chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain, Lymphadenopathy, Pain in extremity
Clinical narrative: Swollen lymph nodes in right breast; Feeling breast pain; Tenderness down part of arm, on the side; Tenderness in under arm/armpit; This is a spontaneous report from a contactable pharmacist, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 27Mar2021 at 13:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included mild asthma and Monosodium Glutamate (MSG) intolerance. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received type 1 antihistamines and experienced slight allergy. 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 01Apr2021 at 17:30, 5 days after the vaccination, the patient experienced swollen lymph nodes in the right breast, axils and underarm and felt breast pain, tenderness under arm, down part of arm, on the side and in armpit. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events swollen lymph nodes in right breast, axils and underarm and felt breast pain, tenderness under arm, down part of arm, on the side and in armpit was resolving at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Starting having a hard time breathing, continued when  lay down and not able to get a deep breath; This is a spontaneous report received from a contactable consumer (patient) via self-reporting method. A 65-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202), via an unspecified route of administration in the arm right on 03Mar2021 at 15:45 (at the age of 65-years-old) as a single dose for COVID-19 immunization. Medical history included penicillin allergy. Concomitant medication was not reported. The patient previously received sulfur for an unknown indication on an unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Mar2021, the patient Starting having a hard time breathing, continued when  lay down and not able to get a deep breath. Details were as follows: the patient experienced hard time breathing and had continued when she was laying down and not able to get a deep breath. The patient had a visit to the doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. The clinical outcome of Starting having a hard time breathing, continued when  lay down and not able to get a deep breath was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Fatigue, Nausea, Vomiting
Clinical narrative: Abdominal pain; Extreme Nausea; Vomiting; Diarrhea; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Apr2021 at 11:30(at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 03:00 the patient experienced extreme nausea, vomiting, diarrhea, abdominal pain and fatigue. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events extreme nausea, vomiting, diarrhea, abdominal pain and fatigue were resolving at the time of this report.  No follow-up attempts are needed, information about lot number cannot be obtained.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Painful lower left torso and waist and too sore to sleep; Sore left leg; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP6955) via an unspecified route of administration in the left arm on 24Mar2021 at 10:00 (at the age of 77-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other medications within two weeks of vaccination. The patient had no known allergies. 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 did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 24Mar2021, the patient experienced extremely painful lower left torso and waist, then very sore left leg which continued through whole day and at the time of this report and was too sore to sleep. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the reported events which included steroid PAK and tylenol. The clinical outcome of the events too sore to sleep, sore left leg, painful lower left torso and waist was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate increased, Hypoaesthesia
Clinical narrative: Numbness on face; Fast heartrate; Fatigue; Headache; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208), via an unspecified route of administration in the right arm on 15Mar2021 at 16:00 (at the age of 60-year-old), as a single dose for COVID-19 immunisation. Medical history included migraine, allergies and the patient had a history of several foods allergy and environmental allergy. Concomitant medications included cetirizine hydrochloride (ZYRTEC) on unknown date for an unknown indication. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 15Mar2021 at 16:00, the patient experienced numbness on face, headache, fast heartrate and fatigue about 45 minutes after the first dose. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the events. The clinical outcomes of the events numbness on face, headache, fast heartrate and fatigue were resolved on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: 1/4 inch to 1/2 inch size rashes on torso; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8733) via an unspecified route of administration in the left arm on 30Mar2021 at 08:00 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported.  Concomitant medication included tetanus vaccine (MANUFACTURER UNKNOWN) in the left arm on 05Mar2021 for an unknown indication. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient received other vaccine within 4 weeks prior to the COVID-19 vaccine. On 02Apr2021, the patient experienced 1/4-inch to 1/2-inch size rashes on torso. The patient did not receive any treatment for the reported event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event  rashes on torso was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Hypertension, Nausea, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 31Mar2021 at 15:45 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. Concomitant medications included nadolol (MANUFACTURER UNKNOWN) and hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. The patient previously received  doxycycline and experienced allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021 at 09:00, the patient experienced headache, nausea, vomiting, rapid heart rate and high blood pressure. The patient did not receive any treatment for the reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, nausea, vomiting, rapid heart rate and high blood pressure was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: Aching body; Head ache; Nausea; Sore arm; Very tired; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: Er8734) via an unspecified route of administration in the right arm on 05Apr2021 at 12:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included depression, arthritis, Gastroesophageal reflux disease (GERD) and covid-19. The patient had no known allergies. Concomitant medications included esomeprazole magnesium (MANUFACTURER UNKNOWN), vaccinium macrocarpon (CRANBERRY EXTRACT) and calcium (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 13:00, the patient experienced head ache, nausea, aching body, sore arm and very tired. The adverse events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. The patient did not receive any treatment for the events. The clinical outcome of the events head ache, nausea, aching body, sore arm and very tired were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Headache; Muscle ache; chills; extreme tiredness; joint pain; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04Apr2021 at 13:00(at the age of 71-year-old) as a single dose for COVID-19 immunisation. Medical history were reported as none. The patient did not receive any medication within two weeks of vaccination.  The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Mar2021 at 16:00(at the age of 71-year-old) as a single dose for COVID-19 immunisation. 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 did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 05Apr2021 at 06:00, the patient experienced headache, muscle ache, chills, extreme tiredness and joint pain. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  The clinical outcome of the events  headache, muscle ache, chills, extreme tiredness and joint pain was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Lymphadenopathy, Rash
Clinical narrative: Diarrhea; Swollen lymph; Rash located in thetummy area; This is a spontaneous report from a contactable healthcare professional, the patient. A 55-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via intramuscular route of administration in the right arm on 05Apr2021 at 13:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient had a history of allergies to medications, food, or other products. The patient had received other medications (unspecified) within two weeks of vaccination. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021, the patient had experienced swollen lymph, rash located in the tummy area and diarrhea. The patient did not receive any treatment for the reported events. The events did not result in any of these doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events swollen lymph, rash located in the tummy area and diarrhea was resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 28.0
Sex: U
Vaccine: COVID19
Symptoms: Pain, Swelling face
Clinical narrative: I have pain in my left cheek; Have minor swelling in the area.; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old unknown gender patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8729) via an unspecified route of administration in the left arm on 06Apr2021 at 08:30 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medications were not reported. The patient did not receive any medication within two weeks of vaccination. The patient did not have any allergies to medication, 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 did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 09:00 the patient experienced pain in left cheek and had minor swelling in the area. The patient did not receive any treatment for the reported adverse events. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event pain in left cheek and have minor swelling in the area was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Breast swelling, Cough, Fatigue, Headache
Clinical narrative: left breast swollen; Numbness in both hands; Both hands swollen; Coughing; Super weak; Really tired; Severe headache; Left Armpit  swollen and shooting pain; The shot site(upper left arm) started hurting within 12 hours and could not touch or sleep on left side; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old, non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO150) via an unspecified route of administration in the left arm on 04Apr2021 at 12:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient reported of no known allergies to medications, food, or other products. Concomitant medications included paracetamol (TYLENOL EXTRA-STRENGTH) and clonazepam (MANUFACTURER UNKNOWN) 1mg three times a day and more pharma (unspecified) for an unknown indication and from an unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 within 12 hours after vaccination, the patient experienced shot site hurting (upper left arm) and reported that she could not touch or sleep on the left side. The patient reported that it did hurt when she tried to use her left arm. On 05Apr2021 at 20:00, the patient experienced left armpit and breast swollen and shooting pain, numbness in both hands, both hands swollen, coughing, super weak, really tired and severe headache. It was unknown if any therapeutic measures were taken as a result of the reported events. The event resulted in doctor or other healthcare professional office/clinic visit on 06Apr2021 at 14:45. The clinical outcome of the event left armpit and breast swollen and shooting pain, numbness in both hands, both hands swollen, coughing, super weak, really tired, severe headache and shot site hurting were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lymphadenopathy, Peripheral swelling, Vaccination site pain
Clinical narrative: left breast swollen; Numbness in both hands; Both hands swollen; Coughing; Super weak; Really tired; Severe headache; Left Armpit  swollen and shooting pain; The shot site(upper left arm) started hurting within 12 hours and could not touch or sleep on left side; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old, non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO150) via an unspecified route of administration in the left arm on 04Apr2021 at 12:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient reported of no known allergies to medications, food, or other products. Concomitant medications included paracetamol (TYLENOL EXTRA-STRENGTH) and clonazepam (MANUFACTURER UNKNOWN) 1mg three times a day and more pharma (unspecified) for an unknown indication and from an unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 within 12 hours after vaccination, the patient experienced shot site hurting (upper left arm) and reported that she could not touch or sleep on the left side. The patient reported that it did hurt when she tried to use her left arm. On 05Apr2021 at 20:00, the patient experienced left armpit and breast swollen and shooting pain, numbness in both hands, both hands swollen, coughing, super weak, really tired and severe headache. It was unknown if any therapeutic measures were taken as a result of the reported events. The event resulted in doctor or other healthcare professional office/clinic visit on 06Apr2021 at 14:45. The clinical outcome of the event left armpit and breast swollen and shooting pain, numbness in both hands, both hands swollen, coughing, super weak, really tired, severe headache and shot site hurting were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: my periods are irregular; This is a spontaneous report from a contactable other healthcare professional. A 33-year-old, non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL0142) via intramuscular route of administration in the right arm on 10Jan2021 at 09:00 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. No relevant medical history reported. The patient did not receive any other medication within two weeks of vaccination. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 01Feb2021, the patient reported that since she received the COVID vaccine series her menstrual cycle was disrupted. The patient reported that she noticed a big change for two complete cycles. The patient reported that her period cycle was regular and was of 28 days. The patient reported that her ovulation occurred earlier and her periods were irregular. The patient also reported that her period arrived a day or two early and she had 2 normal days of bleeding and then it went away for over 24 hours, followed by medium flow the following day. The patient reported that this was abnormal for her. The patient also reported that she was going to contact her physician for the same but saw information about other women who experienced changes in their menstrual cycle after the vaccine. The patient reported that she had no other symptoms but she thought it was important to report this. No therapeutic measures were taken as a result of the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event menstrual cycle was irregular was resolved with lasting effects on an unknown date in 2021. The patient received subsequent second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date in 2021, as a single dose for COVID-19 immunisation  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: High fever ( 101F) 12 hrs after vaccination; Chills; Swollen lymphnodes under vaccinated arm; Aches; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP6953) via an unspecified route of administration in the left arm on 01Apr2021 at 14:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high. Concomitant medication were not reported. 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 did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 02Apr2021 at 02:00, the patient experienced chills, ache and swollen lymph nodes under vaccinated arm and at 02:30,  12 hours after vaccination, the patient experienced high fever(101F). The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. On 02Apr2021 at 02:30, the patient underwent  body temperature measurement which was 101 Degrees Fahrenheit(F). The clinical outcome of the event high fever  was recovered on 03Apr2021 (lasted 1.5 days) and that of chills, ache and swollen lymph nodes under vaccinated arm was recovered on an unspecified date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Rash on both forearms; Itching; Bumps; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the arm left on 05Apr2021 at 16:15 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, hypertension, COPD (chronic obstructive pulmonary disease), asthma, fibromyalgia, anxiety, depression, arthritis and fatty liver. The patient had no known allergies to medications, food, or other products. Concomitant medications included  many prescribed medications (MANUFACTURER UNKNOWN) taken on unknown date for unknown indication. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 00:00, the patient experienced rash on both forearms and bumps (swelling) and itching. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures taken were unknown. The clinical outcome of the events rash on both forearms and bumps and itching were unknown at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Flushing, Throat irritation
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Mar2021 at 16:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and allergy to walnuts and melon. Concomitant medications included insulin (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), famotidine (MANUFACTURER UNKNOWN) and metformin (MANUFACTURER UNKNOWN); all on unknown dates for unspecified indications. The patient previously took miconazole nitrate (MONISTAT) and fluconazole (DIFLUCAN); both on unknown dates for unspecified indications and experienced drug allergy. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 24Mar2021 at 16:00, the patient experienced throat felt irritated, blood pressure increased and face and neck became flushed. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of throat felt irritated, blood pressure increased and face and neck became flushed and included treatment with BENADRYL. The clinical outcome of the events throat felt irritated, blood pressure increased and face and neck became flushed was recovered on an unknown date in 2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Tenderness
Clinical narrative: Swelling/soft lump under left arm pit; Tender to touch; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old, non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP8732) via an unspecified route in left arm on 02Apr2021 at 12:00 (at the age of 46-year-old) as single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The medical history of patient included Crohn's disease. Concomitant medications included rosuvastatin calcium (CRESTOR), glucosamine (MANUFACTURER UNKNOWN), mesalazine (LIALDA) and mesalazine (CANASA) started on an unknown date for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unspecified route in left arm on 12Mar2021 at 09:30 hours as single dose for COVID-19 immunisation. The patient did not receive any other vaccination within 4 weeks prior to the COVID vaccine. Post the vaccination, the patient was not tested for COVID-19. On 03Apr2021 at 20:00, the patient had swelling/soft lump under left arm pit and tender to touch. No treatment was given for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event swelling/soft lump under left arm pit and tender to touch was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Severe left arm pain; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Apr2021 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no allergies to medications, food, or other products. The patient did not receive any other medications within two weeks. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 an unknown date in Apr2021 at 09:15, the patient experienced severe left arm pain, which was unbearable. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event severe left arm pain was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia
Clinical narrative: Headache; joint pain; Muscle aches; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 03Apr2021 at 15:30, as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no allergies to medications, food, or other products. Concomitant medication included zolpidem tartrate (AMBIEN). The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 04Apr2021, the patient experienced headache and joint pain for 24 hours and muscle aches for 48 hours. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event headache and joint pain resolved in duration of 24 hours in Apr2021 and the event muscle aches resolved in duration of 48 hours in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Tremor
Clinical narrative: Rash on neck, chest, underarm and upper back; Violent body shakes; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730), via an unspecified route of administration in the left arm on 03Apr2021 at 11:15 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid (hypothyroidism). The patient had no known allergies to medications, food, or other products. Concomitant medication included levothyroxine (LEVOTHYROXINE) taken from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via an unspecified route of administration in the left arm on 13Mar2021 at 11:15 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. 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 did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 04Apr2021 at 01:30, the patient experienced violent body shakes (not chills). On 05Apr2021 at 11:15, 48 hours after the vaccination, the patient experienced a rash on the neck, chest, underarm and upper back. The patient reported that the rash looked like a bad sunburn. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events rash on neck, chest, underarm and upper back and violent body shakes was resolved on an unspecified date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Influenza like illness, Nausea, Pain, Pyrexia
Clinical narrative: Mild flu like symptoms; Body aches; Fever; Nausea; Vomited; Painful lower back pain; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 26Mar2021 at 09:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included HIV (human immunodeficiency virus) positive and COVID-19 in 2020. The patient was allergic to shellfish. Concomitant medications included emtricitabine, elvitegravir, cobicistat, tenofovir alafenamide fumarate (GENVOYA), cromoglicic acid (CROMOLYN), cetirizine hydrochloride (ZYRTEC) and pea protein. The patient previously took sodium valproate (DEPAKOTE) and experienced specific allergy (drug). The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 04:00, the patient experienced mild flu like symptoms, body aches, mild fever, mild nausea, vomited once and the biggest issue was painful lower back pain. The patient had contracted COVID-19 in 2020 ( last year) and it did not bother his lower back but this vaccine really messed with his lower back for a full day. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for events. The clinical outcome of the event mild flu like symptoms, body aches, fever, nausea, vomited and painful lower back pain was recovered on an unspecified date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Mild flu like symptoms; Body aches; Fever; Nausea; Vomited; Painful lower back pain; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 26Mar2021 at 09:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included HIV (human immunodeficiency virus) positive and COVID-19 in 2020. The patient was allergic to shellfish. Concomitant medications included emtricitabine, elvitegravir, cobicistat, tenofovir alafenamide fumarate (GENVOYA), cromoglicic acid (CROMOLYN), cetirizine hydrochloride (ZYRTEC) and pea protein. The patient previously took sodium valproate (DEPAKOTE) and experienced specific allergy (drug). The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 04:00, the patient experienced mild flu like symptoms, body aches, mild fever, mild nausea, vomited once and the biggest issue was painful lower back pain. The patient had contracted COVID-19 in 2020 ( last year) and it did not bother his lower back but this vaccine really messed with his lower back for a full day. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for events. The clinical outcome of the event mild flu like symptoms, body aches, fever, nausea, vomited and painful lower back pain was recovered on an unspecified date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Sensory disturbance
Clinical narrative: during night sleep I heard my ownvoice from a distance saying a wordloudly, then another.; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN8727) via an unspecified route of administration in the left arm on 25Mar2021 at 00:15 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Medical history included osteopenia, eye floaters, penicillin allergy and blueberries allergy. Concomitant medications included alendronate sodium (FOSAMAX), calcium (MANAFACTURER UNKNOWN), multivitamin, flax seed meal (MANAFACTURER UNKNOWN), calcium (MANAFACTURER UNKNOWN) all from an unknown date for an unspecified indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 03Mar2021 at 12:15 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 29Mar2021 the patient experienced during night sleep heard own voice from a distance saying a word loudly, then another. The patient did not receive any treatment for the event. The clinical outcome of the event during night sleep I heard my own voice from a distance saying a word loudly, then another was recovered on an unspecified date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue
Clinical narrative: Fatigue; Joint Pain and more joint pain in Elbow of arm of administration; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 05Apr2021 at 09:30 (at the age of 50-year-old), as a single dose for COVID-19 immunisation. Medical history included GERD (Gastro esophageal reflux disease). The patient did not have a history of allergies to any food or medications or others products. Concomitant medications included omeprazole (PRILOSEC), lisinopril (MANUFACTURER UNKNOWN) both started on unknown date for an unknown indication. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination.  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 05Apr2021 at 18:00, the patient experienced fatigue and joint pain and more joint pain in elbow of arm of administration. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the events. The clinical outcome of the event fatigue and joint pain and more joint pain in elbow of arm of administration was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Headache; Fatigue; Brain fog; Chills; Hot flashes; Nausea; Low Energy; Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 01Apr2021 at 14:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included stroke, on Nov2020 and seasonal allergy. The patient had known allergies to medications, food, or other products. The patient received medication (unspecified) within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 18:30, the patient experienced headache, fatigue, brain fog, chills, hot flashes, nausea, low energy and dizziness. Therapeutic measures were not taken for the adverse events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, fatigue, brain fog, chills, hot flashes, nausea, low energy and dizziness was resolving at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hot flush, Nausea
Clinical narrative: Headache; Fatigue; Brain fog; Chills; Hot flashes; Nausea; Low Energy; Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 01Apr2021 at 14:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included stroke, on Nov2020 and seasonal allergy. The patient had known allergies to medications, food, or other products. The patient received medication (unspecified) within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 18:30, the patient experienced headache, fatigue, brain fog, chills, hot flashes, nausea, low energy and dizziness. Therapeutic measures were not taken for the adverse events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, fatigue, brain fog, chills, hot flashes, nausea, low energy and dizziness was resolving at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling, Erythema, Pruritus
Clinical narrative: swollen, red,hot itchy ears; swollen, red,hot itchy ears; swollen, red,hot itchy ears; This is a spontaneous report from a contactable consumer. A 43-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199), via an unspecified route of administration in the left arm on an unknown date in Mar2021 and also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration and unspecified anatomical site on an unknown date in 2021 as a single dose for COVID-19 immunisation. Medical history included colon cancer, HELLP (hemolysis, elevated liver enzymes, low platelet count) syndrome and hemochromatosis. It was unknown whether the patient was pregnant or not. Concomitant medication included daily vitamins (MANUFACTURER UNKNOWN) for an unknown indication and on an unknown date. The patient did not have a history of allergy to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 an unknown date in Mar2021, the patient experienced swollen, red, hot itchy ears and has progressed from there. The patient did not think it had anything to do with the vaccine and since second shot things have gotten much worse. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events which included treatment with steroids and antibiotics. The clinical outcome of the events swollen red, hot itchy ears was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.