chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, SARS-CoV-2 test
Clinical narrative: I got shingles within a week of getting the 1st pfizer vaccination; This is a spontaneous report from a 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: ER8729, expiration date: an unknown date in Jul2021) via an unspecified route of administration in the left arm on 12Apr2021 at 16:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. 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 medications within two weeks of vaccination. On 19Apr2021 at 00:00, within a week of getting the 1st Pfizer vaccination, the patient got shingles. The adverse event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the reported event which included treatment with valaciclovir (VALACYCLOVIR) and tramadol (MANUFACTURER UNKNOWN). Since the vaccination, the patient had been tested for COVID-19. On 03Jul2021, the patient underwent SARS-COV-2 test (polymerase chain reaction (PCR)) and the result was negative. The clinical outcome of the event shingles was resolved on an unknown date in 2021. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172, expiration date: an unknown date in Aug2021) via an unspecified route of administration in the left arm on 03May2021 at 16:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Palpitations, Panic attack, Syncope
Clinical narrative: fainting; Patient had palpitations; panic attack; patient "zoned out"; This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. A patient of unspecified age and gender received bnt162b2 (COMIRNATY; solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient had palpitations, fainting, panic attack and patient zoned out. The patient had to see cardiologist who said that the patient was not to get any further COVID vaccines. Outcome of the events was unknown.  The lot number for the vaccine, [Comirnaty], was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between syncope and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: person beside my table said his father had the vaccine and then two days later experienced a fatal blood clot; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (COMIRNATY, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at a dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced a fatal blood clot (medically significant, life threatening). The reporter stated that while in restaurant person beside the reporter's table said his father had the vaccine and then two days later experienced a fatal blood clot. The outcome of the event was unknown.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Movement disorder, Muscle discomfort, Sleep disorder
Clinical narrative: Within a couple of weeks following the second injection, "I" started experiencing Left and right shoulder pain; Muscular discomfort; Lack of range of motion. It has been basically noticeable since February with some days more intense than others; Able to relieve some pain thru exercise such as Pickleball and find it worse when I do nothing. Such as sleeping! Cannot sleep on my stomach at all anymore.; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810), via an unspecified route of administration in the left arm on 12Feb2021 at 09:30 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. The patient had no 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 other medicines (unspecified) within two weeks prior to vaccination. The patient previously received pseudoephedrine (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249) via an unspecified route of administration in the left arm on 22Jan2021 at 09:00 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. On 24Feb2021 at 12:00, within a couple of weeks following the second injection the patient started experiencing left and right shoulder pain, muscular discomfort and lack of range of motion. It had been basically noticeable since an unspecified date in Feb2021, with some days more intense than others. The patient was able to relieve some pain through exercise, such as pickleball and found it was worse when patient did nothing such as sleeping. The patient could not sleep on stomach at all anymore. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the event shoulder pain and included exercise, such as pickleball. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left and right shoulder pain, muscular discomfort and lack of range of motion and could not sleep on stomach at all anymore were not resolved at the time of this report.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Immunisation, Pain, Pyrexia
Clinical narrative: Intense pain from face to feet on left side; Fever; Chills; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 320308D) in the left arm on 04Nov2021 at 11:30 (at the age of 72-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. The patient received other vaccines within four weeks prior to the vaccination which included influenza vaccine (flu) (MANUFACTURER UNKNOWN) on 20Oct2021 for immunization. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and doxepin (MANUFACTURER UNKNOWN), both for an unknown indication from an unknown date and unknown if ongoing. The patient previously received thiomersal (THIMEROSAL) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246) in the left arm on 08Feb2021 (at the age of 71-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) in the left arm on 01Mar2021 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. On 04Nov2021 at 12:00, the patient experienced intense pain from face to feet on left side, fever and chills. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events intense pain from face to feet on left side, fever and chills were resolving at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pyrexia
Clinical narrative: The patient received third/booster dose of BNT162b2; Fever after booster shot; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old female patient received third 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 was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks of COVID vaccine. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date, both as single dose for COVID-19 immunisation. On an unknown date, after booster shot, the patient experienced fever. 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of event fever after booster shot was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: This spontaneous report from two contactable consumers, reporting same event under the same suspect product for 7 patients. This is one of 7 reports. A patient, of unspecified age and gender, received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, singe dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Reporter stated seven patients lost/losing their hair since they had the vaccination. Also reported these seven patients experienced hair changing or falling out right after Pfizer vaccination (7 patients have lost hair). The outcome of the event: unknown. The lot number for BNT162B2 not provided and will be requested during follow-up. Sender's comments: Linked report(s): US-PFIZER INC-202101342968 same drug/event, different patient.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Tinnitus, Vertigo
Clinical narrative: Vertigo; severe tinnitus; Numbness in limbs; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old patient of unknown gender received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The medical history included 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 concomitant medications included lisinopril (MANUFACTURER UNKNOWN) 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:EP6955 ) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient previously received codeine (MANUFACTURER UNKNOWN) and experienced allergy. On 03May2021, the patient experienced vertigo, severe tinnitus and numbness in limbs. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events vertigo, severe tinnitus and numbness in limbs were not resolved at the time of this report.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Night sweats
Clinical narrative: Night sweats; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Nov2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included type 1 diabetes, androgenic alopecia, hashimotos, sulfonamide allergy and COVID-19 diagnosed, prior to the vaccination. The patient received other medicines (unspecified) within two weeks prior to vaccination. On 04Nov2021 at 02:00, the patient experienced night sweats. The patient received the vaccine on tuesday and for the past two nights from the time of reporting  he had been waking up in a pool of sweat. Further reported that hopefully it would not continue. 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 night sweats was unknown at the time of this report.   The lot number for BNT162b2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died; This is a spontaneous report from a non-contactable consumer, this consumer report same events for 5 patients, this is the second of five report.   A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient died on an unspecified date.  It was not reported if an autopsy was performed. Reporter said they tried to say nurse didn't die, but she had an obituary so she clearly did die so that's just one, reporter had seen 4 self.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101524663 same reporter/product/event, different patient; Reported Cause(s) of Death: died
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died; This is a spontaneous report from a non-contactable consumer, this consumer report same events for 5 patients, this is the 3 of five report.   A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient died on an unspecified date.  It was not reported if an autopsy was performed. Reporter said they tried to say nurse didn't die, but she had an obituary so she clearly did die so that's just one, reporter had seen 4 self.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101524663 same reporter/product/event, different patient; Reported Cause(s) of Death: died
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died; This is a spontaneous report from a non-contactable consumer, this consumer report same events for 5 patients, this is the 4 of five report.   A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient died on an unspecified date.  It was not reported if an autopsy was performed. Reporter said they tried to say nurse didn't die, but she had an obituary so she clearly did die so that's just one, reporter had seen 4 self.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101524663 same reporter/product/event, different patient; Reported Cause(s) of Death: died
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died; This is a spontaneous report from a non-contactable consumer, this consumer report same events for 5 patients, this is the fifth of five reports.  A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient died on an unspecified date.  It was not reported if an autopsy was performed. Reporter said they tried to say nurse didn't die, but she had an obituary so she clearly did die so that's just one, reporter had seen 4 self.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101524663 same reporter/product/event, different patient; Reported Cause(s) of Death: died
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment, Product administered at inappropriate site, SARS-CoV-2 test, Swelling
Clinical narrative: I have memory problems. Have a hard time thinking and processing; Head feels swollen at times, no pain; Vaccine location: Left leg; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left leg on 25Apr2021 at 13:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. 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 vaccination. Concomitant medications included omeprazole (OMEPRAZOL) and unspecified birth control medication; both taken for unknown indications 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: ER8734) via an unspecified route of administration in the left arm on 04Apr2021 at 12:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient previously took amoxicillin; clavulanic acid (AUGMENTIN) for unknown indication and experienced drug allergy. On 26Apr2021 at 11:00, the patient had memory problems, had a hard time thinking and processing never had prior to shot and head felt swollen at times, no pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On an unknown date in 2021, the patient underwent SARS-COV-2 test (polymerase chain reaction (PCR)) by test type nasal swab and the result was negative. 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 she had memory problems, had a hard time thinking and processing and head felt swollen at times, no pain was not resolved at the time of this report.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site mass, Vaccination site warmth
Clinical narrative: Red lump at injection site; Warm to touch; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the left arm on 04Nov2021 at 07:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient had unspecified medical history. The patient also had unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medication within two weeks of vaccination. The patient received first dose of influenza vaccine (FLU VACCINE) via an unspecified route of administration in the right arm on 05Oct2021, within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration on 13Jan2021 (at the age of 45-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration on 03Feb2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. On 04Nov2021 at 08:00, the patient experienced red lump at injection site, which was approximately 2 inches in diameter. It was warm to touch, and lasted about 2 days. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of events red lump at injection site and warm to touch was resolved on 06Nov2021, after a duration of 2 days.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Myalgia, Pyrexia, Rash
Clinical narrative: Fever for 2 days; Rash all over body; Rash all over body with welts; Headache; Stomach pains; Muscle pain; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04Nov2021 at 18:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paracetamol (TYLENOL) 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. On 05Nov2021 at 10:00, the patient experienced fever for 2 days, rash all over body with welts, headache, stomach pains and muscle pain. 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever was resolved on 07Nov2021; while that of rash all over body with welts, headache, stomach pains, muscle pain was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Fever for 2 days; Rash all over body; Rash all over body with welts; Headache; Stomach pains; Muscle pain; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04Nov2021 at 18:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paracetamol (TYLENOL) 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. On 05Nov2021 at 10:00, the patient experienced fever for 2 days, rash all over body with welts, headache, stomach pains and muscle pain. 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever was resolved on 07Nov2021; while that of rash all over body with welts, headache, stomach pains, muscle pain was resolving 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: Dysmenorrhoea, Heavy menstrual bleeding, Menstruation irregular, Polymenorrhoea
Clinical narrative: Had 2 periods in October which is unusual; "My" cycle has been thrown off; Experiencing painful periods with heavy flow; Experiencing painful periods with heavy flow; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the left arm on an unknown date in Aug2021 at 17:15 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid, endometriosis and polycystic ovarian syndrome (PCOS). It was unknown whether the patient had any 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 vaccination. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) for an unknown 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: FA7484) via an unspecified route of administration in the left arm on an unknown date in Aug2021 at 17:15 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. On 05Sep2021 at 06:00, the patient's cycle has been thrown off and she experienced painful periods with heavy flow. On unknown dates in Oct2021, she also had 2 periods which was unusual. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any 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 events cycle has been thrown off, painful periods with heavy flow and had 2 periods which was unusual were not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Localised oedema, Myalgia
Clinical narrative: Edema under left armpit/ Edema is not lymph node, it is generalized and larger than a deck of cards but soft.; Muscles in left shoulder were painful; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2588) via an unspecified route of administration in the left arm on 04Nov2021 at 11:30 (at the age of 50-year-old), as a single dose for COVID-19 immunisation. Medical history included asthma, obesity, heart arrhythmia and COVID-19. The patient had no known allergies. 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 COVID vaccine. The patient received unspecified concomitant medications. On 07Nov2021 at 11:00, the patient experienced edema under left armpit (vaccine was administered in left shoulder), muscles in left shoulder were painful for 2 days but reduced. The patient reported that edema was not lymph node, it was generalized and larger than a deck of cards but soft. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown if 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 muscles in left shoulder were painful was recovering while of the event edema under left armpit (vaccine was administered in left shoulder), edema was not lymph node, it was generalized and larger than a deck of cards but soft was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Immunisation, Peripheral swelling
Clinical narrative: Arm bruising covering entire circumference of the upper arm from injection site to elbow / quarter size dark red bruises/circles in a straight line from elbow down to wrist; Swelling covering entire circumference of the upper arm from injection site to elbow; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old male patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FG3527) via an unspecified route of administration in the left arm on 04Nov2021 at 11:30 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included post cerebrovascular accident (CVA), aortic stenosis, baroreceptor failure and high blood pressure (HBP). 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 received unspecified concomitant medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the right arm on 10Feb2021 at 16:30 (at the age of 73-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 03Mar2021 at 12:30 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. On 05Nov2021 at 08:00, the patient experienced arm bruising and swelling covering entire circumference of the upper arm from injection site to elbow; quarter size dark red bruises/circles in a straight line from elbow down to wrist. 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 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 event arm bruising and swelling covering entire circumference of the upper arm from injection site to elbow and quarter size dark red bruises/circles in a straight line from elbow down to wrist was not resolved at the time of this report.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Immunisation, Myalgia, Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the right arm on 04Nov2021 (at the age of 31-year-old), as a single dose for COVID-19 immunisation. Medical history included asthma. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received triamcinolone acetonide(AZMACORT) and tetryzoline hydrochloride (VISINE); both for unspecified indication from unknown date and experienced drug allergy and also received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the right arm on 12Jan2021 (at the age of 30-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the right arm on 01Feb2021 (at the age of 30-year-old), both as single dose for COVID-19 immunisation. On 05Nov2021, the patient experienced nausea, muscle/joint aches, headache, soreness/redness around injection site and injection site had a red ring around it approximately 1 in diameter and still had sore/"firm" feeling days later. 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 not been tested for COVID-19. The clinical outcome of the event nausea, muscle/joint aches, headache, soreness/redness around injection site and injection site had a red ring around it approximately 1 in diameter and was still sore/"firm" feeling days later was resolving at the time of this report.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the right arm on 04Nov2021 (at the age of 31-year-old), as a single dose for COVID-19 immunisation. Medical history included asthma. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received triamcinolone acetonide(AZMACORT) and tetryzoline hydrochloride (VISINE); both for unspecified indication from unknown date and experienced drug allergy and also received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the right arm on 12Jan2021 (at the age of 30-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the right arm on 01Feb2021 (at the age of 30-year-old), both as single dose for COVID-19 immunisation. On 05Nov2021, the patient experienced nausea, muscle/joint aches, headache, soreness/redness around injection site and injection site had a red ring around it approximately 1 in diameter and still had sore/"firm" feeling days later. 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 not been tested for COVID-19. The clinical outcome of the event nausea, muscle/joint aches, headache, soreness/redness around injection site and injection site had a red ring around it approximately 1 in diameter and was still sore/"firm" feeling days later was resolving at the time of this report.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Immunisation, Nausea, Neck pain
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2689) via an unspecified route of administration in the left arm on 05Nov2021 at 13:30 (at the age of 59-year-old), as a single dose for COVID-19 immunisation. Medical history included diabetes and high blood pressure. 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 COVID vaccine. Concomitant medications included LISINOPRIL 20mg, MONTELUKAST 10mg, and JARDIANCE 25mg, all for an unknown indication on an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2589) via an unspecified route of administration in the left arm on an unknown date (reported at 13:30) and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date; both as single dose for COVID-19 immunisation. On 06Nov2021 at 06:00, the patient experienced fever, violent chills, headaches, night sweats, neck joint 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, violent chills, headaches, night sweats, neck joint pain, and nausea was resolving at the time of this report.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2689) via an unspecified route of administration in the left arm on 05Nov2021 at 13:30 (at the age of 59-year-old), as a single dose for COVID-19 immunisation. Medical history included diabetes and high blood pressure. 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 COVID vaccine. Concomitant medications included LISINOPRIL 20mg, MONTELUKAST 10mg, and JARDIANCE 25mg, all for an unknown indication on an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2589) via an unspecified route of administration in the left arm on an unknown date (reported at 13:30) and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date; both as single dose for COVID-19 immunisation. On 06Nov2021 at 06:00, the patient experienced fever, violent chills, headaches, night sweats, neck joint 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, violent chills, headaches, night sweats, neck joint pain, and nausea was resolving at the time of this report.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Lacrosse ball sized swollen injection site; Redness at injection site; Pain at injection site; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FG3527) via an unspecified route of administration in the left arm on 29Oct2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sulfa. 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 desogestrel, ethinylestradiol (KARIVA), lysine (MANUFACTURER UNKNOWN), colecalciferol (VITAMIN D3) and ascorbic acid (VITAMIN C), all 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: EH9899) via unspecified route of administration in the left arm on 29Dec2020 (at the age of 26-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in the left arm on 19Jan2021 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. On 30Oct2021, the patient experienced lacrosse ball sized swollen injection site, redness and pain at injection site. The events resulted in doctor or other healthcare professional office/clinic visit. 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 lacrosse ball sized swollen injection site, redness and pain at injection site were resolved on an unknown date in 2021.
Sex: M
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: got very sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   The reporter considered the sickness to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported for reporter's brother in-law. The age at vaccination was not reported. The patient received a dose of Shingles vaccine and got very sick from the vaccine. Follow-up would not be possible as no contact details provided.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Illness, Pain in extremity
Clinical narrative: Sick; fever; chilling; sore arm; This case was reported by a consumer and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of no adverse event (received 1st dose on an unknown date and had no problem).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness, fever, chills and pain in arm. On an unknown date, the outcome of the sickness, fever, chills and pain in arm were unknown.   It was unknown if the reporter considered the sickness, fever, chills and pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The case was self-reported by patient. The age at vaccination was unknown. The patient stated that, he/she had fever and chilling and a sore arm.  The patient also asked if anyone else got sick after getting the second shingles shot. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Three days later I had full blown case.; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (got shingles several times a year).   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 days after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The patient had reoccurring shingles, his/her doctor thought he/she should have the vaccine. The patient received shingles vaccine and 3 days later had full blown case of shingles. The patient stated that, shingles was not preventable, if you had the virus (chicken pox)you were more than likely to get shingles than not get shingles.  The patient also stated that, he/she got shingles several times a year and in between had gotten the shingles vaccine and it only brought them on again.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Shingle Shot hurts like hell; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was self-reported. The age at vaccination was unknown. The patient reported that the shingles shot hurt like hell. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: I had the shots and got them agaiin/Suspected vaccination failure; Got them agaiin; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingles vaccine and Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient had the Shingles shots and got shingles again. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose after 1 month (instead of 2); This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 8th November 2021, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The patient received the first dose of Shingrix on 6th October 2021 The pharmacist reported that the patient received the second dose of Shingrix after 1 month (instead of 2) from first dose which led to shortening of vaccination schedule. The Health Care Professional didn't had patients demographic information. The reporter Consented to follow up