chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Sluggishness, Vomiting
Clinical narrative: throwing up non stop/throwing up all fluids now; feeling really woozy; Nauseous; Diarrhea; Sluggish; she broke out in a sweat; all her energy went away; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 20May2021 at 11:15 (Lot Number: EW0168) as 1st dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she just got her first dose of Pfizer COVID vaccine at 11:15 am on 20May2021. At around 12:30 or 1pm, she started feeling really woozy and nauseous. Since 2:3 or 3:00pm, she has been throwing up non-stop. She stated that all her energy went away, felt sluggish was nauseous and she broke out in a sweat. She even had diarrhea a few times and that threw her off. She was throwing up all fluids now and she was scared to drink anything. The patient did not receive treatment for the events. the events did not require a visit to emergency room or physician office. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: arm was numb; This is a spontaneous report received from a contactable consumer (patient). A 40-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in the left Arm on 15Apr2021 at 12: 50 PM (Lot Number: EW0158) as single dose (at the age of 40-year-old) for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  Reported her arm was numb on the side where she received the injection on 15Apr2021. It went numb pretty quickly after the first dose - then it was numb for about 24 hours. It went away completely in two days. The outcome of the event was recovered on 17Apr2021.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Has a temperature this morning of 104.4; This is a spontaneous report from a contactable Consumer or other non-health professional. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient did not used other Products. No Investigation Assessment was provided. Consumer stated that, the patient experienced temperature of 104.4 after he got his second shot of Pfizer yesterday on an unspecified date. The patient underwent lab tests and procedures which included body temperature: 104.4 on an unspecified date. No therapeutic measures were taken in response to event. The outcome of the event was unknown.   Reporter was concerned about whether patient need to visit emergency room or was that the normal reaction. Reporter was provided with the number of Pfizer Medical Information Department.  Follow-up attempts are needed; information about lot/batch number requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Syncope
Clinical narrative: Fainted; Feeling very light-headed; Slightly nauseous; This is a spontaneous report from a non-contactable consumer (patient). A 50-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EW0179, expiration date unknown) via unspecified route of administration on left arm on 15May2021 at 12:00 PM at age of 50-year-old at single dose for COVID-19 immunization. Patient was not pregnant at time of vaccination and events onset. Medical history included back pain. Patient had no known allergies. Patient previously received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EW0171, expiration date unknown) on 24Apr2021 at 12:00 PM at age of 50-year-old via unspecified route of administration on left arm for COVID-19 immunisation. Concomitant medications included cyclobenzaprine, gabapentin, both administered within 2 weeks of vaccination. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, patient hasn't been tested for COVID-19. In the morning after the injection on 16May2021 at 09:30 AM, patient was in the kitchen and started feeling very light-headed and slightly nauseous. Patient sat in a chair but still felt the same. She got up to go lie down and fainted. After crawling to the couch and lying down for a few minutes, she felt better. The events didn't result in emergency room visit or physician office visit. Outcome of the events was recovered. No treatment received for the events.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Allergy test, Angioedema, Peripheral swelling, Swelling face, Urticaria
Clinical narrative: Angioedema; face and hand swelling; face and hand swelling; generalized hives and into mouth requiring ER visit; This is a initial spontaneous report processed with follow up from a contactable consumer (patient's mother). A contactable consumer reported for her son. A 33-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE for Covid-19 immunization. The patient medical history was not reported. No prior history of allergic response to any medication or food. The patient concomitant medications were not reported. Patient received second dose of Pfizer vaccine 2 and half weeks ago. Within 48 hours the patient had experienced angioedema, face and hand swelling, generalized hives and into mouth requiring ER (emergency room) visit and ongoing high doses of steroids and antihistamines due to persistent symptoms. The patient has completed the untoward reaction form and sent it to the directed website but no response. Currently the patient has an appointment with PRIVACY 21May2021 out of desperation of what to do. Patient received treatment for the events. The patient underwent lab tests and procedures which included serum allergy test: negative on an unspecified date. The outcome of the events was still experiencing side effects.  Information about Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Diarrhoea, Headache
Clinical narrative: He remains ill, even now; Severe diarrhea x5 days; Weakness; Headache; Stomach ache; Nausea; Joint pain; This is a spontaneous report from a contactable consumer. A male patient (reporter's brother-in-law) of an unspecified age received bnt162b2 (Pfizer-BioNTech Covid-19 vaccine) via an unspecified route of administration as a single dose on 08Apr2021 (lot number unknown) at an unknown age for COVID-19 immunization. The patient's medical history included diabetes. Concomitant medications was none. On that day (08Apr2021), the patient had severe diarrhea for 5 days. He also experienced weakness, headache, stomach ache, nausea, and joint pain. He remained ill, even now (in May2021). He got tested for Covid-19, which was negative (in 2021). The reporter thought maybe he had gotten Covid-19 before the vaccine. They thought his reaction was bad, because of his diabetes, his levels were high. He took Tylenol and Motrin. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Nausea, SARS-CoV-2 test
Clinical narrative: He remains ill, even now; Severe diarrhea x5 days; Weakness; Headache; Stomach ache; Nausea; Joint pain; This is a spontaneous report from a contactable consumer. A male patient (reporter's brother-in-law) of an unspecified age received bnt162b2 (Pfizer-BioNTech Covid-19 vaccine) via an unspecified route of administration as a single dose on 08Apr2021 (lot number unknown) at an unknown age for COVID-19 immunization. The patient's medical history included diabetes. Concomitant medications was none. On that day (08Apr2021), the patient had severe diarrhea for 5 days. He also experienced weakness, headache, stomach ache, nausea, and joint pain. He remained ill, even now (in May2021). He got tested for Covid-19, which was negative (in 2021). The reporter thought maybe he had gotten Covid-19 before the vaccine. They thought his reaction was bad, because of his diabetes, his levels were high. He took Tylenol and Motrin. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Pain, Pneumonia, Pulmonary pain, SARS-CoV-2 test
Clinical narrative: It went into my lungs/lung infection/shortness of breath; pain; cough; My lungs hurt when i breathed; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 08May2021 10:30 (Batch/Lot Number: E100171) as 1ST DOSE, SINGLE for covid-19 immunisation at Pharmacy or Drug Store. Medical history included gout from an unknown date and unknown if ongoing, known allergies to latex. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The day after the vaccine on 09May2021 at 06:00 AM, patient developed a cough. It went into his lungs within a couple of days and was eventually put on strong antibiotics with a lung infection. His lungs hurt when he breathed, patient had shortness of breath. It's currently 20May2021 and patient still had pain when he cough but it seems to be improving. The events resulted in Doctor or other healthcare professional office/clinic visit. Events treatments included an inhaler, antibiotics, cough pearls. Covid test post vaccination included Nasal Swab COVID 19 test on 18May2021 and the result was pending. Patient was not recovered from events.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive, Therapeutic response unexpected
Clinical narrative: Had a positive result after getting the Covid-19 vaccine; Had a positive result after getting the Covid-19 vaccine; Her father has rheumatoid arthritis including pain all over. After getting the vaccine, the pain went away. He also had a rash on his arm that cleared up after getting the vaccine; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (reporter's father) with unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date at single dose for COVID-19 immunization. Medical history included patient had rheumatoid arthritis including pain all over, rash on his arm. Concomitant medications were not reported. The patient had a positive result after getting the vaccine. Patient had rheumatoid arthritis including pain all over. After getting the vaccine, the pain went away. He also had a rash on his arm that cleared up after getting the vaccine. The outcome of events was unknown.   Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Peripheral swelling, Rash, Skin discolouration
Clinical narrative: Painful rash on both legs; Painful rash on both legs; Colors range from red with variations of purple looking and feeling bruised  with no injuries, sometimes brown also,; my legs and they are swollen; tingling sensations in my right and left hands; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (not pregnant) received second dose of BNT162B2 (lot number: EN6203) on 19Mar2021 (41-year-old) on left arm at single dose for COVID-19 immunization. Medical history were none. Concomitant medications included bupropion hydrochloride (Wellbutrin), topiramate (TOPAMAX), phentermine, montelukast sodium (SINGULAIR). Historical vaccine included first dose of BNT162B2 (lot number: EN6202) on 26Feb2021 (41-year-old) at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered Hospital. patient did not receive any other vaccines within 4 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. Patient had Painful rash on both legs that continues to change on 31Mar2021. It has been on knees down in different places. The spots on the back of her lower legs continue to hurt. Colors range from red with variations of purple looking and feeling bruised with no injuries, sometimes brown also, mornings it is painful to stand on my legs and they are swollen , also some tingling sensations in her right and left hands. The events were occurred on 31Mar2021. The events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse event: Steroid shot, prednisone, antibiotic. The outcome of the events was not recovered.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Lymphadenopathy, Night sweats, Pyrexia, SARS-CoV-2 test
Clinical narrative: TIA; Swollen lymph nodes in chest and abdomen; enlarged spleen; fever; night sweats; exhaustion; This is a spontaneous report from contactable consumer. This 60-years-old male consumer(patient) reported for himself that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot unknown: unknown) at single dose for COVID-19 immunization on 03Apr2021. Relevant history and concomitant drugs were unknown. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced TIA (Transient ischaemic attack), Swollen lymph nodes in chest and abdomen, enlarged spleen, fever, night sweats, and exhaustion. Emergency room/department or urgent care was need, the patient was hospitalized due to the events. Outcome of events was not resolved. The patient was very sick in the hospital per patient's wife. The patient had SARS-CoV-2 test (Nasal Swab) in Apr2021 (After post vaccination) with negative result.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Splenomegaly, Transient ischaemic attack
Clinical narrative: TIA; Swollen lymph nodes in chest and abdomen; enlarged spleen; fever; night sweats; exhaustion; This is a spontaneous report from contactable consumer. This 60-years-old male consumer(patient) reported for himself that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot unknown: unknown) at single dose for COVID-19 immunization on 03Apr2021. Relevant history and concomitant drugs were unknown. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced TIA (Transient ischaemic attack), Swollen lymph nodes in chest and abdomen, enlarged spleen, fever, night sweats, and exhaustion. Emergency room/department or urgent care was need, the patient was hospitalized due to the events. Outcome of events was not resolved. The patient was very sick in the hospital per patient's wife. The patient had SARS-CoV-2 test (Nasal Swab) in Apr2021 (After post vaccination) with negative result.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anaemia, Condition aggravated, Delirium, Haemophagocytic lymphohistiocytosis, IL-2 receptor assay
Clinical narrative: TIA; Swollen lymph nodes in chest and abdomen; enlarged spleen; fever; night sweats; exhaustion; This is a spontaneous report from contactable consumer. This 60-years-old male consumer(patient) reported for himself that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot unknown: unknown) at single dose for COVID-19 immunization on 03Apr2021. Relevant history and concomitant drugs were unknown. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced TIA (Transient ischaemic attack), Swollen lymph nodes in chest and abdomen, enlarged spleen, fever, night sweats, and exhaustion. Emergency room/department or urgent care was need, the patient was hospitalized due to the events. Outcome of events was not resolved. The patient was very sick in the hospital per patient's wife. The patient had SARS-CoV-2 test (Nasal Swab) in Apr2021 (After post vaccination) with negative result.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Neurological examination, Positron emission tomogram, Pyrexia, SARS-CoV-2 test
Clinical narrative: TIA; Swollen lymph nodes in chest and abdomen; enlarged spleen; fever; night sweats; exhaustion; This is a spontaneous report from contactable consumer. This 60-years-old male consumer(patient) reported for himself that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot unknown: unknown) at single dose for COVID-19 immunization on 03Apr2021. Relevant history and concomitant drugs were unknown. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced TIA (Transient ischaemic attack), Swollen lymph nodes in chest and abdomen, enlarged spleen, fever, night sweats, and exhaustion. Emergency room/department or urgent care was need, the patient was hospitalized due to the events. Outcome of events was not resolved. The patient was very sick in the hospital per patient's wife. The patient had SARS-CoV-2 test (Nasal Swab) in Apr2021 (After post vaccination) with negative result.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Splenomegaly, Thrombocytopenia, Transaminases increased
Clinical narrative: TIA; Swollen lymph nodes in chest and abdomen; enlarged spleen; fever; night sweats; exhaustion; This is a spontaneous report from contactable consumer. This 60-years-old male consumer(patient) reported for himself that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot unknown: unknown) at single dose for COVID-19 immunization on 03Apr2021. Relevant history and concomitant drugs were unknown. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced TIA (Transient ischaemic attack), Swollen lymph nodes in chest and abdomen, enlarged spleen, fever, night sweats, and exhaustion. Emergency room/department or urgent care was need, the patient was hospitalized due to the events. Outcome of events was not resolved. The patient was very sick in the hospital per patient's wife. The patient had SARS-CoV-2 test (Nasal Swab) in Apr2021 (After post vaccination) with negative result.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid the 1st week of May.; tested positive for Covid the 1st week of May; This is a spontaneous report from a Pfizer sponsored program. A non-contactable consumer (patient) reported for himself that a male patient of an unspecified age received bnt162b2, dose 1 via an unspecified route of administration on 19Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received 1st Pfizer Covid vaccine on 19Apr2021 and tested positive for Covid the 1st week of May2021. The patient underwent lab tests and procedures which included Covid test: positive in May2021. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oral pain, Pain in jaw, Swelling face
Clinical narrative: my face was swollen; right side of my mouth and jaw hurting; right side of my mouth and jaw hurting; This is a spontaneous report from a contactable consumer (patient). A 50-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0186), dose 2 via an unspecified route of administration, administered in left arm on 16May2021 at 08:45 as 2nd dose, single for COVID-19 immunization (at the age of 50-years). Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0175), dose 1 via an unspecified route of administration, administered in left arm on 25Apr2021 as 1st dose, as a single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. Neither the patient diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had received no other medications within 2 weeks of vaccination. On 18May2021, the patient woke up with the right side of my mouth and jaw hurting and her face was swollen. The first day, she tried to rinse with salt water and applied hot compresses to her face it didn't do anything. So she decided to do a tele doc video call the after the second day it wasn't getting better. The doctor prescribed antibiotics and told to her it was her tooth, however, she knew that it wasn't her tooth. The outcome of events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021582710 different patient, same drug and event
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: Can I take Tylenol because I do have allergies issues; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 20May2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient asked if the patient can take paracetamol (TYLENOL), acetylsalicylic acid (ASPIRIN) or antihistamine, because the patient did have allergies issues. The outcome of the event was unknown.
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Lymph node pain
Clinical narrative: faint; pain in joints; light headness; swollen painful lymphnodes; swollen lymph node; fever; fatigued; headache; This is a spontaneous report from a contactable consumer (patient). A 51-year-old patient of an unspecified gender received bnt162b2 (BNT162B2) dose 2 via an unspecified route of administration administered in left arm on 20Mar202114:20 (Lot Number: EP7534) as single dose for COVID-19 immunisation. Medical history included ulceritive colitis from 1996 and ongoing, fibromyalgia from 2010 and ongoing, premenstrual dysphoric disorder from 2002 and ongoing, spinal stenosis from 2011 and ongoing. Concomitant medications included trazodone taken for sleep from Feb2021 and ongoing; bupropion hydrochloride (WELLBUTRIN) taken for disturbance from 16Feb2021; cyclobenzaprine taken for muscle spasms from 2016 and ongoing; suvorexant (BELSOMRA) taken for sleep deficit from 2018 and ongoing. The patient previously took first dose of BNT162B2 on 27Feb2021 (lot# EN6203) via intramuscular in left upper arm for COVID-19 immunisation and experienced events extreme fatigue swollen lymph node. COVID virus tests were negative on 07Jan2021 and 15Jan2021. The patient experienced fever and headaches on 21Mar2021. The patient had swollen, painful lymph nodes, and pain in joint and fatigue on an unspecified date. The patient got faint every time stand up. The patient experienced lightheadedness regularly but not every time stand up. No treatment was received for events fever, headache, fatigued. The outcome of events fever was recovered in Mar2021, outcome of event headache was recovering, outcome of other was unknown.
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pyrexia, SARS-CoV-2 test, Syncope
Clinical narrative: faint; pain in joints; light headness; swollen painful lymphnodes; swollen lymph node; fever; fatigued; headache; This is a spontaneous report from a contactable consumer (patient). A 51-year-old patient of an unspecified gender received bnt162b2 (BNT162B2) dose 2 via an unspecified route of administration administered in left arm on 20Mar202114:20 (Lot Number: EP7534) as single dose for COVID-19 immunisation. Medical history included ulceritive colitis from 1996 and ongoing, fibromyalgia from 2010 and ongoing, premenstrual dysphoric disorder from 2002 and ongoing, spinal stenosis from 2011 and ongoing. Concomitant medications included trazodone taken for sleep from Feb2021 and ongoing; bupropion hydrochloride (WELLBUTRIN) taken for disturbance from 16Feb2021; cyclobenzaprine taken for muscle spasms from 2016 and ongoing; suvorexant (BELSOMRA) taken for sleep deficit from 2018 and ongoing. The patient previously took first dose of BNT162B2 on 27Feb2021 (lot# EN6203) via intramuscular in left upper arm for COVID-19 immunisation and experienced events extreme fatigue swollen lymph node. COVID virus tests were negative on 07Jan2021 and 15Jan2021. The patient experienced fever and headaches on 21Mar2021. The patient had swollen, painful lymph nodes, and pain in joint and fatigue on an unspecified date. The patient got faint every time stand up. The patient experienced lightheadedness regularly but not every time stand up. No treatment was received for events fever, headache, fatigued. The outcome of events fever was recovered in Mar2021, outcome of event headache was recovering, outcome of other was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Bleeding time prolonged
Clinical narrative: Asthma attack/breathing problems; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received bnt162b2 (Pfizer/BioNTech COVID-19 vaccine), dose 1 intramuscular, administered in left arm on 19Mar2021 08:30 A.M. (Lot Number: EP7534), at the age of 67-years-old, as single dose for COVID-19 immunization. Medical history included hysterectomy from 1991, ongoing pancreatic cyst- benign, followed yearly, ongoing prolonged bleeding time, idiopathic, allergies: many dyes, shellfish, bandaids, nickel, Neosporin, artificial sugars (all are ongoing). Family medical history included Mother and Aunt- Lupus and lymphoma; Sister- Graves' disease and breast CA. The patient's concomitant medications were not reported. The patient stated that after the 1st shot, she had an asthma attack in the middle of the night on 19Mar2021. This was not typical for her. Treatment included Benadryl, orally from 20Mar2021 to 20Mar2021 for asthma attack, breathing problems after 1st vaccine at midnight. The event was reported as not serious. The patient underwent lab tests and procedures which included bleeding time prolonged, idiopathic on an unknown date. The outcome of the event was unknown. The patient received the 2nd dose on 09Apr2021 08:30 A.M. (Lot number: EW0153).
Sex: F
Vaccine: COVID19
Symptoms: Bleeding time, Headache, Pain, Pain in extremity, Pain in jaw
Clinical narrative: shooting pains in all parts of the body/Awake all night shooting pains all over the body all night; Shock like pains in legs, arms, head, jaw intermittent; Shock like pains in legs, arms, head, jaw intermittent; jaw intermittent; This is a spontaneous report from a contactable consumer (Patient) and in response to HCP letter sent to physician via telephonic follow-up activity.  A female patient of an unspecified age received second dose of BNT162B2 (Pfizer COVID-19 Vaccine, solution for injection, Lot Number: EW0153; Expiration Date: 09Apr2021), via intramuscular route of administration, administered in left arm on 09Apr2021 at 08:30 as single dose for COVID-19 immunisation. Medical history included hysterectomy in 1991, Pancreatic Cyst-Benigh in 2016, patient is allergic to many dyes, shellfish, bandaids, nickel, neosporin, artificial sugars, ongoing idiopathic condition followed yearly at medical facility, prolonged bleeding time. Patient had familial history: mother and aunt had Lupus and Lymphoma and patient sister had Graves disease and Breast CA. Patient previously took first dose of BNT162B2 (Pfizer COVID-19 Vaccine, solution for injection, Lot Number: EP7534; Expiration Date: 19Mar2021), via intramuscular route of administration, administered in left arm on 19Mar2021 at 08:30 as single dose for COVID-19 immunisation and on 20Mar2021 (after 1st vaccine at midnight), patient had asthma attack breathing problems which was not typical for her, considered non-serious and was treated with Benadryl and recovered. On 09Apr2021 at 09:00 PM (same day after 2nd vaccination), patient was awake all-night shooting pains all over the body all night/shooting pains in all parts of her body and experienced shock like pains in legs, arms, head, jaw intermittent. Patient stated that shooting pains all over the body were not very painful, but it was strange. Patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included bleeding time: Prolonged   on   Norm high (Idiopathic) on an unspecified date. Patient stated that she was sent a paper in the mail for a refund for the vaccine that also says she had an ineffective vaccine which was not true. Additionally, her insurance covered her vaccine, and she was not sure why she was being offered a refund. Patient called Pfizer, only to make them aware of her side effects and not interested in a refund. Patient stated she knew a 37-year-old who died with no underlying conditions, and another person who had very bad side effects. After getting shooting pains, she has since spoken with friends who have heard of others with these side effects. The outcome of all the events was unknown.    Follow-up attempts are needed. Further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: After my 2nd dose I got all covid symptoms which lasted for 3 days; After my 2nd dose I got all covid symptoms which lasted for 3 days/cough lasted for a month and I still have no got my taste back. My lymph nodes were swollen under my right arm; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 2021 (Batch/Lot number was not reported) as 2nd dose, single dose, dose 1 via an unspecified route of administration, administered in Arm Right on 14Jan2021 (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Feb2021, after my 2nd dose I got all covid symptoms which lasted for 3 days. They cough lasted for a month and I still have no got my taste back. My lymph nodes were swollen under my right arm. It's been 3 months and I can't taste. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the adverse event for the past 3 weeks. The outcome of the events was not recovered.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Hypoglycaemia, Syncope
Clinical narrative: blood sugar was 500/high blood sugar; fainted because of hypoglycemia; fainted because of hypoglycemia; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller mentioned her oncologist who stated that his wife didn't have diabetes. Ten days after his wife (patient) got the second dose of the Covid Vaccine her blood sugar was 500.  Caller stated that her oncologist wife was placed on medication for the high blood sugar and then fainted because of hypoglycemia.  She says the wife was taken back off of the medication and was fine. Outcome of events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of blood sugar increased due to temporal relationship.  The events 'fainted because of hypoglycemia' were associated with blood sugar medication and unrelated to BNT162B2 vaccine. Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose abnormal
Clinical narrative: having a blood sugar problem; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number was not reported), via an unspecified route of administration on 16Apr2021 (at an unspecified age) as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had her first dose of the vaccine 16Apr2021 and wanted to set up an appointment for her second dose of the vaccine. It had been longer than 21 days since the first dose of the vaccine. She was scheduled to have the second dose 07May2021 but was hospitalized and was having medical issues. Her hospitalization occurred after her first dose of the vaccine. Her husband called the paramedics because she was having a blood sugar problem on an unspecified date. She stated this event had nothing to do with the vaccine. The outcome of the event was unknown.  Information on the batch/lot number has been requested.; Sender's Comments: There is no sufficient evidence that the reported blood sugar problem, although temporally related, may be related to administration of BNT162B2. Of note, medical history and concomitant medications were not provided to determine pre-existing risk factors or conditions that may have led to the event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage
Clinical narrative: had very little bleeding; This is a spontaneous report from a contactable consumer. This report is split from information received by Pfizer from Bristol-Myers Squibb (manufacturer control number US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-048189). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unknown route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient took the COVID vaccine and had very little bleeding. The outcome of event was unknown.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Diplopia, Eye movement disorder, Facial paralysis
Clinical narrative: Cranial Nerve VII Palsy; Double Vision requiring an eye patch on one eye so that I can see single objects; Medial drifting of left eye. Inability of left eye to move laterally past midline.; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: ER8733), at the age of 83 years old, in right arm on 30Apr2021 at single dose for covid-19 immunisation (The patient also received the second dose of BNT162B2 (lot number: EW0169), at the age of 83 years old, on 30Apr2021 at single dose for covid-19 immunisation, pending clarification). The patient was not diagnosed with covid-19 prior to vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID) and omeprazole. The patient did not receive any other vaccines within 4 weeks prior to vaccination. The patient experienced cranial nerve VII palsy on Apr2021. On Apr2021, double vision requiring an eye patch on one eye so that she can see single objects, medial drifting of left eye and inability of left eye to move laterally past midline. The patient was hospitalized for the events for 4 days. The patient was unknown if she was tested for covid-19 since the vaccination. Therapeutic measures were taken as a result of events and included treatment with prednisone. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Product dose omission issue
Clinical narrative: because of blood pressure and AFIB issues and had a pacemaker implanted and missed her 2nd shot.; because of blood pressure and AFIB issues and had a pacemaker implanted and missed her 2nd shot.; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 78-years-old female patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on 06Apr2021 (age at vaccination 78 years) as single dose for COVID-19 immunization. Medical history included previously had a stroke 3 months ago. Been in Anaphylactic shock in the past due to severe allergic reactions to medication. Concomitant medications included was not reported. she was on Eliquis which a blood thinner and taking other heart medication. On 27Apr2021 the patient was admitted to the hospital, she had previously a stroke 3 month ago and she was admitted to the hospital for implant of a pacemaker on Apr27. she was recently released from the hospital and patient was in the rehab for about 2 weeks. she wants to know it safe for her to get the second shot under these circumstances. Patient on Eliquis used as a blood thinner and taking other heart medications. She going to be 79 next months and patient just wanted to know if there's a risk for patient. and she also had been in anaphylactic shock in the past due to severe allergic reactions to medication. she wants to confirm that the weather needs to reschedule for 1 dose if patient missed the 42 days window. Consumer was provided Pfizer Medical Information website. On 27Apr2021 the patient experienced because of blood pressure and AFIB issues and had a pacemaker implanted and missed her 2nd shot. The outcome of events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Feeling abnormal, Mental impairment
Clinical narrative: Feels out of it Mentally; chills; lack of energy/Zero Energy; loss of appetite; nausea; feeling super crappy/Not feeling 100%; This is a spontaneous report from a contactable consumer (patient, self-reported). A 25-years-old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot Number: EW0177, Expiration date: Unknown), dose 2 via an unspecified route of administration in the left arm, on 15May2021 in afternoon at 15:00-16:00 (age at the time 25-year-old) last Saturday, as single dose for her autoimmune disease (COVID-10 immunization). The patient's medical history included colitis ulcerative from 2012 and ongoing and has auto immune diseases. The patient previously received bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot Number: ER8736, Expiration date: Unknown), dose 1 via an unspecified route of administration in the left arm, on 24Apr2021 (age at the time 25-year-old), as single dose for COVID-10 immunization. No additional vaccines administered on same date of the Pfizer suspect. Concomitant medications included azathioprine and balsalazide was anti-inflammatory taken for colitis ulcerative from 2012, the patient takes a bunch of other medications, but these are the only two, she felt these concomitant medications could be related to her adverse events and she takes valsalide. The patient reported she took high dose of immunosuppressants. No prior vaccination within 4weeks. On 16May2021 (Sunday morning) at 07:00-08:00, the patient started having chills, still feels mentally out of it, lack of energy/Zero energy, nausea, loss of appetite, feeling super crappy, not feeling 100% and everything CDC has on the list. She enquired that how long will her side effects last, and any connection to the immunosuppressants. On 24May2021, today, the patient still feels out of it mentally, had zero energy, and she tried going into work and can't do what she needs to do. The patient stated that it took her up until Friday to stop having chills and to stop feeling super crappy. The patient doesn't know if there was any information about how long it will take to fully recover, and she was worried, and her boss was worried about her too. The patient did not visit emergency room. The patient enquired her physician last week and her boss wants her to go see a doctor or someone, so she probably will be going to some form of Urgent Care today. Therapeutic measures were taken with Tylenol. The patient underwent lab tests and procedures which were not included. The clinical outcome of the events loss of appetite, and asthenia was not recovered, chills was recovered on 21May2021, all other events was recovering.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Feels out of it Mentally; chills; lack of energy/Zero Energy; loss of appetite; nausea; feeling super crappy/Not feeling 100%; This is a spontaneous report from a contactable consumer (patient, self-reported). A 25-years-old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot Number: EW0177, Expiration date: Unknown), dose 2 via an unspecified route of administration in the left arm, on 15May2021 in afternoon at 15:00-16:00 (age at the time 25-year-old) last Saturday, as single dose for her autoimmune disease (COVID-10 immunization). The patient's medical history included colitis ulcerative from 2012 and ongoing and has auto immune diseases. The patient previously received bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot Number: ER8736, Expiration date: Unknown), dose 1 via an unspecified route of administration in the left arm, on 24Apr2021 (age at the time 25-year-old), as single dose for COVID-10 immunization. No additional vaccines administered on same date of the Pfizer suspect. Concomitant medications included azathioprine and balsalazide was anti-inflammatory taken for colitis ulcerative from 2012, the patient takes a bunch of other medications, but these are the only two, she felt these concomitant medications could be related to her adverse events and she takes valsalide. The patient reported she took high dose of immunosuppressants. No prior vaccination within 4weeks. On 16May2021 (Sunday morning) at 07:00-08:00, the patient started having chills, still feels mentally out of it, lack of energy/Zero energy, nausea, loss of appetite, feeling super crappy, not feeling 100% and everything CDC has on the list. She enquired that how long will her side effects last, and any connection to the immunosuppressants. On 24May2021, today, the patient still feels out of it mentally, had zero energy, and she tried going into work and can't do what she needs to do. The patient stated that it took her up until Friday to stop having chills and to stop feeling super crappy. The patient doesn't know if there was any information about how long it will take to fully recover, and she was worried, and her boss was worried about her too. The patient did not visit emergency room. The patient enquired her physician last week and her boss wants her to go see a doctor or someone, so she probably will be going to some form of Urgent Care today. Therapeutic measures were taken with Tylenol. The patient underwent lab tests and procedures which were not included. The clinical outcome of the events loss of appetite, and asthenia was not recovered, chills was recovered on 21May2021, all other events was recovering.  Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Chills, Heavy menstrual bleeding, Hypomenorrhoea, Inappropriate schedule of product administration
Clinical narrative: I am a very regular person in my 28 day menstrual cycle.   After my first shot on march 31st. I had a sore for about 4 or 5 days. I was fine. But my period came unexpectedly 5 days early on April 15. It was a very light flow and only 3 days long. My regular period is about 7 days.  My next period came on May 8th. At first spotting, then full period. This was a more normal 7 days.  I had my second dose vaccine injection on May 17th at 11am.  I had a fever for 3 days with shivers and body pains. Suddenly the fevers and chills just stopped after 3rd day.  No one else in my family in our household got obvious side effects (all men).  I got a vaginal yeast infection which was treated at home with over the counter medication on May 27th.  Very rare to get for me.   My 3rd period started on June 2nd. Very heavy flow with a lot of back pain.   My periods are now random and just not normal.