chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: Fatigue, sleepiness; Fatigue, sleepiness; This is a spontaneous report from a contactable physician. A 44-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number EK5730), intramuscular in left arm on 19Dec2020 14:00 at a single dose for covid-19 vaccination administered in the hospital. Medical history included asthma and Known allergies to sulfa. The patient was not pregnant. The patient's concomitant medications were not reported.  On 20Dec2020 14:00, the patient experienced Fatigue and sleepiness starting 24 hours after vaccination, resolved by 48 hours post vaccine. The patient did not receive any treatment for the events. The outcome of the events was recovered on 21Dec2020. The events were assessed as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Chills, body aches for hours; Chills, body aches for hours; This is a spontaneous report from a contactable nurse, the patient. A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm on 26Dec2020 at 18:00 (at the age of 28-years-old) as a single dose for COVID-19 immunization. Medical history included depression, chronic pain, obesity. The patient was not pregnant at the time of vaccination. Concomitant medications included escitalopram oxalate (LEXAPRO), melatonin, fluticasone propionate (FLONASE), paracetamol (TYLENOL), and ibuprofen; all for unknown indications from unknown dates and unknown if ongoing. The patient previously took cefdinir (OMNICEF) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 27Dec2020 at 5:00, the patient experienced chills and body aches for hours. The patient did not receive treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the chills and body aches for hours was not resolved.   Information on the lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Chills, Eye pruritus, Ocular hyperaemia, Pruritus
Clinical narrative: allergic reactions; rash on all my chest and in abdomen; Itchiness; Eyes got red; eyes got red and itch; Chills; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received BNT162B2 (Lot: EH9899), via an unspecified route of administration on deltoid right on 22Dec2020 at single dose for COVID-19 immunization. Medical history included blood pressure high, hypothyroidism, and environmental allergies. Concomitant medications included amlodipine besilate (NORVASC) at 10 mg, daily for blood pressure high, and levothyroxine sodium (TIROSINT) at 112 mcg (ug) for hypothyroidism. Patient got Covid Vaccine on Tuesday (22Dec2020) night and was fine on Wednesday (23Dec2020). She expected the normal side effects like maybe a little fever like that but she believed she was having allergic reactions. It started from 24Dec2020 and she got a rash on all her chest and in abdomen and also just like itchiness feeling all over. So she took some diphenhydramine hydrochloride (BENADRYL) and a PPI 'a cup of' them on 24Dec2020 and she thought that she only had to do that one's today (25Dec2020) and the only thing she noticed when she got the shot (Covid Vaccine) they kept her there for like 15 minutes and her eyes got red and itch. She didn't scratch them but they felt like itchy and she never had that before. She never had a problem with the vaccine before. She didn't know if that was the true allergic reaction to the vaccines or if it just something she had internal allergies and she just didn't know what it was. But she was okay at the time of the report. She took some diphenhydramine hydrochloride a little while before and a PPI (unspecified medication). She was still itchy but it was not that bad and she seemed to be doing fine. Her arm was fine. She was not having any (unspecified), except sometimes. 24Dec2020 she had chills which she expected and she was all good but the side effects whatever happened that way was not the allergic portion. She tried to contact the doctor. The doctor just switched his clinic only for geriatric patients. She had to find another doctor. She knew a Doctor whom she could try and call and she actually went to the infectious disease physician and he said she should go to get the vaccine, now she was trying with that too. She got allergic to anything. Covid Shot was the only thing new that she had in her life but like she was not sure if it was triggered by something out like (unspecified) because she had always environmental allergies too. She didn't know because she was going to consult the Physician on Monday. She was just going to see the regular doctor. She was just seeing that first that anything because she knew it didn't happen very often but the Covid vaccine she just wanted to make report. She was going to the Physician on Monday because right now she thought she didn't know how long it lasted like. Outcome of the events was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: allergic reactions; rash on all my chest and in abdomen; Itchiness; Eyes got red; eyes got red and itch; Chills; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received BNT162B2 (Lot: EH9899), via an unspecified route of administration on deltoid right on 22Dec2020 at single dose for COVID-19 immunization. Medical history included blood pressure high, hypothyroidism, and environmental allergies. Concomitant medications included amlodipine besilate (NORVASC) at 10 mg, daily for blood pressure high, and levothyroxine sodium (TIROSINT) at 112 mcg (ug) for hypothyroidism. Patient got Covid Vaccine on Tuesday (22Dec2020) night and was fine on Wednesday (23Dec2020). She expected the normal side effects like maybe a little fever like that but she believed she was having allergic reactions. It started from 24Dec2020 and she got a rash on all her chest and in abdomen and also just like itchiness feeling all over. So she took some diphenhydramine hydrochloride (BENADRYL) and a PPI 'a cup of' them on 24Dec2020 and she thought that she only had to do that one's today (25Dec2020) and the only thing she noticed when she got the shot (Covid Vaccine) they kept her there for like 15 minutes and her eyes got red and itch. She didn't scratch them but they felt like itchy and she never had that before. She never had a problem with the vaccine before. She didn't know if that was the true allergic reaction to the vaccines or if it just something she had internal allergies and she just didn't know what it was. But she was okay at the time of the report. She took some diphenhydramine hydrochloride a little while before and a PPI (unspecified medication). She was still itchy but it was not that bad and she seemed to be doing fine. Her arm was fine. She was not having any (unspecified), except sometimes. 24Dec2020 she had chills which she expected and she was all good but the side effects whatever happened that way was not the allergic portion. She tried to contact the doctor. The doctor just switched his clinic only for geriatric patients. She had to find another doctor. She knew a Doctor whom she could try and call and she actually went to the infectious disease physician and he said she should go to get the vaccine, now she was trying with that too. She got allergic to anything. Covid Shot was the only thing new that she had in her life but like she was not sure if it was triggered by something out like (unspecified) because she had always environmental allergies too. She didn't know because she was going to consult the Physician on Monday. She was just going to see the regular doctor. She was just seeing that first that anything because she knew it didn't happen very often but the Covid vaccine she just wanted to make report. She was going to the Physician on Monday because right now she thought she didn't know how long it lasted like. Outcome of the events was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia
Clinical narrative: Loss of sense of smell, no other COVID symptoms; This is a spontaneous report from a non-contactable other healthcare professional. A 42-year-old female patient started to received first dose of BNT162B2, intramuscular (left arm), on 17Dec2020 14:00, at a single dose, for COVID-19 vaccination. The patient had no relevant medical history and was not taking concomitant medications. On 25Dec2020, the patient had loss of sense of smell; no other COVID symptoms. Outcome of the event was not recovered.  No follow-up attempts are possible. Information on lot/batch cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Cough, Dizziness, Headache, Heart rate increased
Clinical narrative: Fever; Cough; Body aches; Headache; Back pain; Dizziness; increased heart rate; Insomnia; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on right arm at 09:30 AM on 21Dec2020 at single dose for COVID-19 immunization. Medical history reported as none, no known allergies. The patient's concomitant medications were not reported. The patient experienced fever, cough, body aches, headache, back pain, dizziness, increased heart rate, insomnia at 01:00 PM on 24Dec2020. All events were reported as non-serious. The patient received Tylenol as treatment. The outcome of events was unknown. The patient was not diagnosed COVID prior vaccination, patient was not tested COVID post vaccination.  Information about lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain, Pyrexia
Clinical narrative: Fever; Cough; Body aches; Headache; Back pain; Dizziness; increased heart rate; Insomnia; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on right arm at 09:30 AM on 21Dec2020 at single dose for COVID-19 immunization. Medical history reported as none, no known allergies. The patient's concomitant medications were not reported. The patient experienced fever, cough, body aches, headache, back pain, dizziness, increased heart rate, insomnia at 01:00 PM on 24Dec2020. All events were reported as non-serious. The patient received Tylenol as treatment. The outcome of events was unknown. The patient was not diagnosed COVID prior vaccination, patient was not tested COVID post vaccination.  Information about lot/batch number has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Vaccination site pain
Clinical narrative: Muscle aches, chills, pain at injection site; Muscle aches, chills, pain at injection site; Muscle aches, chills, pain at injection site; This is a spontaneous report from a contactable nurse, the patient. A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Ek9231) solution for injection intramuscular in the left arm on 26Dec2020 at 10:30 (at the age of 23-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history and concomitant medications were unknown. 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. On 27Dec2020 at 01:00, the patient experienced muscle aches, chills, and pain at injection site. No treatment was provided for the events muscle aches, chills, and pain at injection site. The outcome of the events muscle aches, chills, and pain at injection site was recovering. Since the vaccination, the patient has not been tested for COVID-19.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: positive with Covid; having Covid symptoms; positive with Covid; having Covid symptoms; This is a spontaneous report from a contactable nurse. A 54-year-old female patient (mother) received BNT162B2 (Batch/lot number: EK5730), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications were not reported. Patient got the vaccine administered on 18Dec2020 and after that she was diagnosed positive with Covid on 24Dec2020, so now she was having Covid symptoms obviously after the vaccine but like not due to the vaccine. Reporter was just concerned what her next dose supposed to be scheduled for 08Jan2021, was she still supposed to get the second dose or what. No treatment received. Patient was just taking vitamins. Reporter also reported that typically it was not supposed to be but was trying to get the information on enhanced immune response. Outcome of the event was unknown.; Sender's Comments: The reported positive with Covid after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This is a spontaneous report from a non-contactable physician. A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Dec2020 in left arm at single dose for COVID-19 immunization. Medical history included rheumatoid arthritis and known allergies to fire ants from an unknown date and unknown if ongoing. Concomitant medication included etanercept (ENBREL) and drospirenone, ethinylestradiol (YASMIN). The patient experienced hives in Dec2020. The facility where the most recent COVID-19 vaccine was administered was on the hospital. 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 was recovered in Dec2020. Therapeutic measure such as anti-histamine was taken as a result of hives. The event was considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.  No follow-up attempts are possible, information about lot/batch cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Developed left facial numbness but no weakness present; This is a spontaneous report from a contactable physician (patient). A 37-year-old female patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) with unknown lot number and expiration date, intramuscularly at the left arm on 17Dec2020 at 16:15 (04:15 PM) at single dose for COVID-19 immunization. The patient was vaccinated at a hospital. 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. The patient has not been tested for COVID-19 since the vaccination. The patient's medical history included hypothyroidism, hypertension, and premenstrual dysphoric disorder (PMDD). The patient had no allergies to medications, food, or other products. Concomitant medication included atenolol, fluoxetine hydrochloride (PROZAC), and levothyroxine; all received within 2 weeks of vaccination. The patient reported that on 17Dec2020 at 18:00 (06:00 PM), she developed left facial numbness but no weakness present. Symptoms come and go. Sometimes last for hours, never had this before. The patient did not receive treatment for the event. The clinical outcome of the event was not recovered. The event was reported as non-serious.   Information on the lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Palpitations, Tachycardia
Clinical narrative: Tachycardia to 120s; Palpitations; This is a spontaneous report from a contactable physician (patient). A 35-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration on the left arm on 19Dec2020 16:45 at a single dose for COVID-19 immunization. The patient's medical history included hypertriglyceridemia. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 19Dec2020, the patient experienced tachycardia to 120s and palpitations. No treatment was received for the events. The patient underwent lab tests and procedures which included heart rate was 120s on 19Dec2020. Outcome of the events not recovered. The events were considered non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate irregular, Palpitations, Sinus rhythm
Clinical narrative: Heart palpitations occurring 5-10 times a minute with sinus rhythm but irregular heart beat; Heart palpitations occurring 5-10 times a minute with sinus rhythm but irregular heart beat; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284), via an unspecified route of administration on the left arm on 23Dec2020 09:00 at a single dose for COVID-19 immunization. The patient's medical history included allergies to dust mites, sinusitis, depression. The patient was not pregnant. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), montelukast sodium (SINGULAIR), fluticasone propionate (FLONASE), and lamotrigine (LAMICTAL). 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 24Dec2020 23:00, the patient experienced heart palpitations occurring 5-10 times a minute with sinus rhythm but irregular heart beat. There is no history of any cardiovascular diseases or abnormal findings. No caffeine or alcohol intake on the day of the occurrence. No treatment was received for the adverse events. Outcome of the irregular heart beat was not recovered while of the remaining event was recovered on 25Dec2020 23:00. The events were considered non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Facial asymmetry, Pain in jaw
Clinical narrative: sudden pain in my Jaw; the left side of my face is not equal to the right side of my face; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender started to receive BNT162B2 (lot number: EK3730), via an unspecified route of administration on 17Dec2020 at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Dec2020, the patient experienced a sudden pain in her/his jaw and now the left side of her/his face is not equal to the right side of his/her face. Stated, "I am getting ready to go into the ER and I have a work-up done but I want you to know if you all as well". The outcome of the event was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Pain in extremity, Peripheral swelling, Pruritus, Vaccination site erythema
Clinical narrative: I have been having big red circle on my arm and its swollen and it's painful; Red mark is spreading, its getting bigger and bigger; I have been having big red circle on my arm and its swollen and it's painful; I have been having big red circle on my arm and its swollen and it's painful; like starting to get itchy; This is a spontaneous report from a contactable consumer (patient). An unknown age and gender patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number and Expiration date Unknown) on 23Dec2020 at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. Patient stated had the COVID vaccine on Wednesday and within the past few days, had been having big red circle on arm and its swollen and it's painful, patient was not able to lift arm and unleash having pain, it's like starting to get itchy and arm is swollen. The red mark was spreading, it was getting bigger and bigger, it's been 2 days drew circle on it last night and this morning you can already see the red color out of the circle. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Sore throat; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 32-year-old female patient received BNT162B2 (lot EK5730) via an unspecified route of administration on 22Dec2020 10:30 AM at a single dose as COVID-19 vaccine. Medical history was not reported. Concomitant medications included lysine supplement and loratadine (other medications in two weeks). The patient had known allergies to amoxicillin. It was reported that the patient had an adverse event of sore throat, 4 days after vaccine on 26Dec2020 14:30 (02:30 PM) assessed as non-serious. It did not result in death, not life threatening, did not caused/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The patient was vaccinated in a hospital (facility where the most recent COVID-19 vaccine was administered). She had no other vaccine within four weeks prior to the COVID vaccine and had no Covid prior to vaccination. She had the Covid tested (other) post vaccination on 23Dec2020 with a negative result. The patient was not pregnant at the time of vaccination. The outcome of the event was unknown.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia
Clinical narrative: Loss of sense of smell; This is a spontaneous report from a contactable physician (patient). A 31-year-old male patient received the first dose of BNT162B2 (lot EL1284) via an unspecified route of administration on 23Dec2020 07:00 (07:00 AM) at a single dose on the left arm as COVID-19 vaccine. Medical history included seasonal allergies. There were no concomitant medications. The patient had an adverse event of loss of sense of smell on 24Dec2020 assessed as non-serious. It did not result in death, not life threatening, did not caused/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. There was no treatment for the event. The patient was vaccinated in a hospital (facility where the most recent COVID-19 vaccine was administered). He had no other vaccine within four weeks, no other medications within two weeks prior to the COVID vaccine, and no Covid prior to vaccination. He did not have the Covid tested post vaccination. The outcome of the event was not recovered.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Back pain, Body temperature, Chest pain, Ear pain
Clinical narrative: pain under right arm pit; very stiff neck; pain radiating into ear; pains radiating down right arm, chest and back; pains radiating down right arm, chest and back; nausea; Vomiting; severe chest and back pains on right; severe chest and back pains on right; This is a spontaneous report from a contactable Other Health Professional (patient). A 79-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration in right arm on 18Dec2020 08:30 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. The patient medical history was not reported. Concomitant medication in two weeks included citalopram, levothyroxine, atorvastatin, anastrozol.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 3rd day (21Dec2020), the patient experienced severe chest and back pains on right at time of 12:30 AM. On 4th day (22Dec2020) pains radiating down right arm, chest and back, nausea and vomiting. On 5th day (23Dec2020) pain under right arm pit, very stiff neck, pain radiating into ear. Temperature was normal. On 6th day (24Dec2020) most symptoms dissipated. On 7th day (25Dec2020) almost back to normal. No treatment received for the events. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of events was recovered in Dec2020.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Nausea, Pain, Pain in extremity, Vomiting
Clinical narrative: pain under right arm pit; very stiff neck; pain radiating into ear; pains radiating down right arm, chest and back; pains radiating down right arm, chest and back; nausea; Vomiting; severe chest and back pains on right; severe chest and back pains on right; This is a spontaneous report from a contactable Other Health Professional (patient). A 79-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration in right arm on 18Dec2020 08:30 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. The patient medical history was not reported. Concomitant medication in two weeks included citalopram, levothyroxine, atorvastatin, anastrozol.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 3rd day (21Dec2020), the patient experienced severe chest and back pains on right at time of 12:30 AM. On 4th day (22Dec2020) pains radiating down right arm, chest and back, nausea and vomiting. On 5th day (23Dec2020) pain under right arm pit, very stiff neck, pain radiating into ear. Temperature was normal. On 6th day (24Dec2020) most symptoms dissipated. On 7th day (25Dec2020) almost back to normal. No treatment received for the events. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of events was recovered in Dec2020.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Rash erythematous
Clinical narrative: Red rash on face, neck, chest and arm; difficulty swallowing; This is a spontaneous report from a contactable nurse (patient). A 22-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot ELO140) intramuscular on 26Dec2020 18:30 (06:30 PM) at a single dose on the right arm as COVID-19 vaccine. Medical history included previously diagnosed with COVID-19 prior to vaccination. The patient had no known allergies to medications, food, or other products. There were no concomitant medications. The patient had adverse events of red rash on face, neck, chest and arm; and difficulty swallowing, both on 26Dec2020 19:00 (07:00 PM) assessed as non-serious. It did not result in death, not life threatening, did not caused/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. There was no treatment for the events. The patient was vaccinated in a hospital (facility where the most recent COVID-19 vaccine was administered). He had no other vaccine within four weeks prior to the COVID vaccine, no other medications within two weeks of vaccination. He did not have Covid tested post vaccination. The outcome of the events was recovered on Dec2020.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia, Vaccination site pain
Clinical narrative: Fever; chills; headache; fatigue; injection site pain; This is a spontaneous report from a contactable physician (patient). A 26-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not available), intramuscularly on 23Dec2020 at 12:15 PM on Left arm at single dose for COVID-19 immunization in hospital. The patient medical history included asthma and previously COVID+, prior to vaccination, patient was diagnosed with COVID-19. No known allergy, no allergies to medications, food, or other products. Concomitant medications included salbutamol (ALBUTEROL), montelukast and loratadine. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever, chills, headache, fatigue, injection site pain; lasted approximately 24 hours on 24Dec2020 at 12:00 AM. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as result of the events included Ibuprofen. The outcome of the events was recovered in Dec2020. 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: U
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: Loss of taste; This is a spontaneous report from a contactable nurse (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot # EK9231, Expiration Date: Apr2021), on 23Dec2020 at single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient experienced loss of taste on 27Dec2020. The outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea
Clinical narrative: chills; nausea; This is a spontaneous report from a contactable consumer (patient's son). A female patient of an unspecified age (reported as 62, unknown units) received bnt162b2, lot number and expiration date were unknown, via an unspecified route of administration on 24Dec2020 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter asked if his mom can still go to work if she is feeling all of the symptoms. The reporter was calling on behalf of his mom (who speaks Spanish only) as she received the COVID vaccine on 24Dec2020. The patient started feeling nausea and chills as of 26Dec2020 until present. The reporter would like to know how long do the symptoms usually last. The outcome of the events was not recovered.  Information for Lot/Batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Neck pain, Pain in extremity, Painful respiration
Clinical narrative: Chest, back and left neck pain (chest and back pain worse with breathing); Chest, back and left neck pain (chest and back pain worse with breathing)/ Left and right neck pain; Chest, back and left neck pain (chest and back pain worse with breathing); Chest, back and left neck pain (chest and back pain worse with breathing); Arm Pain at injection site; Arm Pain at injection site; This is a spontaneous report from a non-contactable physician (patient). A 31-years-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/ Lot number: EK5730), intramuscularly on 22Dec2020 09:45 at single dose on left arm for COVID-19 immunization in hospital. Medical history included gastrooesophageal reflux disease (reported as GERD). No true allergies; unable to take NSAIDs or eat bananas or avocados 2/2 GERD. Concomitant medication within 2 weeks of vaccination included colecalciferol (VITAMIN D). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced arm pain at injection site on Day 1 (22Dec2020); chest, back and left neck pain (chest and back pain worse with breathing) on Day 2 (23Dec2020); left and right neck pain on Day 3, resolved on Day 4. No treatment received for the adverse events. The events outcome was resolved on 25Dec2020. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Chest, back and left neck pain (chest and back pain worse with breathing); Chest, back and left neck pain (chest and back pain worse with breathing)/ Left and right neck pain; Chest, back and left neck pain (chest and back pain worse with breathing); Chest, back and left neck pain (chest and back pain worse with breathing); Arm Pain at injection site; Arm Pain at injection site; This is a spontaneous report from a non-contactable physician (patient). A 31-years-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/ Lot number: EK5730), intramuscularly on 22Dec2020 09:45 at single dose on left arm for COVID-19 immunization in hospital. Medical history included gastrooesophageal reflux disease (reported as GERD). No true allergies; unable to take NSAIDs or eat bananas or avocados 2/2 GERD. Concomitant medication within 2 weeks of vaccination included colecalciferol (VITAMIN D). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced arm pain at injection site on Day 1 (22Dec2020); chest, back and left neck pain (chest and back pain worse with breathing) on Day 2 (23Dec2020); left and right neck pain on Day 3, resolved on Day 4. No treatment received for the adverse events. The events outcome was resolved on 25Dec2020. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Strong myalgias in buttocks and hamstrings bilaterally at 2 days migrating to calfs at 3 days. Dull ache pain. gone in buttock on day 3, gone in hamstrings day 4, still slight in calves.; This is a spontaneous report from a contactable physician (patient). A 61-year-old male patient received bnt162b2, lot number and expiration date unknown, at the Hospital, via an unspecified route of administration on 23Dec2020 at 11:45, at a single dose for Covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Medical history included psoriatic arthritis from an unknown date, for which patient took Enbrel 50 3 weeks prior to injection (in 2020). The patient had no known allergies. Concomitant medications included propranolol hydrochloride (INDERAL LA, 60 mg) and olmesartan medoxomil (BENICAR, 40 mg). In 26Dec2020 at 04:00, the patient experienced strong myalgias in buttocks and hamstrings bilaterally at 2 days migrating to calfs at 3 days. Dull ache pain. Gone in buttock on day 3, gone in hamstrings day 4, still slight in calves. The event was reported as non-serious. No treatment was received for the adverse event. The outcome of the event was recovering.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Cough, Myalgia, Nasal congestion
Clinical narrative: Joint pain; Muscle pain; A slight fever of 100 F; Cough; Congestion; This is a spontaneous report from a contactable other healthcare professional (patient's wife). A male patient of an unspecified age received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had since been working with COVID patients. Yesterday (27Dec2020) evening he woke up with joint pain, muscle pain, a slight fever of 100 F, cough and congestion. The reporter was wondering if he could still get COVID after the first shot or if it's a side effect from a vaccine. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Joint pain; Muscle pain; A slight fever of 100 F; Cough; Congestion; This is a spontaneous report from a contactable other healthcare professional (patient's wife). A male patient of an unspecified age received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had since been working with COVID patients. Yesterday (27Dec2020) evening he woke up with joint pain, muscle pain, a slight fever of 100 F, cough and congestion. The reporter was wondering if he could still get COVID after the first shot or if it's a side effect from a vaccine. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Rash, Rash pruritic
Clinical narrative: Rash on my back, it is very itchy; Rash on my back, it is very itchy; This is a spontaneous report from a contactable consumer (patient herself).  A 47-year-old female received first dose of bnt162b2 (BNT162B2 also reported as Pfizer BioNTech Vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on Dec2020 at single dose (dose 1) for Covid-19 vaccination. The patient's medical history was not reported.  Concomitant medications included levothyroxine sodium (SYNTHROID) and vitamin D. The patient experienced rash on her back, it was very itchy on an unspecified date in Dec2020.  She reported that she took Benadryl but might not get any relief from it. She had lab work but it was more than 14 days ago, no results reported. The outcome of events not recovered.   Information on the Lot/Batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: intermittent numbness and tingling L arm. Sometimes radiating to my hand.; intermittent numbness and tingling L arm. Sometimes radiating to my hand.; This is a spontaneous report from a contactable nurse (patient herself). A 52-year-old female patient, not pregnant, received her first dose of bnt162b2 (BNT162B2 also reported as Pfizer BIONTECH Covid-19 vaccine, lot EH9899, expiry date not reported), via an unspecified route of administration in the left arm on 21Dec2020 11:15, single dose (dose 1) for Covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The patient's medical history and concomitant medications were not reported. The patient previously took amoxicillin and had drug allergy. Approximately 4days after injection (25Dec2020), the patient started having intermittent numbness and tingling in left arm that sometimes radiating to her hand. She reported that she still have these symptoms as of today. No treatment was given. The outcome of the events was not recovered.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Facial pain, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Developed right sided facial numbness; numbness of right side of anterior tongue; numbness progressed to some facial pain as well; This is a spontaneous report from a contactable Other Health Professional (patient).  A 47-year-old male received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1685, intramuscular in the right arm, first dose given on 23Dec2020 12:30 at a single dose for COVID vaccination. Medical history included asthma, seasonal allergic rhinitis and Bell's Palsy affecting that side of the face. Concomitant medication included loratadine, pseudoephedrine sulfate (CLARITIN-D) and montelukast sodium (SINGULAIR). The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. He was not diagnosed with COVID-19 prior to and post vaccination. The patient previously took and had allergies to Keflex, Vicodin and Motrin. It was reported that the patient developed right-sided facial numbness and numbness of right side of anterior tongue. These occurred within 10- 15 minutes of vaccine administration on 23Dec2020 at 12:45 PM. It was mentioned that the patient has history of Bell's Palsy that was affecting that side of the face. The patient had numbness progressed to some facial pain as well. Symptoms lasted for 6 days and slowly abated with prednisone treatment which was given at 20 mg BID (twice a day) x 5 days. The events were reported as non-serious. The outcome of the events patient developed right-sided facial numbness and numbness of right side of anterior tongue and numbness progressed to some facial pain as well was recovering.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise
Clinical narrative: Chills- HA's and feeling unwell; Chills- HA's and feeling unwell; Chills- HA's and feeling unwell; This is a spontaneous report from a contactable Other Health Professional (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EH 9899, intramuscular in the Arm Right, first dose on 16Dec2020 18:45 (or 06:45 PM) at a single dose for Covid-19 immunization. Medical history included blood pressure abnormal (reported as BP). The patient's concomitant medication included unspecified statin for BP. The patient had not received any other vaccine in four weeks. The patient experienced chills, HA (headache), was feeling unwell X four events  (pending clarification) on 16Dec2020 (onset time at 0200, pending clarification) with outcome of Recovered/Resolved with sequel. The events were reported as non-serious which requires sleep and rest. The patient was not diagnosed with COVID-19 prior to vaccination nor was she tested since the vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Influenza virus test, Investigation, Malaise, Myalgia
Clinical narrative: of low grade fever, pain at injection site and malaise on the first few days. On day 7 through day 10, recipient reports a high fever of 101.8 and severe myalgia; of low grade fever, pain at injection site and malaise on the first few days. On day 7 through day 10, recipient reports a high fever of 101.8 and severe myalgia; of low grade fever, pain at injection site and malaise on the first few days. On day 7 through day 10, recipient reports a high fever of 101.8 and severe myalgia; of low grade fever, pain at injection site and malaise on the first few days. On day 7 through day 10, recipient reports a high fever of 101.8 and severe myalgia; This is a spontaneous report from a contactable physician. A 61 years old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Unknown since misplaced/discarded) via an unspecified route of administration on an unspecified date in 2020 at a single dose for COVID-19 immunization. The patient had dengue fever in 2018. The patient concomitant medications were not reported. Caller requested information for her husband who received the Covid 19 vaccine. Vaccine recipient was "asymptomatic" with a report of low grade fever, pain at injection site and malaise on the first few days in 2020. On day 7 through day 10, recipient reports a high fever of 101.8 and severe myalgia. Caller stated her husband tested negative for Covid, flu and rsv post vaccination and blood work comes back good in 2020. Caller wanted to know if her husband should get the second dose of the Covid 19 vaccination.   Information on the Batch/Lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory syncytial virus test, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: of low grade fever, pain at injection site and malaise on the first few days. On day 7 through day 10, recipient reports a high fever of 101.8 and severe myalgia; of low grade fever, pain at injection site and malaise on the first few days. On day 7 through day 10, recipient reports a high fever of 101.8 and severe myalgia; of low grade fever, pain at injection site and malaise on the first few days. On day 7 through day 10, recipient reports a high fever of 101.8 and severe myalgia; of low grade fever, pain at injection site and malaise on the first few days. On day 7 through day 10, recipient reports a high fever of 101.8 and severe myalgia; This is a spontaneous report from a contactable physician. A 61 years old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Unknown since misplaced/discarded) via an unspecified route of administration on an unspecified date in 2020 at a single dose for COVID-19 immunization. The patient had dengue fever in 2018. The patient concomitant medications were not reported. Caller requested information for her husband who received the Covid 19 vaccine. Vaccine recipient was "asymptomatic" with a report of low grade fever, pain at injection site and malaise on the first few days in 2020. On day 7 through day 10, recipient reports a high fever of 101.8 and severe myalgia. Caller stated her husband tested negative for Covid, flu and rsv post vaccination and blood work comes back good in 2020. Caller wanted to know if her husband should get the second dose of the Covid 19 vaccination.   Information on the Batch/Lot number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Headache, Nausea, SARS-CoV-2 test
Clinical narrative: waves of nausea for 2 days after; Dizziness; headache; difficulty with higher thought processes - feeling "zoned out"; difficulty with higher thought processes - feeling "zoned out"; This is a spontaneous report from a contactable other healthcare professional (patient).  A 51-year-old female (not pregnant at the time of vaccination) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number unknown due to not available/provided to reporter at the time of report completion), intramuscular at left arm on 23Dec2020 09:00 at single dose for COVID-19 immunization at a "Nursing Home/Senior Living Facility". The patient's medical history included Gluten and FODMAP food allergy. Concomitant medications received within 2 weeks of vaccination: dietary supplements. No other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and had been tested for COVID-19 post the vaccination. COVID-19 test post vaccination on 23Dec2020 result was negative. It was reported that on 23Dec2020 09:30, the patient experienced dizziness, headache, difficulty with higher thought processes - feeling "zoned out", and "waves of nausea for 2 days after". No treatment was taken for the above events. The outcome of the events was recovered in Dec2020.  Information on the lot/batch number has been requested.