chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Tinnitus, Vaccination site pain
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.
Sex: F
Vaccine: COVID19
Symptoms: Diaphragmalgia, Lymphadenopathy, Musculoskeletal chest pain, Vaccination site pain
Clinical narrative: Injection site pain; swollen lymph node under arm on the left side (injection on left arm).; pain in diaphragm/ rib; pain in diaphragm/ rib; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), via an unspecified route of administration in the left  arm on 31Mar2021 at 09:00 (at the age of 41-year-old), as a single dose for COVID-19 immunisation. Medical history included high triglycerides and the patient had a history of seasonal and environmental allergies. The patient received unspecified medication within two weeks prior to vaccination. 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 05Apr2021, the patient experienced injection site pain, swollen lymph node under arm on the left side and 5-6 days later occasional pain in diaphragm/rib when taking in normal deep breath. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the adverse events. The clinical outcome of the events injection site pain, swollen lymph node and occasional pain in diaphragm/rib was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus (ringing in ear); This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient 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 18Mar2021 at 11:00 (at the age of 57-years-old) and also 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 08Apr2021 at 11:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient medical history was reported as none. The patient had no allergies to medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021, after the first dose, the patient experienced tinnitus (ringing in ear). It was reported that the event did not result in doctor/other health care professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event tinnitus (ringing in ear) was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Sore Arm; Chills; Fever; Headache; Body aches; Arm was swollen from vaccine for 3 days; This is a spontaneous report from a 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: EW0153) via an unspecified route of administration in the left arm on 08Apr2021 at 12:00 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient has no allergies to medications, food or other products. 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. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on an unknown date in Mar2021 at 00:00 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. On 08Apr2021, 22:30 the patient experienced sore arm, chills, fever, headache, body aches and arm was swollen from vaccine for three days. No therapeutic measures were taken for the events. The clinical outcome of the events sore arm, chills, fever, headache, body aches was recovered on an unknown date in Apr2021 and arm was swollen from vaccine for three days was recovered on 11Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Sore Arm; Chills; Fever; Headache; Body aches; Arm was swollen from vaccine for 3 days; This is a spontaneous report from a 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: EW0153) via an unspecified route of administration in the left arm on 08Apr2021 at 12:00 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient has no allergies to medications, food or other products. 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. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on an unknown date in Mar2021 at 00:00 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. On 08Apr2021, 22:30 the patient experienced sore arm, chills, fever, headache, body aches and arm was swollen from vaccine for three days. No therapeutic measures were taken for the events. The clinical outcome of the events sore arm, chills, fever, headache, body aches was recovered on an unknown date in Apr2021 and arm was swollen from vaccine for three days was recovered on 11Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Headache, Palpitations
Clinical narrative: Headache; joint pain; palpitation; chest pain; This is a spontaneous report from a contactable other healthcare professional. A 40-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0158) via an unspecified route of administration on 08Apr2021(at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any other medications 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 09Apr2021, the patient experienced headache, joint pain, palpitation and chest pain. 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/clinic visit and emergency room/department or urgent care. The clinical outcome of the events headache, joint pain, palpitation and chest pain 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: Hypomenorrhoea
Clinical narrative: Started menstruation four days early; 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: UNKNOWN) via an unspecified route of administration in the left arm on 11Apr2021 at 14:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID), spironolactone (MANUFACTURER UNKNOWN) and mirtazapine (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received fluconazole (DIFLUCAN) and experienced allergy. On 11Apr2021 at 15:00, after receiving vaccine, the menstruation started four days early. Therapeutic measures were not taken as a result of the event. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event menstruation started four days early was resolved on an unknown date in Apr2021.   No follow-up attempts are required; information about lot number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, SARS-CoV-2 test
Clinical narrative: Developed shingles two weeks after 2nd dose; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 20Mar2021 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient had medical history of known allergies to anticholinergic drugs. Concomitant medications included antibiotics, loratadine (CLARITIN), vitamin d nos (VIT D), ascorbic acid (VITAMIN C), cyanocobalamin (vitamin B12), bifidobacterium Infantis, lactobacillus acidophilus (PROBIOTIC) and fish oil (MANUFACTURER UNKNOWN); all from an unknown date for an unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 27Feb2021 at 13:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 01Apr2021, two weeks after second dose, the patient experienced shingles. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of shingles which included treatment with valacyclovir (VALTREX). On 04Apr2021, the patient underwent lab tests and procedures, which included PCR test (nasal swab) and the result was pending. The clinical outcome of shingles was recovering at the time of this report.   No follow-up attempts are possible; No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Migraine, Pyrexia
Clinical narrative: Severe Migraine; fatigue; feeling feverish; This is a spontaneous report from a non-contactable consumer, the patient. A 35-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 01Apr2021 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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 10Apr2021, the patient experienced severe migraine, fatigue, and feeling feverish still, more than 10 days after. The patient did not receive any treatment for 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 events severe migraine, fatigue, and feeling feverish was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Mouth ulceration
Clinical narrative: Mouth ulcers both upper and bottom inner lips and near gum area; Menstruation seemed to be a little heavier than usual; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 03Apr2021 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included pork allergy. Concomitant medications included unspecified vitamins (MANUFACTURER UNKNOWN). 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 07Apr2021, the patient experienced mouth ulcers both in upper and bottom inner lips and near gum area and menstruation also seemed to be a little heavier than usual. 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 mouth ulcers in both upper and bottom inner lips and near gum area and menstruation seemed to be a little heavier than usual was unknown at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Musculoskeletal stiffness, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6205) via an unspecified route of administration in the arm right on 09Apr2021 at 10:00 hours (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history included anxiety and depression. Concomitant medications included loratadine (MANUFACTURER UNKNOWN) 10mg, famotidine (MANUFACTURER UNKNOWN) 5mg, D3 (MANUFACTURER UNKNOWN) 50 ug and ubidecarenone (COQ10) all for unknown indication from an unknown date. The patient had no known allergies to medications, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the arm right on 19Mar2021 at 11:00 hours (at the age of 29-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 09Apr2021, first day afternoon, the patient was mostly fine but tired. In the evening patient started getting chills/shaking and achy/sensitive all over. Very bad headache in the middle of the night, took acetaminophen to relieve the pain. On 10Apr2021, second day the patient was fine in morning then got chills again with aches and a fever in the afternoon. Took Acetaminophen again. On 11Apr2021, the third day patient experienced stiff neck, sore (and slightly swollen) right arm and slightly stiff back. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of pain, headache and fever which included treatment with acetaminophen (MANUFACTURER UNKNOWN). The clinical outcome of the events tired, very bad headache in the middle of the night, getting chills/shaking and achy/sensitive all over, fever, stiff neck, sore right arm and slightly swollen right arm and slightly stiff back were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Sensitive skin, Tremor
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6205) via an unspecified route of administration in the arm right on 09Apr2021 at 10:00 hours (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history included anxiety and depression. Concomitant medications included loratadine (MANUFACTURER UNKNOWN) 10mg, famotidine (MANUFACTURER UNKNOWN) 5mg, D3 (MANUFACTURER UNKNOWN) 50 ug and ubidecarenone (COQ10) all for unknown indication from an unknown date. The patient had no known allergies to medications, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the arm right on 19Mar2021 at 11:00 hours (at the age of 29-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 09Apr2021, first day afternoon, the patient was mostly fine but tired. In the evening patient started getting chills/shaking and achy/sensitive all over. Very bad headache in the middle of the night, took acetaminophen to relieve the pain. On 10Apr2021, second day the patient was fine in morning then got chills again with aches and a fever in the afternoon. Took Acetaminophen again. On 11Apr2021, the third day patient experienced stiff neck, sore (and slightly swollen) right arm and slightly stiff back. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of pain, headache and fever which included treatment with acetaminophen (MANUFACTURER UNKNOWN). The clinical outcome of the events tired, very bad headache in the middle of the night, getting chills/shaking and achy/sensitive all over, fever, stiff neck, sore right arm and slightly swollen right arm and slightly stiff back were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Peripheral coldness
Clinical narrative: Numbness in left pinky; cold left fingers; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the arm left on 11Apr2021 at 14:30 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included cannabidiol (MANUFACTURER UNKNOWN), collagen (MANUFACTURER UNKNOWN), vitamin d nos (MANUFACTURER UNKNOWN), multi-vitamin (MANUFACTURER UNKNOWN), CRAN (Unspecified) and vitamin e (MANUFACTURER UNKNOWN) all for an 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 11Apr2021 at 14:45, the patient experienced numbness in left pinky and cold left fingers. 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 numbness in left pinky and cold left fingers was not recovered at the time of the report.   No follow-up attempts are needed. Information about the lot number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Polymenorrhoea
Clinical narrative: In the 20 days since my 1st dose, I have had my period 3 times. It has been very heavy and the cramps are horrible compared to my normal cycle.; In the 20 days since my 1st dose, I have had my period 3 times. It has been very heavy and the cramps are horrible compared to my normal cycle.; In the 20 days since my 1st dose, I have had my period 3 times. It has been very heavy and the cramps are horrible compared to my normal cycle.; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 22Mar2021 at 15:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient previously took Morphine and experienced drug allergy. Concomitant medications taken within two weeks prior to vaccination included vitamins nos, zinc (VITAMINS NOS;ZINC) (reported as Flinstones), cetirizine hydrochloride (ZYRTEC), magnesium (MANUFACTURER UNKNOWN), cyanocobalamin (VITAMIN B12), vitamin d nos (VITAMIN D) and omeprazole (OME) all 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. From 24Mar2021 at 10:00, in the 20 days since her first dose, the patient has had her period three times. It has been very heavy and the cramps were horrible compared to her normal cycle. The patient was very regular and got her period every 28 days for years prior to the vaccine. 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 in the 20 days since first dose, the patient has had her period three times, it has been very heavy and the cramps were horrible compared to normal cycle was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Chest pain, Diarrhoea, Dyspnoea
Clinical narrative: diarrhea; aches all over; My stomach became very distended; Severe upper back pain; nausea; shortness of breath; pain radiated around to the front,chest (directly under breast); pain radiated around to the front,chest (directly under breast) andstomach.; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0153), via an unspecified route of administration in left arm on 10Apr2021 at 15:00 (at the age of 35-year-old) as single dose for COVID-19 immunisation. Medical history included diabetes type 2. The patient did not have allergies to medications, food, or other products. Concomitant medication included Metformin (MANUFACTURER UNKNOWN), Glipizide (MANUFACTURER UNKNOWN), Ranitidine (MANUFACTURER UNKNOWN) and MULTI-VITAMIN all from an unknown date, for unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On 10Apr2021 at 23:00, the patient experienced severe upper back pain (directly under shoulder blades). Back pain was so severe, it caused nausea and shortness of breath. After 2 hours the pain radiated around to the front, chest (directly under breast) and stomach. The patient stomach became very distended and was hard to the touch. The pain was extreme!! Pain that patient would not expect from a vaccine. The pain lasted 5 hours then became much less. April 11th during the day, the patient had manageable back pain, aches all over and diarrhoea. April 12th, she continued to have back pain, aches all over and diarrhoea. She was expecting not to feel well, soreness in the arm and possible aches and pain but what she experienced was so painful and so severe that she was worried that she had an unexpected reaction to the vaccine. She was now worried about getting the next dose and she would not be recommending her family members to get vaccinated until science knows more about this vaccine. The patient wanted to know if this was a normal reaction. If people in this much pain after receiving this vaccine. The patient asked for advice. No therapeutic measure were taken as a result of the adverse events. The adverse event 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 back pain, nausea, shortness of breath, pain radiated around to the front, chest (directly under breast) and stomach, manageable back pain, aches all over, diarrhoea and distended stomach were recovering at the time of report. The clinical outcome of the event general body pain was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Gastric dilatation, Nausea, Pain
Clinical narrative: diarrhea; aches all over; My stomach became very distended; Severe upper back pain; nausea; shortness of breath; pain radiated around to the front,chest (directly under breast); pain radiated around to the front,chest (directly under breast) andstomach.; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0153), via an unspecified route of administration in left arm on 10Apr2021 at 15:00 (at the age of 35-year-old) as single dose for COVID-19 immunisation. Medical history included diabetes type 2. The patient did not have allergies to medications, food, or other products. Concomitant medication included Metformin (MANUFACTURER UNKNOWN), Glipizide (MANUFACTURER UNKNOWN), Ranitidine (MANUFACTURER UNKNOWN) and MULTI-VITAMIN all from an unknown date, for unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On 10Apr2021 at 23:00, the patient experienced severe upper back pain (directly under shoulder blades). Back pain was so severe, it caused nausea and shortness of breath. After 2 hours the pain radiated around to the front, chest (directly under breast) and stomach. The patient stomach became very distended and was hard to the touch. The pain was extreme!! Pain that patient would not expect from a vaccine. The pain lasted 5 hours then became much less. April 11th during the day, the patient had manageable back pain, aches all over and diarrhoea. April 12th, she continued to have back pain, aches all over and diarrhoea. She was expecting not to feel well, soreness in the arm and possible aches and pain but what she experienced was so painful and so severe that she was worried that she had an unexpected reaction to the vaccine. She was now worried about getting the next dose and she would not be recommending her family members to get vaccinated until science knows more about this vaccine. The patient wanted to know if this was a normal reaction. If people in this much pain after receiving this vaccine. The patient asked for advice. No therapeutic measure were taken as a result of the adverse events. The adverse event 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 back pain, nausea, shortness of breath, pain radiated around to the front, chest (directly under breast) and stomach, manageable back pain, aches all over, diarrhoea and distended stomach were recovering at the time of report. The clinical outcome of the event general body pain was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Headache, Inappropriate schedule of product administration
Clinical narrative: inappropriate schedule of vaccine administereddose 1- 20210111, dose 2- 20210125; Fever of 104.0; chills; muscle aches; headache; dizziness; body aches; pain at site of vaccination; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 24-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 25Jan2021 at 14:00 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously received cephalosporin nos (MANUFACTURER UNKNOWN) on an unspecified date for an unspecified indication and experienced drug allergy. Concomitant medication included spironolactone (MANUFACTURER UNKNOWN) from an unknown date, for an unspecified indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 11Jan2021 at 14:00 (at the age of 24-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 25Jan2021 the patient experienced fever of 104.0, chills, muscle aches, headache, dizziness, body aches and pain at site of vaccination. On 25Jan2021 the body temperature of the patient was measured and the result was 104.0 (unspecified unit). 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 adverse events. The clinical outcomes of the events fever of 104.0, chills, muscle aches, headache, dizziness, body aches and pain at site of vaccination were recovered on an unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pyrexia, Vaccination site pain
Clinical narrative: inappropriate schedule of vaccine administereddose 1- 20210111, dose 2- 20210125; Fever of 104.0; chills; muscle aches; headache; dizziness; body aches; pain at site of vaccination; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 24-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 25Jan2021 at 14:00 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously received cephalosporin nos (MANUFACTURER UNKNOWN) on an unspecified date for an unspecified indication and experienced drug allergy. Concomitant medication included spironolactone (MANUFACTURER UNKNOWN) from an unknown date, for an unspecified indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 11Jan2021 at 14:00 (at the age of 24-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 25Jan2021 the patient experienced fever of 104.0, chills, muscle aches, headache, dizziness, body aches and pain at site of vaccination. On 25Jan2021 the body temperature of the patient was measured and the result was 104.0 (unspecified unit). 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 adverse events. The clinical outcomes of the events fever of 104.0, chills, muscle aches, headache, dizziness, body aches and pain at site of vaccination were recovered on an unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Arm numbness; Pins and needles; Very sore arm; Joint pain; This is a spontaneous report from a non-contactable consumer, the patient. A 29-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 10Apr2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included fruit allergy (Pineapple allergy). Concomitant medication was not reported. 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 4 weeks prior to the COVID vaccine. On 10Apr2021, the patient experienced arm numbness, pins and needles, very sore arm and joint pain. 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 arm numbness, pins and needles, very sore arm and joint pain were unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: numbness tingling in my lower left leg; numbness tingling in my lower left leg; 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: EW0153) via an unspecified route of administration in the left arm on 08Apr2021 at 11:45 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. Medical history included known allergy to peanut. Concomitant medications were not reported. Prior to the vaccination, the patient was not tested positive for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not take any other vaccine within 4 weeks prior to the vaccination. The clinical course was reported as follows: on 13Apr2021 at 14:00, the patient experienced numbness and tingling in the lower left leg. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the events numbness and tingling in the lower left leg was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash from face down to neck, and slightly passed to shoulders; This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151 ) via an unspecified route of administration in the left arm on 08Apr2021 at 10:45 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021 at 09:00, the patient experienced rash from her face down to neck, and rash slightly passed to her shoulders. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event rash from face down to neck, and slightly passed to shoulders was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Allodynia, Arthralgia, Body temperature, Fatigue, Pyrexia
Clinical narrative: Allodynia (skin sensitivity) all over but especially noticeable on my left thigh; In addition to the usual fever (100.7); Joint aches; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 07Apr2021 at 14:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine and Raynaud's. The patient had history of known allergies reaction to some detergents and medical tape adhesives (with prolonged exposure). Concomitant medications included erenumab (AIMOVIG), estradiol (DIVIGEL), progesterone (MANUFACTURER UNKNOWN), rosuvastatin (MANUFACTURER UNKNOWN) and baclofen (BACLOF); all from an unknown date for unknown indication. The patient previously received 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 14:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. She also received estrogen gel (MANUFACTURER UNKNOWN) on unknown date for an unspecified indication and experienced allodynia (have been using that medication every day for years). The patient did not receive any other vaccine within four weeks prior to the COVID 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. On 08Apr2021 at 15:00, in the afternoon of the day after receiving second COVID dose, the patient experienced in addition to the usual fever (100.7), joint aches, fatigue and had allodynia (skin sensitivity) all over but especially noticeable on left thigh at the exact location the patient had applied an estrogen gel (hormone replacement) early that morning. The patient had been using that medication every day for years and had never had that feeling any other time. The patient got allodynia when she had a bad migraine, so she recognized it, but never before had it been more intense in one particular area of her body, and the patient did not have a bad migraine at the time so it was not migraine related. The patient had read that there had been reports of women having more reactions to the vaccine than men, and thought might be useful to know that the patient had this reaction in the exact spot where she had applied estrogen. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of allodynia (skin sensitivity) all over but especially noticeable on my left thigh, fever (100.7), joint aches and fatigue were recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Lip blister
Clinical narrative: Blisters on lower lip; This is a spontaneous report from a contactable nurse. A 29-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the right arm on 08Apr2021 at 10:15 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto's thyroiditis and polycystic ovarian syndrome (PCOS). The patient had no known allergies to medications, food or other products. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID 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. On 11Apr2021 at 08:00, the patient experienced blisters on the lower lip showed up 3 days post vaccine. The patient had no history of lip blisters. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of blisters on lower lip was not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Carpal tunnel syndrome, Lymphadenopathy, Vaccination site pain
Clinical narrative: swollen axillary lymph node on right side.; aggravated arthritis/carpal tunnel in right forearm & wrist; aggravated arthritis/carpal tunnel in right forearm & wrist; soreness at injection site.; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 10Apr2021 at 16:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, arthritis and carpal tunnel syndrome. The patient previously took sulfa and experienced sulfonamide allergy, Concomitant medications taken within two weeks of vaccination included levothyroxine sodium (SYNTHROID), bupropion (MANUFACTURER UNKNOWN), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and multivitamin (unspecified), all from unknown date for unknown indication. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 20Mar2021 at 16:00 (at the age of 48-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 12Apr2021, the patient experienced swollen axillary lymph node on right side, aggravated arthritis/carpal tunnel in right forearm and wrist, soreness at injection site. 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 swollen axillary lymph node on right side, aggravated arthritis/carpal tunnel in right forearm and wrist, soreness at injection site was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Pain in extremity
Clinical narrative: Stomach ache; arm ache; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO161) via an unspecified route of administration in the arm left on 13Apr2021 at 18:45 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history included depression, anxiety and Attention-Deficit/Hyperactivity Disorder (ADHD). The patient had no known allergies to medications, food or other products. Concomitant medications included melatonin (MANUFACTURER UNKNOWN) and escitalopram oxalate (LEXAPRO), both taken for unspecified indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on 09Mar2021 at 19:00 (at the age of 19-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. It was unknown if the patient received any other vaccines within four weeks 4 weeks prior to the COVID vaccine. On 13Apr2021 at 20:45, the patient experienced stomach ache and arm ache. The events did not result in a visit to the doctors 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 stomach ache and arm ache were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.