believed these symptoms were due to the vaccine. On 04Jan2021, the patient was Exposure to SARS-CoV-2. It was also reported that on 16Jan2021, the patient experienced coughing, fatigue, lost taste/smell, congestion, sore throat, headache, respiratory symptoms, general achiness and also had COVID-19 on an unknown date. It was reported that general achiness and respiratory symptoms possibly related to Covid-19 which resulted in emergency room visit on 16Jan2021. The cough was treated with benzonatate pearls. The following relevant laboratory tests were performed: Rapid COVID-19 (12Jan2021), negative, COVID 19 PCR test (15Jan2021), negative, and chest x-ray (16Jan2021), clear, negative. The action taken in response to the events for abaloparatide was unknown. The outcome of the events COVID-19, light headedness, stomach pain, exposure to sars-cov-2 was unknown, for the events nausea, general achiness, respiratory symptoms, loss of taster intermittent loss of smell, coughing, congestion, sore throat, fatigue, headache was not recovered and for the events injection site pain, extreme exhaustion was recovered on 31Dec2020.  Information on batch/lot number was requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 29Dec2020, and contracted COVID on an unspecified date.  No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.  Further information like COVID infection date needed for a full meaningful medical assessment.
Sex: F
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: She had a small infection; This spontaneous report is received from a Pfizer sponsored program. A contactable consumer (Patient) reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received the first dose of Covid19 vaccine shot and she was due for a second dose on 11Feb2021. She had a small infection and was prescribed antibiotics Amoxicillin today. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Condition aggravated, Feeling abnormal, Headache
Clinical narrative: lymph nodes under arm pits feel like golf balls was reported as worsened/lymph nodes under arm feel like golf balls was reported as worsened; lymph nodes under her arm pits and under her arm feel like golf balls/lymph nodes in neck swollen; Fever is 99.6 this morning; hurt all over from her toes to her fingers and from her fingers to her toes; lack of sleep; Headache; Chills; feels like wires are squeezing and pressing her/Feels awful; This is a spontaneous report from a contactable consumer.  A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 05Feb2021 13:00 at single dose for covid-19 immunisation. Medical history included ongoing fibromyalgia Diagnosed with it 5-6 years ago, ongoing chronic lymphocytic leukaemia Diagnosed almost a year ago. The patients concomitant medications were not reported. The patient experienced, lack of sleep on 05Feb2021 21:00. It was reported that she got the vaccine more than 48 hours ago. Stated that she feels awful on 05Feb2021 10:00. Stated that she has a fever on 06Feb2021, chills and headache on 05Feb2021 19:00, hurt all over from her toes to her fingers and from her fingers to her toes on 05Feb2021 22:00. Stated that she is in a lot of pain and that it feels like wires are squeezing and pressing her on 05Feb2021. Stated that it is horrible. Stated that the lymph nodes under her arm pits and neck feel like golf ball under arm and arm pit on 06Feb2021 12:00. Stated today the doctor will see her because it will have been 3 days in a few hours. Clarified that this is for the Covid vaccine. Stated that she is working in a retirement place with an older person. Stated that they decided to give to it to her. Stated that she asked her doctor and he told her that it was okay. Later clarified that the lymph nodes in her neck are just swollen and the lymph nodes under her arm pits and under her arm feel like golf balls. Stated that her fever is 99.6 this morning (06Feb2021). Stated that it improved when she took three Advil (600mg). Stated that she feels like wires are squeezing and pressing her again when the Advil wears off. Was told to alternate with Tylenol and is taking a lot of liquids. Clarified that she thought that the pain was fibromyalgia but that it felt worst than fibromyalgia. Stated that the lack of sleep improved because she takes a higher dosage of Advil or Ibuprofen for sleep. Outcome of the event fever is 99.6 this morning, hurt all over from her toes to her fingers and from her fingers to her toes, feels awful, lack of sleep recovering. Outcome of the event lymph nodes under arm feel like golf balls was reported as worsened (Condition worsened) was unknown. Outcome of the other events was not recovered.   Information on the lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Lymphadenopathy, Oral herpes, Pain
Clinical narrative: lymph nodes under arm pits feel like golf balls was reported as worsened/lymph nodes under arm feel like golf balls was reported as worsened; lymph nodes under her arm pits and under her arm feel like golf balls/lymph nodes in neck swollen; Fever is 99.6 this morning; hurt all over from her toes to her fingers and from her fingers to her toes; lack of sleep; Headache; Chills; feels like wires are squeezing and pressing her/Feels awful; This is a spontaneous report from a contactable consumer.  A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 05Feb2021 13:00 at single dose for covid-19 immunisation. Medical history included ongoing fibromyalgia Diagnosed with it 5-6 years ago, ongoing chronic lymphocytic leukaemia Diagnosed almost a year ago. The patients concomitant medications were not reported. The patient experienced, lack of sleep on 05Feb2021 21:00. It was reported that she got the vaccine more than 48 hours ago. Stated that she feels awful on 05Feb2021 10:00. Stated that she has a fever on 06Feb2021, chills and headache on 05Feb2021 19:00, hurt all over from her toes to her fingers and from her fingers to her toes on 05Feb2021 22:00. Stated that she is in a lot of pain and that it feels like wires are squeezing and pressing her on 05Feb2021. Stated that it is horrible. Stated that the lymph nodes under her arm pits and neck feel like golf ball under arm and arm pit on 06Feb2021 12:00. Stated today the doctor will see her because it will have been 3 days in a few hours. Clarified that this is for the Covid vaccine. Stated that she is working in a retirement place with an older person. Stated that they decided to give to it to her. Stated that she asked her doctor and he told her that it was okay. Later clarified that the lymph nodes in her neck are just swollen and the lymph nodes under her arm pits and under her arm feel like golf balls. Stated that her fever is 99.6 this morning (06Feb2021). Stated that it improved when she took three Advil (600mg). Stated that she feels like wires are squeezing and pressing her again when the Advil wears off. Was told to alternate with Tylenol and is taking a lot of liquids. Clarified that she thought that the pain was fibromyalgia but that it felt worst than fibromyalgia. Stated that the lack of sleep improved because she takes a higher dosage of Advil or Ibuprofen for sleep. Outcome of the event fever is 99.6 this morning, hurt all over from her toes to her fingers and from her fingers to her toes, feels awful, lack of sleep recovering. Outcome of the event lymph nodes under arm feel like golf balls was reported as worsened (Condition worsened) was unknown. Outcome of the other events was not recovered.   Information on the lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Low grade fever 99.5; This is a spontaneous report from a contactable consumer (patient herself). A 54-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: Unknown and Expiration date: Unknown), via an unspecified route of administration in right arm on 24Jan2021 10:30 AM (at the age of 54-year-old) at single dose for COVID-19 immunisation in Public Health Clinic/Veterans Administration facility. The patient's medical history included high blood pressure, anxiety, bipolar. Concomitant medications included escitalopram oxalate (LEXAPRO), lamotrigine (LAMICTAL), quetiapine fumarate (SEROQUEL); the patient received all the drugs within 2 weeks of vaccination. The patient previously took phenytoin sodium (DILANTIN), levofloxacin (LEVAQUIN), hydrocodone bitartrate, paracetamol (VICODIN) and experienced drug allergy for all the drugs. 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. The patient has not been tested for COVID-19 since the vaccination. On 24Jan2021 16:00, the patient experienced low grade fever 99.5. The patient underwent lab tests and procedures which included body temperature: 99.5 (low grade fever 99.5) on 24Jan2021. The event was considered as non-serious by the consumer. The patient was treated with Tylenol for the adverse event. The outcome of the event was recovered on an unspecified date in 2021.   Information on the lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pain in extremity, Poor peripheral circulation
Clinical narrative: Sore big toes on both feet; bruising under toenails; poor circulation on both big toes; This is a spontaneous report from a contactable Other Health Professional. A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 03Jan2021 at 09:30am (Batch/Lot Number: EL3246) as single dose for covid-19 immunisation. The patient had none medical history. The patients Concomitant medication included buprenorphine hydrochloride (SUBUTEX) taken for an unspecified indication, start and stop date were not reported. The patients past drug included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose1 administered in Arm Left arm on 23Dec2020 at 09:30am(Batch/Lot Number: EK5730) as single dose for covid-19 immunisation. The patient experienced sore big toes on both feet, bruising under toenails and poor circulation on both big toes on 15Jan2021 at 20:00. The outcome of the events was not recovered.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus-ringing in ears. Ears began ringing one day after shot and has been ringing for 6 days nonstop; This is a spontaneous report from a contactable consumer (patient). A 42-Year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration in the left arm on 02Feb2021 at 14:45 (at the age of 42-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine and didn't receive any other medications within two weeks of vaccination. On 03Feb2021, at 16:00 the patient experienced tinnitus-ringing in ears. Ears began ringing one day after shot and has been ringing for 6 days nonstop. The patient visited physician office. It was unknown whether the patient received any treatment for the event. The event was reported as non-serious by the reporter. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia, Paraesthesia, Paraesthesia oral, Swollen tongue
Clinical narrative: my tongue was tingling and was slightly swollen; difficulty swallowing saliva but could swallow water; my tongue was tingling and was slightly swollen; I felt some tingling in my face; I felt light headed right after the shot; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection; Lot Number: EM9810), via an unspecified route of administration in the left arm on 04Feb2021 at 16:15 (at the age of 60-years-old) as a single dose for COVID-19 vaccination. Medical history included depression, anxiety and the patient was diagnosed with COVID-19 prior to vaccination. No allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination included 6 prescribed meds daily plus vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient was not tested for COVID-19. Upon vaccination on 04Feb2021 at 16:15, patient felt light headed right after the shot. She waited 15 minutes and started driving home. she felt some tingling in her face. By the time she got home, 35 minutes after the shot, her tongue was tingling and was slightly swollen. She had some difficulty swallowing saliva but could swallow water. Her tongue was still slightly swollen the next morning but did not tingle. No seriousness criteria was reported. The patient did not receive any treatment for the events. The outcome of events was recovered on an unspecified date of Feb2021.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Headache, Hypoaesthesia, Peripheral coldness
Clinical narrative: Pain and swelling (about the size of a boiled egg) on the shot site; Pain and swelling (about the size of a boiled egg) on the shot site; Cold hands and feet after receiving shot; My right hand also was numb and needed to be rubbed to increase circulation; Fever; joint aches; headache; This is a spontaneous report from a contactable consumer reported that: A 76-years-old female patient received bnt162b2 (BNT162B2; Manufacturer Pfizer-BioNTech), via an unspecified route of administration, administered in Arm Right on 26Jan2021 (Batch/Lot Number: EL9261) as SINGLE DOSE for COVID-19 immunisation. Medical history included cerebrovascular accident, allergic to sulfa drugs (drug hypersensitivity). The patient received concomitant medications included losartan (LOSARTAN), atorvastatin (ATORVASTATIN), vitamin b12 nos (VITAMIN B 12 [VITAMIN B12 NOS]), acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication, start and stop date were unknown. The patient did not receive any other vaccines with in four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. On 27Jan2021 03:00, the patient experienced Pain and swelling (about the size of a boiled egg) on the shot site. Cold hands and feet after receiving shot, including all night. My right hand also was numb and needed to be rubbed to increase circulation. Fever, joint aches, headache. The patient underwent lab tests and procedures which included body temperature: results unknown .Outcome of the events were recovered on unspecified date.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Pain and swelling (about the size of a boiled egg) on the shot site; Pain and swelling (about the size of a boiled egg) on the shot site; Cold hands and feet after receiving shot; My right hand also was numb and needed to be rubbed to increase circulation; Fever; joint aches; headache; This is a spontaneous report from a contactable consumer reported that: A 76-years-old female patient received bnt162b2 (BNT162B2; Manufacturer Pfizer-BioNTech), via an unspecified route of administration, administered in Arm Right on 26Jan2021 (Batch/Lot Number: EL9261) as SINGLE DOSE for COVID-19 immunisation. Medical history included cerebrovascular accident, allergic to sulfa drugs (drug hypersensitivity). The patient received concomitant medications included losartan (LOSARTAN), atorvastatin (ATORVASTATIN), vitamin b12 nos (VITAMIN B 12 [VITAMIN B12 NOS]), acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication, start and stop date were unknown. The patient did not receive any other vaccines with in four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. On 27Jan2021 03:00, the patient experienced Pain and swelling (about the size of a boiled egg) on the shot site. Cold hands and feet after receiving shot, including all night. My right hand also was numb and needed to be rubbed to increase circulation. Fever, joint aches, headache. The patient underwent lab tests and procedures which included body temperature: results unknown .Outcome of the events were recovered on unspecified date.
Sex: M
Vaccine: COVID19
Symptoms: Injury
Clinical narrative: Injury; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (Patient's wife) reported for a male patient (Husband) that: A male patient of an unspecified age started to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), via an unspecified route of administration from an unspecified date to an unspecified date at SINGLE DOSE for covid-19 immunization. The patient medical history was unknown. The patient's concomitant medication was unknown. On unspecified date, the caller mentioned that her husband had an injury after the first dose and will need to take Tylenol for pain. The caller would like to know when can her husband take pain medications after the first dose. Outcome of the event was unknown.  Information on Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Caller's husband experienced foot pain; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (Patient's wife) reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, the caller's husband experienced foot pain on an unknown date. The outcome of the event was reported as unknown.  Information on the lot/batch number has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: muscle cramping in the right calf; This is a spontaneous report from a contactable consumer (Patient's husband).  A 78-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: EL3246), on Left Arm via an unspecified route of administration on 30Jan2021 9:15 AM at single dose for covid-19 immunisation. The patient medical history was not reported. The patients concomitant medication included unspecified Vitamins since 50 year. It was reported that Patient experiencing muscle cramping in the right calf, began 30Jan2021 9:15am, cramping started that afternoon. 6 hours later or so. Patient questioned was this a normal side effect. Just feels different. The Fax sheet he received stating the indication was to administer the vaccine as 2 doses, 3 weeks apart. However, the card he received at vaccination center had both him and his wife scheduled 27Feb2021 which was 4 weeks. He also had to report a side effect for his wife. His wife got her vaccine on the left arm, but right leg calf muscle was constantly acting like a Charlie Horse, it's cramping, like the muscle was pulling in the right calf. His Wife's first dose was on 30Jan2021 at 9:15 AM, and in the afternoon on the same day was when right calf cramping started, since then it has been constant. The Right Calf Cramping was definitely the same. He did not know if it was worse or not but she was just complaining last night about it, it's continuing, it has caused her to wake up during the night. for both him and his wife the second dose may be schedule on 27Feb2021. He clarifies that he was not sure what his wife was told, but the young woman gave the same date on his card and said this was the earliest date that he can be scheduled. Outcome of the event was not recovered
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Fever of 101.4; Chills; Aches; Fatigue; This is a spontaneous report from a contactable consumer.  A 76-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jan2021 (Batch/Lot Number: EL9263) as SINGLE DOSE for an unspecified indication.  Medical history included ongoing acute myeloid leukaemia, ongoing hypertension. Concomitant medications included gilteritinib fumarate (XOSPATA) taken for an unspecified indication, start and stop date were not reported; timolol taken for an unspecified indication, start and stop date were not reported; lisinopril taken for an unspecified indication, start and stop date were not reported; levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported; latanoprost (LATANOPROST) taken for an unspecified indication, start and stop date were not reported; hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for an unspecified indication, start and stop date were not reported.  The patient experienced fever of 101.4 (pyrexia) (non-serious) on 30Jan2021 10:00, chills (chills) (non-serious) on 30Jan2021 10:00, aches (pain) (non-serious) on 30Jan2021 10:00, fatigue on 30Jan2021 10:00.  The patient underwent lab tests and procedures which included body temperature: 101.4 on 30Jan2021.  There was not treatment received for the adverse events. The events were considered as non-serious by the other healthcare professional. The outcome of the events were reported as recovered.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Fatigue, Feeling cold
Clinical narrative: she was freezing cold but no temperature registered; nausea; no energy; she was sleepy; head hurt; chills but no temperature; fever; fatigue/exhausted; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EN9810, expiry: unknown), intramuscular in the muscle of her right shoulder on 05Feb2021 11:00 at a single dose for covid-19 immunization at a public health department. The patient has no medical history and concomitant medications. The patient is experiencing chills but no temperature on Feb2021, fever on Feb2021, fatigue on Feb2021, nausea, and no energy. She had her first shot last Friday (05Feb2021) and was fine. She stated that yesterday afternoon (11Feb2021), she felt really bad. She called the clinic to see if it was symptoms of Covid. She stated that she was freezing cold, but no temperature registered on 12Feb2021 at 13:00. Her head hurt on 11Feb2021 13:00 and she took Ibuprofen but it never let up, so she took Tylenol. She was sleepy on 11Feb2021 14:00 and was napping so she laid on the couch. The patient was also nauseous on 11Feb2021 14:00 but never threw up. She called the clinic to see if she should get tested for Covid. She stated that since she got up that she is exhausted, felt like she had no energy on 11Feb2021 14:00. The patient wanted to know if she needed to be concerned or if this is something that will run its course. She had to go get blood work at the hospital on Wednesday and that everyone had on masks and she did not think that she was exposed. The patient has no prior vaccinations (within 4 weeks). The outcome of the events feeling cold and feeling of total lack of energy was recovering, head pain and nausea recovered on 11Feb2021 while event sleepy was not recovered. The outcome of the other events was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia, Somnolence
Clinical narrative: she was freezing cold but no temperature registered; nausea; no energy; she was sleepy; head hurt; chills but no temperature; fever; fatigue/exhausted; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EN9810, expiry: unknown), intramuscular in the muscle of her right shoulder on 05Feb2021 11:00 at a single dose for covid-19 immunization at a public health department. The patient has no medical history and concomitant medications. The patient is experiencing chills but no temperature on Feb2021, fever on Feb2021, fatigue on Feb2021, nausea, and no energy. She had her first shot last Friday (05Feb2021) and was fine. She stated that yesterday afternoon (11Feb2021), she felt really bad. She called the clinic to see if it was symptoms of Covid. She stated that she was freezing cold, but no temperature registered on 12Feb2021 at 13:00. Her head hurt on 11Feb2021 13:00 and she took Ibuprofen but it never let up, so she took Tylenol. She was sleepy on 11Feb2021 14:00 and was napping so she laid on the couch. The patient was also nauseous on 11Feb2021 14:00 but never threw up. She called the clinic to see if she should get tested for Covid. She stated that since she got up that she is exhausted, felt like she had no energy on 11Feb2021 14:00. The patient wanted to know if she needed to be concerned or if this is something that will run its course. She had to go get blood work at the hospital on Wednesday and that everyone had on masks and she did not think that she was exposed. The patient has no prior vaccinations (within 4 weeks). The outcome of the events feeling cold and feeling of total lack of energy was recovering, head pain and nausea recovered on 11Feb2021 while event sleepy was not recovered. The outcome of the other events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: minimal arm pain; This is a spontaneous report via a Pfizer-sponsored program Support from a contactable consumer (patient). This contactable consumer reported the same events for two patients (herself and her husband). This is the first of two reports.   A 66-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date (Batch/Lot number and expiry date were not reported) at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient received the first dose of the Pfizer Covid 19 vaccine along with her 73-year-old husband on an unspecified date (reported as 'Tuesday night'. She reported minimal arm pain and only hurt when she touched it on an unspecified date. She wanted to know how long after dose two would potential side effects show up. She was considering rescheduling her second dose so she doesn't miss work. The outcome of the event was unknown. The event was reported as non-serious.   Information on the batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021185860 same reporter/drug/event, different patient
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: persistent headache; This is a spontaneous report from a contactable 64-year-old female consumer reported that. A 64-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3Z47), via an unspecified route of administration in the left arm, on 11Feb2021 09:00 AM, SINGLE DOSE for covid-19 immunisation. Medical history was none. The patient's concomitant medications were unknown. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19.  The patient was not received treatment. The patient was not pregnant at the time of vaccination. On Feb2021 at 6:00 PM, the patient experienced persistent headache. Outcome of the event was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Heart rate, Heart rate abnormal, Somnolence
Clinical narrative: tired; sleepy; pulse has been up and down from 103-104 back to the 70's; Pain in the armpit area and it is sore to the touch; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age (reported 66, units not specified) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), via an unspecified route of administration on 09Feb2021 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunization. The patient reported being tired and sleepy and her pulse has been up and down from 103-104 back to the 70's in Feb2021. The patient also had pain in the armpit area, and it is sore to the touch in Feb2021. The patient wanted to know if the shot does something to the lymph nodes, and if it is a side effect of the vaccine. The outcome of the events was unknown.   Information on Lot /Batch Number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: Itching terribly; This is a spontaneous report from a contactable consumer (patient). This 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 (lot number: EL3249 and expiry date unknown) at a single dose and then the second dose via an unspecified route of administration on 09Feb2021 13:30 (lot number: EL9261 and expiry date unknown) at a single dose for COVID-19 immunisation. There were no medical history and concomitant medications. She got the first shot on 19Jan2021 and about a week and half later, she started itching terribly for about 48 hours and was off and on, mostly at night. She got her second dose of the vaccine Tuesday, 09Feb2021 13:30, and she started itching terribly Tuesday night, around 19:00-19:-30 and she had been itching since. It is ongoing but has gotten better because she has been taking Benadryl. She called the place where she got the shot done and they said it was not a side effect, to call her internal medicine, doctor and she called them and they told to call Pfizer because they do believe it is a side effect. She is trying to clarify if itching is associated with the product. Outcome of the event was recovering.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Itching terribly; This is a spontaneous report from a contactable consumer (patient). This 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 (lot number: EL3249 and expiry date unknown) at a single dose and then the second dose via an unspecified route of administration on 09Feb2021 13:30 (lot number: EL9261 and expiry date unknown) at a single dose for COVID-19 immunisation. There were no medical history and concomitant medications. She got the first shot on 19Jan2021 and about a week and half later, she started itching terribly for about 48 hours and was off and on, mostly at night. She got her second dose of the vaccine Tuesday, 09Feb2021 13:30, and she started itching terribly Tuesday night, around 19:00-19:-30 and she had been itching since. It is ongoing but has gotten better because she has been taking Benadryl. She called the place where she got the shot done and they said it was not a side effect, to call her internal medicine, doctor and she called them and they told to call Pfizer because they do believe it is a side effect. She is trying to clarify if itching is associated with the product. Outcome of the event was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Headache
Clinical narrative: headache/She stated she felt kind of headachy and her head was a bit fuzzy; felt lightheaded/Light-headed; head was a bit fuzzy; This is a spontaneous report from two contactable consumer. This female consumer (patient) was reported for herself. A female patient of an unspecified age received first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration on 11Feb2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache/she stated she felt kind of headachy and her head was a bit fuzzy, felt lightheaded/light-headed on 12Feb2021. The caller stated she received her first dose of the vaccine yesterday and felt fine. This morning she had a headache and felt lightheaded. She stated she felt kind of headachy and her head was a bit fuzzy, it was like the feeling you get when you are catching a cold when you just feel bleh. She stated she took two Ibuprofen and her friend told her she wasn't supposed to do that, and she needed to call her doctor immediately. She stated the headache isn't even terrible, it is just annoying, and she feels good otherwise. She stated she will skip the Ibuprofen for a couple of days. She didn't read the instructions. She thought it said okay to take Ibuprofen, so she took 2 Ibuprofen. She doesn't want to do a side effect report. She feels like these side effects are minimal. She wasn't really worried about it until a friend freaked out and told her she wasn't supposed to take Ibuprofen. The events were reported as non-serious. The outcome of events was unknown.    Information about lot/batch has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Intense ringing in ears, primarily left ear; This is a spontaneous report from a contactable healthcare professional, the patient. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL9266, first dose) solution for injection intramuscular in the right arm on 12Feb2021 at 15:00 (at the age of 33-years-old) at single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included Charcot Marie tooth. Concomitant medication included intrauterine contraceptive device (IUD). The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient experienced intense ringing in ears, primarily left ear on 12Feb2021, it began about 3 hours after vaccine and was still occurring 18 hours later. No treatment was provided for event intense ringing in ears. The outcome of the event intense ringing in ears was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Oropharyngeal pain, Pain, Pain of skin, Sensitive skin
Clinical narrative: skin sensitivity/pain; skin sensitivity/pain; whole body achiness; sore throat; fatigue; This is a spontaneous report from a contactable healthcare professional (patient). This 36-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE; lot number EN5318) via an unspecified route of administration on 12Feb2021 at 12:30 (at the age of 36-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included irritable bowel syndrome (IBS) and degenerative L5 disc. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included levonorgestrel (MIRENA), vitamin B6, cranberry, and fish oil from unknown dates for unknown indications. The patient received BNT162B2 (dose 1; lot number EL3248; left arm) on 15Jan2021 at 13:00 for COVID-19 immunization. The patient previously received neomycin from an unknown date for an unspecified indication and experienced allergy. On 13Feb2021 at 10:00 the patient experienced whole body achiness, skin sensitivity/pain, fatigue, and sore throat. The patient did not receive any treatment for the events. The outcomes of body achiness, skin sensitivity/pain, fatigue, and sore throat were not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.