chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: mild back spasm in morning and severe back spasm by evening; sudden stabbing pain; spasm in her left calf; spasm in her left calf; difficult to walk; unusual aches in legs/feet; severe pain in her right knee; This is a spontaneous report from a contactable consumer (patient).   A 62-year-old (non-pregnant) female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0183), via an unspecified route of administration, administered in right arm on 16May2021 at 13:00 as dose 2, single for COVID-19 immunisation (age at vaccination was 62 years). The patient was not pregnant at time of vaccination. The patient medical history included ACL repair on left knee, hypothyroidism from an unknown date and unknown if ongoing, arthritis from an unknown date and unknown if ongoing, has not bothered her. She had no known allergies. She was not diagnosed with COVID-19 prior to vaccination, and not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccine in four weeks prior COVID vaccine. Concomitant medications included levothyroxine taken for an unspecified indication, start and stop date were not reported, cobamamide (VITAMIN B12 (COBAMAMIDE)) taken for an unspecified indication, start and stop date were not reported and Beta vulgaris, Brassica spp., Cyanocobalamin, Folic acid, Pyridoxine hydrochloride, Saccharomyces cerevisiae (VEGAN B12) taken for an unspecified indication, start and stop date were not reported. The patient's concomitant medication included Levothyroxine, vitamin B12, Vegan (in two weeks). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0176), via an unspecified route of administration, administered in right arm on 25Apr2021 13:00 (age at vaccination was 62 years) as dose 1, single for COVID-19 immunization. On 17May2021 at 19:00, the patient experienced mild back spasm on waking the morning of the vaccine, she had a severe back spasm by the evening. It made her scream when she walked as it was a very sudden stabbing pain. The next day or 2 it disappeared. The patient developed a spasm in her left calf so that it was difficult to walk. That went on for about a week. For the past 3 months, she had unusual aches in legs/feet and severe pain in her right knee. The patient underwent lab tests and procedures which included X-ray: X-ray showed no arthritis on an unspecified date. No therapeutic measures were taken as a result of events. The patient visited to doctor or other healthcare professional office/clinic as a result of events. The outcome of the events mild back spasm in morning severe back spasm by evening, sudden stabbing pain, spasm in her left calf and difficult to walk was recovered on an unspecified date in May2021. The outcome of the events she had unusual aches in legs/feet and severe pain in her right knee was not recovered.    Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Flushing, Headache, Inappropriate schedule of product administration
Clinical narrative: Start Date/Time: [Pfizer] 4May2021 03:00 PM/Start Date/Time: [Pfizer] 12Jul2021 04:30 PM; Start Date/Time: [Pfizer] 4May2021 03:00 PM/Start Date/Time: [Pfizer] 12Jul2021 04:30 PM; my entire body became flush; I was hot to the touch; felt very tired; headache; This is a spontaneous report from a contactable Other HCP (patient). A 37-year-old female patient received bnt162b2 (BNT162B2; solution for injection, Batch/Lot number, Expiration date was not provided), via an unspecified route of administration in the right arm on 12Jul2021 04:30 (Age at vaccination: 37-years) as dose 2, single for covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included latex allergy. Patient is allergic to latex but unaware of any other allergies. Patient concomitant medications included Subutex taken for unknown indication, start and stop date unknown. Historical vaccine included BNT162bs (BNT162B2; solution for injection, Batch/Lot number, Expiration date was not provided) on 04May2021 at 03:00 PM in arm left as dose 1, single for covid-19 immunization. On 12Jul2021, within seconds of receiving the second dose, patient stood up to exit the vaccine area and her entire body became flush, she was hot to the touch and then felt very tired and a headache. When she woke up after eight hours, most side effects were gone from the event, still experiencing extreme tiredness. Ae treatment: Self-treatment with Benadryl. The outcome of the events her entire body became flush, she was hot to the touch and then felt very tired and a headache was recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: Start Date/Time: [Pfizer] 4May2021 03:00 PM/Start Date/Time: [Pfizer] 12Jul2021 04:30 PM; Start Date/Time: [Pfizer] 4May2021 03:00 PM/Start Date/Time: [Pfizer] 12Jul2021 04:30 PM; my entire body became flush; I was hot to the touch; felt very tired; headache; This is a spontaneous report from a contactable Other HCP (patient). A 37-year-old female patient received bnt162b2 (BNT162B2; solution for injection, Batch/Lot number, Expiration date was not provided), via an unspecified route of administration in the right arm on 12Jul2021 04:30 (Age at vaccination: 37-years) as dose 2, single for covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included latex allergy. Patient is allergic to latex but unaware of any other allergies. Patient concomitant medications included Subutex taken for unknown indication, start and stop date unknown. Historical vaccine included BNT162bs (BNT162B2; solution for injection, Batch/Lot number, Expiration date was not provided) on 04May2021 at 03:00 PM in arm left as dose 1, single for covid-19 immunization. On 12Jul2021, within seconds of receiving the second dose, patient stood up to exit the vaccine area and her entire body became flush, she was hot to the touch and then felt very tired and a headache. When she woke up after eight hours, most side effects were gone from the event, still experiencing extreme tiredness. Ae treatment: Self-treatment with Benadryl. The outcome of the events her entire body became flush, she was hot to the touch and then felt very tired and a headache was recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Heart rate, Nasal congestion, Pain
Clinical narrative: Her nose was really stuff and she was congested a bit; Fever; Body aches; dizzy; heart palpitations; vision got blurry; Hives; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTEHC COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm left on 17Aug2021 at 08:20 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTEHC COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation and experienced hives. On 17Aug2021, the patient experienced heart palpitations, vision got blurry, hives and dizzy. On 18Aug2021, the patient experienced fever, body aches and nose was really stuff and she was congested a bit. It was reported that she was dizzy and her vision got blurry maybe 10-15 minutes after getting this shot. This got better about 30 minute after the shot, the dizzy and blurred vision didn't last. she also had heart palpitations. This started at the same time and she had this for about 4 hours. It wasn't completely consistent but there were some episodes that were uncomfortable and that were bad. She took her blood pressure and that was ok but her heart rate was elevated in the 100's. Then it got better and after 12 hours it went away completely. She also had hives this started 30 minutes after getting the second dose. It resolved completely after 2 hours, it didn't get much worse and then left completely. Patient got Fever This started around 2am. it didn't get high, it was low graded. it lasted until 10pm on the 18Aug2021, it would down when she took Tylenol and then finally went away. Body aches started at 2am on 18Aug2021 and resolved around 1pm that afternoon. Her nose was really stuff and she was congested a bit, this was not very long and started around 08:30am and resolved around 11pm. The patient underwent lab tests and procedures which included heart rate: 100's on 17Aug2021 (her heart rate was elevated in the 100's, then it got better), blood pressure measurement: normal on 17Aug2021. Therapeutic measure was taken as a result of fever.. Outcome of the events heart palpitations, vision got blurry, hives, dizzy was recovered on 17Aug2021 and other events was recovered on 18Aug2021.  No follow up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia, Urticaria, Vision blurred
Clinical narrative: Her nose was really stuff and she was congested a bit; Fever; Body aches; dizzy; heart palpitations; vision got blurry; Hives; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTEHC COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm left on 17Aug2021 at 08:20 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTEHC COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation and experienced hives. On 17Aug2021, the patient experienced heart palpitations, vision got blurry, hives and dizzy. On 18Aug2021, the patient experienced fever, body aches and nose was really stuff and she was congested a bit. It was reported that she was dizzy and her vision got blurry maybe 10-15 minutes after getting this shot. This got better about 30 minute after the shot, the dizzy and blurred vision didn't last. she also had heart palpitations. This started at the same time and she had this for about 4 hours. It wasn't completely consistent but there were some episodes that were uncomfortable and that were bad. She took her blood pressure and that was ok but her heart rate was elevated in the 100's. Then it got better and after 12 hours it went away completely. She also had hives this started 30 minutes after getting the second dose. It resolved completely after 2 hours, it didn't get much worse and then left completely. Patient got Fever This started around 2am. it didn't get high, it was low graded. it lasted until 10pm on the 18Aug2021, it would down when she took Tylenol and then finally went away. Body aches started at 2am on 18Aug2021 and resolved around 1pm that afternoon. Her nose was really stuff and she was congested a bit, this was not very long and started around 08:30am and resolved around 11pm. The patient underwent lab tests and procedures which included heart rate: 100's on 17Aug2021 (her heart rate was elevated in the 100's, then it got better), blood pressure measurement: normal on 17Aug2021. Therapeutic measure was taken as a result of fever.. Outcome of the events heart palpitations, vision got blurry, hives, dizzy was recovered on 17Aug2021 and other events was recovered on 18Aug2021.  No follow up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Pain in extremity
Clinical narrative: mensural bleeding; Bleeding with the clump; one side clump; soreness on the arm; This is a spontaneous report from a contactable nurse (patient). A 58-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0187), via an unspecified route of administration, administrated in Deltoid Left on 19Aug2021 (age at the time of vaccination 58-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 vaccine, via an unspecified route of administration on 07July2021 (age at the time of vaccination 58-years-old), as a single dose for COVID-19 immunization and patient experienced mensural bleeding; Bleeding with the clump; one side clump. On an unspecified date, the patient experienced mensural bleeding; Bleeding with the clump; one side clump; and soreness on the arm. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (01Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Immunisation, Lymphadenopathy, Off label use, Peripheral swelling
Clinical narrative: I received, the third booster shot 2 days ago; I received, the third booster shot 2 days ago; I am having some swelling underneath my arm pit area; It's just swollen underneath my arm pit; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 63-years-old female patient received bnt162b2 (BNT162B2, formulation: solution for injection, lot number:SC3181, expiration date: not reported), via an unspecified route of administration, administered in Arm Left on 18Aug2021 (age at vaccination 63 years) as dose 3 booster, single for covid-19 immunization.  Medical history included high blood pressure from an unknown date and unknown if ongoing. Concomitant medication included nifedipine (NIFEDIPINE) 30 mg orally, twice a day taken for hypertension, start and stop date were not reported. Patient had first dose of bnt162b2 (BNT162B2, formulation: solution for injection, lot number: EL9262, expiration date: not reported), via an unspecified route of administration, administered in Arm right on 18Jan2021 single for covid-19 immunization. Patient had second dose of bnt162b2 (BNT162B2, formulation: solution for injection, lot number: EL9266, expiration date: not reported), via an unspecified route of administration, administered in Arm right on 23Feb2021 single for covid-19 immunization. Patient did not have prior vaccination within 4 weeks. On an unspecified date in Aug2021, the patient mentioned "i am having some swelling underneath my arm pit area, it's just swollen underneath my arm pit, i received, the third booster shot 2 days ago".  The patient underwent lab tests and procedures which included blood test: had the antibody on 2021. Patient did not have any treatment for the events. Clinical outcome of the events was reported as not recovered for am having some swelling underneath my arm pit area, it's just swollen underneath my arm pit and unknown for rest events.  Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Chest discomfort, Dizziness, Feeling abnormal
Clinical narrative: Became lightheaded, dizzy; WEAK; HOT FLASH; anxiety; feeling foggy; heavy to achy feeling in my heart for 6 hours after dose; headache; nausea; arm pain for the next three days.; This is a spontaneous report from a contactable consumer or other non-hcp (patient herself). A 30-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EW0183, Expiry date: Unknown) via an unspecified route of administration in Arm Left on 20Aug2021 13:45 as dose 1, single (at the age of 30-years-old) for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. The patient medical history was not reported. There were no known allergies and no concomitant medications. Patient did not receive other vaccine in four weeks. Patient did not have other medication in two weeks. Patient was not tested for COVID post vaccination. No COVID prior vaccination. On 20Aug2021 13:45, the patient experienced lightheaded, dizzy and weak 15sec after dose, followed by hot flash, this occurred four times within one hour, had prolonged anxiety, feeling foggy and heavy to achy feeling in my heart for 6 hours after dose and also experienced headache, nausea and arm pain for the next three days. Patient didn't receive treatment for the events. The outcome for events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hot flush, Nausea, Pain in extremity
Clinical narrative: Became lightheaded, dizzy; WEAK; HOT FLASH; anxiety; feeling foggy; heavy to achy feeling in my heart for 6 hours after dose; headache; nausea; arm pain for the next three days.; This is a spontaneous report from a contactable consumer or other non-hcp (patient herself). A 30-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EW0183, Expiry date: Unknown) via an unspecified route of administration in Arm Left on 20Aug2021 13:45 as dose 1, single (at the age of 30-years-old) for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. The patient medical history was not reported. There were no known allergies and no concomitant medications. Patient did not receive other vaccine in four weeks. Patient did not have other medication in two weeks. Patient was not tested for COVID post vaccination. No COVID prior vaccination. On 20Aug2021 13:45, the patient experienced lightheaded, dizzy and weak 15sec after dose, followed by hot flash, this occurred four times within one hour, had prolonged anxiety, feeling foggy and heavy to achy feeling in my heart for 6 hours after dose and also experienced headache, nausea and arm pain for the next three days. Patient didn't receive treatment for the events. The outcome for events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: was having leg pain; This is a spontaneous report received from a contactable consumer or other non hcp.A 84-years-old female patient received bnt162b2 (COMIRNATY,Batch/Lot number was not reported), via an unspecified route of administration on 12Aug2021, as Dose number unknown,single for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced she was having leg pain on 12Aug2021.She stated her dosage changed from 100mg to 75mg 2 wk on and 2wk off.The outcome of the event was unknown.The patient didn't received any treatment for the event.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Mass
Clinical narrative: lump on her neck; lymph nodes on her neck that are still swollen; tired; mild headache; This is a spontaneous report from a contactable Consumer or other non-HCP (patient reported for herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 1 via an unspecified route of administration on 06Aug2021 (Lot number was not reported), as DOSE 1, SINGLE for covid-19 immunisation. Medical history included she had COVID-19 at the beginning of March. The patient concomitant medications were not reported. On an unspecified date in Aug2021, the patient experienced lymph nodes on her neck that are still swollen, tired, mild headache and lump on her neck on 09Aug2021. It was reported that patient was due to receive her second dose of Pfizer Covid-19 Vaccine on an unspecified date (Friday). She still had lymph nodes on her neck that are still swollen. She received her first dose on Friday, 06Aug2021. That Saturday she felt ok. She was tired a little and had a mild headache. On Monday, she experienced a lump on her neck, and she went to emergency room, and it was actually going down now. The patient was asking what she experienced normal and should she get her second dose of the Pfizer Covid-19 Vaccine on Friday or not. Received call from consumer regarding the Pfizer COVID vaccine. She took the first dose and goes back this Friday to take second dose. After the first dose, she had lymph nodes on her neck swollen. It has not gone down and needs to go down some more. She wants to know if it will be ok to get second dose with this still swollen. She stated that she has friends that were fully vaccinated in mid-March and February and today, they have caught COVID-19. They experienced no symptoms, and they were all fine. Investigation Assessment was not provided. The case was reported as non-serious. She did not wish to complete report and did not wish to provide a date of birth or address. No further details provided. The patient outcome of the events was Unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: feels like she is high, like under the influence; This is a spontaneous report received from a contactable consumer or other non hcp. A 23-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: unknown, Expiration Date: unknown) via an unspecified route of administration in Arm Right on 24Aug2021 14:00 (age at vaccination 23years old) as single dose for covid-19 immunisation. Medical history included from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took Valtrex she has been on this for a couple of months on unspecified date. On 24Aug2021 the patient experienced feels like she is high, like under the influence. Additional information provided she feels like she is high, like under the influence. She is feeling began 20-25 minutes after she had the vaccine today, 24Aug2021. She had to wait 15 minutes after the vaccine and then she sat in the parking lot for another 20 minutes to make sure she was understanding her body correctly. She had to go home, and she doesn't have anybody out where she lives so she was driving as careful as she could. She feels so high in her body. She can't stop crying because she is so high. The clinical outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Fibrin D dimer, Swelling
Clinical narrative: Lower extremity swelling bilaterally; This is a spontaneous report from a contactable Physician.   A 13-year-old male patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number and expiry date were not reported), via intramuscular route of administration at arm right, on 10Aug2021 (age at vaccination: 13 years), as a dose 2, single for COVID-19 immunization. The patient's medical history includes asthma and ADHD. The patient concomitant medications include albuterol, beclometasone dipropionate (QVAR), cetirizine and fluticasone propionate (flonase). The patient previously received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number and expiry date were not reported), via intramuscular route of administration at arm right, on an unspecified date in Jul2021, age at vaccination: 13 years), as a dose 1, single for COVID-19 immunization. On an unspecified date in Aug2021, the patient had lower extremity swelling bilaterally. Reportedly the patient D-Dimer test was normal. The patient visited Emergency room/department or urgent care as a result of adverse event. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. Outcome of the event was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Muscle spasms
Clinical narrative: cramping; more discomfort; This is a spontaneous report received from a contactable consumer or other non hcp. A 50-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration in Arm Left on 24Aug2021 (age at vaccination 50years old) as single dose for covid-19 immunisation. The most recent COVID-19 vaccine was administered in hospital. The patient has known allergies reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination reported as none. Medical history included none from an unknown date and unknown if ongoing. There were no concomitant medications. The patient had historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, formulation: Solution for injection, Batch/lot number: EW0165) via an unspecified route of administration in Arm Left on 03Aug2021 at 02:30 PM (age at vaccination 50years old) as single dose for covid-19 immunisation. Since the vaccination, the patient had not been tested positive for COVID-19. The patient experienced cramping, more discomfort on unspecified date in Aug2021. She reported events as change in menstrual cycle. Her period had ended two days prior to my 1st dose. It started again right after her injection and lasted from the 03Aug -19Aug an ultra-tampon was soaked right after insertion. Her period finally ended on the 19Aug and began again right after my 2nd dose, which was 24Aug cramping and more discomfort than usual, as if she was a young woman. The patient did not receive any treatment for the adverse events. The clinical outcome of the event was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Drug eruption
Clinical narrative: Drug eruption rash over breasts; This is a spontaneous case received from a contactable physician. A 27-year-old non-pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number was not reported) via an unspecified route of administration on 13Aug2021 (age at vaccination 27-year-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient was not pregnant at time of vaccination. The patient medical history and concomitant medication was reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19. On 15Aug2021, the patient experienced drug eruption rash over breasts. Since the vaccination, the patient had not been tested for COVID-19. Event resulted to visit doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Seriousness of the event was reported as non-serious. Therapeutic measures were taken as a result of the events with topical steroids and antihistamine. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Agitation, Anxiety, Autoimmune disorder, Cough
Clinical narrative: I have an autoimmune disease.; Rash around eyes; Itchy AF; Headaches; Mental-Confirmed dx of PTSD.; Fatigue; Decreased appetite; Loss of taste; bouts of extreme agitation; nasty cough; Depression; Unable to work in previous profession; anxiety; This is a spontaneous report from Pfizer-sponsored program via a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was unknown), 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. On an unspecified date, the patient had an autoimmune disease. This case is serious (medically significant). On an unspecified date, the patient had rash around eyes, itchy, headaches come and go, mental-confirmed dx of PTSD (post-traumatic stress disorder), fatigue, decreased appetite, loss of taste, bouts of extreme agitation, nasty cough, depression, unable to work in previous profession and anxiety. The patient had no more UTI so far. It was reported that flu like symptoms have decreased but still have a nasty cough. The patient starting to have full memory, writing in normal handwriting again for longer periods of time. The eyesight was getting slightly better. It comes and goes. The patient took 4 new daily pharmaceutical medications. The patient had multiple threats of eviction, shitty credit due to unpaid bills. The patient was paying out the ass for medical bills and neurologist/psychiatrist. Currently looking for new place to live since moratorium ends soon. The patient was unemployment and applied and appealed multiple times. The vaccine messed me up in so many ways but thank goodness and was blessed to be a fighter. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number was not provided and would be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Depression, Fatigue, Headache, Loss of personal independence in daily activities
Clinical narrative: I have an autoimmune disease.; Rash around eyes; Itchy AF; Headaches; Mental-Confirmed dx of PTSD.; Fatigue; Decreased appetite; Loss of taste; bouts of extreme agitation; nasty cough; Depression; Unable to work in previous profession; anxiety; This is a spontaneous report from Pfizer-sponsored program via a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was unknown), 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. On an unspecified date, the patient had an autoimmune disease. This case is serious (medically significant). On an unspecified date, the patient had rash around eyes, itchy, headaches come and go, mental-confirmed dx of PTSD (post-traumatic stress disorder), fatigue, decreased appetite, loss of taste, bouts of extreme agitation, nasty cough, depression, unable to work in previous profession and anxiety. The patient had no more UTI so far. It was reported that flu like symptoms have decreased but still have a nasty cough. The patient starting to have full memory, writing in normal handwriting again for longer periods of time. The eyesight was getting slightly better. It comes and goes. The patient took 4 new daily pharmaceutical medications. The patient had multiple threats of eviction, shitty credit due to unpaid bills. The patient was paying out the ass for medical bills and neurologist/psychiatrist. Currently looking for new place to live since moratorium ends soon. The patient was unemployment and applied and appealed multiple times. The vaccine messed me up in so many ways but thank goodness and was blessed to be a fighter. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number was not provided and would be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Post-traumatic stress disorder, Pruritus, Rash
Clinical narrative: I have an autoimmune disease.; Rash around eyes; Itchy AF; Headaches; Mental-Confirmed dx of PTSD.; Fatigue; Decreased appetite; Loss of taste; bouts of extreme agitation; nasty cough; Depression; Unable to work in previous profession; anxiety; This is a spontaneous report from Pfizer-sponsored program via a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was unknown), 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. On an unspecified date, the patient had an autoimmune disease. This case is serious (medically significant). On an unspecified date, the patient had rash around eyes, itchy, headaches come and go, mental-confirmed dx of PTSD (post-traumatic stress disorder), fatigue, decreased appetite, loss of taste, bouts of extreme agitation, nasty cough, depression, unable to work in previous profession and anxiety. The patient had no more UTI so far. It was reported that flu like symptoms have decreased but still have a nasty cough. The patient starting to have full memory, writing in normal handwriting again for longer periods of time. The eyesight was getting slightly better. It comes and goes. The patient took 4 new daily pharmaceutical medications. The patient had multiple threats of eviction, shitty credit due to unpaid bills. The patient was paying out the ass for medical bills and neurologist/psychiatrist. Currently looking for new place to live since moratorium ends soon. The patient was unemployment and applied and appealed multiple times. The vaccine messed me up in so many ways but thank goodness and was blessed to be a fighter. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number was not provided and would be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Headache, Off label use, Pyrexia
Clinical narrative: I experienced moderate fever and mild headache 12-14 hrs post dose.; I experienced moderate fever and mild headache 12-14 hrs post dose.; I received the 3rd booster shot yesterday; I received the 3rd booster shot yesterday; This is a spontaneous report from a contactable consumer (patient) reported herself. A 45-years-old female patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: unknown), via an unknown route of administration on 22Aug2021 as dose 3, single for COVID-19 immunization at hospital. The patient's medical history included autoimmune condition. Concomitant medication was not reported. The patient received BNT162B2 on an unknown date as historical vaccine as dose 1 and dose 2, single for covid-19 immunization. On 22Aug2021, the patient experienced moderate fever and mild headache 12-14 hrs post dose. I received the 3rd booster shot yesterday. Event took place after use of product. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Investigation
Clinical narrative: Loose stools for several months; This is a spontaneous report from a contactable consumer (patient) or other non hcp (patient).   A 66-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and Expiration date was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 08Apr2021, at 11:00 (at the age of 66-Years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history was reported as none. Concomitant medication included omeprazole (PRILOSEC [OMEPRAZOLE]) taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine and experienced allergies. Other medications in two weeks Prilosec. Patient did not have covid prior to vaccination. Patient was not tested for covid prior or post vaccination. Patient did not receive any vaccine in four weeks. The patient was not pregnant at the time of vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left (at the age of 66-Years-old) on 09Mar2021 at 11:00 as DOSE 1, SINGLE for covid-19 immunisation. On 18May2021, at 12:00 AM the patient experienced loose stools for several months which resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included investigation and showed positive on Antibiotics after testing positive for the Campyl on an unspecified date. Therapeutic measures were taken as a result of loose stools for several months. At the time of this report, the outcome of event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: Gout attack; This is a spontaneous report from a contactable other Health Care Professional. A 84-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 1 via an unspecified route of administration on an unspecified date at the age of 84-years-old as DOSE 1, SINGLE for Covid-19 immunization.The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. There were no concomitant medications. The patient experienced gout attack .The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Immunisation, Off label use
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A patient, of unspecified age and gender, received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported) via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. Medical history included DiGeorge's syndrome. The patient's concomitant medications not reported. Historical vaccines included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose; and the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose for COVID-19 immunisation. Patient stated after the third COVID-19 shot, "I was sick for 2 days." The outcome of sickness recovered on unspecified date. The lot number for the vaccine, BNT162B2, not provided and will be requested during follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: I got it on Friday and Under my arm, My arm pit is going to swollen.; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date not reported), via an unspecified route of administration on an unknown date in 2021 as dose number unknown, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in 2021, the patient experienced arm pit was going to swollen. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea, Exercise tolerance decreased, Fatigue
Clinical narrative: near fainting; dizziness; exercise intolerance; extreme nausea; migraines; vision changes; brain fog; shakiness; adrenaline surges; general weakness; neck pain; shortness of breath; general fatigue; orthostatic intolerance; This is a spontaneous report from a contactable consumer (patient). A 28-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8733, Expiry date: not reported), via an unspecified route of administration, administered in right arm on 26Mar2021 16:30 (at the age of 28 years) as dose 2, single for covid-19 immunisation. The patient medical history was none and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6199, Expiry date: not reported), via an unspecified route of administration, administered in right arm on 05Mar2021 16:30 as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 30Mar2021 06:00, the patient experienced near fainting, dizziness, exercise intolerance, extreme nausea, migraines, vision changes, brain fog, shakiness, adrenaline surges, general weakness, neck pain, shortness of breath, general fatigue, orthostatic intolerance. Event resulted to visit Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Migraine, Nausea, Neck pain, Orthostatic intolerance
Clinical narrative: near fainting; dizziness; exercise intolerance; extreme nausea; migraines; vision changes; brain fog; shakiness; adrenaline surges; general weakness; neck pain; shortness of breath; general fatigue; orthostatic intolerance; This is a spontaneous report from a contactable consumer (patient). A 28-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8733, Expiry date: not reported), via an unspecified route of administration, administered in right arm on 26Mar2021 16:30 (at the age of 28 years) as dose 2, single for covid-19 immunisation. The patient medical history was none and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6199, Expiry date: not reported), via an unspecified route of administration, administered in right arm on 05Mar2021 16:30 as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 30Mar2021 06:00, the patient experienced near fainting, dizziness, exercise intolerance, extreme nausea, migraines, vision changes, brain fog, shakiness, adrenaline surges, general weakness, neck pain, shortness of breath, general fatigue, orthostatic intolerance. Event resulted to visit Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Restlessness, Tremor, Visual impairment
Clinical narrative: near fainting; dizziness; exercise intolerance; extreme nausea; migraines; vision changes; brain fog; shakiness; adrenaline surges; general weakness; neck pain; shortness of breath; general fatigue; orthostatic intolerance; This is a spontaneous report from a contactable consumer (patient). A 28-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8733, Expiry date: not reported), via an unspecified route of administration, administered in right arm on 26Mar2021 16:30 (at the age of 28 years) as dose 2, single for covid-19 immunisation. The patient medical history was none and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6199, Expiry date: not reported), via an unspecified route of administration, administered in right arm on 05Mar2021 16:30 as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 30Mar2021 06:00, the patient experienced near fainting, dizziness, exercise intolerance, extreme nausea, migraines, vision changes, brain fog, shakiness, adrenaline surges, general weakness, neck pain, shortness of breath, general fatigue, orthostatic intolerance. Event resulted to visit Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Off label use, Urine analysis, Urine analysis abnormal
Clinical narrative: codeine in my urine analysis; I had my 3rd shot of the Pfizer covid vaccine; I had my 3rd shot of the Pfizer covid vaccine; This is a spontaneous report received from a contactable consumer or other non hcp via Product Quality Complaint Group. A 47-years-old male patient received bnt162b2 (Comirnaty, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0170, expiry date unknown) via an unspecified route of administration on 23Aug2021 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. The patient medical history and patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown, expiry date unknown) via unspecified route on an unknown date (at the age of 47-Year-Old) as dose 1, single and BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown, expiry date unknown) via unspecified route on an unknown date (at the age of 47-Year-Old) as dose 2, single for COVID-19 immunization. On 23Aug2021 patient stated 'I had my 3rd shot of the Pfizer covid vaccine' and codeine in my urine analysis'. Patient stated he needed information on the ingredients of the Pfizer covid vaccine. He had a urinary analysis done. Patient stated I had codeine in my system. On 23Aug2021 I had my 3rd shot of the Pfizer covid vaccine. On 24Aug2021 I had a urine analysis which presented codeine in my urine analysis'. Patient was asking if codeine was in the Pfizer covid vaccine. The patient underwent lab tests and procedures on 24Aug2021 which included Urine analysis: codeine in my urine analysis. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.