chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Presyncope, Vision blurred
Clinical narrative: Presyncope Vasovagel symptoms; Lightheadedness; Blurred vision; Sweating; This is a spontaneous report from a contactable consumer, the parent. A 16-years-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 05May2021 at 16:45 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had known allergies to Zithromax. Concomitant medications were not reported. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 14Apr2021 at 16:45 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other medications or vaccines within four weeks prior to the vaccination. On 06May2021 at 08:00, the patient experienced presyncope vasovagal symptoms with dizziness, lightheadedness, blurred vision and sweating. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of reported events. The clinical outcome of the events presyncope vasovagal symptoms with dizziness, lightheadedness, blurred vision and sweating were recovered on 06May2021.   No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Hot flush
Clinical narrative: extreme fatigue; brain fog; Occasional mild chills; hot flashes; This is a spontaneous report from a contactable consumer, the patient. A 37-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 arm left on 23Apr2021 at 09:00(at the age of 37-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. Concomitant medications included liothyronine (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN) started on an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 26Mar2021 at 09:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Apr2021 at 21:00 the patient experienced extreme fatigue, brain fog, occasional mild chills and hot flashes. The events resulted in doctor or other healthcare professional office/clinic visits, and the emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the event extreme fatigue, brain fog, occasional mild chills and hot flashes were not recovered at the time of the report.   No follow-up attempts are needed; information about the lot number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Hard swollen lymph node at the base of the left side of neck. Swollen to the size of a walnut.; painful  lymph node at the base of the left side of neck.; This is a spontaneous report from a non-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: EW0171) via an unspecified route of administration in the left arm on an unknown date in Apr2021 at 8:30, (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not have allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021 at 12:00, the patient experienced hard, painful swollen lymph node at the base of the left side of neck. It was swollen to the size of a walnut. No therapeutic measures were taken as a result of the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event swollen lymph node and pain lymph nodes was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: Six days after the shot my lymph nodes under my armpit swelled up so big; Muscle pain; Fever; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the arm left on 27Apr2021 at 15:15(at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history included covid-19. The patient did not have any allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 29Apr2021 at 07:00 the patient experienced mini fever and fatigue. The next day she thought she was fine so she went to work. On 30Apr2021 she started getting really bad muscle aches. The next few days she had fevers of about 100.8deg. On 03May2021, Six days after the shot her lymph nodes under her armpit swelled up so big that she could see them as red bumps and she can barely raise her arms above her head. She was in so much pain and it feels like her kidneys hurt. On an unknown date the patient checked her body temperature for few days after vaccination and it was 100.8deg.The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of fever and included treatment with Tylenol, it was unknown whether she took treatment for other events. The clinical outcome of the event Fever, Fatigue Muscle pain and lymphadenopathy were not resolved at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swollen tongue, Urticaria
Clinical narrative: I broke out in hives.; My tongue swole up; I became extremely itchy all over the place; This is a spontaneous report from a non-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: UNKNOWN), via an unspecified route of administration in the right arm on 09Apr2021(at the age of 30-years-old) as a single dose for COVID-19immunisation. The patient's medical history included COVID-19. The patient had no known allergies to medicines, food or other products. The patient did not receive any medication within two weeks of the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 09Apr2021, with in five minutes, the patient reported that she broke out in hives, her tongue swelled up and she became extremely itchy all over the place. The events resulted in a doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events broke out in hives, tongue swelled up and extremely itchy all over which included treatment with BENADRYL. The clinical outcome of the event broke out in hives, swollen tongue and extremely itchy all over the place 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.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Nausea, Pain
Clinical narrative: chills; body aches; headache; queasiness; lightheaded; This is a spontaneous report from a non-contactable consumer, the patient. A 68-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on an unknown date in Apr2021 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, blood pressure high. The patient was allergic to shellfish (mild).  Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and semaglutide (OZEMPIC) taken from unknown date for unspecified indication. 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 an unknown date in Mar2021 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021 a day after receiving the vaccine, the patient experienced chills, body aches, headache, queasiness and lightheaded. The patient reported that, it lasted for full 8 days and felt normal on day 9 post vaccination. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the events chills, body aches, headache, queasiness and lightheaded were resolved on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Swelling face
Clinical narrative: Left side of face is swollen (slight) as compared to the right side; Feels numb as if coming out of novacaine, and feeling is not as sharp as right side.; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep7533), via an unspecified route of administration in the left arm on 05May2021 at 09:30 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had known allergies which included crustaceans. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05May2021, the patient experienced left side of face is swollen (slight) as compared to the right side where the patient can see the cheek bone. Feels numb as if coming out of novacaine, and feeling was not as sharp as right side. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events left side of face is swollen (slight) as compared to the right side where the patient can see the cheek bone and feels numb as if coming out of novacaine, and feeling is not as sharp as right side were not resolved at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia
Clinical narrative: Minor nerve pain with first shot and second shot intense nerve pain throughout my body, still some nerve pain in hands on and off.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the right arm on 23Mar2021 at 11:30 as a single dose and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the right arm on 13Apr2021 at 15:30 as a single dose for COVID-19 immunisation.  Medical history was not reported. Concomitant medications included cetirizine hydrochloride (manufacturer: ZYRTEC)  and vitamin d (MANUFACTURER UNKNOWN).The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 the patient experienced minor nerve pain with first shot and after second shot intense nerve pain throughout the body, still some nerve pain in hands on and off. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcomes of the event nerve pain was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Body temperature normal, Dizziness, Heart rate
Clinical narrative: dizziness; Elevated blood pressure at 148/93 mmHg; Heart rate normal; Temperature normal; This is a spontaneous report from a contactable pharmacist. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via intramuscular route of administration in the left arm on 03Mar2021 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient did not receive any medication within two weeks of vaccination. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Mar2021, the patient experienced dizziness. Elevated blood pressure at 148/93 mmHg. Heart rate and temp were within normal limits. 5 minutes after vaccine administration, patient reported feeling better. She denied numbness, tingling, pain, and headache. Blood pressure was 148/84 mmHg. The patient did not receive any treatment for the events. The clinical outcome of the events dizziness, blood pressure high, heart rate normal, body temperature normal was recovered on 03Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate normal, Hypertension
Clinical narrative: dizziness; Elevated blood pressure at 148/93 mmHg; Heart rate normal; Temperature normal; This is a spontaneous report from a contactable pharmacist. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via intramuscular route of administration in the left arm on 03Mar2021 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient did not receive any medication within two weeks of vaccination. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Mar2021, the patient experienced dizziness. Elevated blood pressure at 148/93 mmHg. Heart rate and temp were within normal limits. 5 minutes after vaccine administration, patient reported feeling better. She denied numbness, tingling, pain, and headache. Blood pressure was 148/84 mmHg. The patient did not receive any treatment for the events. The clinical outcome of the events dizziness, blood pressure high, heart rate normal, body temperature normal was recovered on 03Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Chills, Fatigue, Lethargy
Clinical narrative: Fever; Chills; Lethargy; Tired; Weak; (L) armpit pain and swollen lymph node in (L) armpit; (L) armpit pain and swollen lymph node in (L) armpit; Was in bed Saturday night and all day Sunday; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 01May2021 at 11:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and allergies. Concomitant medications included salbutamol (ALBUTEROL), taken from an unknown date. The patient previously took benzoyl peroxide (CLEARASIL) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 10Apr2021 at 11:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021 at 18:45, about 7 hours after the second dose, the patient experienced fever and chills, lethargy, tired/weak, armpit pain and swollen lymph node in the left side. For about 32 hours, the patient was in bed on Saturday night and all day on Sunday, ate homemade chicken soup and drank one fizzy drink. The patient took albuterol for her asthma. It was bearable and she thought that it was just her immune system responding to the shot, her blood type. The mild symptoms of the side effects did not last very long about a day and a half. 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 events and the treatment included cough and throat relief, mucus which contained vitamin C, dark honey, ivy leaf and elderberry extract, zinc etc. The clinical outcome of the events fever and chills, lethargy, tired/weak, armpit pain and swollen lymph node in the left side and was in bed all night and day were resolved on an unknown date in May2021.    No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: Fever; Chills; Lethargy; Tired; Weak; (L) armpit pain and swollen lymph node in (L) armpit; (L) armpit pain and swollen lymph node in (L) armpit; Was in bed Saturday night and all day Sunday; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 01May2021 at 11:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and allergies. Concomitant medications included salbutamol (ALBUTEROL), taken from an unknown date. The patient previously took benzoyl peroxide (CLEARASIL) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 10Apr2021 at 11:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021 at 18:45, about 7 hours after the second dose, the patient experienced fever and chills, lethargy, tired/weak, armpit pain and swollen lymph node in the left side. For about 32 hours, the patient was in bed on Saturday night and all day on Sunday, ate homemade chicken soup and drank one fizzy drink. The patient took albuterol for her asthma. It was bearable and she thought that it was just her immune system responding to the shot, her blood type. The mild symptoms of the side effects did not last very long about a day and a half. 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 events and the treatment included cough and throat relief, mucus which contained vitamin C, dark honey, ivy leaf and elderberry extract, zinc etc. The clinical outcome of the events fever and chills, lethargy, tired/weak, armpit pain and swollen lymph node in the left side and was in bed all night and day were resolved on an unknown date in May2021.    No follow-up attempts are needed. No further information is expected.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Chills, Electrocardiogram, Headache
Clinical narrative: he had a racing heart; blood pressure was slightly low but still within normal range; on the verge of vomiting; fever; chills; nausea; headache; has felt sick; This is a This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reported for a 18-year-old male patient that: A 18-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0176), via an unspecified route of administration in left arm on 06May2021 at 15:00 (at the age of 18-year-old) as dose 2, single for COVID-19 immunisation at medical facility. Medical history included COVID-19 in late Feb2021-early Mar2021 and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0176), via an unspecified route of administration on 15Apr2021 at 12:20 (at the age of 18-year-old) as dose 1, single for COVID-19 immunisation. The patient had drug allergy to amoxicillin and developed hives. It was reported that the patient had both doses of the vaccine. He had the second dose on 06May2021. The patient has felt sick with nausea and headache started on the 07May2021. He had his most severe symptoms on 07May2021. He also had fever and chills. These symptoms continued through the weekend, 08May2021-09May2021. On 09May2021, her son started having a racing heart. Her son went to the urgent care on Monday, 10May2021 and had an EKG (electrocardiogram) and a blood pressure check. His blood pressure was slightly low but still within normal range. He may have had blood work or labs done but she and her son had to leave the urgent care because the urgent care was backed up and running behind. Her son was waking up today with nausea and headache. He cannot keep missing school. He no longer has the fever, chills, or racing heart. She reports his fever was just a low-grade fever, she just felt his forehead, she guesses his temperature was only elevated by a degree. He has not vomited but was on the verge of vomiting. She reports her son did have the COVID 19 virus in late Feb2021-early Mar2021. She reports her son had an allergic reaction to Amoxicillin when he was a baby and he developed hives. The caller asked if having COVID prior to getting the vaccine would affect the side effects you have after the vaccine. The patient underwent lab tests and procedures which included blood pressure: unknown result on 10May2021, EKG (electrocardiogram): unknown result on 10May2021. The outcome of he had a racing heart, fever, chills was reported as resolved on an unknown in 2021; nausea, headache, on the verge of vomiting was not resolved and blood pressure was slightly low but still within normal range, has felt sick was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Nausea, Palpitations, Pyrexia, Vomiting
Clinical narrative: he had a racing heart; blood pressure was slightly low but still within normal range; on the verge of vomiting; fever; chills; nausea; headache; has felt sick; This is a This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reported for a 18-year-old male patient that: A 18-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0176), via an unspecified route of administration in left arm on 06May2021 at 15:00 (at the age of 18-year-old) as dose 2, single for COVID-19 immunisation at medical facility. Medical history included COVID-19 in late Feb2021-early Mar2021 and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0176), via an unspecified route of administration on 15Apr2021 at 12:20 (at the age of 18-year-old) as dose 1, single for COVID-19 immunisation. The patient had drug allergy to amoxicillin and developed hives. It was reported that the patient had both doses of the vaccine. He had the second dose on 06May2021. The patient has felt sick with nausea and headache started on the 07May2021. He had his most severe symptoms on 07May2021. He also had fever and chills. These symptoms continued through the weekend, 08May2021-09May2021. On 09May2021, her son started having a racing heart. Her son went to the urgent care on Monday, 10May2021 and had an EKG (electrocardiogram) and a blood pressure check. His blood pressure was slightly low but still within normal range. He may have had blood work or labs done but she and her son had to leave the urgent care because the urgent care was backed up and running behind. Her son was waking up today with nausea and headache. He cannot keep missing school. He no longer has the fever, chills, or racing heart. She reports his fever was just a low-grade fever, she just felt his forehead, she guesses his temperature was only elevated by a degree. He has not vomited but was on the verge of vomiting. She reports her son did have the COVID 19 virus in late Feb2021-early Mar2021. She reports her son had an allergic reaction to Amoxicillin when he was a baby and he developed hives. The caller asked if having COVID prior to getting the vaccine would affect the side effects you have after the vaccine. The patient underwent lab tests and procedures which included blood pressure: unknown result on 10May2021, EKG (electrocardiogram): unknown result on 10May2021. The outcome of he had a racing heart, fever, chills was reported as resolved on an unknown in 2021; nausea, headache, on the verge of vomiting was not resolved and blood pressure was slightly low but still within normal range, has felt sick was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Glossodynia, Swollen tongue
Clinical narrative: My tongue feels like swelling and sore; I am wondering it looks different; My tongue feels like swelling and sore; I am wondering it looks different; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient).  A patient of unspecified age and gender received first dose of BNT162B2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. No medical history and no concomitant medications were not reported. It was reported that consumer stated just had my Pfizer (first) shot on Friday and experiencing some symptoms. Consumed waned to ask Are they enough normal. Stated tongue feels like swelling and sore, kind of it looks different. Patient wondering if it was normal, or she was supposed to go and visit Doctor. The outcome for the events was reported as unknown at the time of this report.   Information on the lot/batch number has been requested.  Follow-up (27Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: Neck started hurting on one side; This is a spontaneous report from a contactable consumer or other non hcp.   A 12-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: Not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 14May2021 12:00 (at the age of 12-Years-old) as single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered reported as Pharmacy. Vaccine was not administered at a hospital facility. No additional vaccines were administered on same date of the Pfizer suspect. The patient medical history and concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect was none. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine (prior vaccination was none). The patient experienced neck started hurting on one side on 17May2021 15:00. When he turns his head it hurts more, but if not moving it does not hurt as much. RA was not resulted to require a visit of emergency room or physician office. Relevant tests were none. The outcome of the event was reported as not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Chest pain
Clinical narrative: aching and sore to touch left upper chest/left breast; aching and sore to touch left upper chest/left breast; This is a spontaneous report from a contactable nurse. A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8730), via intramuscular in arm left on 04Apr2021 at 12:30 PM (at the age of 76-year-old) as a dose 1, single for COVID-19 immunisation. The patient's medical history included COVID-19. The patient's concomitant medications were not reported. The patient stated that, one day post vaccine aching and sore to touch left upper chest/left breast on 05Apr2021 at 12:30 PM, that lasted approximately 24 hours. The patient received any other vaccines within 4 weeks prior to the COVID vaccine was reported as unknown. Prior to vaccination, the patient was diagnosed with COVID-19. The reporter classified the events as non-serious. Treatment received for the events was reported as unknown. The outcome of the events was recovered on an unspecified date in Apr2021.  Follow-up attempts completed. No further information expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: tachycardia; This is a spontaneous report received from a contactable consumer (Patient). A 17-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot number: Ewol68), via an unspecified route of administration, administered in right arm on 12May2021 at 03:15 PM (at the age of 17-years-old) as dose 2, single for COVID-19 immunisation at Public Health Clinic facility. Medical history included allergy to amoxicillin. The patient did not receive any other vaccines within four of vaccination. Concomitant medication(s) included doxycycline (DOXYCYCLINE) and unspecified birth control medication. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot number: ER8735), via an unspecified route of administration, administered in right arm on 22Apr2021 at 01:15 PM as dose 1, single for COVID-19 immunisation. The patient did not have Covid prior vaccination. On 13May2021 at 09:00 PM, the patient experienced tachycardia. The event resulted in emergency room/department or urgent care. The patient not tested for COVID post vaccination. The patient did not receive any treatment for AE. The outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain
Clinical narrative: pain to her bones; This is a spontaneous report received from a contactable consumer. This 51-year-old female consumer (patient) reported that:  A 51-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution injection, Batch/Lot number was not reported), via an unspecified route of administration on 21Apr2021 (at the age of 51-year-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took first dose of bnt162b2 on unspecified date as single dose for covid-19 immunisation. Patient reported that she had the second dose of the COVID-19 vaccine on 21Apr2021, and she had experienced pain to her bones on an unspecified date in 2021. The outcome of the events was Unknown.   Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Vaccination site erythema, Vaccination site rash
Clinical narrative: Erythematous, hot rash at injection site; Erythematous, hot rash at injection site; This is a spontaneous report from a contactable physician based on the information reported to Pfizer on behalf of Moderna, (Manufacturer Control No: MOD-2021-068713).   A 121-year-old female patient (secretary) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown; Expiration date: Not reported), via intramuscular route on 02Apr2021 as dose 1, single ( at the age of 121-years-old) for COVID-19 immunization. Medical history and concomitant medications were not reported. On 05Apr2021, the patient experienced Erythematous, hot rash at injection site. It measures 3.5 x 2.5 inches, north to south. It was reported that, patient received the injection last Friday (02Apr2021), but the rash did not develop until Monday (05Apr2021). It is better today (unspecified date) and seems to be decreasing in size. Further information and Consent for Safety to contact was not obtained as caller was in a hurry to get off the phone. There is no product complaint associated with this case. The outcome of both event was unknown.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Night sweats, Pain
Clinical narrative: Feeling aches, hip, head; Chills; Lost my appetite; Night sweats; This is a spontaneous report from a contactable consumer (the patient).   A 73-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 24May2021 09:15 (at the age of 73-year-old), as dose 1, single for covid-19 immunization. Medical history included Shellfish allergy, covid-19 (If covid prior vaccination: Yes). Concomitant medications included ramipril (ALTACE), simvastatin, and omeprazole, HRT. Patient did not receive any other vaccine in four weeks. The patient previously took neosporin (bacitracin,neomycin sulfate,polymyxin b sulfate) and experienced drug hypersensitivity, polysporin (bacitracin zinc,neomycin sulfate,polymyxin b sulfate) and experienced drug hypersensitivity. Patient had not tested for covid post vaccination. At about 7pm the evening of the day (24May2021) patient got the shot at 9:15AM, she started feeling aches, hip, head. She also had chills. She lost her appetite for the next three days and continued to have aches pains and night sweats. Her sheets were soaked wet each morning. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment. All events resolved on an unknown date.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Sciatica
Clinical narrative: We have both come down with like Sciatica pain, both in our right knees both of us; both of us had the same shots and both of us came down with the same pain; This is a spontaneous report from a contactable consumer (husband). A 71-years-old female patient received second dose of BNT162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, the patient and her husband, both had their shots which had been Pfizer. Stated that, the consumer don't know the dates of when patient had her list. Stated that, they have both come down with like Sciatica pain, both in their right knees both of them and they had been trying also pain medication. It seemed really strange of both of them, had the same shots and both of them came down with the same pain. Consumer stated that, he remember a Pfizer community and he told his doctor about that was happening. He was talking to a pharmacist the other day and he told the patient to call you guys and give you the information. The outcome of the event was unknown.    Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021623543 Different patient, same drug/event.
Age: 65.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Joint stiffness, Therapeutic product effect decreased
Clinical narrative: Joint pain; Joint stiffness; humira was not effective as before; This is a spontaneous report based on the information received by Pfizer. A contactable consumer of a 65-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number & Expiry date not reported) via unspecified route of administration on 05Mar2021 (at age of 65-year-old) as dose 2, single for COVID-19 Immunisation. Patient medical history include alcohol use occasionally, four to five glass of wines per week from 1973, tobacco user from 2002 to 2007, premature atrial con-traction, penicillin (penicillin allergy manifested by tissue swelling). Patient concomitant medications include adalimumab (Humira, solution for injection in pre-filled pen, 40 mg, 1 in 2 week) used for ankylosing spondylitis rheumatoid arthritis from sep2018 to an unspecified date. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number & Expiry date not reported) via Intra-muscular route of administration on 06Feb2021 as dose 1, single for COVID-19 Immunisation and experienced pulse rapid, dizziness, flu like symptoms, weakness, feeling abnormal, Ankylosing spondylitis. On 12Apr2021 (one month, 7 days) after vaccination of second dose patient experienced Joint pain, Joint stiffness. On 12Apr2021, the patient experienced Humira was not effective as before, joint pain and joint stiffness. primary reporter did not have the lot number information, because the packaging was discarded. The patient was treated with prednisone. The reporter & as causality for the event of Humira was not effective as before, joint pain, joint stiffness and feeling like been run over by truck with Humira was a reasonable possibility. The outcome of events was not recovered.    Follow-up attempts are needed. Further information is expected.  Follow-up (29Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Headache
Clinical narrative: severe headache; loss of appetite; This is a spontaneous report from a contactable consumer (Patient) via Pfizer-sponsored program. A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on an unspecified date (at the age of 43-years-old) as dose 1, single for COVID-19 immunization. No medical history and concomitant medications were reported. On an unspecified date, after first Covid vaccine dose, patient tried to work on his laptop, after five minutes of staring, he got a severe headache and has not been working for the past two to three weeks because of it. His doctor put him on Motrin and Tylenol. The patient also had loss of appetite. Therapeutic measures were taken as a result of severe headache. The patient wanted to know if those side effects were normal to experience. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Disorientation, Maternal exposure during pregnancy, Pharyngeal swelling, Swollen tongue
Clinical narrative: Is pregnant yes/delivery date 02Sep2021/ gestational period 24weeks; throat and tongue swelling, confusion/disorientation,; throat and tongue swelling, confusion/disorientation,; throat and tongue swelling, confusion/disorientation,; throat and tongue swelling, confusion/disorientation,; This is a spontaneous report received from a contactable consumer. This 42-year-old consumer (patient) reported for herself.  A 42-year-old (pregnant) female patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EW0162, Expiration date: unknown), via unspecified route, administered on the left arm 17May2021 (at the age of 42-year-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Patient took other vaccine Fisher Titus on the same date. The patient medical history includes asthma, undiagnosed chronic issues with swelling, heart palpitations, vertigo, exercise intolerance. Past drug event includes urethane induced drug hypersensitivity. The patient had history of allergies with latex allergy, latex cross reactive foods allergy egg allergy, dust allergy, allergy to moulds, mite allergy, allergy to animals. Concomitant medications were not reported. Prior to vaccination the patient was not diagnosed with covid and since the vaccination the patient has not been tested for covid. No other vaccine received within 4 weeks prior to vaccination and no other medications received with in 2 weeks of vaccination. On 17May2021 after the vaccination, the patient experienced throat and tongue swelling, confusion/disorientation. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. Treatment was received with Zantac and Zyrtec. The outcome of the events was recovered in 2021.  No follow-up attempts possible. No further information expected.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Headache, SARS-CoV-2 test, Sinus headache, Sinus pain
Clinical narrative: Headaches; Sinus/tension headache; Sinus/tension headache; Get pain that increases through out the day in my upper and lower sinuses; Pain in all of my upper teeth; This is a spontaneous report from a contactable consumer or other non hcp. A 47-years-old female patient received BNT162b2 (CONMINTARY, Solution for injection, Lot No: Ew0170), via an unspecified route of administration, administered in Arm Right on 30Apr2021 08:45 as 2nddose, single for covid-19 immunisation. Historical vaccination was BNT162b2 (CONMINTARY, Solution for injection, Lot No: Er8737,), via an unspecified route of administration, administered in Right arm on 07Apr2021 at12:45 PM as 1stdose, single for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing, rubber sensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included naproxen sodium (ALEVE) taken for an unspecified indication, start and stop date were not reported. The patient experienced headaches on, sinus/tension headache on, sinus/tension headache on 01May2021 12:00, get pain that increases throughout the day in my upper and lower sinuses, pain in all of my upper teeth on May2021 with outcome of not recovered. The patient underwent lab tests and procedures which included computerized tomogram: clear in 2021, sars-cov-2 test: negative   on 29May2021.  Therapeutic measures were taken as a result of headaches, sinus/tension headache, sinus/tension headache, get pain that increases throughout the day in my upper and lower sinuses, pain in all of my upper teeth. The adverse event result in visit to emergency room. Treatment was received. Upon follow-up on 12Jul2021 attempts are completed. No further information is expected. Device date was 04Jun2021.The outcome of the events was recovered.  Follow-Up (12Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tension headache, Toothache
Clinical narrative: Headaches; Sinus/tension headache; Sinus/tension headache; Get pain that increases through out the day in my upper and lower sinuses; Pain in all of my upper teeth; This is a spontaneous report from a contactable consumer or other non hcp. A 47-years-old female patient received BNT162b2 (CONMINTARY, Solution for injection, Lot No: Ew0170), via an unspecified route of administration, administered in Arm Right on 30Apr2021 08:45 as 2nddose, single for covid-19 immunisation. Historical vaccination was BNT162b2 (CONMINTARY, Solution for injection, Lot No: Er8737,), via an unspecified route of administration, administered in Right arm on 07Apr2021 at12:45 PM as 1stdose, single for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing, rubber sensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included naproxen sodium (ALEVE) taken for an unspecified indication, start and stop date were not reported. The patient experienced headaches on, sinus/tension headache on, sinus/tension headache on 01May2021 12:00, get pain that increases throughout the day in my upper and lower sinuses, pain in all of my upper teeth on May2021 with outcome of not recovered. The patient underwent lab tests and procedures which included computerized tomogram: clear in 2021, sars-cov-2 test: negative   on 29May2021.  Therapeutic measures were taken as a result of headaches, sinus/tension headache, sinus/tension headache, get pain that increases throughout the day in my upper and lower sinuses, pain in all of my upper teeth. The adverse event result in visit to emergency room. Treatment was received. Upon follow-up on 12Jul2021 attempts are completed. No further information is expected. Device date was 04Jun2021.The outcome of the events was recovered.  Follow-Up (12Jul2021): Follow-up attempts are completed. No further information is expected.