chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation, Neck pain, Swelling
Clinical narrative: Pain in neck on same side as vaccine; Very swollen armpit on same side; Very swollen armpit on same side. Painful as well; Administration date 13Oct2021 at 09:30, dose number=3; This is a spontaneous report from a contactable other healthcare professional, the patient. A 52-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 13Oct2021 at 09:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included the first dose of influenza vaccine (MANUFACTURER UNKNOWN) in the left arm on 04Oct2021, estradiol (ESTRACE) and progesterone (MANUFACTURER UNKNOWN); all from an unknown date for unknown indication and unknown if ongoing. The patient previously received the the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1284) via an unspecified route of administration in the left arm on 06Jan2021 at 13:00 (at the age of 51-years-old) and the patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246) via an unspecified route of administration in the left arm on 27Jan2021 at 13:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. On 13Oct2021 at 09:30, the patient had "administration date 13Oct2021 at 09:30, dose number=3". On 13Oct2021 at 20:30, the patient had pain in neck on same side as vaccine and very swollen armpit on same side, painful as well. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain in neck on same side as vaccine, very swollen armpit on same side and painful as well was not resolved at the time of this report. The clinical outcome of the event "administration date 13Oct2021 at 09:30, dose number=3" was unknown at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: This is a spontaneous report from a noncontactable consumer (patient). A 32-year-old (non-pregnant) female patient received the second dose of BBNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EW0167), at the age of 32, via an unspecified route of administration, in the left arm, on an unknown date, in May 2021, single dose, for COVID-19 immunisation. Medical history included post-traumatic stress disorder (PTSD), fibromyalgia and known allergy to latex. Prior to vaccination, patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications within two weeks of the vaccination. The patient did not receive other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EW0175), at the age of 32, via an unspecified route of administration, in the left arm, on an unknown date, in Apr 2021, single dose, for COVID-19 immunisation. On an unknown date in May 2021 (following the second dose), patient experienced temporary amenorrhea that lasted for 8 weeks. The events did not result in doctor or other health care professional office/clinic visit/emergency room/department or urgent care. Since the vaccination, patient has not tested for COVID-19. No therapeutic measures taken as a result of the events. The outcome of temporary amenorrhea lasting 8 weeks following second dose resolved on an unknown date in 2021. No follow-up attempts possible. No further information  expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Macule, Muscle spasms, Nausea
Clinical narrative: Fever of 104 for 24 hours; muscle spasms and charlie horses throughout legs and back for 12 hours; Horrible headache for 2 full days after vaccine; Bad nausea for 12 hours; I had been in menopause for a year and it started my menstrual cycle back fully on day 2 after the vaccine; had spotted after the 2st vaccine; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in Arm Left on 08Oct2021 20:30 (at the age of 51 years old, Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history included sporadic anemia, hashimotos disease, vitiligo. Concomitant medication in two weeks included levothyroxine sodium (SYNTHROID). No other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnancy at time of vaccination. The patient previously received first dose of bnt162b2 on 17Sep2021 08:30 PM in left arm for covid-19 immunisation, propylthiouracil for thyroid disorder and experienced drug allergies, Cataflam and experienced drug allergies, tetanus and flu vaccines and experienced allergy to vaccines. The patient had been in menopause for a year, and it started her menstrual cycle back fully on day 2 after the vaccine on 09Oct2021 with outcome of unknown. The patient experienced fever of 104 for 24 hours, muscle spasms and charlie horses throughout legs and back for 12 hours, horrible headache for 2 full days after vaccine and bad nausea for 12 hours on 09Oct2021 13:15 with outcome of recovered with lasting effects in Oct2021. The patient had spotted after the 2st vaccine in Oct2021 with outcome of unknown. No treatment received. Events were reported as non-serious and did not result in death, life threatening: caused/prolonged hospitalization, disabling/incapacitating, congenital anomaly/birth defect. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage, Pyrexia
Clinical narrative: Fever of 104 for 24 hours; muscle spasms and charlie horses throughout legs and back for 12 hours; Horrible headache for 2 full days after vaccine; Bad nausea for 12 hours; I had been in menopause for a year and it started my menstrual cycle back fully on day 2 after the vaccine; had spotted after the 2st vaccine; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in Arm Left on 08Oct2021 20:30 (at the age of 51 years old, Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history included sporadic anemia, hashimotos disease, vitiligo. Concomitant medication in two weeks included levothyroxine sodium (SYNTHROID). No other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnancy at time of vaccination. The patient previously received first dose of bnt162b2 on 17Sep2021 08:30 PM in left arm for covid-19 immunisation, propylthiouracil for thyroid disorder and experienced drug allergies, Cataflam and experienced drug allergies, tetanus and flu vaccines and experienced allergy to vaccines. The patient had been in menopause for a year, and it started her menstrual cycle back fully on day 2 after the vaccine on 09Oct2021 with outcome of unknown. The patient experienced fever of 104 for 24 hours, muscle spasms and charlie horses throughout legs and back for 12 hours, horrible headache for 2 full days after vaccine and bad nausea for 12 hours on 09Oct2021 13:15 with outcome of recovered with lasting effects in Oct2021. The patient had spotted after the 2st vaccine in Oct2021 with outcome of unknown. No treatment received. Events were reported as non-serious and did not result in death, life threatening: caused/prolonged hospitalization, disabling/incapacitating, congenital anomaly/birth defect. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Fatigue, Immunisation, Neck pain
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 84-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 11Oct2021 (at the age of 84-years-old) as a single dose for COVID-19 immunisation. Medical history included car accident that had resulted in two weeks in hospital and four weeks in rehabilitation at hospital. Concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the 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 on an unknown date as a single dose for COVID-19 immunisation and the second 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. On 11Oct2021, the patient experienced pain and was unable to lie in bed due to aching in back. She also had low grade fever and pain in neck. Pain got worse at night or when she was lying down. The patient was weak and tired. She boicex more pain than her car accident. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of events and included treatment with ibuprofen (MANUFACTURER UNKNOWN) with minimal relief and oxycodone (MANUFACTURER UNKNOWN), one pill which was left from accident with moderate relief. The clinical outcome of the events pain, aching in back, low grade fever, pain in neck, weak and tired were not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 84-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 11Oct2021 (at the age of 84-years-old) as a single dose for COVID-19 immunisation. Medical history included car accident that had resulted in two weeks in hospital and four weeks in rehabilitation at hospital. Concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the 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 on an unknown date as a single dose for COVID-19 immunisation and the second 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. On 11Oct2021, the patient experienced pain and was unable to lie in bed due to aching in back. She also had low grade fever and pain in neck. Pain got worse at night or when she was lying down. The patient was weak and tired. She boicex more pain than her car accident. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of events and included treatment with ibuprofen (MANUFACTURER UNKNOWN) with minimal relief and oxycodone (MANUFACTURER UNKNOWN), one pill which was left from accident with moderate relief. The clinical outcome of the events pain, aching in back, low grade fever, pain in neck, weak and tired were not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Migraine
Clinical narrative: Intractable migraine; The patient administered with third booster dose; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 13Oct2021 at 11:15(at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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: EN6207) via an unspecified route of administration in the right arm on 25Mar2021 (at the age of 46-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNWON) via an unspecified route of administration in the right arm on 29Apr2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 13Oct2021 at 13:15, the patient experienced intractable migraine. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event intractable migraine was not recovered at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Immunisation, Off label use, SARS-CoV-2 test
Clinical narrative: The patient received the third/booster dose of BNT162b2; The patient received the third/booster dose of BNT162b2; Had sudden extreme knee pain that started 1-3 days later; Have arthritis in left knee which was diagnosed as being mild with no need for a replacement / Had sudden extreme knee pain that started 1-3 days later; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received the third dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 301458A) via an unspecified route of administration in the left arm on 05Oct2021 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetic and the patient had arthritis in the left knee which was diagnosed as being mild with no need for a replacement.  It was monitored by her orthopedic doctor and the patient had received one injection in Mar2021. The patient did not have any problems since then, walking 2.5 miles a day. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included metformin (MANUFACTURER UNKNOWN), ramipril (MANUFACTURER UNKNOWN), levothyroxine sodium (SYNTHROID), amlodipine (MANUFACTURER UNKNOWN) and vitamin D nos (MANUFACTURER UNKNOWN), all taken for an unspecified indication from an unknown date and unknown if ongoing. The patient previously received the first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the left arm on 06Feb2021 (at the age of 74-years-old) and also received the second dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 27Feb2021 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Oct2021, 1 to 3 days later since getting the booster, the patient had sudden extreme knee pain. The orthopedic office said that she could not get a cortisone shot to relieve the pain until 4 weeks after she received her booster shot. She was taking pain relief medications, ice packs, and rubbing it with VOLTAREN but no relief. It had been 10 days at the time of this report since her booster shot, and the patient had asked if she has to wait the full 4 weeks. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of extreme knee pain and included treatment with unspecified pain relief medications, ice packs and diclofenac (VOLTAREN). Since the vaccination, the patient had been tested for COVID-19. On 31Aug2021, the patient underwent SARS-CoV-2 test (nasal swab) and the result was negative. The clinical outcome of the event extreme knee pain was not resolved at the time of this report.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Immunisation, Myalgia
Clinical narrative: Chills; Muscle pain; Sore arm; Tired; Lightheaded; Nausea; 3rd booster dose; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 14Oct2021 at 16:30 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient received influenza vaccine (MANUFACTURER UNKNOWN) via an unspecified route of administration on 27Sep2021 for immunisation within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via an unspecified route of administration on 23Jan2021 (at the age of 66-year-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the right arm on 13Feb2021 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. On 15Oct2021 at 08:00, the patient experienced chills, muscle pain, sore arm, tired, lightheaded and nausea. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, muscle pain, sore arm, tired, lightheaded and nausea was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: Chills; Muscle pain; Sore arm; Tired; Lightheaded; Nausea; 3rd booster dose; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 14Oct2021 at 16:30 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient received influenza vaccine (MANUFACTURER UNKNOWN) via an unspecified route of administration on 27Sep2021 for immunisation within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via an unspecified route of administration on 23Jan2021 (at the age of 66-year-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the right arm on 13Feb2021 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. On 15Oct2021 at 08:00, the patient experienced chills, muscle pain, sore arm, tired, lightheaded and nausea. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, muscle pain, sore arm, tired, lightheaded and nausea was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Swelling at injection site with a 2" diameter; Swelling at injection site with a 2" diameter with itching; Swelling; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183) via an unspecified route of administration on an unknown date in 2021 (at the age of 37-years-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.  The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 14Oct2021, the patient experienced swelling at injection site with a 2" diameter with itching and swelling. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swelling at injection site with a 2" diameter with itching and swelling was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Immunisation, Neck pain, Pain in extremity
Clinical narrative: Sharpe pain to chest and back.; Sharpe pain to my chest and back; Radiating pain in neck and left arm; Radiating pain in neck and left arm; Palpitations; 3rd Booster dose; This is a spontaneous report from a contactable nurse, the patient. A 40-year-old male patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 301358A) via an unspecified route of administration in the left arm on 30Sep2021 at 14:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes mellitus (DM). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received  the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 03Feb2021 at 10:45 (at the age of 40-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 24Feb2021 at 10:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. On 05Oct2021 at 14:30, the patient experienced sharp pain in his chest and back, radiating pain in neck and left arm and palpitations. On 28Sep2021, the patient underwent PCR test via nasal swab and the result was negative. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events sharp pain in chest and back, radiating pain in neck and left arm and palpitations was not resolved at the time of this report.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, SARS-CoV-2 test
Clinical narrative: Sharpe pain to chest and back.; Sharpe pain to my chest and back; Radiating pain in neck and left arm; Radiating pain in neck and left arm; Palpitations; 3rd Booster dose; This is a spontaneous report from a contactable nurse, the patient. A 40-year-old male patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 301358A) via an unspecified route of administration in the left arm on 30Sep2021 at 14:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes mellitus (DM). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received  the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 03Feb2021 at 10:45 (at the age of 40-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 24Feb2021 at 10:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. On 05Oct2021 at 14:30, the patient experienced sharp pain in his chest and back, radiating pain in neck and left arm and palpitations. On 28Sep2021, the patient underwent PCR test via nasal swab and the result was negative. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events sharp pain in chest and back, radiating pain in neck and left arm and palpitations was not resolved at the time of this report.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Insomnia, Pruritus, Pyrexia
Clinical narrative: Patient received the third dose; Insomnia; itching; fever; This is a spontaneous report from a contactable consumer. An adult male patient of an unknown age received third booster 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. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN); both via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On an unknown date, after the third dose, the patient experienced insomnia, itching and fever. The clinical outcome of the events insomnia, itching and fever was unknown at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Postpartum haemorrhage
Clinical narrative: Gave birth on 23Sep2021 and postpartum bleeding stopped first week of October/1 hour post 2nd covid vaccine on 16Oct2021 bleeding began again and hasn't stopped; This is a spontaneous report from a contactable consumer (patient). A 31-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: FF8839, Expiry date: Unknown) via an unspecified route of administration, administered in right arm on 16Oct2021 12:00 (at the age of 31-years-old) as dose 2, single for COVID-19 immunisation. Patient did not have any other vaccine in 4 weeks. Patient was not pregnant at the time of vaccination. Patient was not tested for COVID post vaccination. Medical history included Chronic migraine from an unknown date and unknown if ongoing. Patient has known allergies of reglan. Concomitant medication(s) included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported; minerals nos, vitamins nos (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) taken for an unspecified indication, start and stop date were not reported. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0168) administered in right arm on 24Sep2021 14:30 (at the age of 31-years-old) as dose 1, single for COVID-19 immunisation. Patient gave birth on 23sep2021 and postpartum bleeding stopped first week of october/1 hour post 2nd covid vaccine on 16oct2021 13:00 bleeding began again and has not stopped. Patient did not received treatment for event. The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Nervousness
Clinical narrative: Felt very shaky following day; Shivering uncontrollably; Intense joint and muscle pain.; Intense joint and muscle pain.; Strong headache; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 75-years-old non-pregnant female patient received a dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: FF2590), dose 3 via an unspecified route of administration, administered in Arm Left on 14Oct2021 12:00 (at the age of 75-years-old) as dose 3 (booster), single for covid-19 immunisation. Medical history included High blood pressure, asthma, obesity, diverticulum, atrial fibrillation and Dust mites from an unknown date and unknown if ongoing. Concomitant medications included influenza vaccine (FLU VACCINE VII) taken (Arm Right) for an unspecified indication from 07Oct2021. It was reported that she was not a pregnant at the time of vaccination. patient received flu shot prior to four weeks of vaccination. She was not diagnosed with COVID prior vaccination and not tested with COVID post vaccination. Patient previously received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EN6204), via an unspecified route of administration, administered in Arm Left on 09Mar2021 as dose 2, single (at the age of 75-years-old) and patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EL9266) for via an unspecified route of administration, administered in Arm Left on 16Feb2021 (at the age of 75-years-old) as dose 1, single for COVID-19 immunisation. On 15Oct2021, the patient woke at 3:00 a.m. and experienced intense joint and muscle pain, strong headache and by 5:00 a.m, shivering uncontrollably which lasted until 11:00 a.m. The patient Stayed in bed most of the day on 16Oct2021 felt very shaky following day. It was reported as patient not received treatment for the events. The outcome of felt very shaky following day was unknown and outcome of Intense joint and muscle pain, strong headache was recovering and shivering uncontrollably was recovered on 15Oct2021.  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Immunisation, Off label use, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer or other non HCP. A 66-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection), dose 3 intramuscular, administered in arm right on 15Oct2021 13:00 (Batch/Lot Number: FH8020) (at the age of 66-years-old) as dose 3 (booster), single for COVID-19 immunisation. Medical history included, 2 heart valves replaced from an unknown date and unknown if ongoing , atrial fibrillation from an unknown date and unknown if ongoing , cardiac failure from an unknown date and unknown if ongoing , thyroid from an unknown date and unknown if ongoing , high cholesterol increased from an unknown date and unknown if ongoing. Concomitant medication(s) included allopurinol taken for an unspecified indication, start and stop date were not reported; carvedilol taken for an unspecified indication, start and stop date were not reported; digoxin taken for an unspecified indication, start and stop date were not reported; sacubitril valsartan sodium hydrate (ENTRESTO) taken for an unspecified indication, start and stop date were not reported; simvastatin taken for an unspecified indication, start and stop date were not reported; tamsulosin taken for an unspecified indication, start and stop date were not reported; levothyroxine taken for an unspecified indication, start and stop date were not reported; torsemide taken for an unspecified indication, start and stop date were not reported; warfarin taken for an unspecified indication, start and stop date were not reported; potassium chloride taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (ASPIRIN (E.C.)) taken for an unspecified indication, start and stop date were not reported; diphenhydramine hydrochloride (UNISOM [DIPHENHYDRAMINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient had no known allergies. The patient had previously received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection), dose 2 via intramuscular, administered in arm right on 27Feb2021 03:00 PM (at the age of 65 years) (Batch/Lot Number: EL9266) and also received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection), dose 1 via intramuscular, administered in arm right on 28Jan2021 03:00 PM (Batch/Lot Number: EN5318) for covid-19 immunization. The patient previously received influenza vaccine (INFLUENZA VACCINE) for immunisation on 06Oct2021. On 16Oct2021 14:00 the patient experienced Headache, fatigue, and vomiting. The patient not received treatment for the events. The outcome of the events (Headache, fatigue, and vomiting) was recovered on an unknown date in Oct2021.    Follow-Up (26Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: sever headache; This is a spontaneous report from a non-contactable consumer (nurse, patient). A 35-year-old female patient received second dose of BNT162B2 (Comirnaty, Solution for injection, lot/batch number: FF2590 and expiry date was not reported), via an unspecified route of administration in arm left, on 10Oct2021 at 01:30 PM (age at vaccination: 35 years), as a dose 2, single for COVID-19 immunization. The patient's medical history includes allergies to sulfa and multiple Sclerosis. The concomitant medications include ocrelizumab (ocrevus), carbamazepine (tegretal), gabapentin, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (adderall), vitamin D[vitamin D nos] (vitamin D) all from an unknown date for an unknown indication. It was reported that the patient had covid prior vaccination and was not covid tested post vaccination. Reportedly the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient historical vaccine includes BNT162B2 (Comirnaty, Solution for injection, lot/batch number: 301358A and expiry date was not reported), via an unspecified route of administration in arm left, on 19Sep2021 at 04:30 PM, as a dose 1, single for COVID-19 immunization. On 14Oct2021, 4 days after second dose a severe headache that was persisted for 4 days. The headache was constant and was located on the right side behind her right eye. It was reported that the headache was not responding to ibuprofen or Tylenol. Noticed hcp and as a treatment of adverse event the patient was prescribed with a steroid dose pack starting at 80mg. Outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Swelling
Clinical narrative: Right armpit area is swollen; Body is very sore and achy; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: FF2593) via an unspecified route of administration, administered in arm right on 13Oct2021 (age at vaccination 27 years) as dose 1, single for covid-19 immunisation. When probed for second dose vaccination due date, consumer stated, "It can be the "27th. The patient's medical history included none. Concomitant medication included influenza vaccine (FLU) taken for an unspecified indication from Oct2021 to Oct2021. When probed if any prior vaccinations within 4 weeks, patient stated, "he got the Flu shot about a week before first dose of Covid-19 vaccination. When probed for Flue shot LOT, consumer stated, "he had none of that information, he just understand it was a Flu shot. He got his (first dose vaccine) shot in his right arm and under his armpit area in his right arm was all swollen. It was like that about a day now. patient stated typically his body was very sore and achy, it's been swollen under armpit. When probed if any treatment for the event, consumer stated, "No, he had not. The outcome of events was unknown.  Follow-up attempts are completed. No further information was expected.
Age: 29.0
Sex: U
Vaccine: COVID19
Symptoms: Discomfort, Pain, SARS-CoV-2 test, Swelling
Clinical narrative: swelling under my arm, in the armpit; discomfort; lifting my arm above my shoulder without pain; This is a spontaneous report from a contactable consumer or other non hcp. A 29-years-old patient of an unspecified gender received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: FF8841), via an unspecified route of administration, administered in Arm Left on 15Oct2021 17:30 (at the age of 29-years-old) as dose 3 (booster), single for covid-19 immunisation, the patent also received influenza vaccine (FLU), via an unspecified route of administration from 15Oct2021 (Batch/Lot number was not reported) to 15Oct2021, at unspecified dose for immunization and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP), via an unspecified route of administration from 15Oct2021 (Batch/Lot number was not reported) to 15Oct2021, at unspecified dose for immunization. Medical history included Allergies: Sulfa based drugs and immunization. Concomitant medications included losartan, estradiol and spironolactone. The patient received first dose of BNT162B2 on 18Mar2021 at 02:30 PM (Batch/Lot No: EP7534, Location of injection: Arm Right) and received second dose on 08Apr2021 at 02:30 PM (batch/Lot No: EW0153, Location of injection: Arm Right) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was tested for COVID-19 since the vaccination. On 16Oct2021 the patient experienced swelling under my arm, in the armpit, discomfort and lifting my arm above my shoulder without pain. The patient reported that the day after covid booster, woke with a large amount of swelling under arm, in the armpit. There was almost constant discomfort, and it prevents from letting the arm fully relax at the side or lifting the arm above shoulder without pain. The amount of swelling is fairly large, as when the patient looks into the mirror, armpit no longer has a concave profile. It is now convex. The patient had gotten 2 other vaccines that day. They were a Tdap and a flu shot. The swelling in armpit is on the left side, which is the same arm as where covid booster was administered and the flu shot, the Tdap shot was in my right arm, but the patient reported that might be mixing up which arms the flu and Tdap shots went into. The patient had not gone to the physician, because it had only been about 36-40 hours, and the swelling has gone down slightly (but not much). The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 10Sep2020 Date is approximate. The action taken in response to the events for influenza vaccine was not applicable, for diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid was not applicable. The outcome of all the events was not resolved. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Vaccination site erythema
Clinical narrative: Arm was numb; Red at injection site for several days after injection; This is a spontaneous report from a contactable consumer. An adult female patient of unknown age received the second 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. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown if the patient had received any other vaccines within four weeks prior to the 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 on an unknown date as a single dose for COVID-19 immunisation. On an unknown date, the patient arm was numb and red at the injection site for several days after injection. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events arm was numb and red at injection site for several days after injection was recovered on an unknown date.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itchy; 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: UNKNOWN) via an unspecified route of administration in the right arm on 12Oct2021 at 13:15 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included cancer and known allergies to bee venom. Prior to vaccination, the patient was not diagnosed with COVID -19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 12Oct2021 at 13:15, the patient experienced itchy. The event itchy did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event itchy was unknown at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Musculoskeletal discomfort, Vaccination site pain
Clinical narrative: 2 hours after 2nd vaccination, "my" back spasmed; 2 hours after 2nd vaccination, "my" back spasmed and was uncomfortable; Since the 2nd vaccination, "my" left arm at injection site off and on feels like "I" had just received the injection.; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 30Mar2021 at 16:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. The medical history included thyroid and unspecified allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included levothyroxine sodium (L-THYROXINE) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 11Mar2021 at 13:15 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. On 30Mar2021, at 18:00, 2 hours after 2nd vaccination, the patient's back spasmed and was uncomfortable and lifted about 6 hours later. Since the 2nd vaccination, the patient's left arm at injection site off and on felt like she had just received the injection. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left arm at injection site off and on felt like had just received the injection, back spasmed and uncomfortable were not resolved at the time of this report. The patient also received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30130BA) via an unspecified route of administration in the right arm on 15Oct2021 at 10:30 (at the age of 68-years-old) as a single dose for COVID-19 immunisation.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy, Off label use
Clinical narrative: Swollen neck on the left side, maybe a lymph node; Third dose/ Booster dose; Off-label use; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Oct2021 at 14:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Concomitant medications included pentosan polysulfate sodium (ELMIRON) and an unspecified vitamin; both for unknown indications from unknown dates and unknown if ongoing. 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 06Feb2021 (at the age of 44-years-old) and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 27Feb2021 (at the age of 44-years-old); both as a single dose for COVID-19 immunisation. On 15Oct2021 at 13:00, the patient experienced swollen neck on the left side, might be a lymph node. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen neck on the left side, maybe a lymph node was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.