chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Immunisation, Lymph node pain, Lymphadenopathy, Musculoskeletal stiffness
Clinical narrative: Still 7 days later, swelling; Still 7 days later tenderness; Still difficult to squeeze my arm against my chest wall; Realized in morning my left armpit/ lymph node area was extremely swollen, painful; Realized in morning my left armpit/ lymph node area was extremely swollen, painful.; Booster dose\dose 3 received; About 7 hours after dose 3 , I developed shoulder injection tightness.; Then middle of night, I woke with same arm, forearm pain; Deep throbbing into fingers; Tingling into fingers; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received third dose (booster) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an unspecified route of administration on 15Oct2021 (at the age of 65-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medication was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration on 29Mar2021(at the age of 64-years-old), as a single dose for COVID-19 immunisation and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration on 19Apr2021 (at the age of 64-years-old), as a single dose for COVID-19 immunisation. On 15Oct2021, about 7 hours after dose 3,  the patient experienced  shoulder injection tightness, then in the middle of night, patient woke with up pain in same arm, forearm pain, deep throbbing into fingers, tingling into fingers. On 16Oct2021, the patient realized in morning left armpit/ lymph node area was extremely swollen and painful. On 20Oct2021, 7 days later, the patient still experienced, swelling, tenderness and it was still difficult to squeeze arm against her chest wall. 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events about 7 hours after dose 3, developed shoulder injection tightness, then middle of night, patient woke with same arm, forearm pain, deep throbbing into fingers, tingling into fingers, the patient realized in morning left armpit/ lymph node area was extremely swollen and painful were resolving and the patient still experienced 7 days later, swelling, tenderness and still difficult to squeeze arm against chest wall  was not resolved at the time of this report.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Paraesthesia, Swelling, Tenderness
Clinical narrative: Still 7 days later, swelling; Still 7 days later tenderness; Still difficult to squeeze my arm against my chest wall; Realized in morning my left armpit/ lymph node area was extremely swollen, painful; Realized in morning my left armpit/ lymph node area was extremely swollen, painful.; Booster dose\dose 3 received; About 7 hours after dose 3 , I developed shoulder injection tightness.; Then middle of night, I woke with same arm, forearm pain; Deep throbbing into fingers; Tingling into fingers; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received third dose (booster) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an unspecified route of administration on 15Oct2021 (at the age of 65-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medication was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration on 29Mar2021(at the age of 64-years-old), as a single dose for COVID-19 immunisation and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration on 19Apr2021 (at the age of 64-years-old), as a single dose for COVID-19 immunisation. On 15Oct2021, about 7 hours after dose 3,  the patient experienced  shoulder injection tightness, then in the middle of night, patient woke with up pain in same arm, forearm pain, deep throbbing into fingers, tingling into fingers. On 16Oct2021, the patient realized in morning left armpit/ lymph node area was extremely swollen and painful. On 20Oct2021, 7 days later, the patient still experienced, swelling, tenderness and it was still difficult to squeeze arm against her chest wall. 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events about 7 hours after dose 3, developed shoulder injection tightness, then middle of night, patient woke with same arm, forearm pain, deep throbbing into fingers, tingling into fingers, the patient realized in morning left armpit/ lymph node area was extremely swollen and painful were resolving and the patient still experienced 7 days later, swelling, tenderness and still difficult to squeeze arm against chest wall  was not resolved at the time of this report.
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Induration, Pain
Clinical narrative: This is a spontaneous report from a contactable nurse, the patient. A 76-year-old patient of an unknown gender received the third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8027) via an unspecified route of administration in the left arm on 12Oct2021 at 11:30 (at the age of 76-year-old) as a single dose for COVID-19 immunisation. Medical history included HTN (hypertension), obesity, hypothyroid (hypothyroidism) and known allergies to sulfonamide (sulfa). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), indapamide (LOZOL), levothyroxine (L-THYROXINE), paracetamol (TYLENOL) and potassium (MANUFACTURER UNKNOWN); all for an unknown indication, from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the right arm on 20Feb2021 (at the age of 75-year-old) as a single dose for COVID-19 immunisation and experienced no adverse event. The patient previously received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM6205) via an unspecified route of administration in the right arm on 14Mar2021 (at the age of 75-year-old) as a single dose for COVID-19 immunisation and experienced no adverse event. The patient previously took influenza vaccine (MANUFACTURER UNKNOWN) for immunisation, on an unknown date and experienced erythema and induration but that lasted less time and was not painful. On 13Oct2021, at 11: 30, 24 hours after the injection, the patient experienced erythema and induration that lasted for 6 days and was 6-7 cm. On an unknown date in Oct2021, erythema and induration also became painful, similar to bee sting. 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events erythema and induration 24 hours after injection and was 6-7 cm was recovered on 19Oct2021, at 11:30, after the duration of 6 days, whereas it also became painful, similar to bee sting was recovered on an unknown date in Oct2021.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Severe tingling everywhere especially in feet; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the arm on 24Apr2021 (at the age of 28-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 vaccination. On 26Apr2021, the patient experienced severe tingling everywhere especially in feet. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of severe tingling everywhere especially in feet and included treatment with gabapentin (MANUFACTURER UNKNOWN). The clinical outcome of the event severe tingling everywhere especially in feet was unknown at the time of this report.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Migraine
Clinical narrative: Had a migraine headache everyday; This is a spontaneous report from a contactable nurse, patient. A 50-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 08Apr2021 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. 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 received unspecified concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1284) via an unspecified route of administration in the left arm on 15Mar2021 at (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient previously took meloxicam (MOBIC) and experienced drug allergy. On 01May2021, the patient experienced had a migraine headache every day. The patient had seen a neurologist and an MRI was ordered, that confirmed a new diagnosis of migraines. The patient did not have migraines prior to the vaccination. On an unknown date the patient underwent an magnetic resonance imaging (MRI) and the result was a new diagnoses of migraines. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of event which included an unspecified treatment and was ongoing at the time of this report. The clinical outcome of the event migraine headache was not resolved at the time of this report.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Fever; Headache; Tiredness; Abdominal pain; Nausea; This is a spontaneous report from a contactable healthcare professional, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30155BA) via an unspecified route of administration in the left arm on 06Oct2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was unspecified. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 07Oct2021 at 16:00, the patient experienced fever, headache, tiredness, abdominal pain and nausea. 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 fever, headache, tiredness, abdominal pain and nausea was resolved on an unknown date in Oct2021.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain in the biceps (shot location) when contracted or pressed; pain level was not high enough to obstruct arm movement, but discouraged. The pain faded away after two days.; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30155BA) via an unspecified route of administration in the left arm on 18Oct2021 (at the age of 27-years-old), as a single dose for COVID-19 immunisation. Medical history included allergy (unspecified). The patient received unspecified medications within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the COVID vaccine. On 18Oct2021, the patient experienced pain in the biceps (shot location) when contracted or pressed; pain level was not high enough to obstruct arm movement, but discouraged. The pain faded away after two days. The event did not result in doctor or other health care 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 pain in the biceps (shot location) when contracted or pressed was resolved on 20Oct2021.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Peripheral swelling
Clinical narrative: My arm is swelling up; third COVID-19 vaccine; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection; lot number and expiry date were not reported) via unspecified route of administration on 20Oct2021 as dose 3 (booster), single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection; lot number and expiry date were not reported) via unspecified route of administration on unspecified dates at dose 1 and 2, single for COVID-19 immunization. The patient received their third COVID-19 vaccine and reported that the swelling in arm was getting pretty big from an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Immunisation, Nausea, Pain in extremity
Clinical narrative: Booster dose; Fever; Headache; Nausea; Chills; Sore arm; This is a spontaneous report from a contactable consumer. A 61-year-old non-pregnant female patient received third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an intramuscular route of administration in the left arm on 19Oct2021 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and was not sure of having known allergies. Prior to 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. Concomitant medications included ascorbic acid (ESTER C) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an intramuscular route of administration in the left arm on 05Feb2021 (at the age of 60-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an intramuscular route of administration in the left arm on 26Feb2021 (at the age of 60-year-old), both as a single dose for COVID-19 immunisation. On 20Oct2021, the patient experienced fever, headache, nausea, chills and sore arm. 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, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events fever, headache, nausea, chills and sore arm was recovered with sequelae on an unknown date in Oct2021.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Booster dose; Fever; Headache; Nausea; Chills; Sore arm; This is a spontaneous report from a contactable consumer. A 61-year-old non-pregnant female patient received third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an intramuscular route of administration in the left arm on 19Oct2021 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and was not sure of having known allergies. Prior to 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. Concomitant medications included ascorbic acid (ESTER C) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an intramuscular route of administration in the left arm on 05Feb2021 (at the age of 60-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an intramuscular route of administration in the left arm on 26Feb2021 (at the age of 60-year-old), both as a single dose for COVID-19 immunisation. On 20Oct2021, the patient experienced fever, headache, nausea, chills and sore arm. 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, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events fever, headache, nausea, chills and sore arm was recovered with sequelae on an unknown date in Oct2021.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Immunisation, Myalgia
Clinical narrative: The following day, skin sensitivity; General myalgia; Extreme fatigue; Headache; The patient received the third/booster dose of BNT162b2; The patient received the third/booster dose of BNT162b2; Very sore at injection site; Intense joint pain / continued intense joint pain; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the third dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8839) via intramuscular route of administration in the left arm on 20Oct2021 at 23:45 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included Polycystic Ovarian Syndrome (PCOS), Hypermobile Ehlers-Danlos syndrome (hEDS), previously had Lyme disease, bad car accident which required hospitalization and shoulder surgery, kidney stone, previous asthma and migraines. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccines within four weeks prior to the vaccination which included influenza vaccine (flu vaccine) (MANUFACTURER UNKNOWN) for immunization on 29Sep2021. Concomitant medications included drospirenone; ethinylestradiol betadex clathrate (YAZ), sertraline (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), verapamil (MANUFACTURER UNKNOWN), naratriptan (MANUFACTURER UNKNOWN), famotidine (MANUFACTURER UNKNOWN) and gliclazide (CLARITIN), all taken for an unspecified indication on an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via intramuscular route of administration in the left arm on 11Feb2021 at 14:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via intramuscular route of administration in the left arm on 02Mar2021 at 12:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Oct2021, within a couple hours of vaccination, the patient experienced very sore at injection site. On an unknown date in Oct2021, the patient experienced overnight intense joint pain. On 21Oct2021, the following day, the patient experienced skin sensitivity, general myalgia (continued intense joint pain), extreme fatigue and headache. 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. On 18Aug2021, the patient underwent SARS-COV-2 test (Polymerase Chain Reaction (PCR)) through (nasal swab) and the result was negative. The clinical outcome of the events very sore at injection site, overnight intense joint pain, skin sensitivity, general myalgia (continued intense joint pain), extreme fatigue and headache were not resolved at the time of this report.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, SARS-CoV-2 test, Sensitive skin, Vaccination site pain
Clinical narrative: The following day, skin sensitivity; General myalgia; Extreme fatigue; Headache; The patient received the third/booster dose of BNT162b2; The patient received the third/booster dose of BNT162b2; Very sore at injection site; Intense joint pain / continued intense joint pain; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the third dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8839) via intramuscular route of administration in the left arm on 20Oct2021 at 23:45 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included Polycystic Ovarian Syndrome (PCOS), Hypermobile Ehlers-Danlos syndrome (hEDS), previously had Lyme disease, bad car accident which required hospitalization and shoulder surgery, kidney stone, previous asthma and migraines. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccines within four weeks prior to the vaccination which included influenza vaccine (flu vaccine) (MANUFACTURER UNKNOWN) for immunization on 29Sep2021. Concomitant medications included drospirenone; ethinylestradiol betadex clathrate (YAZ), sertraline (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), verapamil (MANUFACTURER UNKNOWN), naratriptan (MANUFACTURER UNKNOWN), famotidine (MANUFACTURER UNKNOWN) and gliclazide (CLARITIN), all taken for an unspecified indication on an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via intramuscular route of administration in the left arm on 11Feb2021 at 14:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via intramuscular route of administration in the left arm on 02Mar2021 at 12:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Oct2021, within a couple hours of vaccination, the patient experienced very sore at injection site. On an unknown date in Oct2021, the patient experienced overnight intense joint pain. On 21Oct2021, the following day, the patient experienced skin sensitivity, general myalgia (continued intense joint pain), extreme fatigue and headache. 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. On 18Aug2021, the patient underwent SARS-COV-2 test (Polymerase Chain Reaction (PCR)) through (nasal swab) and the result was negative. The clinical outcome of the events very sore at injection site, overnight intense joint pain, skin sensitivity, general myalgia (continued intense joint pain), extreme fatigue and headache were not resolved at the time of this report.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Lymphadenopathy, Malaise
Clinical narrative: Injection site pain; Tiredness; Headache; Chills; Fever; Injection site swelling; Nausea; Feeling unwell; Swollen lymph nodes; Arm pain; Off label use; The patient received booster dose; This is a spontaneous report from a non-contactable consumer, the patient. A 74-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261) via an unspecified route of administration in the arm right on 25Sep2021 at 17:30 (at the age of 74-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 vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the arm left on 20Jan2021 at 19:00 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. The patient previously received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the arm right on 10Feb2021 at 19:45 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. On 26Sep2021 at 08:00, the patient experienced tiredness, headache, chills, fever, injection site swelling, nausea, feeling unwell, swollen lymph nodes, arm pain and injection site pain. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not tested for COVID-19. The clinical outcome of the event tiredness, headache, chills, fever, injection site swelling, nausea, feeling unwell, swollen lymph nodes, arm pain and injection site pain was resolved on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: Injection site pain; Tiredness; Headache; Chills; Fever; Injection site swelling; Nausea; Feeling unwell; Swollen lymph nodes; Arm pain; Off label use; The patient received booster dose; This is a spontaneous report from a non-contactable consumer, the patient. A 74-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261) via an unspecified route of administration in the arm right on 25Sep2021 at 17:30 (at the age of 74-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 vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the arm left on 20Jan2021 at 19:00 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. The patient previously received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the arm right on 10Feb2021 at 19:45 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. On 26Sep2021 at 08:00, the patient experienced tiredness, headache, chills, fever, injection site swelling, nausea, feeling unwell, swollen lymph nodes, arm pain and injection site pain. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not tested for COVID-19. The clinical outcome of the event tiredness, headache, chills, fever, injection site swelling, nausea, feeling unwell, swollen lymph nodes, arm pain and injection site pain was resolved on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: Smelling metal everywhere I go. I can still smell but 80% of the time I am smelling metal or like the smell of coins; This is a spontaneous report from a contactable other healthcare professional, the patient. A 27-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 on an unknown date in Oct2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines and COVID-19. Prior to the vaccination, the patient was 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 concomitant medication. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) for unknown indication and experienced drug allergy. On an unknown date in Oct2021, the patient experienced smelling metal everywhere she went. She could still smell (at the time of this report) but 80% of the time she was smelling metal or like the smell of coins. 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 smelling metal everywhere she went, she could still smell but 80% of the time she was smelling metal or like the smell of coins was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Influenza like illness, Lethargy
Clinical narrative: Normal flu like symptoms; Chills; Sweats; Lethargy; Headache / persistent headache at back of head / persisting through second day; The patient received the third/booster dose of BNT162b2; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer. A 51-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 on 19Oct2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included Attention Deficit Hyperactivity Disorder (ADHD), possible perimenopause and possible cardiac arrhythmia (occasionally skipped heartbeats). The patient was allergic to penicillin and coconut. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccines within four weeks of vaccination which included influenza vaccine (flu shot) (MANUFACTURER UNKNOWN) for immunization on 05Oct2021. Concomitant medications included methylphenidate (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), lurasidone hydrochloride (LATUDA), ibuprofen (ADVIL) and paracetamol (TYLENOL) (as needed) and acetylsalicylic acid (ASPIRIN), all taken for an unspecified indication from an unknown date 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 on an unknown date in Mar2021 (at the age of 50-years-old) and also 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 in Apr2021 as a single dose for COVID-19 immunisation. On 20Oct2021, on the day after vaccination, the patient experienced normal "flu like symptoms" including chills/sweats, lethargy and headache; persistent headache at back of head started the day after vaccine, was persisting through 21Oct2021, the second day and only somewhat eased with Advil/Tylenol. Consistent with mild to moderate adverse event and no medical intervention was necessary at that time. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were taken as a result of the event headache; persistent headache at back of the head and included treatment with ibuprofen (ADVIL) and paracetamol (TYLENOL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events normal "flu like symptoms" including chills/sweats, lethargy and headache; persistent headache at back of head started the day after vaccine and was persisting through second day 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: Immunisation, Lymph node pain, Lymphadenopathy
Clinical narrative: Booster dose; Enlarged lymph nodes near collar bone on same side as vaccine; noticeable lump and swelling; Slight enlarged neck lymph nodes.; Enlarged lymph nodes near collar bone on same side as vaccine; noticeable lump and swelling; painful and tender to touch; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Oct2021 at 10:15 (at the age of 37-year-old), as a single dose for COVID-19 immunisation. Medical history included asthma and allergies (unspecified). Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any vaccine within four weeks prior to COVID vaccine. Concomitant medications included cetirizine (MANUFACTURER UNKNOWN), vitamin d nos (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN) and salbutamol sulfate (PROAIR); all from unknown date for unknown indication 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 and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration; both on an unknown date as a single dose for COVID-19 immunisation. On 08Oct2021, the patient experienced enlarged lymph nodes near collar bone on same side as vaccine; noticeable lump and swelling; painful and tender to touch. Slight enlarged neck lymph nodes. Swollen area got smaller and less painful after 2 days and was completely gone in about a week. 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 enlarged lymph nodes\ noticeable lump and swelling\ slight enlarged neck lymph nodes and painful and tender to touch was resolved on an unknown date in Oct2021.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen and painful lymph nodes under arm and along clavicle starting approximately 12 hours after vaccine administration.; Swollen and painful lymph nodes under arm and along clavicle starting approximately 12 hours after vaccine administration; The patient received BNT162b as booster dose; The patient received BNT162b as booster dose; This is a spontaneous report from a non-contactable pharmacist, the patient. A 29-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2590) via an unspecified route of administration in the right arm on 19Oct2021 at 15:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included influenza vaccine inact sag 4v (FLUCELVAX QUADRIVALENT) on 11Oct2021 taken for an unknown indication on an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730) via an unspecified route of administration in the left arm  on 17Dec2020 at 14:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL0142) via an unspecified route of administration in the right arm on 07Jan2021 at 14:15  (at the age of 28 -year-old)  as a single dose for COVID-19 immunisation. On 20Oct2021 at 03:00, the patient experienced swollen and painful lymph nodes under arm and along clavicle starting approximately 12 hours after vaccine administration. 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 swollen and painful lymph nodes under arm and along clavicle were recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Libido decreased
Clinical narrative: Booster dose; "I" have not had any interest in sex or masturbation since receiving the booster on 08-October 2021; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old male patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2588) via an unspecified route of administration in the arm left on 08Oct2021 at 19:00 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. The medical history included benign prostatic hyperplasia. 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 concomitant medications included tamsulosin hydrochloride (TAMULOSIN), ascorbic acid (VITAMIN C) and ibuprofen (MANUFACTURER UNKNOWN); all 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: EN6200) via an unspecified route of administration in the arm right on 24Feb2021 at 14:00 (at the age of 70-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the arm left on 17Mar2021 at 16:00 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. On 08Oct2021 at 19:00, since receiving the booster, the patient had not had any interest in sex or masturbation. The patient considered this as a blessing and not a curse. The adverse event 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event had not had any interest in sex or masturbation was not resolved at the time of this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: positive sar covid test; positive sar covid test; This is a spontaneous report from a contactable consumer. This consumer (patient) reported in response to consumer letter sent via follow-up letter in crosslinked case. A 67-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 intramuscular, administered in Arm Left on 23Feb2021 (Lot Number: EL9267) as DOSE 2, SINGLE and dose 1 intramuscular, administered in arm Right on 02Feb2021 (Lot Number: EL9264) as DOSE 1, SINGLE for covid-19 immunisation at Pharmacy or drug store. Medical history included ongoing High blood pressure. Concomitant medications included lisinopril taken for hypertension from an unspecified start date and ongoing. On 26Jul2021 the patient experienced positive SARS-CoV-2 test. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Jul2021. The clinical outcome of the event positive sars covid test (COVID-19) was recovered on an unspecified date in 2021.  No follow-up attempts possible. No further information expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Myalgia, Vaccination site pain
Clinical narrative: After 3rd dose: Muscle soreness at injection site; Muscle soreness at injection site and some surrounding muscles (neck, shoulder).; Patient was administered with Booster dose 3, BNT162B2; This is a spontaneous report from a non-contactable consumer, the patient. A 52-year-old female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration on 21Oct2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. It was not reported if the patient 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: EL3428) via an unspecified route of administration on 12Jan2021 (at the age of 51-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3428) via an unspecified route of administration on 02Feb2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. On 22Oct2021, after third dose, the patient experienced muscle soreness at injection site and some surrounding muscles which included neck, shoulder. Soreness was present at the time of report, even 24 hours after injection. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event muscle soreness at injection site and some surrounding muscles which included neck, shoulder was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Immunisation, Off label use, Palpitations, Tachycardia
Clinical narrative: Resting heart rate of 105 bpm with palpitations lasting the last 17 hours.; Resting heart rate of 105 bpm with palpitations lasting the last 17 hours.; Off label use; A third (booster) dose of BNT162b2 was administered; This is a spontaneous report from a contactable consumer, the patient. A 37-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 21Oct2021 at 08:45 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included influenza vaccine (MANUFACTURER UNKNOWN) taken on 09Oct2021 for an unknown indication. 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 right arm on 02Feb2021 at 08:15 (at the age of 36-years-old) as a single dose for COVID-19 immunisation and received the second dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 24Feb2021 at 08:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient received flu vaccine within four weeks prior to the COVID-19 vaccine. On 21Oct2021 at 20:15, the patient experienced resting heart rate of 105 beats per minute (bpm) with palpitations lasting the last 17 hours. On 21Oct2021, the patient underwent lab test which included heart rate test and the result was 105 bpm. 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 resting heart rate of 105 bpm with palpitations lasting the last 17 hours was resolved on 22Oct2021.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Overdose, Product administered to patient of inappropriate age
Clinical narrative: inadvertently received a full dose of the adult version of the Pfizer Covid vaccine; 6 years old boy, who inadvertently received a full dose of the adult version of the Pfizer Covid vaccine; loose stool; abdominal pain; This is a spontaneous report from a contactable consumer or other non-HCP (parent reporting for son) via Medical Information Team. A 6-year-old male patient received BNT162b2 (COMIRNATY, Solution for injection, Lot Number- UNKNOWN) via an unspecified route of administration on an unspecified date as dose number unknown single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Mother stated her son inadvertently received a full dose of the adult version of the Pfizer COVID-19 vaccine. She stated her child was complaining of loose stool, abdominal pain. She would like to know the side effects to look for specifically myocarditis and pericarditis. She would also like to know side effects of children who may have received a dose 3 times what is called for a child his age. The father and mother of the patient were very upset with lack of information provided to them, as they are very concerned that their child may develop, myocarditis, or pericarditis. Parents informed that, although the safety efficacy of the vaccine dose of 10ug, was comparable to those receiving the full dose of 30ug, there was no information with regards to side effects of a child smaller than 12 receiving a full dose, since the study conducted by Pfizer, provided a dose of 10ug and not 30ug. The reporter asked, what information do we have about the side effects the kids in the study had. The outcome of loose stool, abdominal pain was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow up.