chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: received the covid-19 vaccine and died; This is a spontaneous report. A contactable consumer reported for a male patient (reporter's cousin) of an unspecified age received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the COVID-19 vaccine and died on an unspecified date. The reporter stated that "All the vaccines have Graphene oxide and that is what is killing people. Some countries are not giving any vaccines at this time. His cousin received the COVID-19 vaccine and died, but is not sure which vaccine his cousin had. None of the CEO's have had the COVID-19 vaccine, and that this is genocide." It was unknown if an autopsy was performed.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Reported Cause(s) of Death: received the covid-19 vaccine and died
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Hypoaesthesia, Lip swelling, Pharyngeal disorder, Pruritus
Clinical narrative: tightening of throat; 5 hours after 2nd dose I experienced a thickening of my throat; voice change; numbness of nose and left jaw and cheek; swollen lips; Itching of face; This is a spontaneous report from a contactable Consumer (patient). A 47-year-old female (not pregnant) patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number FA7485, on 16Aug2021 13:00 at single dose in left arm (at the age of 47-year-old) for COVID-19 immunization. Medical history included Chiari, Syringomylia, allergy to pineapple, and covid. The patient had covid prior vaccination. The patient had no covid tested post vaccination. Concomitant medication was none. The patient had no other vaccine in four weeks. The patient previously received first dose of BNT162B2 lot Number: FA6780 on 26Jul2021 13:00 in left arm for COVID-19 Immunization. On 16Aug2021 18:00 (5 hours after 2nd dose) the patient experienced a thickening of her throat,  tightening of throat, voice change, numbness of nose and left jaw and cheek, swollen lips. Itching of face. No respiratory issues.  She immediately took 2 Benadryl.  Symptoms did not get worse and started to clear within 15-20 min. She called her PC and had them document in her medical record.  The outcome of all events was resolved in Aug2021.  Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: tightening of throat; 5 hours after 2nd dose I experienced a thickening of my throat; voice change; numbness of nose and left jaw and cheek; swollen lips; Itching of face; This is a spontaneous report from a contactable Consumer (patient). A 47-year-old female (not pregnant) patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number FA7485, on 16Aug2021 13:00 at single dose in left arm (at the age of 47-year-old) for COVID-19 immunization. Medical history included Chiari, Syringomylia, allergy to pineapple, and covid. The patient had covid prior vaccination. The patient had no covid tested post vaccination. Concomitant medication was none. The patient had no other vaccine in four weeks. The patient previously received first dose of BNT162B2 lot Number: FA6780 on 26Jul2021 13:00 in left arm for COVID-19 Immunization. On 16Aug2021 18:00 (5 hours after 2nd dose) the patient experienced a thickening of her throat,  tightening of throat, voice change, numbness of nose and left jaw and cheek, swollen lips. Itching of face. No respiratory issues.  She immediately took 2 Benadryl.  Symptoms did not get worse and started to clear within 15-20 min. She called her PC and had them document in her medical record.  The outcome of all events was resolved in Aug2021.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Ear pain, Fatigue, Feeling abnormal, Headache
Clinical narrative: sporadic pains in both shins and in my left arm where vaccine was given; sporadic pains in both shins and in my left arm where vaccine was given; My throat was sore on the left side; some pain in my left ear.; stiff neck; tight left shoulder blade; sciatica pain; Within 20 minutes I had a strange sensation across my eye area. It was a strange numb, tingly sensation.; Within 20 minutes I had a strange sensation across my eye area. It was a strange numb, tingly sensation.; fatigue; brain fog; headaches sometimes; inflammation; nerve pain; nerve pain and impairment; sporadic pains in both shins; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female (not pregnant) patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number FE3592, on 27Aug2021 03:30 at single dose in left arm (at the age of 56-year-old) for COVID-19 immunization. Medical history included attention deficit hyperactivity disorder (ADHD), allergy to Wheat, dairy and soy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), multivitamin and paracetamol (TYLENOL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Aug2021 03:45 (within 20 minutes) the patient had a strange sensation across her eye area. It was a strange numb, tingly sensation. The next morning she was having sporadic pains in both shins and in left arm where vaccine was given. Her throat was sore on the left side and had some pain in her left ear. That afternoon she started having significant numbness and tingling over her face from above her eyes all the way down around her nose and around her gums. Her arms and hands became numb and tingly also. Later that night, she started experiencing a stiff neck, tight left shoulder blade, and a shooting pain down her left buttocks into the back of her thigh much like sciatica pain. Today was day 4 since her vaccine and she continue to have fatigue, brain fog, pain and stiffness down left side as mentioned above, and headaches- sometimes behind left eye and sometimes over forehead and base of skull. This was concerning that the vaccine had created inflammation including nerve pain and impairment.  No treatment was received for all events. The outcome of all events was not resolved.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Inflammation, Muscle tightness, Musculoskeletal stiffness, Nervous system disorder
Clinical narrative: sporadic pains in both shins and in my left arm where vaccine was given; sporadic pains in both shins and in my left arm where vaccine was given; My throat was sore on the left side; some pain in my left ear.; stiff neck; tight left shoulder blade; sciatica pain; Within 20 minutes I had a strange sensation across my eye area. It was a strange numb, tingly sensation.; Within 20 minutes I had a strange sensation across my eye area. It was a strange numb, tingly sensation.; fatigue; brain fog; headaches sometimes; inflammation; nerve pain; nerve pain and impairment; sporadic pains in both shins; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female (not pregnant) patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number FE3592, on 27Aug2021 03:30 at single dose in left arm (at the age of 56-year-old) for COVID-19 immunization. Medical history included attention deficit hyperactivity disorder (ADHD), allergy to Wheat, dairy and soy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), multivitamin and paracetamol (TYLENOL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Aug2021 03:45 (within 20 minutes) the patient had a strange sensation across her eye area. It was a strange numb, tingly sensation. The next morning she was having sporadic pains in both shins and in left arm where vaccine was given. Her throat was sore on the left side and had some pain in her left ear. That afternoon she started having significant numbness and tingling over her face from above her eyes all the way down around her nose and around her gums. Her arms and hands became numb and tingly also. Later that night, she started experiencing a stiff neck, tight left shoulder blade, and a shooting pain down her left buttocks into the back of her thigh much like sciatica pain. Today was day 4 since her vaccine and she continue to have fatigue, brain fog, pain and stiffness down left side as mentioned above, and headaches- sometimes behind left eye and sometimes over forehead and base of skull. This was concerning that the vaccine had created inflammation including nerve pain and impairment.  No treatment was received for all events. The outcome of all events was not resolved.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Oropharyngeal pain, Pain in extremity, Paraesthesia, Sciatica
Clinical narrative: sporadic pains in both shins and in my left arm where vaccine was given; sporadic pains in both shins and in my left arm where vaccine was given; My throat was sore on the left side; some pain in my left ear.; stiff neck; tight left shoulder blade; sciatica pain; Within 20 minutes I had a strange sensation across my eye area. It was a strange numb, tingly sensation.; Within 20 minutes I had a strange sensation across my eye area. It was a strange numb, tingly sensation.; fatigue; brain fog; headaches sometimes; inflammation; nerve pain; nerve pain and impairment; sporadic pains in both shins; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female (not pregnant) patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number FE3592, on 27Aug2021 03:30 at single dose in left arm (at the age of 56-year-old) for COVID-19 immunization. Medical history included attention deficit hyperactivity disorder (ADHD), allergy to Wheat, dairy and soy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), multivitamin and paracetamol (TYLENOL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Aug2021 03:45 (within 20 minutes) the patient had a strange sensation across her eye area. It was a strange numb, tingly sensation. The next morning she was having sporadic pains in both shins and in left arm where vaccine was given. Her throat was sore on the left side and had some pain in her left ear. That afternoon she started having significant numbness and tingling over her face from above her eyes all the way down around her nose and around her gums. Her arms and hands became numb and tingly also. Later that night, she started experiencing a stiff neck, tight left shoulder blade, and a shooting pain down her left buttocks into the back of her thigh much like sciatica pain. Today was day 4 since her vaccine and she continue to have fatigue, brain fog, pain and stiffness down left side as mentioned above, and headaches- sometimes behind left eye and sometimes over forehead and base of skull. This was concerning that the vaccine had created inflammation including nerve pain and impairment.  No treatment was received for all events. The outcome of all events was not resolved.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sporadic pains in both shins and in my left arm where vaccine was given; sporadic pains in both shins and in my left arm where vaccine was given; My throat was sore on the left side; some pain in my left ear.; stiff neck; tight left shoulder blade; sciatica pain; Within 20 minutes I had a strange sensation across my eye area. It was a strange numb, tingly sensation.; Within 20 minutes I had a strange sensation across my eye area. It was a strange numb, tingly sensation.; fatigue; brain fog; headaches sometimes; inflammation; nerve pain; nerve pain and impairment; sporadic pains in both shins; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female (not pregnant) patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number FE3592, on 27Aug2021 03:30 at single dose in left arm (at the age of 56-year-old) for COVID-19 immunization. Medical history included attention deficit hyperactivity disorder (ADHD), allergy to Wheat, dairy and soy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), multivitamin and paracetamol (TYLENOL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Aug2021 03:45 (within 20 minutes) the patient had a strange sensation across her eye area. It was a strange numb, tingly sensation. The next morning she was having sporadic pains in both shins and in left arm where vaccine was given. Her throat was sore on the left side and had some pain in her left ear. That afternoon she started having significant numbness and tingling over her face from above her eyes all the way down around her nose and around her gums. Her arms and hands became numb and tingly also. Later that night, she started experiencing a stiff neck, tight left shoulder blade, and a shooting pain down her left buttocks into the back of her thigh much like sciatica pain. Today was day 4 since her vaccine and she continue to have fatigue, brain fog, pain and stiffness down left side as mentioned above, and headaches- sometimes behind left eye and sometimes over forehead and base of skull. This was concerning that the vaccine had created inflammation including nerve pain and impairment.  No treatment was received for all events. The outcome of all events was not resolved.
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder
Clinical narrative: having problems with her left eye twisting; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced having problems with her left eye twisting. The outcome of event was unknown.   The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient).  A 6-decade-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose, 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 medical history was not reported. The patient's and concomitant medications were not reported. The patient experienced positive covid-19 test with symptoms on an unspecified date after both doses of vaccine. Expressed symptoms not great, felt like a super bad hangover with a bad cold, cough, no smell/taste. No problem breathing or anything. The patient underwent lab tests and procedures which included sars-cov-2 test positive on an unspecified date. Outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fall, Hyperhidrosis, Loss of consciousness
Clinical narrative: blackout (falling to the floor and unable to get up on my on); weakness; blackout (falling to the floor and unable to get up on my on); sweats; Chills; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female (not pregnant) patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number FD0809, on 31Aug2021 08:15 at single dose in left arm (at the age of 63-year-old) for COVID-19 immunization. Medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Concomitant medication included unspecified medication. The patient received other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 lot number= FC3180 on 10Aug2021 10:45 AM in left arm for COVID-19 Immunization. The patient previously received olmesartan medoxomil (BENICAR) and experienced allergy. On 31Aug2021, the patient experienced Chills on the day of second vaccine. The following morning (01Sep2021 02:30), the patient experienced weakness, blackout (falling to the floor and unable to get up on her on), sweats. No treatment was received for all events. The outcome of all events was resolving.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain, Colitis, Colonoscopy, Computerised tomogram
Clinical narrative: severe stabbing pains in abdomen/colon; Within 5 hours i started having severe stabbing pains in my abdomen/colon; abdomen swelled; CT showed my colon to be swollen / An emergency colonoscopy showed it to be extremely inflamed; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient (not pregnant) received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 13Aug2021 at 12: 00 PM (Lot Number: FA7484) at the age of 77-year-old as single dose for COVID-19 immunization. Medical history included breast cancer twice, ovarian cancer from 2013 to May2021 and sulfa allergy. COVID prior vaccination was none. COVID tested post vaccination was none. The patient didn't received other vaccine in four weeks. Concomitant medication included niraparib tosylate monohydrate (ZEJULA), fexofenadine hydrochloride (ALLEGRA) and Multivitamin. The patient previously received Codeine and experience allergy. On 13Aug2021 at 05:00pm, within 5 hours, the patient started having severe stabbing pains in abdomen/colon and abdomen swelled to where he looked 7 months pregnant. The pain was so bad he doubled over every time it hit. 1000mg of Tylenol was necessary to help pain that subsided by midnight. Patient had to take Tylenol 2-3 times a day for 5 days. The swelling was gone by the end of a week. Patient had the same reaction with the same time lapse to Neulasta. A CT showed colon to be swollen. An emergency colonoscopy showed it to be extremely inflamed. The colonoscopy was done at (Name withheld). The patient was Terrified of Getting A Second Dose 3Sep21 and most likely will not. No treatment was received. The outcome of events was recovered.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal pain
Clinical narrative: severe stabbing pains in abdomen/colon; Within 5 hours i started having severe stabbing pains in my abdomen/colon; abdomen swelled; CT showed my colon to be swollen / An emergency colonoscopy showed it to be extremely inflamed; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient (not pregnant) received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 13Aug2021 at 12: 00 PM (Lot Number: FA7484) at the age of 77-year-old as single dose for COVID-19 immunization. Medical history included breast cancer twice, ovarian cancer from 2013 to May2021 and sulfa allergy. COVID prior vaccination was none. COVID tested post vaccination was none. The patient didn't received other vaccine in four weeks. Concomitant medication included niraparib tosylate monohydrate (ZEJULA), fexofenadine hydrochloride (ALLEGRA) and Multivitamin. The patient previously received Codeine and experience allergy. On 13Aug2021 at 05:00pm, within 5 hours, the patient started having severe stabbing pains in abdomen/colon and abdomen swelled to where he looked 7 months pregnant. The pain was so bad he doubled over every time it hit. 1000mg of Tylenol was necessary to help pain that subsided by midnight. Patient had to take Tylenol 2-3 times a day for 5 days. The swelling was gone by the end of a week. Patient had the same reaction with the same time lapse to Neulasta. A CT showed colon to be swollen. An emergency colonoscopy showed it to be extremely inflamed. The colonoscopy was done at (Name withheld). The patient was Terrified of Getting A Second Dose 3Sep21 and most likely will not. No treatment was received. The outcome of events was recovered.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, UNK
Symptoms: Anhedonia, Confusional state, Dyspnoea
Clinical narrative: Confusion, shock as in not being able to move around much or lack of interest, hard to breath.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Chest discomfort, Dyspnoea, Electrocardiogram, Fibrin D dimer
Clinical narrative: Likely allergic reaction, shortness of breath, chest and throat tightness
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Throat tightness, Troponin
Clinical narrative: Likely allergic reaction, shortness of breath, chest and throat tightness
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Polymenorrhoea
Clinical narrative: Menstral cycle happening more frequently.  About every 17 to 21 days. Normal cycle is about every 28 to 32 days.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Adnexa uteri pain, Arthralgia, Burning sensation, Chills, Gait disturbance
Clinical narrative: Face swelled up on one side; all joints hurt, but where  I broke my elbow and wrist it felt like I broke it all over again; chills; skin hurt and felt like it was on fire, still hurts, not on fire anymore; my uterus and ovaries hurt so bad I could not even walk.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Swelling face, Uterine pain
Clinical narrative: Face swelled up on one side; all joints hurt, but where  I broke my elbow and wrist it felt like I broke it all over again; chills; skin hurt and felt like it was on fire, still hurts, not on fire anymore; my uterus and ovaries hurt so bad I could not even walk.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction; This is a spontaneous report from a contactable consumer (patient) received through a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: ER8735) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that after her first dose of the Pfizer vaccine, she experiences a severe allergic reaction on an unspecified date. she also mentioned that she already missed her second dose because she was afraid to take the second dose that is because of experience she had with the first dose, which is severe allergic reaction." she also wants to know how to go about this afterwards you know because everything is shutting down and there are lot of 'cases' that require vaccine cards (Further clarification was unknown)."Consumer was provided with the number of Pfizer Medical Information Department. When probed the permission to file safety report, consumer stated, "she thinks she will call them at another time because she on my Lunch break and she have to go back to work soon. The event outcome was unknown.  QR comment: Reporter type was not available over the call as the consumer was unwilling to answer further questions, hence reporter type was captured as consumer or non-healthcare professional by default.  Product details (Expiration date, NDC# and UPC#) treatment and other details could not be probed over the call as the consumer was not willing to share further information. Hence, Limited information was available over the call.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable consumer (patient) via a program.   A 13-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration at the left arm on 12Aug2021, at the age of 13 years old (Batch/lot number: EW0170) as single dose for covid-19 immunisation. Medical history included Seasonal allergy. The patient's concomitant medication included ZYRTEC. On unknown date the patient tested positive for Covid with outcome of unknown.  No follow-up attempts possible. No further information expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 infection; COVID-19 infection; This is a spontaneous report from a contactable consumer. A non-pregnant 49-year-old male patient received bnt162b2 (Formulation: Solution for injection) via unspecified route of administration on unspecified in Mar2021 (Lot number and expiration date: not reported, age at vaccination: 49-year-old) as single dose (dose number unknown) for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. On unspecified in Aug2021, patient experienced COVID-19 infection. Lab test included COVID-19: positive on Aug2021. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Treatment adverse event was unknown. COVID was not present prior vaccination. COVID was tested post vaccination. The outcome of events was unknown.  No follow up attempts are possible. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Rash, Urticaria, Vaginal haemorrhage
Clinical narrative: This is a spontaneous report from a noncontactable consumer (patient). A 20-year-old female (not pregnant) patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EW0169), at the age of 20, left arm, on Apr 26, 2021, single dose, for COVID-19 immunization. Medical history  not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not tested for COVID-19 since the vaccination. Concomitant medication: none. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. In 2021, patient experienced 23-day long vaginal bleeding (heavy) and hive-like rash for weeks. She was prescribed cream but it did not help. There was bruising on inner thigh. Treatment included ointment for rash, and new birth control to fix bleeding. The outcome of all events not resolved. No follow-up attempts possible. No further information expected.
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood test
Clinical narrative: 4 months after 2nd injection developed AFIB; This is a spontaneous report from a contactable consumer (patient).  A 64-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 intramuscular, administered in Arm Right on 07Apr2021 (Batch/Lot Number: ER8729) as age at vaccination of 64-years-old, as single dose, for covid-19 immunisation. Medical history included chronic fatigue syndrome from 2004 and ongoing, migraine from an unknown date and unknown if ongoing. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular, administered in upper left shoulder on 17Mar2021 (Batch/Lot Number: EP7534), age at vaccination of 64-years-old, as single dose, for covid-19 immunisation and experienced acute diarrhea. Concomitant medication included sumatriptan (SUMATRIPTAN) taken for migraine from 2016 and ongoing. The patient did not receive any other vaccines. The patient experienced Afib (atrial fibrillation) in Aug2021 (4 months after 2nd injection).  The patient underwent lab tests and procedures which included blood test with normal results on 25Mar2021. Outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Culture throat, Illness, Influenza like illness, Influenza virus test, Migraine
Clinical narrative: Everyday I have migraine; I have tingling like all over the body; Not persisting, Comes and go.; I have nausea almost everyday; I can not really eat because like I am nauseous all the time; I have body ache all the time; it feels like flu; I have body ache all the time; it feels like flu; I already started being sick and I have not been stopped being sick since then; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: FC3181), dose 1 intramuscular, administered in Arm Left (Upper left arm) on 09Aug2021 as dose 1, single for covid-19 immunisation. Medical history included hypothyroidism, iron deficiency anemia. The patient's concomitant medications were not reported. The patient stated she had migraine from basically every day. She took the vaccine on 09Aug2021 (first shot). It's migraine every day. She had tingling like all over the body, its not persisting it come and go tinkling. She had nausea almost every day also she have body ache all the time, it felt like flu. Yesterday she went to the hospital and they were tell her that she didn't have Covid but did diagnose with her having adverse event with vaccine. It was like two days after that not even it was the day after she got it on the 9th and on the 10th (Confirmed as Start date of adverse event as 10Aug2021). She already started being sick and she has not been stopped being sick since then. Reminder for 1st and 2nd shot and then the date that is for 2nd shot. She stated, yesterday since she had flu or Covid. She went to the urgent care. No she didn't have that with me, they gave her a PCR test and a rapid test and then they gave her a flu test and strep throat test that was it. The patient stated, treatment of Adverse Event was Excedrin Migraine (as Treatment). Yeah its actual name is Excedrin Migraine. It has different variant she was actually using the migraine one. She stated "That's Excedrin that's it, that's all I have using it, Yeah that's it that's all I have been doing and then I cannot really eat because like I am nauseous all the time, I don't take anything for that." When probed for using Excedrin on daily basis for migraine, Consumer stated, "Yes every day." The patient mentioned that she was not diagnosed with Covid but with adverse events of Covid-19 vaccine. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Paraesthesia, Polymerase chain reaction, SARS-CoV-2 test
Clinical narrative: Everyday I have migraine; I have tingling like all over the body; Not persisting, Comes and go.; I have nausea almost everyday; I can not really eat because like I am nauseous all the time; I have body ache all the time; it feels like flu; I have body ache all the time; it feels like flu; I already started being sick and I have not been stopped being sick since then; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: FC3181), dose 1 intramuscular, administered in Arm Left (Upper left arm) on 09Aug2021 as dose 1, single for covid-19 immunisation. Medical history included hypothyroidism, iron deficiency anemia. The patient's concomitant medications were not reported. The patient stated she had migraine from basically every day. She took the vaccine on 09Aug2021 (first shot). It's migraine every day. She had tingling like all over the body, its not persisting it come and go tinkling. She had nausea almost every day also she have body ache all the time, it felt like flu. Yesterday she went to the hospital and they were tell her that she didn't have Covid but did diagnose with her having adverse event with vaccine. It was like two days after that not even it was the day after she got it on the 9th and on the 10th (Confirmed as Start date of adverse event as 10Aug2021). She already started being sick and she has not been stopped being sick since then. Reminder for 1st and 2nd shot and then the date that is for 2nd shot. She stated, yesterday since she had flu or Covid. She went to the urgent care. No she didn't have that with me, they gave her a PCR test and a rapid test and then they gave her a flu test and strep throat test that was it. The patient stated, treatment of Adverse Event was Excedrin Migraine (as Treatment). Yeah its actual name is Excedrin Migraine. It has different variant she was actually using the migraine one. She stated "That's Excedrin that's it, that's all I have using it, Yeah that's it that's all I have been doing and then I cannot really eat because like I am nauseous all the time, I don't take anything for that." When probed for using Excedrin on daily basis for migraine, Consumer stated, "Yes every day." The patient mentioned that she was not diagnosed with Covid but with adverse events of Covid-19 vaccine. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Felt that both legs and hands were numb almost like paralysis; Tingling on right leg; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 28Aug2021 (Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient in 2021 felt that her both legs and hands were numb almost she had like paralysis. She went to the hospital and they checked her out. The patient was checked, and she did not have anything like that. She was watched for a while now and she was feeling ok with no issues but a little bit tingling on the right leg. The patient was wondering if this was the side effect of the vaccine shot and the reporter did not know. The outcome of numbness of extremities was recovered in 2021 and outcome of tingling was not recovered.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: had miscarriage after the vaccination; This is a spontaneous report from a Pfizer sponsored program via non-contactable consumer. This consumer reported similar events for two patients. This is the first of two reports. This is a maternal report. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: Unknown, Expiration date: Not reported), via an unspecified route of administration, on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was pregnant at the time of vaccination. The patient had a miscarriage after the vaccination on an unspecified date. The mother reported she became pregnant while taking BNT162B2. The pregnancy resulted in spontaneous abortion. The fetal outcome is intrauterine death. The outcome of the event was unknown at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on plausible dose- event relationship post-vaccination  and  the causal role of BNT162B2 vaccine cannot be excluded for the reported events. 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,Linked Report(s) : US-PFIZER INC-202101144532 Same reporter/event, diff patient
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: had miscarriage after the vaccination; This is a spontaneous report from a Pfizer sponsored program received from a non-contactable consumer. This consumer reported similar events for two patients. This is the second of two reports. This is a maternal report. 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 an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was pregnant at the time of vaccination. The patient had miscarriage after the vaccination on an unspecified date. The mother reported she became pregnant while taking BNT162B2. The pregnancy resulted in spontaneous abortion. The fetal outcome is intrauterine death. 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101144476 Same reporter/ event, diff patient
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: after taking both doses of the Pfizer COVID-19 vaccine did he get COVID; after taking both doses of the Pfizer COVID-19 vaccine did he get COVID; This is a spontaneous report from a contactable consumer(patient). A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), DOSE 2 via an unspecified route of administration on 14Apr2021 (at the age of 59-year-old) (Batch/Lot Number: EN6204) as dose2, single and DOSE 1 via an unspecified route of administration on 24Mar2021 (at the age of 59-year-old) (Batch/Lot number: Confirmed to be either EN4200 or EN4600) as dose1,single for covid-19 immunisation. Medical history reported as none. There were no concomitant medications. Patient wants to know why after taking both doses of the Pfizer COVID-19 vaccine did he get COVID. He states that his boss also tested positive for COVID. He states he did reach out to his doctor at the hospital, but he is out sick, and they are supposed to give information to the nurse. He stated he thought he signed up for V Safe and he wants to report that he got the virus after getting the vaccine. Patient reported that he took both doses of the Pfizer COVID vaccine and he has tested positive for the COVID virus on 01SEP2021 via a nasal swab. This case assessed as non-serious by the reporter. Event resulted to visit Physician Office. The patient underwent lab tests and procedures which included COVID nasal swab: positive on 01Sep2021. The outcome of the event COVID-19 was reported as unknown.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Swelling, Swelling face
Clinical narrative: Swelling of lower face; Swelling of neck; great difficulty breathing; great difficulty swallowing; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional. A 96-year-old non pregnant female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot Number: not reported) via an unspecified route of administration, administered in Arm Right on 01Sep2021 at 10:30 (at the age of 96-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The medical history included fructose intolerant and known allergies: Imitation color in food, gluten. The patient had no COVID prior to vaccination and was not tested for COVID post vaccination. Concomitant medications included benazepril, amlodipine and atorvastatin. On 01Sep2021 at 07:30PM the patient developed swelling of lower face and neck, great difficulty breathing and swallowing and was very close to calling 911. The patient received treatment with Benadryl. The outcome of the events was recovering.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Computerised tomogram, Drug ineffective, Electrocardiogram, Malaise
Clinical narrative: positive for Coronavirus/COVID-19 test; positive for Coronavirus/COVID-19 test; not feeling well; This is a spontaneous report from a program received from a contactable consumer (patient). A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left in 2021 (at the age of 57-years) (Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included blood pressure high. Concomitant medication included atenolol taken for blood pressure high. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient called to ask if he should take the second dose on 07Sep2021. He stated that on 28Aug2021, he was not feeling well, so the next day (29Aug2021) he went to the hospital (emergency department). They ran tests and took an EKG and did a CAT Scan, both with unknown results; then they told him he was positive for Coronavirus/COVID-19 test. He was there for about five hours and then he stayed for a few more hours and then they released him. He was not admitted to the hospital. The patient clarified that the events resulted in emergency room visit. Therapeutic measure was taken as the result of the events which included IV treatment (unspecified). The patient is on quarantine. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: positive for Coronavirus/COVID-19 test; positive for Coronavirus/COVID-19 test; not feeling well; This is a spontaneous report from a program received from a contactable consumer (patient). A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left in 2021 (at the age of 57-years) (Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included blood pressure high. Concomitant medication included atenolol taken for blood pressure high. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient called to ask if he should take the second dose on 07Sep2021. He stated that on 28Aug2021, he was not feeling well, so the next day (29Aug2021) he went to the hospital (emergency department). They ran tests and took an EKG and did a CAT Scan, both with unknown results; then they told him he was positive for Coronavirus/COVID-19 test. He was there for about five hours and then he stayed for a few more hours and then they released him. He was not admitted to the hospital. The patient clarified that the events resulted in emergency room visit. Therapeutic measure was taken as the result of the events which included IV treatment (unspecified). The patient is on quarantine. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: the patient experienced CORONA VIRUS; the patient experienced CORONA VIRUS; This is a solicited report based on the information received by Pfizer (Mfr. Control No.: 21K-163-4053032-00) from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 20Jul2021 (Batch/Lot number was not reported) (age at vaccination 53 years) as DOSE 1, SINGLE for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at Citrate free for psoriasis. Medical history included psoriasis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. In 2021, the patient experienced Corona virus. Pfizer-BioNTech COVId-19 vaccine was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 20Jul2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. The outcome of event was recovering. The action taken in response to the event for bnt162b2 was not applicable, for adalimumab was unknown.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of CORONA VIRUS was not provided. Causality for PFIZER BIONTECH COVID-19 VACCINE(Injection): Causality as per reporter (Drug/Vaccine): Probable.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, Oropharyngeal pain, Pain, SARS-CoV-2 test
Clinical narrative: sore throat; body pain; felt miserable; received first Comirnaty vaccine on 12Aug2021 and a week later tested positive for Covid-19 on 20Aug2021; This is a Follow-up spontaneous report from a program. This contactable male consumer (patient) reported that, a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: not reported), dose 1 via an unspecified route of administration on 12Aug2021 as a DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced received first comirnaty vaccine on 12Aug2021 and a week later tested positive for covid-19 on 20Aug2021. On an unspecified date the patient had, sore throat, body pain and felt miserable. It was reported that, the patient received first Comirnaty vaccine on 12Aug2021 and a week later tested positive for Covid-19 on 20Aug2021. He went to the hospital for his covid infection and complained of sore throat, body pain, and felt miserable for 3-4 days. He was scheduled for a 2nd dose of the Comirnaty vaccine and wanted to see if it's ok to get the second dose. The patient asked, how long do isolate after being infected with COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test that was positive on 20Aug2021. Outcome of all the events were unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.