chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation, Swelling
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30145BA) via an unspecified route of administration in the left arm on 24Nov2021 at 09:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN), simvastatin (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN); all for unspecified indications from unknown dates and unknown if ongoing. 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: ER873) via an unspecified route of administration in the left arm on 04Apr2021 at 13:45 (at the age of 52-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 29Apr2021 at 14:15 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. On 25Nov2021 at 06:00, the patient experienced swollen and pain in the left armpit, close to the left breast. 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 events swollen and pain in the left armpit, close to the left breast was not resolved at the time of the report.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Gait disturbance, Hepatic cirrhosis, Immunisation, Muscle spasms
Clinical narrative: Booster dose; spiral cirrhosis; muscle pain in her thighs and legs; Arthritis in her left hip; cramps in the right leg/ cramps in thighs, right hip; has a hard time walking/ can't barely walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 81 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), administration date: Jan2021, for COVID-19 immunization; Bnt162b2 (Dose: 2), administration date: Feb2021, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster dose"; HEPATIC CIRRHOSIS (medically significant), outcome "unknown", described as "spiral cirrhosis"; MYALGIA (non-serious), outcome "unknown", described as "muscle pain in her thighs and legs"; MUSCLE SPASMS (non-serious) with onset Oct2021, outcome "unknown", described as "cramps in the right leg/ cramps in thighs, right hip"; GAIT DISTURBANCE (non-serious) with onset Oct2021, outcome "unknown", described as "has a hard time walking/ can't barely walk"; ARTHRITIS (non-serious), outcome "unknown", described as "Arthritis in her left hip". The events "spiral cirrhosis", "muscle pain in her thighs and legs", "cramps in the right leg/ cramps in thighs, right hip", "has a hard time walking/ can't barely walk" and "arthritis in her left hip" were evaluated at the physician office visit. Therapeutic measures were taken as a result of hepatic cirrhosis, myalgia, muscle spasms, gait disturbance, arthritis, prescribed with Aspirin, Tylenol and Tramadol which works sometimes. Putting heat compress seems to help but it wasn't like this before she got her shot also stated that it just seems more persistent.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Booster dose; spiral cirrhosis; muscle pain in her thighs and legs; Arthritis in her left hip; cramps in the right leg/ cramps in thighs, right hip; has a hard time walking/ can't barely walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 81 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), administration date: Jan2021, for COVID-19 immunization; Bnt162b2 (Dose: 2), administration date: Feb2021, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster dose"; HEPATIC CIRRHOSIS (medically significant), outcome "unknown", described as "spiral cirrhosis"; MYALGIA (non-serious), outcome "unknown", described as "muscle pain in her thighs and legs"; MUSCLE SPASMS (non-serious) with onset Oct2021, outcome "unknown", described as "cramps in the right leg/ cramps in thighs, right hip"; GAIT DISTURBANCE (non-serious) with onset Oct2021, outcome "unknown", described as "has a hard time walking/ can't barely walk"; ARTHRITIS (non-serious), outcome "unknown", described as "Arthritis in her left hip". The events "spiral cirrhosis", "muscle pain in her thighs and legs", "cramps in the right leg/ cramps in thighs, right hip", "has a hard time walking/ can't barely walk" and "arthritis in her left hip" were evaluated at the physician office visit. Therapeutic measures were taken as a result of hepatic cirrhosis, myalgia, muscle spasms, gait disturbance, arthritis, prescribed with Aspirin, Tylenol and Tramadol which works sometimes. Putting heat compress seems to help but it wasn't like this before she got her shot also stated that it just seems more persistent.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: Headache; sore arm; muscle aches; fatigue; chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2) (Lot number: FG3527, Expiration Date: 28Feb2022) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headache"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; MYALGIA (non-serious), outcome "unknown", described as "muscle aches"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; CHILLS (non-serious), outcome "unknown", described as "chills".
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal discomfort
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 79-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 (at the age of 79-years-old), as a single dose for COVID-19 immunisation. Medical history included arthritis and thyroid. 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 unspecified medications for thyroid and arthritis; unspecified vitamins for unspecified indication; all 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 in the left arm on an unknown date as a single dose for COVID-19 immunisation. On an unknown date in 2021, after shot, the patient experienced discomfort on left shoulder and up neck, little later pain continued up left side of head causing bad pain, which patient had at the time of this report. 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 events discomfort on left shoulder, up neck and little later pain continued up left side of head causing bad pain was not resolved 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: Haemorrhage, Vascular pain
Clinical narrative: After the injection, there was a lot of blood oozing and it was cleaned and covered with a bandage.; Ever since I had the shot, I feel pains in my vain from my shoulder connecting to my right ear because I had it on my right shoulder.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient. Other Case identifier(s): -PFIZER INC-202101689554 (Pfizer).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm right, administration date 16Nov2021 13:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HAEMORRHAGE (medically significant) with onset Nov2021, outcome "unknown", described as "After the injection, there was a lot of blood oozing and it was cleaned and covered with a bandage."; VASCULAR PAIN (non-serious) with onset Nov2021, outcome "unknown", described as "Ever since I had the shot, I feel pains in my vain from my shoulder connecting to my right ear because I had it on my right shoulder.".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Feeling abnormal, Head discomfort, Palpitations, Vertigo
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8839) via an unspecified route of administration in the left arm on 11Oct2021 at 17:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient did not have 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 medication within two weeks of vaccination. On 20Oct2021 at 13:15, the patient experienced racing heart, vertigo-type symptoms, brain fog, floating sensation in limbs, pressure in temples and onset anxiety. The events resulted 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 events racing heart, vertigo-type symptoms, brain fog, floating sensation in limbs, pressure in temples and onset anxiety were not resolved at the time of this report.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Interchange of vaccine products, Off label use, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the second (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8028) via an unspecified route of administration in the left arm on 27Nov2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of JNJ-78436735 ( COVID-19 VACCINE; Lot number: 202A21A) via an unspecified route of administration in the left arm on 04May2021 as a single dose for COVID-19 immunisation. On 27Nov2021 at 17:00, the patient had experienced injection site soreness so far and wasn't any pain for the first couple of hours or so and then got worse. It was reported that it was still sore more than 24 hours later. 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 injection site soreness was not resolved at the time of this report.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Stabbing pain, upper left side of chest; This is a spontaneous report from a contactable consumer, the patient. A 15-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 an unknown date in Sep2021 at 12:00 (at the age of 15-years-old) as a single dose for COVID-19 immunisation. The medical history included asthma, chronic obstructive pulmonary disease (COPD), attention deficit hyperactivity disorder (ADHD) and COVID-19 infection. The patient had no known allergies. Prior to 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 fluticasone furoate/ umeclidinium bromide/vilanterol trifenatate (TRELEGY), dexamfetamine sulfate/amfetamine sulfate/ dexamfetamine saccharate/amfetamine aspartate monohydrate (MYDAYIS), salbutamol sulfate (PROAIR), paracetamol (TYLENOL) and guanfacine (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. On an unknown date in Sep2021 at 17:00, the patient experienced stabbing pain in the upper left side of chest for two weeks before improving gradually over next two weeks. The adverse event resulted 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 'stabbing pain, upper left side of chest' was resolved on an unknown date in 2021.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Immunisation, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Nov2021 at 13:30 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included mitro-valve prolapse, blood pressure, sulfa allergy and unspecified allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications received within two weeks of vaccination included vitamins (unspecified) for unknown indication, unspecified blood pressure medications and allergy pills; all from 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 in the left arm on 31Mar2021 at 15:00 (at the age of 53-year-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Apr2021 at 15:00 (at the age of 53-year-old); both as single dose for COVID-19 immunisation. The patient experienced arm swollen and painful within minutes on 24Nov2021 at 13:45. The patient experienced fever, chills, inability of body to regulate temperature through 26Nov2021 (reported as Friday) evening. On 27Nov2021, (reported as Saturday), injection site and surrounding area was swollen, red and extremely itchy. 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, chills, inability of body to regulate temperature was resolved on 26Nov2021, while that of the events arm swollen and painful within minutes, injection site and surrounding area was swollen, red and extremely itchy 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Temperature regulation disorder, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Nov2021 at 13:30 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included mitro-valve prolapse, blood pressure, sulfa allergy and unspecified allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications received within two weeks of vaccination included vitamins (unspecified) for unknown indication, unspecified blood pressure medications and allergy pills; all from 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 in the left arm on 31Mar2021 at 15:00 (at the age of 53-year-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Apr2021 at 15:00 (at the age of 53-year-old); both as single dose for COVID-19 immunisation. The patient experienced arm swollen and painful within minutes on 24Nov2021 at 13:45. The patient experienced fever, chills, inability of body to regulate temperature through 26Nov2021 (reported as Friday) evening. On 27Nov2021, (reported as Saturday), injection site and surrounding area was swollen, red and extremely itchy. 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, chills, inability of body to regulate temperature was resolved on 26Nov2021, while that of the events arm swollen and painful within minutes, injection site and surrounding area was swollen, red and extremely itchy 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: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation, Pain in extremity, Swelling
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional, the patient. A 46-year-old non-pregnant female patient received the third dose (booster) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8028) via intramuscular route of administration in the left arm on 24Nov2021 at 12:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EH9899) via intramuscular route of administration in the left arm on 05Jan2021 at 12:00 (at the age of 45-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via intramuscular route of administration in the left arm on 26Jan2021 at 12:00 (at the age of 45-years-old); both as a single dose for COVID-19 immunisation. On 24Nov2021 at 12:15, the patient experienced left arm pit pain and swelling. The patient could not raise arm without pain and could not sleep on it. 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 left arm pit pain and swelling and can't raise arm without pain. can't sleep on it was not resolved at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Chills, Feeling abnormal, Headache
Clinical narrative: bad headache (felt like nerve pain); bad headache (felt like nerve pain); achy body; body felt heavy; stomach ache; mild fever; chills/shivering all night; feels weak; sleepiness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.An adult (non-pregnant) female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as dose 2, single dose for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as dose 1, single dose for COVID-19 immunization and experienced body felt heavy. On an unspecified date in Jun2021, the patient experienced bad headache (felt like nerve pain), achy body, body felt heavy, stomach ache, mild fever, chills/shivering all night, feels weak, sleepiness. It was unknown if therapeutic measures were taken as a result of the events. Outcome of the events was recovered on an unspecified date.The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Pain, Pyrexia, Somnolence
Clinical narrative: bad headache (felt like nerve pain); bad headache (felt like nerve pain); achy body; body felt heavy; stomach ache; mild fever; chills/shivering all night; feels weak; sleepiness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.An adult (non-pregnant) female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as dose 2, single dose for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as dose 1, single dose for COVID-19 immunization and experienced body felt heavy. On an unspecified date in Jun2021, the patient experienced bad headache (felt like nerve pain), achy body, body felt heavy, stomach ache, mild fever, chills/shivering all night, feels weak, sleepiness. It was unknown if therapeutic measures were taken as a result of the events. Outcome of the events was recovered on an unspecified date.The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: the rashes in some parts of the body and somewhat like whole parts of the body; then there was a little hives; itchy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. Other Case identifier(s): -PFIZER INC-202101689586 (Pfizer).  A 10 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Nov2021 (Lot number: FK5127) at the age of 10 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "allergy: allergy with the egg" (unspecified if ongoing), notes: allergy: allergy with the egg. The patient took concomitant medications. The following information was reported: RASH (medically significant) with onset 27Nov2021, outcome "recovering", described as "the rashes in some parts of the body and somewhat like whole parts of the body"; URTICARIA (medically significant) with onset 27Nov2021, outcome "recovered" (2021), described as "then there was a little hives"; PRURITUS (medically significant) with onset 27Nov2021, outcome "recovered" (2021), described as "itchy". Therapeutic measures were taken as a result of rash, urticaria, pruritus.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: On 16Nov2021 I tested PCR Positive and had symptoms of covid; On 16Nov2021 I tested PCR Positive and had symptoms of covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 25Mar2021 09:00 (Lot number: EL3247) at the age of 48 years as dose 2, single and intramuscular, administered in arm left, administration date 04Mar2021 09:00 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. Relevant medical history included: "post exposure to my unvaccinated 11year old daughter" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Nov2021, outcome "recovered" (Nov2021) and all described as "On 16Nov2021 I tested PCR Positive and had symptoms of covid". The event "on 16Nov2021 I tested PCR positive and had symptoms of covid" and "on 16Nov2021 I tested PCR positive and had symptoms of covid" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Nov2021) positive, notes: Nasal Swab.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: extreme body aches; fatigue; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Feb2021 12:00 (Lot number: EN6201) at the age of 44 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hepatitis B" (unspecified if ongoing); "depression" (unspecified if ongoing); "insomnia" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number=EN6201, Administration time=12:00 PM, Administrator route=Intramuscular, Vaccine location=Left arm), administration date: 05Feb2021, when the patient was 44 years old, for COVID-19 immunisation. The following information was reported: PAIN (non-serious) with onset 27Feb2021 12:00, outcome "recovering", described as "extreme body aches"; FATIGUE (non-serious) with onset 27Feb2021 12:00, outcome "recovering", described as "fatigue". Therapeutic measures were not taken as a result of pain, fatigue.Additional information: The patient did not receive other vaccine product on the vaccination day. The facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed as COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Vomiting
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A female patient received bnt162b2 (BNT162B2), administration date 22Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 24Feb2021, outcome "recovered" (24Feb2021), described as "chills"; VOMITING (non-serious) with onset 24Feb2021, outcome "recovered" (24Feb2021), described as "vomiting"; ASTHENIA (non-serious) with onset 24Feb2021, outcome "recovered" (24Feb2021), described as "felt weak". Additional information: The patient's age was reported as 93, unit: unknown. Patient had no fever and symptoms resolved later that day. Patient was querying what side effects should she expect for the second dose. 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: Gait inability
Clinical narrative: This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 24Feb2021 (Lot number: EN6198, Expiration Date: Jun2021) at the age of 61 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "heart medicine" (unspecified if ongoing). Concomitant medications included: PLAVIX taken for cardiac disorder; METOPROLOL. The following information was reported: GAIT INABILITY (non-serious) with onset 24Feb2021, outcome "recovered", described as "I cannot even walk, everything was stunning and I had to go straight to bed". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Medical Information Team (159558). The reporter is the patient. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in left arm, administration date 01Mar2021 (Lot number: EN6205) at the age of 43 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "cancer" (unspecified if ongoing); "non hodgkins lymphomas" (unspecified if ongoing); "Had some surgeries" (unspecified if ongoing); "Chemo" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Flu shot, reaction(s): "diarrhea", "headaches", "nausea", "arm swells up"; Anthrax. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 01Mar2021, outcome "recovering", described as "a bit of pain in her arm/her arm got sore at injection site". Additional information: The patient reported she stayed for 45 minutes after the vaccination due to her medical history and felt fine when she walked. Patient added she has had no fever, has not been tired, none of the usual side effects that she would normally feel with a shot. No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Headache, Nausea, Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient. A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in left arm, administration date 24Feb2021 at 14:00 (Lot number: EN6203) at the age of 68 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Enlarged prostate" (unspecified if ongoing); "sleep" (unspecified if ongoing). Concomitant medications included: FLOMAX [MORNIFLUMATE] taken for prostatomegaly, start date: Nov2017 (ongoing); MELATONIN [CALCIUM;MELATONIN;PYRIDOXINE HYDROCHLORIDE] taken for sleep disorder, start date: 2018 (ongoing). The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 24Feb2021, outcome "recovered" (26Feb2021), described as "pain in the arm from the shot"; HEADACHE (non-serious) with onset 25Feb2021, outcome "not recovered", described as "headache"; DIZZINESS (non-serious) with onset 03Mar2021, outcome "recovering", described as "felt lightheaded"; NAUSEA (non-serious) with onset 03Mar2021, outcome "recovered" (03Mar2021), described as "nausea"; FEELING ABNORMAL (non-serious) with onset 03Mar2021, outcome "recovering", described as "feels a little bit off". No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 26Feb2021 10:00 (Lot number: EL9267) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "thyroid radiated" (unspecified if ongoing); "Hyperthyroidism" (ongoing); "Blood pressure", start date: 2020 (ongoing); "coffee makes her jittery" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hyperthyroidism (ongoing); LISINOPRIL taken for blood pressure measurement, start date: 2020 (ongoing); AMLODIPINE taken for blood pressure measurement, start date: 2020 (ongoing); ASPIRIN [ACETYLSALICYLIC ACID], start date: Oct2020 (ongoing). The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "tiredness"; SOMNOLENCE (non-serious) with onset Feb2021, outcome "not recovered", described as "dozing off before falling asleep". Additional Information: The patient experienced the adverse event tiredness 3-5 days after receiving the vaccine. The patient stated that she did not drink coffee anymore due to her "having to take a thyroid pill and blood pressure medicine. The events did not result to emergency room or physician's office visit. The patient did not undergo any relevant tests. The patient did not receive prior vaccinations (within 4 weeks). The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date of the Pfizer suspect. No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Vaccination site pain, Vaccination site swelling, Weight
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 75 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Mar2021 15:00 (Lot number: EN6203) at the age of 75 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Thyroid", start date: 2019 (unspecified if ongoing), notes: about 2 years ago. Concomitant medication(s) included: LEVOTHYROXINE SODIUM taken for thyroid disorder, start date: 2019. Vaccination history included: Bnt162b2 (Lot Number /Expiry Date: EN5318 / not provided, Route: injection, Anatomical Location: left arm, Dose no. : 1), administration date: 08Feb2021, when the patient was 74 years old, for COVID-19 Immunization; Flu vaccine (before 4 weeks prior to this vaccine), for immunisation.The following information was reported: HEADACHE (non-serious) with onset 01Mar2021, outcome "recovering", described as "headache"; VACCINATION SITE PAIN (non-serious) with onset 01Mar2021, outcome "not recovered", described as "Soreness at injection site"; FATIGUE (non-serious) with onset 01Mar2021, outcome "recovering", described as "Tiredness"; VACCINATION SITE SWELLING (non-serious) with onset 01Mar2021, outcome "not recovered", described as "Swelling at the injection site". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: The patient did not receive additional vaccines on same date of the vaccine. The patient had no relevant family medical history. The events did not result to emergency or physician's office visit. No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Sedation
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 75 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Mar2021 15:00 (Lot number: EN6203) at the age of 75 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Thyroid", start date: 2019 (unspecified if ongoing), notes: about 2 years ago. Concomitant medication(s) included: LEVOTHYROXINE SODIUM taken for thyroid disorder, start date: 2019. Vaccination history included: Bnt162b2 (Lot Number /Expiry Date: EN5318 / not provided, Route: injection, Anatomical Location: left arm, Dose no. : 1), administration date: 08Feb2021, when the patient was 74 years old, for COVID-19 Immunization; Flu vaccine (before 4 weeks prior to this vaccine), for immunisation.The following information was reported: HEADACHE (non-serious) with onset 01Mar2021, outcome "recovering", described as "headache"; VACCINATION SITE PAIN (non-serious) with onset 01Mar2021, outcome "not recovered", described as "Soreness at injection site"; FATIGUE (non-serious) with onset 01Mar2021, outcome "recovering", described as "Tiredness"; VACCINATION SITE SWELLING (non-serious) with onset 01Mar2021, outcome "not recovered", described as "Swelling at the injection site". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: The patient did not receive additional vaccines on same date of the vaccine. The patient had no relevant family medical history. The events did not result to emergency or physician's office visit. No follow-up attempts are possible. No further information is expected.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Needle issue, Pain in extremity, Underdose, Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Medical Information Team (159558). The reporter is the patient. A 94 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 23Feb2021 (Batch/Lot number: unknown) at the age of 94 years, as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (DOSE 1, SINGLE (MANUFACTURER UNKNOWN)), for COVID-19 immunisation.The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 23Feb2021, outcome "unknown", described as "the "needle hurt but it was not terrible""; FEELING COLD (non-serious) with onset 2021, outcome "unknown", described as "chilly but did not have chills"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "arm was sore"; NEEDLE ISSUE (non-serious) with onset 23Feb2021, described as "vaccine provider mentioned that "the needle was broken""; UNDERDOSE (non-serious) with onset 23Feb2021, described as "the patient was not sure if she got all of the dose or not".No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Nausea, Pain in extremity
Clinical narrative: This is a spontaneous report received from contactable consumer from medical information team. The reporter is the patient. A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 02Mar2021 08:20 (Lot number: EV6203, EN6203) at the age of 61 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "diabetes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing). The patient took concomitant medications for diabetes, high blood pressure, and cholesterol. Vaccination history included: BNT162B2 (first dose, Lot Number: EZ9265), administration date: 09Feb2021, when the patient was 61 years old, for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 02Mar2021, outcome "recovering", described as "arm was hurting"; FATIGUE (non-serious) with onset 03Mar2021, outcome "not recovered", described as "he felt really tired"; ASTHENIA (non-serious) with onset 03Mar2021, outcome "not recovered", described as "weakness"; NAUSEA (non-serious) with onset 03Mar2021 11:00, outcome "not recovered", described as "has been really nauseous". Additional information: He wanted to know how long these side effects would last. Nothing was really bad. He read in the papers that this was normal. The patient asked how long does the events last. Two lot numbers were reported for the second dose of BNT162B2. The events did not require a visit to the emergency room nor the physician office.No follow-up attempts are possible. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 81 year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left, administration date 27Jan2021 11:00 (Lot number: EL9261) at the age of 81 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heart stents" (ongoing); "Diabetes type 2" (ongoing); "Acid reflux (esophageal)" (ongoing); "Blood pressure" (unspecified if ongoing); "Supplementation therapy" (ongoing); "Heart medication" (ongoing); "Thyroid" (ongoing); "Blood thinner" (unspecified if ongoing); "sensitive skin" (unspecified if ongoing), notes: not been responsive to over the counter moisturizer creams; "Diet controlled" (unspecified if ongoing). Concomitant medication(s) included: DEXILANT taken for gastrooesophageal reflux disease (ongoing); RANEXA taken for cardiac disorder (ongoing); BENICAR taken for cardiac disorder (ongoing); SYNTHROID taken for thyroid disorder (ongoing); PLAVIX taken for blood disorder; TOPROL XL taken for blood pressure abnormal; BAYER ASPIRIN taken for cardiac disorder (ongoing); COQ-10 taken for cardiac disorder (ongoing); VITAMIN D3 taken for supplementation therapy (ongoing). The following information was reported: FATIGUE (non-serious) with onset Jan2021, outcome "unknown", described as "Just a little tired from it". Additional Information: The events did not result to emergency room or physician's office visit. The patient did not receive prior vaccinations (within 4 weeks). The patient took thyroid medications, and blood thinners and blood pressure medications. She said that took something to up her thyroid, but also took something to down it. She did not know which one it is. The patient did not undergo relevant tests. The patient also took the second dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE) administered in right arm on 17Feb2021 at 10:30 and experienced she lost her sense of taste and it lasted about 1 days, stated that she tried something spicy and it just tasted like cardboard, she got a rash on her legs between her knees and her ankles on both legs, it was a itchy and bumpy rash and stated that it is subsiding but it was still there. No follow-up attempts are possible. No further information is expected.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Vaccination site discolouration, Vaccination site pruritus
Clinical narrative: This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient. A 90 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 24Feb2021 (Lot number: EL9266) at the age of 90 years, as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Multiple allergies", start date: 1961 (unspecified if ongoing); "Neuropathy" (unspecified if ongoing). The patient took concomitant medication. Vaccination history included: BNT162B2 (DOSE 1, SINGLE (Lot No: EN9581) intramuscularly, administered in left arm), administration date: 03Feb2021, when the patient was 90 years old, for COVID-19 immunisation. The following information was reported: VACCINATION SITE DISCOLOURATION (non-serious) with onset 25Feb2021, outcome "not recovered", described as "there was an area, approximately 1" in circumference, around the vaccine injection site that was pink"; VACCINATION SITE PRURITUS (non-serious) with onset 25Feb2021, outcome "not recovered", described as "Injection site itching". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site discolouration, vaccination site pruritus.Additional information: The patient reported that she received two unspecified allergy shots in her left arm since the first BNT162B2 vaccine dose, and gets allergy shots every other week (has been getting these allergy shots for a long time). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient also clarified that itching at the injection site was not extreme.