chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever for over 4 weeks beginning 3 days post second shot. Fever ranges from 99.3-100.1.; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 08Mar2021 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies. Concomitant medications included estrogen nos, progesterone, testosterone (BIOIDENTICAL HORMONES) and thyroid (MANUFACTURER UNKNOWN) for an unknown indication from unknown start date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 11Feb2021 (at the age of 54-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 COVID vaccine. On 11Mar2021 at 18:00 the patient experienced fever for over 4 weeks beginning 3 days post second shot of vaccine. fever ranges from 99.3-100.1 (unspecified units).  Patient's normal temperature was low around 96-97 (unspecified units). The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the event fever was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Neck pain
Clinical narrative: Shooting stabbing pain in right eyeball; Neck pain; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration in the left arm on 20Mar2021 at 13:00 (at the age of 45-year-old), as a single dose for COVID-19 immunisation. Medical history included autoimmune pancreatitis, hypothyroidism, colitis, shellfish allergy, allergy to nuts and other food allergy. Concomitant medications included mesalazine (CANASA), pancrelipase (PANCREAZE), levothyroxine (MANUFACTURER UNKNOWN) and omeprazole (PRILOSEC), all for an unknown indication from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unknown date, 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 21Mar2021, the patient experienced shooting stabbing pain in right eyeball and neck pain. The patient did not receive any treatment for the events. The adverse events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. The clinical outcome of the events shooting stabbing pain in right eyeball and neck pain was resolved on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: Fasting Blood glucose 130 mg/dl on 4/3/21 with all other lab testing dating back to 2018 staying between 74-78mg/dl; This is a spontaneous report from a contactable consumer. A 39-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6208), via an unspecified route of administration in the left arm on 16Mar2021 at 18:15 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not have any allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021, the patient's fasting blood glucose was 130 mg/dl while all other lab testing dating back to 2018 had been staying between 74- 78mg/dl. The patient underwent lab tests and procedures which included fasting blood glucose on 03Apr2021 and result was 130mg/dl and fasting blood glucose on unknown dates of 2018 and result was 74-78mg/dl. The clinical outcome of the fasting blood glucose 130 mg/dl (fasting blood glucose increased) was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Headache, Pruritus, Pyrexia, Rash
Clinical narrative: Low grade fever; My sinuses were very in distress; Headache; Small pimples which spread all over my head; then by yesterday it's all over my torso; it's very, very itchy; Small pimples which spread all over my head; then by yesterday it's all over my torso; it's very, very itchy; I developed itching on my scalp/Small pimples which spread all over my head; then by yesterday it's all over my torso; it's very, very itchy; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8737), via an unspecified route of administration on 15Mar2021 and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8737), via an unspecified route of administration in right arm (upper) on 05Apr2021 at 09:00 (at the age of 65 years old) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included loratadine (CLARITINE) for allergies; vitamins nos for an unspecified indication, start and stop date were not reported. She stated, she just she spoke to her doctor this morning on the telephone regarding a possible reaction to the Pfizer Covid vaccine she received on Monday and he said that she should report it. She further stated she did have some reaction and that she was aware that may have occurred it was low grade fever and her sinuses were very in distress, headache and by Monday evening she developed itching on her scalp and small pimples which spread all over her head and then by yesterday it's all over her torso and it's very, very itchy, she sent her doctor a picture and he advised her what to do to get some relief and took some Benadryl. She stated, it was important to let her doctor know she mean specially if they have to do a booster or something and she had already had a reaction this way so. Consumer stated, for the rash and itching, to help with the itching, she took Benadryl. Therapeutic measures were taken as a result of i developed itching on my scalp/small pimples which spread all over my head; then by yesterday it's all over my torso; it's very, very itchy with Benadryl. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus disorder
Clinical narrative: Low grade fever; My sinuses were very in distress; Headache; Small pimples which spread all over my head; then by yesterday it's all over my torso; it's very, very itchy; Small pimples which spread all over my head; then by yesterday it's all over my torso; it's very, very itchy; I developed itching on my scalp/Small pimples which spread all over my head; then by yesterday it's all over my torso; it's very, very itchy; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8737), via an unspecified route of administration on 15Mar2021 and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8737), via an unspecified route of administration in right arm (upper) on 05Apr2021 at 09:00 (at the age of 65 years old) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included loratadine (CLARITINE) for allergies; vitamins nos for an unspecified indication, start and stop date were not reported. She stated, she just she spoke to her doctor this morning on the telephone regarding a possible reaction to the Pfizer Covid vaccine she received on Monday and he said that she should report it. She further stated she did have some reaction and that she was aware that may have occurred it was low grade fever and her sinuses were very in distress, headache and by Monday evening she developed itching on her scalp and small pimples which spread all over her head and then by yesterday it's all over her torso and it's very, very itchy, she sent her doctor a picture and he advised her what to do to get some relief and took some Benadryl. She stated, it was important to let her doctor know she mean specially if they have to do a booster or something and she had already had a reaction this way so. Consumer stated, for the rash and itching, to help with the itching, she took Benadryl. Therapeutic measures were taken as a result of i developed itching on my scalp/small pimples which spread all over my head; then by yesterday it's all over my torso; it's very, very itchy with Benadryl. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nasal congestion, Pain in extremity
Clinical narrative: Severe pain in left arm; congestion; severe migraine; This is a spontaneous report from a contactable consumer, the patient. A 16-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 10Apr2021 at 10:00 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. The patient had unspecified medical history. The patient had no allergies to medications, food, or other products. The patient received unspecified medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Mar2021 at 09:15 (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 vaccines within four weeks prior to the vaccination. On 10Apr2021 at 17:00, the patient experienced severe pain in left arm, congestion and severe migraine. 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. The clinical outcome of the events severe pain in left arm, congestion and severe migraine were resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lip pruritus, Lip swelling, Oral pruritus, Swelling
Clinical narrative: The inside of my mouth itched; Chin was swollen and hard to the touch; Lower lip itched; Lower lip swollen; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient 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 03Apr2021 at 09:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to eggplant and the patient had no other relevant medical history. The patient had not received any other medications within 2 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 medications or vaccines within 4 weeks prior to the vaccination. On 09Apr2021 at 17:00, a week after the injection, the patient experienced itching inside her mouth, the chin was swollen and hard to the touch and her lower lip itched on the inside and was swollen. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events itching inside mouth, chin swollen and hard to the touch, lower lip itched and swollen were resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: High pitched noise in the ears; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 18:45 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. Medical history included overweight. The patient was allergic to penicillin. The patient did not receive any medications 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 08Apr2021 at 20:45, two hours after the vaccine, the patient experienced high pitched noise in the ears, which lasted 40 minutes and it had come back, lasting about seven hours and counting. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the event high pitched noise in the ears was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Myalgia, Rash vesicular
Clinical narrative: Muscle Aches; General Malaise; Fatigue; Chicken pox style rash on trunk; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Mar2021 at 13:15 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks prior to vaccination included levothyroxine sodium (SYNTHROID) from unknown date for unknown indication. 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 28Mar2021 at 23:30, the patient experienced muscle aches, general malaise, fatigue, chicken pox style rash on trunk. All began around ten hours after injection. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events muscle aches, general malaise, fatigue, chicken pox style rash on trunk was resolved on an unknown date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Pain in extremity, Pain of skin
Clinical narrative: odd pains just below the skin; "odd pains just below the skin. Almost felt like bee stings. On my legs and arms"; "odd pains just below the skin. Almost felt like bee stings. On my legs and arms. Some on back and abdomen."; "odd pains just below the skin. Almost felt like bee stings. On my legs and arms. Some on back and abdomen."; This is a spontaneous report from a contactable consumer, the patient. A 63-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 right arm on 12Apr2021 at 09:30 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis. The patient had no known allergies. Concomitant medications included adalimumab (HUMIRA), methotrexate (RASUVO) and atenolol (TENORMIN); all taken from an unknown date and unknown if its 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 right arm on 24Mar2021 at 13:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation and the patient had no reactions with first vaccine. 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 12Apr2021 at 19:30, 10 hours after the second vaccine, the patient started to have odd pains just below the skin. Almost felt like bee stings, on her legs and arms, some on back and abdomen. They continued through the night but stopped by 09:00. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events "odd pains just below the skin. Almost felt like bee stings. On the patient's legs and arms. Some on back and abdomen" were recovered on 13Apr2021 at 09:00.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Vaccination site swelling
Clinical narrative: sore arm and slight swelling injection site, minor fatigue; sore arm and slight swelling injection site, minor fatigue; sore arm and slight swelling injection site, minor fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 53-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 09Apr2021 at 09:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patients other medical history was reported as no. The patient previously took penicillin and experienced penicillin allergy. The patient did not receive any other medications within two weeks prior to 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, the patient experienced sore arm and slight swelling injection site, minor fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events sore arm and slight swelling injection site, minor fatigue was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness
Clinical narrative: Stomach pain; Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Ew0162) via an unspecified route of administration in the arm left on 12Apr2021 at 14:45 (at the age of 17-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and penicillin allergy. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 15:00, the patient experienced stomach pain and dizziness. It was unknown  whether any therapeutic measures were taken as a result of the reported events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events stomach pain and dizziness was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site rash
Clinical narrative: red rash around injection site; Headache; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 08Apr2021 at 09:00 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy, gluten (unspecified). The patient previously received amoxicillin (MANUFACTURER UNKNOWN) on an unspecified date for an unspecified indication and experienced drug allergy. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 17Mar2021 at 09:15 (at the age of 27-year-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 08Apr2021 at 19:00 the patient experienced approximately 3 inches red rash around injection site and headache for two days since vaccination and still had at the time of report. No therapeutic measures were taken as a result of the 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 events red rash around injection site and headache was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Blurry vision in left eye; This is a spontaneous report from a non-contactable consumer. A 40-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) in the right arm on 08Apr2021 at 14:45 (at the age of 40-year-old) and first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) in the right arm on 18Mar2021 at 18:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 22Mar2021 the patient experienced Blurry vision in left eye. Blurry vision in left eye - opposite side from which the vaccine was given; it was given in the right arm. This had occurred after receiving both vaccines. The blurry vision occurred 4 days after the first vaccine and a little over 24 hours after the second vaccine. No therapeutic measures were taken as a result of the event. The clinical outcome of the event Blurry vision in left eye - opposite side from which the vaccine was given; it was given in the right arm. This had occurred after receiving both vaccines. The blurry vision occurred 4 days after the first vaccine and a little over 24 hours after the second vaccine was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Injection site reaction, Paraesthesia, Pruritus, Vaccination site pain
Clinical narrative: Soreness at injection site; Extremely itchy from head to bottom of feet; Muscle spasms at injection site; Left leg felt tingly; Weird; This is a spontaneous report from a non-contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 09Apr2021 at 10:15 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, bradycardia, tachycardia and high blood pressure. The patient was allergic to Penicillin (PCN), red dye, sulfa drugs, eel, pesticides in fruit/vegetable and too many food allergies to list. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 19Mar2021 at 10:15 (at the age of 54-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 09Apr2021, the patient experienced soreness at injection site, extremely itchy from head to bottom of feet, muscle spasms at injection site, left leg felt tingly and felt weird for 24 hours. 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. The clinical outcome of the events soreness at injection site, extremely itchy from head to bottom of feet, muscle spasms at injection site, left leg felt tingly and felt weird were recovered on 10Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Glossodynia, Headache, Swollen tongue
Clinical narrative: Under tongue sore; Under tongue sore and swollen; Terrible right side back of headheadache; This is a spontaneous report from a non-contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732), via an unspecified route of administration in the left arm on 03Apr2021 at 16:30 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had known allergies to penicillin and sulfa based drugs. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202), via an unspecified route of administration in the left arm on 13Mar2021 at 16:30 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. Prior to 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 06Apr2021 at 19:30, the patient experienced under tongue sore and swollen and terrible right side back of head headache on day 3 lasting several days. 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. The clinical outcome of the events under tongue sore and swollen and terrible right side back of head headache were not resolved at the time of this report.    No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Enlarged Lymph Nodes, for a week.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCIN; Lot Number: EW0151) via an unspecified route of administration in the right arm on 05Apr2021 at 10:45 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and penicillin allergy. It was reported that the patient was allergic to chick pea. Concomitant medications were not reported. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Apr2021, the patient experienced enlarged lymph nodes, for a week. Therapeutic measures were taken as a result of enlarged lymph nodes and included treatment with oxicodone, ibuprofen, dorflex pain pills. 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 enlarged lymph nodes, for a week was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness to arm all around injection area; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 11Apr2021 at 12:30 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included vitamin b nos (VITAMIN B), vitamin d nos (VITAMIN D) and omeprazole (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknow if ongoing. 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 11Apr2021 at 16:00, the patient experienced soreness to arm all around injection area. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event soreness to arm all around injection area was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Migraine, Nausea, Pain
Clinical narrative: Nausea; Vomiting- unable to keep food or water down for 24+ hours; Light-headedness; Migraine; Body aches; Loss of appetite; This is a spontaneous report from a non-contactable consumer, the patient. A 23-year-old non-pregnant female patient received unknown 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 12:30 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and sulpha drugs allergy. Concomitant medications included multiple unspecified medications. 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 vaccination. On 10Apr2021 at 13:45, the patient experienced nausea, vomiting- unable to keep food or water down for 24plus hours, light-headedness, migraine, body aches and loss of appetite. Therapeutic measures were not taken as a result of the events. 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 nausea, vomiting- unable to keep food or water down for 24 plus hours, light-headedness, migraine, body aches and loss of appetite were resolving at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Nausea; Vomiting- unable to keep food or water down for 24+ hours; Light-headedness; Migraine; Body aches; Loss of appetite; This is a spontaneous report from a non-contactable consumer, the patient. A 23-year-old non-pregnant female patient received unknown 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 12:30 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and sulpha drugs allergy. Concomitant medications included multiple unspecified medications. 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 vaccination. On 10Apr2021 at 13:45, the patient experienced nausea, vomiting- unable to keep food or water down for 24plus hours, light-headedness, migraine, body aches and loss of appetite. Therapeutic measures were not taken as a result of the events. 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 nausea, vomiting- unable to keep food or water down for 24 plus hours, light-headedness, migraine, body aches and loss of appetite were resolving at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Inappropriate schedule of product administration
Clinical narrative: Sore arm; headache; fatigue; chills; foggy headed; inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer, the patient. A 39-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 01Feb2021 at 10:30 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was allergic to amoxicillin family. 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 14Jan2021 at 09:30 as a single dose for COVID-19 immunisation.  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 02Feb2021 at 10:00, the patient experienced sore arm, headache, fatigue, chills and foggy headed. No therapeutic measures were taken as a result of the 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 for the events pain in arm, headache, fatigue, chills and foggy feeling in head were recovered on an unknown date in 2021.   No follow-up attempts are needed; information about lot number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; headache; fatigue; chills; foggy headed; inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer, the patient. A 39-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 01Feb2021 at 10:30 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was allergic to amoxicillin family. 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 14Jan2021 at 09:30 as a single dose for COVID-19 immunisation.  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 02Feb2021 at 10:00, the patient experienced sore arm, headache, fatigue, chills and foggy headed. No therapeutic measures were taken as a result of the 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 for the events pain in arm, headache, fatigue, chills and foggy feeling in head were recovered on an unknown date in 2021.   No follow-up attempts are needed; information about lot number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Pruritus, Rash papular, Throat irritation
Clinical narrative: Raised on face, neck, back, arms, chest and stomach; Flushed on face, neck, back, arms, chest and stomach; Itchy on face, neck, back, arms, chest and stomach; Throat felt itchy/Throat felt scratchy/ Throat felt raw; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 13Apr2021 at 15:00 (at the age of 40-years old) (Batch/Lot Number: ER8734) as DOSE 1, SINGLE for Covid-19 immunisation. Medical history included epilepsy from an unknown date and unknown if ongoing, back pain from an unknown date and unknown if ongoing, allergies to cross reactive foods and latex allergy from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines four weeks prior to the vaccination. The patient experienced raised on face, neck, back, arms, chest and stomach; flushed on face, neck, back, arms, chest and stomach; itchy on face, neck, back, arms, chest and stomach; and throat felt itchy/throat felt scratchy/ throat felt raw all on 13Apr2021 at 16:00. The events resulted in emergency room or urgent care. Therapeutic measures were taken as a result of rash papular, flushing, pruritus, and throat irritation which included IV benadryl, solumedrol, Pepcid, and normal saline. The outcome of the events rash papular, flushing, pruritus, and throat irritation was recovering. It was reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Developed shingles outbreak to left chest approximately 60 hours after 2nd Covid vaccine; This is a spontaneous report from a contactable nurse. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via intramuscular route of administration in the left arm on 07Apr2021 at 12:00 (at the age of 56-year-old), as a single dose for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADD), hashimoto's disease, iritis. The patient was allergic to iodine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included fluoxetine hydrochloride (PROZAC) and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) from an unknown date for an unspecified indication, unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 17Mar2021 at 14:30 (at the age of 56-year-old), as a single dose for COVID-19 immunisation. On 10Apr2021 at 06:00, approximately 60 hours after 2nd Covid vaccine, the patient developed shingles outbreak to left chest. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with acyclovir. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event developed shingles outbreak to left chest approximately 60 hours after 2nd Covid vaccine was not resolved 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: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Intense pain remains in left arm; Intense pain remains in left arm and up into the neck; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 09Apr2021 at 12:30 (at the age of 49-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none and the patient did not have a history of allergies to any food or medications or other products. The patient did not receive any other medications within two weeks prior to vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Apr2021 at 17:00, the patient experienced intense pain remains in left arm and up into the neck. 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. The clinical outcome of the event intense pain remains in left arm and up into the neck was recovering 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: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Body aches; Chills; Low grade temp; Tired; This is a spontaneous report from a contactable healthcare professional. A 42-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 10:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had an unspecified allergy. 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. 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 01Apr2021 at 23:00, the patient experienced body aches, chills, low grade temperature and felt tired. 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. The clinical outcome of the events body aches, chills, low grade temperature and felt tired were resolved on an unknown date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Fatigue, Headache, Pruritus
Clinical narrative: Fever 102 F; Headache; Ear ringing; Itching scalp, tongue, lips and hands; Fatigue; Dizziness; Vaccine site pain; This is a spontaneous report received from a contactable consumer (patient) via a regulatory authority.   A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 08Apr2021 at 09:45 (at the age of 44-year-old), as a single dose for COVID-19 immunization. Medical history included a history of allergies to seafood, chocolate, oat and avocado. Concomitant medications included doxycycline (ORACEA) from an unknown date and for an unspecified indication. 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 has been tested for COVID-19. On 08Apr2021 at 09:45, the patient experienced fever 102 degrees Fahrenheit, headache, ear ringing, itching scalp, tongue, lips and hands, fatigue, dizziness and vaccine site pain. Symptoms lasted for a period of 24 hours. On 09Apr2021, the patient underwent lab test and procedures which included PCR COVID (Nasal swab) test and the results were found to be negative and on 08Apr2021 at 09:45, the patient underwent body temperature test and the result was 102 degrees Fahrenheit. 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 the result of adverse events. The clinical outcome of fever 102 F, headache, ear ringing, itching scalp, tongue, lips and hands, fatigue, dizziness and vaccine site pain were recovered on 09Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.