chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia, Pain, Vertigo
Clinical narrative: Intense chills; Body aches; Muscle soreness; Stiffness; Weakness; Joint pain in lower body; Severe vertigo; Dizziness; Loss of appetite; This is a spontaneous report from a non-contactable consumer, the patient. A 22-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 30Apr2021 at 17:30 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The medical history included obesity, anemia, childhood thyroid disorder, severe childhood bronchitis and recent abortion. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The concomitant medications included sertraline hydrochloride (ZOLOFT) and amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL), all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER0734) via an unspecified route of administration in the left arm on 09Apr2021 at 17:30 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. On 01May2021 at 03:00, the patient experienced intense chills, body aches, muscle soreness, stiffness, weakness, joint pain in lower body, severe vertigo, dizziness and loss of appetite. It was also reported that survey was taken 24 hours after the second shot. The adverse 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events intense chills, body aches, muscle soreness, stiffness, weakness, joint pain in lower body, severe vertigo, dizziness and loss of appetite were resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Chills, Diarrhoea, Pain
Clinical narrative: Normal chills and chills where my body was uncontrollably shaking; Stomach pain; Body aches; Sore arm; Fever highest 103.6; Diarrhea; Normal chills and chills where my body was uncontrollably shaking; 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: EW0170) via an unspecified route of administration in the left arm on 29Apr2021 at 07:15 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and allergy to sulfa medications. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included allium sativum (garlic) (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN) and colecalciferol (VITAMIN D3); all on an unknown date for unknown indication. The patient previously received 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 08:45 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. On 29Apr2021 at 18:00, the patient experienced chills both what patient said were normal chills and chills where her body was uncontrollably shaking, fever highest 103.6, stomach pain, diarrhea, body aches, and sore arm. On 29Apr2021, the patient underwent body temperature and the result was 103.6 (unknown units). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events normal chills and chills where body was uncontrollably shaking, fever highest 103.6, stomach pain, diarrhea, body aches, and sore arm was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Tremor
Clinical narrative: Normal chills and chills where my body was uncontrollably shaking; Stomach pain; Body aches; Sore arm; Fever highest 103.6; Diarrhea; Normal chills and chills where my body was uncontrollably shaking; 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: EW0170) via an unspecified route of administration in the left arm on 29Apr2021 at 07:15 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and allergy to sulfa medications. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included allium sativum (garlic) (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN) and colecalciferol (VITAMIN D3); all on an unknown date for unknown indication. The patient previously received 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 08:45 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. On 29Apr2021 at 18:00, the patient experienced chills both what patient said were normal chills and chills where her body was uncontrollably shaking, fever highest 103.6, stomach pain, diarrhea, body aches, and sore arm. On 29Apr2021, the patient underwent body temperature and the result was 103.6 (unknown units). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events normal chills and chills where body was uncontrollably shaking, fever highest 103.6, stomach pain, diarrhea, body aches, and sore arm was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Lymphadenopathy, Pain, Pain in extremity
Clinical narrative: Vomiting; Fever; Pain in joints; Severe headache; Lymph node swelling; Pain in body; Severe pain in legs; Pain at injection site; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the right arm on 30Apr2021 at 12:45 at the age of 26-years-old as a single dose for COVID-19 immunisation. Medical history included asthma and known allergies to peanuts, legumes, seasonal, animal, and various foods. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included VITAMINS, OMEPRAZOLE, CETRIZINE, AND KRI, all for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the right arm on 09Apr2021 at 10:15 at the age of 26-years-old as a single dose for COVID-19 immunisation. On 01May2021 at 01:00, after second shot, the patient experienced vomiting, fever, pain in joints, severe headache, lymph node swelling, pain in body, severe pain in legs, and pain at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events experienced vomiting, fever, pain in joints, severe headache, lymph node swelling, pain in body, severe pain in legs and pain at injection site was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain, Vomiting
Clinical narrative: Vomiting; Fever; Pain in joints; Severe headache; Lymph node swelling; Pain in body; Severe pain in legs; Pain at injection site; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the right arm on 30Apr2021 at 12:45 at the age of 26-years-old as a single dose for COVID-19 immunisation. Medical history included asthma and known allergies to peanuts, legumes, seasonal, animal, and various foods. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included VITAMINS, OMEPRAZOLE, CETRIZINE, AND KRI, all for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the right arm on 09Apr2021 at 10:15 at the age of 26-years-old as a single dose for COVID-19 immunisation. On 01May2021 at 01:00, after second shot, the patient experienced vomiting, fever, pain in joints, severe headache, lymph node swelling, pain in body, severe pain in legs, and pain at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events experienced vomiting, fever, pain in joints, severe headache, lymph node swelling, pain in body, severe pain in legs and pain at injection site was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Palmar erythema, Rheumatoid factor, X-ray limb
Clinical narrative: Pain in left hip/butt/Mild to moderate joint pain on one side of hip.; Knuckle pain in right hand; Palm turning red and emanating heat; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the right arm on 12Mar2021 at 10:30(at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included gastroesophageal reflux disease (GERD) and anxiety. The patient had known allergy to sulfa drugs and penicillin. 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 sertraline (MANUFACTURER UNKNOWN), multivitamins (MANUFACTURER UNKNOWN) and omeprazole (PRILOSEC) all from an unknown date for unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the left arm on 20Feb2021 at 12:45 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 15Mar2021, 3 days after the second dose, the patient experienced pain in left hip/butt/mild to moderate joint pain on one side of hip. It was reported that, the joint pain seems worse when the patient first got up and seems to improve slightly when she get moving. On an unknown date in 2021, about 3 weeks after the second dose, the patient experienced knuckle pain in right hand that seemed to flare for 1-2 weeks and finally with palm turning red and emanating heat. It hurt to grip the steering wheel of car. The patient went to primary care and got tested for rheumatoid factor and lupus, had hand x-rayed and everything came back completely normal. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events knuckle pain in right hand and palm turning red and emanating heat were recovered with sequelae on an unknown date in 2021. The clinical outcome of the event pain in left hip/butt/mild to moderate joint pain on one side of hip was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: fever; shivers - hot and cold and has thrown-up; thrown up last night and this morning; This is a spontaneous report received from a contactable consumer (patient, self reported). A 20-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 05May2021, as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date was not reported), via an unspecified route of administration on an unspecified date, as dose 1, single for COVID-19 immunization. On an unspecified date in May2021, the patient had high fever, shivering hot and cold, thrown up last night and this morning and mentioned she is in the military and was told by her instructor to call Pfizer. The patient wanted to know on what she should do about the side effects if she would be good to carry on and response included. Response: Spoke from attached documents and as per the Pfizer-BioNTech COVID-19 EUA PI (6 Overall Safety Summary and 6.1 Clinical Trials Experience) LAB-1457-7.0, Revised: 06 April 2021. Gave disclaimer that Pfizer was unable to make any treatment recommendations for individual patients and referred to HCP for further guidance. There were medical questions addressed by this program forwarded/referred to medical information. Outcome of the events were unknown.  No follow up attempts are needed. Information on lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Influenza
Clinical narrative: Callers have cough; Flu; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) reported that:  A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot/batch number was not reported, expiration date was not reported) via an unspecified route of administration on 16Apr2021 as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient went to 16Apr2021 to take first shot and have appointment for 08May2021 for this Friday, but patient can't go (for the second dose), had flu and cough little bit. Patient don't have right to go there. Patient would like to know if she could go next Monday. The clinical outcome of the event was unknown.   .No follow-up attempts were needed, information about lot/batch number could not be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Pain
Clinical narrative: Cough; Pain; This is a spontaneous report from a contactable consumer (patient's sister).  A male patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On an unspecified date, after second dose the patient experienced cough and some pain. It was unknown if the patient received any treatment for the event. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: PNC13
Symptoms: Allergy to vaccine
Clinical narrative: allergic to whatever is in a vaccine; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for immunization. Medical history included hereditary angioedema. The patient's concomitant medications were not reported. The nurse stated "Oh yes, Prevnar 13, I am allergic to whatever is in a vaccine there are some components in a vaccine that I am allergic to". As to other medical conditions, she stated that she had what they call hereditary angioedema because of something that was in flu vaccine and the pneumonia vaccine so she have not had any vaccine since 2016. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a Pfizer-sponsored program via Regulatory Authority.  A contactable consumer reporting for a 57-year-old female patient who received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation; tofacitinib citrate (XELJANZ XR TAB 11MG), via an unspecified route of administration from 02Feb2021 (Batch/Lot number was not reported) to 02Feb2021, at 11mg (tablets) for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient also received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. On an unspecified date, the patient experienced headache. Stated she had a mild headache lasting about 1 hour after COVID vaccine. Patient was off the medication two times due to recommendation from MDO while receiving first and second dose of vaccine. Patient was off medication one week after first dose and 4 days after second dose. Outcome of the event was unknown. The action taken in response to the event for tofacitinib citrate was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose fluctuation, Investigation
Clinical narrative: I have been having issues with irregular Blood Sugar levels after Corona vaccination/ever since I had the vaccine, I've been having some pretty crazy blood sugar number; This is a spontaneous report from a contactable consumer (Patient). A 48-years-old female patient (Unknown if pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EP7533), via an unspecified route of administration, administered in Arm Left on 17Apr2021 (at the age of 48-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Diabetes, Neurosarcoidosis, Pachymeningitis, autoimmune disease (Patient take treatment and go for infusion (Pixiz infudion) once a month. Patient taking a medication called Mycophenolate, but patient was told when get the vaccine to take myself off it for period of time because it suppresses patient immune system because patient had an unknown autoimmune disease so taking that for the autoimmune disease. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced I have been having issues with irregular blood sugar levels after corona vaccination/ever since i had the vaccine, i've been having some pretty crazy blood sugar number. The patient underwent lab tests and procedures which included investigation irregular blood sugar level. Therapeutic measures were taken for irregular blood sugar levels with Metformin, Glipizide, and Insulin. Endocrinologist told me to take more insulin and use more until get steady normal blood sugar levels so as far as treatment that is the best that she recommends at this time Patient wanted to know if vaccine blocking the efficacy of Diabetes treatment. It was reported that patient was supposed to get the second dose this Saturday coming up. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia
Clinical narrative: Fever 100.2-100.6F; Severe headache; Body aches; This is a spontaneous report from a contactable consumer (Pfizer employee), the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via intramuscular route of administration in the left arm on 04May2021 at 09:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included ethinylestradiol/norgestimate (SPRINTEC) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 3248) via intramuscular route of administration in the left arm on 13Apr2021 at 09:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. On 04May2021 at 20:00, the night of the injection, the patient experienced fever of 100.2-100.6 Fahrenheit lasting until noon the next day. The patient also experienced severe headache and body aches for 24 hours following injection. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever 100.2-100.6F, severe headache and body aches was recovered on 05May2021.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fear, Urticaria
Clinical narrative: She is scared to get her second dose tomorrow; got a few hives on my body; This is a spontaneous report from a contactable consumer. This 33-year-old female consumer (patient) reported for herself that a 33-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number were not reported), via an unspecified route of administration on 16Apr2021 at the age of 33-years-old as DOSE 1, SINGLE for covid-19 immunization. The patient medical history included asthmatic and allergies (Patient used Zyrtec) from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. On an unspecified date in Ap2021, the patient experienced got a few hives on my body, She was scared to get her second dose tomorrow. It was reported that patient had already received her first dose of the vaccine. Patient set to have her second shot tomorrow. The first shot patient broke out and got a few hives on her body. Patient was told by the doctor to take Benadryl before going. Patient read that shouldn't take any antihistamines. Patient did not know what really should. Patient asthmatic too. Patient just want to make sure it won't interact. Patient wanted to take precautions. Usually, she uses Zyrtec because she suffers from allergies but they thought she was just nervous. She thought it was weird that she broke out into certain spots. Patient stated that if she has to take something she will go purchase it. If she has to take something, then she will. Patient was worried about getting the second vaccine. Patient thought that somebody else has probably reported this same thing because she has other friends who say that they had small allergic reaction. The outcome of the events was unknown.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Nasopharyngitis, Pyrexia
Clinical narrative: Cold like symptoms; However patient has a fever ranging 101.6 F/ we took my daughters temp. today and it is 101.6F; This is a spontaneous report from a contactable consumer. This consumer (patients father) parent reported for a 16-year-old female patient (reporters daughter). A 16-years-old female patient received (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number was not reported) via an unspecified route of administration on 15Apr2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patients father would like to know what the acceptable range of temperature is to get the second dose of the vaccine which was scheduled on 06May2021. The patient experienced cold like symptoms in the last few days on an unspecified date, however patient has a fever ranging 101.6 f/ we took my daughters temp. today and it is 101.6F on 06May2021. The patient underwent lab tests and procedures which included body temperature: 101.6 Fahrenheit on 06May2021.The outcome of event was unknown.  No follow-up attempts are needed. information about lot/batch number cannot be obtained
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose decreased, Chills, Headache, Pain, Pyrexia
Clinical narrative: bad chills; low blood sugar; intense pain on both sides of his temples, temples felt squeezed in a vice and left temple pain; severe headache; Fever; This is a spontaneous report from a contactable consumer (patient himself). A 68-years-old male patient received BNT162bB2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EWD170; Expiry Date: 31Aug2021), via an unspecified route of administration in Arm Left on 30Apr2021 as dose 2, single (at the age of 68-years-old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received BNT162bB2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EWD150; Expiry Date: 31Jul2021), via an unspecified route of administration in Arm Left on 09Apr2021 as dose 1, single for COVID-19 immunisation. On 01May2021, the patient experienced severe headache, fever and intense pain on both sides of his temples, temples felt squeezed in a vice and left temple pain. On 05May2021, the patient experienced bad chills and low blood sugar. He felt an intense pain on both sides of his temples which eventually sub-sided. 5 days later, he said the pain came back, but it was not as severe, and was only on one side. He said that he was worried because headaches are the start of a brain clot. With this, he wants to know if it is normal for a headache to reoccur after 5 days. It was reported that his temples felt squeezed in a vice lasted 2 days. It was reported that he expected that last night, which was almost a week later, he experienced such bad chills. He put on 2 sweaters, used a comforter, and heat. He stated it was very unusual. He caulked it up to be low blood sugar. Reporter stated he was watching his diet those days. On that morning he woke up with the pain again in his left temple. It was the pain he had the day after the vaccine. The same as the first time, but not as severe, only on one side. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Breast pain, Fatigue, Malaise, Musculoskeletal chest pain
Clinical narrative: Tongue got tingly; Mouth is like if she's eating a sour gummy bear, it was very watery; Very tired; Not feeling well; Body was shaking when she was awake; Weird pain on her right side on her rib; pain shoulder; Pain under my breast; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that,  A 38-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EW0162) (at the age of 38 years old), dose 1 via an unspecified route of administration on 20Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date in Apr2021, the patient experienced, she did not remember when she had her first shot. She received the first shot on 20Apr2021. When she had her first shot, her tongue got tingly, like a tingly sensation, and her mouth was like she was eating a sour gummy bear, it was very watery. She further described as it would come and go for the first day she took the vaccine, she thought the second one too. She was very tired, not feeling well, her body was shaking when she was awake. She also had this weird pain on her right side on her rib. She did not know what it was, it was still not going away. It was not like she broke something, but she had herself doing exercise or something, it was kind of there, the pain. She had never had the pain before, she did not know if it was due to vaccine. She had pain under her breast and shoulder and a few days after she received the shot, she had sour taste in her mouth, the latter has resolved in 2021. The outcome of all the events was unknown, and the outcome of the event mouth is like if she's eating a sour gummy bear, it was very watery was recovered on an unspecified date in 2021 and Weird pain on her right side on her rib was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Stomatitis, Tremor
Clinical narrative: Tongue got tingly; Mouth is like if she's eating a sour gummy bear, it was very watery; Very tired; Not feeling well; Body was shaking when she was awake; Weird pain on her right side on her rib; pain shoulder; Pain under my breast; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that,  A 38-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EW0162) (at the age of 38 years old), dose 1 via an unspecified route of administration on 20Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date in Apr2021, the patient experienced, she did not remember when she had her first shot. She received the first shot on 20Apr2021. When she had her first shot, her tongue got tingly, like a tingly sensation, and her mouth was like she was eating a sour gummy bear, it was very watery. She further described as it would come and go for the first day she took the vaccine, she thought the second one too. She was very tired, not feeling well, her body was shaking when she was awake. She also had this weird pain on her right side on her rib. She did not know what it was, it was still not going away. It was not like she broke something, but she had herself doing exercise or something, it was kind of there, the pain. She had never had the pain before, she did not know if it was due to vaccine. She had pain under her breast and shoulder and a few days after she received the shot, she had sour taste in her mouth, the latter has resolved in 2021. The outcome of all the events was unknown, and the outcome of the event mouth is like if she's eating a sour gummy bear, it was very watery was recovered on an unspecified date in 2021 and Weird pain on her right side on her rib was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Nasopharyngitis
Clinical narrative: a bad cold; cough; This is a spontaneous report from a contactable consumer (patient's wife) from a Pfizer sponsored program. A male patient of an unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: unknown) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient was scheduled this afternoon for his 2nd dose but had a bad cold and cough. The reporter wants to know if it was ok to receive the 2nd dose. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Asthma
Clinical narrative: Asthmatic reaction; This is a spontaneous report received from a contactable Pharmacist. A patient of an unknown age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: unknown) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the first dose of the Pfizer COVID vaccine approximately 3 months ago and they came down with an asthmatic reaction and based off of that they have not been able to get the second dose until this time. Basically, what the pharmacist was trying to ask was if the patient could get the second dose of the Pfizer COVID vaccine or do they need to get another COVID vaccine from another manufacturer. The outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Malaise, Myalgia, Nausea
Clinical narrative: Feeling unwell; Muscle pain; Joint pain; Nausea; Headache; This is a spontaneous report from a contactable consumer (patient) via a program and the Regulatory Authority. A female patient of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via an unspecified route of administration, administered on an unknown date as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced muscle pain, feeling unwell, joint pain, nausea, and headache. Patient reported that she was afraid to take the second dose of the vaccine since she had these terrible side effects. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Malaise
Clinical narrative: experiencing diarrhea; experiencing chills; experiencing tiredness; experiencing muscle pain; experiencing joint pain; experiencing nausea; Not feeling well at all; This is a spontaneous report received from a Program. A contactable consumer (patient) reported for herself. A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FW0161, Expiry date: unknown) on 14Apr2021 via an unspecified route of administration as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that patient received her first dose last 14Apr2021. The second dose was scheduled tomorrow 05May2021. The second week after getting the first dose, she was experiencing diarrhea, chills, tiredness, muscle pain, joint pain, and nausea. She was still experiencing this until now and not sure if she can take the second dose tomorrow on 05May2021. She was notified as well that there was no available second dose from the facility where she gets the first dose. Patient reported that the first week after the vaccine she felt fine, but that the last 2 weeks she has not been feeling well at all. Patient reported that she was supposed to go back tomorrow, 05May2021, to have the second dose of the Covid-19 vaccine. Patient stated that she thinks that with every vaccine, when patient don't feel well, she don't go, and get vaccinated. Patient inquired if that was true because she doesn't think that she should get the second dose of the Covid-19 vaccine if she isn't feeling well. Patient was recommended that to reach out her primary care physician for further guidance. Patient reported that she tried to reschedule the appointment for her second dose of the Covid-19 vaccine that was scheduled for tomorrow, 05May2021. Patient reported that when she tried to reschedule the appointment, the website said that there was not going to be any more vaccines in her area. Patient inquired if she was supposed to have the second dose of the Covid-19 vaccine within 6 weeks of the first dose. Patient declined to complete safety report, stating that she was not feeling well on unspecified date in Apr2021 and didn't feel up to it. She had side effect from the vaccination, and she called her doctor. He said that she felt fine the first week, so this was not side effects. He said if she doesnt feel well she should not get the second dose because she was supposed to go tomorrow. If patient didn't had the side effects immediately does that mean that it's not side effects from the vaccine. She got side effects from the flu vaccine. Patient was having chills, nausea, diarrhea, muscle aches, and pains. Outcome of event Not feeling well at all was unknown and all other events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: experiencing diarrhea; experiencing chills; experiencing tiredness; experiencing muscle pain; experiencing joint pain; experiencing nausea; Not feeling well at all; This is a spontaneous report received from a Program. A contactable consumer (patient) reported for herself. A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FW0161, Expiry date: unknown) on 14Apr2021 via an unspecified route of administration as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that patient received her first dose last 14Apr2021. The second dose was scheduled tomorrow 05May2021. The second week after getting the first dose, she was experiencing diarrhea, chills, tiredness, muscle pain, joint pain, and nausea. She was still experiencing this until now and not sure if she can take the second dose tomorrow on 05May2021. She was notified as well that there was no available second dose from the facility where she gets the first dose. Patient reported that the first week after the vaccine she felt fine, but that the last 2 weeks she has not been feeling well at all. Patient reported that she was supposed to go back tomorrow, 05May2021, to have the second dose of the Covid-19 vaccine. Patient stated that she thinks that with every vaccine, when patient don't feel well, she don't go, and get vaccinated. Patient inquired if that was true because she doesn't think that she should get the second dose of the Covid-19 vaccine if she isn't feeling well. Patient was recommended that to reach out her primary care physician for further guidance. Patient reported that she tried to reschedule the appointment for her second dose of the Covid-19 vaccine that was scheduled for tomorrow, 05May2021. Patient reported that when she tried to reschedule the appointment, the website said that there was not going to be any more vaccines in her area. Patient inquired if she was supposed to have the second dose of the Covid-19 vaccine within 6 weeks of the first dose. Patient declined to complete safety report, stating that she was not feeling well on unspecified date in Apr2021 and didn't feel up to it. She had side effect from the vaccination, and she called her doctor. He said that she felt fine the first week, so this was not side effects. He said if she doesnt feel well she should not get the second dose because she was supposed to go tomorrow. If patient didn't had the side effects immediately does that mean that it's not side effects from the vaccine. She got side effects from the flu vaccine. Patient was having chills, nausea, diarrhea, muscle aches, and pains. Outcome of event Not feeling well at all was unknown and all other events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Vaccination site pain
Clinical narrative: He experienced shortness of breath; bit of dizziness; sore arm right after the shot; This is a spontaneous report from a contactable consumer (patient). A 44-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0175) via an unspecified route of administration, administered in Arm Left on 04May2021 (Age at Vaccination 44-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included Blood pressure high from an unknown date and unknown if ongoing. Concomitant medications were not reported. In May2021 He experienced shortness of breath, a bit of dizziness, and sore arm right after the shot and within 15 minutes it has gone away. It was reported that I have a consumer on the other line, he got the first dose of the Pfizer BioNTech Covid-19 vaccine, and I actually addressed his concern. I have already answered his concern about the side effect that he experienced. Now this was just to report the symptom that he had been when he got the first dose when he had the first dose it was 04May2021 and the second dose was scheduled on 25May2021. He experienced shortness of breath right after getting the first dose, but it was just for about 15 minutes and then right after that it started and he experienced a sort of dizziness, those were the only recorded symptoms that he had. When paraphrased the concern, consumer stated, right after in 5 minutes within a few minutes after the shot. When probed for event outcome, consumer stated Yes, it only lasted in 5 or 10 minutes. Patient did not receive any treatment. The outcome of the events was recovered on May2021.  No follow-up attempts are needed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Dyskinesia, Gait disturbance, Myalgia
Clinical narrative: unable to get out of bed; difficulty walking and has been having to use a walker; edema in legs; sever leg pain (muscle and joint pain)/had joint and muscle pain that affected her whole leg from her hip to her toes; sever leg pain (muscle and joint pain)/severe pain in her legs; sever leg pain (muscle and joint pain)/had joint and muscle pain that affected her whole leg from her hip to her toes; leg swelling/edema in her legs/calf and upper leg are still swollen; This is a spontaneous report received from a contactable consumer (Patient). A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203), via an unspecified route of administration, administered in right arm on 24Feb2021 (at the age of 78 years old) as a single dose for COVID-19 immunization. The patient's medical history included Diabetes and high blood pressure from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261), via an unspecified route of administration, administered in right arm on 04Feb2021 (at the age of 78 years old) as a single dose for COVID-19 immunization. The patient had not visited emergency room or physician office due to the event. On 05Apr2021 the patient experienced sever leg pain, Muscle pain, leg swelling, edema in legs while on an unspecified date the patient was unable to get out of bed. On 12Apr2021 the patient experienced difficulty walking and has been having to use a walker. The reporter reported that the patient received both doses at (Redacted). The patient was not provided with any paperwork or information on who to call to report side effects when patient received her vaccine. Patient's husband received the vaccine at the medical center. The patient called the number that was listed on the papers. The reporter reported that patient's left ankle is back to normal in regards to the swelling. Patient's calf and upper leg are still swollen. The patient underwent lab tests and procedures which included Arthritis on an unspecified date. The outcome of the events of Joint pain, Leg pain, Muscle pain, Swelling of legs was recovering while for Movements abnormal was unknown and for Walking difficulty and edema in legs was not recovered.  No follow-up attempts are needed. No further information is expected.