chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Seizure, Thirst, Tremor
Clinical narrative: my arm hurt; I was hallucinating; my body was convulsing/having a literal seizure; uncomfortable; thirsty and craved water; tired; couldn't get up; felt freezing because I was so cold; teeth were chattering extremely fast; my teeth were chattering extremely fast like I had hypothermia; became very hot; shaking involuntary; This is a spontaneous report from non-contactable consumer (patient). An adult female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in left arm on Apr2021 (Batch/Lot Number: EW0110) as second dose, single for COVID-19 immunisation. The patient's medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included metformin; spironolactone; ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE); all taken for an unspecified indication, start and stop date were not reported, received within 2 weeks of vaccination. Patient historically took the first dose of BNT162B2 (lot number: EW0150) on the left arm on Apr2021 for COVID-19 Immunization. On 27Apr2021, patient went to bed at like 1200 and her arm hurt but she didn't take any medication. Then, patient like woke at about 1:47 and was shaking involuntary, everything was so uncomfortable and she was hallucinating trying to connect all her limbs - like she grew extra arms and legs and she had like her hands had mini hands and a friend that she hadn't seen in a while (who was not there) was holding her head up. She was very thirsty and craved water so bad but she was so tired and shaking that she couldn't get up. After about 30 minutes, she got up and her body was convulsing while standing and her room which is typically warm felt freezing because she was so cold and her teeth were chattering extremely fast like she had hypothermia. She got water, took some ibuprofen and she got back in her bed. she texted a friend at  2 something in the morning because she thought she was having a literal seizure like she couldn't control her body at all. Then, her body eventually stopped shaking on Apr2021 and she was just above sleep level for another hour or two and then became very hot. Since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included covid-19: negative on Apr2021. The outcome of the event 'having a literal seizure' and 'shaking involuntary' was recovered on Apr2021, while for the other events, it was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Biopsy endometrium, Computerised tomogram, Haemorrhage, Menstrual disorder, Ultrasound scan
Clinical narrative: a few days later she started bleeding; she was menopausal, and her period stopped but now, this is kind of unusual/had some very little spotting and then full on like appearing like period; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 2 via an unspecified route of administration in the right arm on 14Apr2021 (Batch/Lot Number: EW0151) as second dose, single for covid-19 immunization. Medical history included hypertension ongoing since 2019; menopause from 2014 (periods stopped in 2014); and only has one ovary and doesn't have the other ovary or any fallopian tubes. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE) on 24Mar2021 (lot number: EP6955) as first dose, single for covid-19 immunization. Ongoing concomitant medications included chlortalidone for hypertension and potassium for an unspecified indication. The patient reported that she had the second vaccine (Pfizer Covid-19 Vaccine) on 14Apr2021 and a few days later (17Apr2021), she started bleeding and she ended up going to emergency room. She added that she was menopausal, and her period stopped in 2014 but now, this is kind of unusual. She mentioned that she went to the hospital last Monday (19Apr2021), she guessed. She added that it probably affected her on Saturday (17Apr2021). She also mentioned that she had some very little spotting on 17Apr2021 and then on Monday it was full on like appearing like period. When asked on the status of the bleeding, she mentioned that it was much less today (26Apr2021) now then it was. She thinks that it's falling down now. She mentioned that she did go to the emergency room and they did a C.T. (computerized tomography) [results unavailable] on 19Apr2021 and that was it. They referred her and the referred people did an ultrasound and an endometrial biopsy on 2021 which was negative. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: his pulse shoot up to 125; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in left arm on 05Mar2021 21:30 (Lot Number: EN6206) as single dose for covid-19 immunization. Medical history included covid-19 from 26Jan2021 to 10Feb2021. There were no concomitant medications. The patient received dose 1 intramuscular left arm on 12Feb2021 07:30 (Lot: EL9266) for covid-19 immunization. The patient experienced his pulse shoot up to 125 on day after 2nd Vaccine. None received prior vaccinations (within 4 weeks). None family medical history relevant to AE. The outcome was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Diarrhoea, Fatigue, Gastritis, Hypersensitivity
Clinical narrative: Almost passed out in shower with low blood pressure; Almost passed out in shower with low blood pressure; Started to experience severe allergies; Severe muscle weakness (especially in left arm); Soreness; Fatigue; Cramping muscle; Recurring swelling/tenderness at injection site; Recurring swelling/tenderness at injection site; Chest pains; Gastritis; Diarrhea; Nausea; This is spontaneous report from a contactable other healthcare professional (the patient). A 30-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER 2613) via an unspecified route of administration in left arm on 13Apr2021 12:30 at age of 30-year-old at single dose for COVID-19 immunisation. Medical history included lyme disease from 2018 and gastritis from 2019. No known allergies. The patient's concomitant medications were not reported. The patient was not diagnose with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. At one and a half weeks after first dose, the patient started to experience severe allergies which is not typical for her. Currently since the two weeks since the vaccine the patient had severe muscle weakness (especially in left arm), soreness and fatigue, cramping muscles, recurring swelling/tenderness at injection site, chest pains, gastritis, diarrhea, nausea, and almost passed out in shower with low blood pressure. The events onset date was 22Apr2021 09:00. No treatment received for the events. Nasal Swab/COVID-19 Active Infection RTPCR/TMA (SARS-CoV-2 RNA, Qualitative NAAT) was negative on 23Apr2021. The outcome of the events was not recovered.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Muscle spasms, Muscular weakness, Nausea, Pain
Clinical narrative: Almost passed out in shower with low blood pressure; Almost passed out in shower with low blood pressure; Started to experience severe allergies; Severe muscle weakness (especially in left arm); Soreness; Fatigue; Cramping muscle; Recurring swelling/tenderness at injection site; Recurring swelling/tenderness at injection site; Chest pains; Gastritis; Diarrhea; Nausea; This is spontaneous report from a contactable other healthcare professional (the patient). A 30-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER 2613) via an unspecified route of administration in left arm on 13Apr2021 12:30 at age of 30-year-old at single dose for COVID-19 immunisation. Medical history included lyme disease from 2018 and gastritis from 2019. No known allergies. The patient's concomitant medications were not reported. The patient was not diagnose with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. At one and a half weeks after first dose, the patient started to experience severe allergies which is not typical for her. Currently since the two weeks since the vaccine the patient had severe muscle weakness (especially in left arm), soreness and fatigue, cramping muscles, recurring swelling/tenderness at injection site, chest pains, gastritis, diarrhea, nausea, and almost passed out in shower with low blood pressure. The events onset date was 22Apr2021 09:00. No treatment received for the events. Nasal Swab/COVID-19 Active Infection RTPCR/TMA (SARS-CoV-2 RNA, Qualitative NAAT) was negative on 23Apr2021. The outcome of the events was not recovered.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, SARS-CoV-2 test, Vaccination site pain, Vaccination site swelling
Clinical narrative: Almost passed out in shower with low blood pressure; Almost passed out in shower with low blood pressure; Started to experience severe allergies; Severe muscle weakness (especially in left arm); Soreness; Fatigue; Cramping muscle; Recurring swelling/tenderness at injection site; Recurring swelling/tenderness at injection site; Chest pains; Gastritis; Diarrhea; Nausea; This is spontaneous report from a contactable other healthcare professional (the patient). A 30-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER 2613) via an unspecified route of administration in left arm on 13Apr2021 12:30 at age of 30-year-old at single dose for COVID-19 immunisation. Medical history included lyme disease from 2018 and gastritis from 2019. No known allergies. The patient's concomitant medications were not reported. The patient was not diagnose with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. At one and a half weeks after first dose, the patient started to experience severe allergies which is not typical for her. Currently since the two weeks since the vaccine the patient had severe muscle weakness (especially in left arm), soreness and fatigue, cramping muscles, recurring swelling/tenderness at injection site, chest pains, gastritis, diarrhea, nausea, and almost passed out in shower with low blood pressure. The events onset date was 22Apr2021 09:00. No treatment received for the events. Nasal Swab/COVID-19 Active Infection RTPCR/TMA (SARS-CoV-2 RNA, Qualitative NAAT) was negative on 23Apr2021. The outcome of the events was not recovered.
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective
Clinical narrative: the patient experienced COVID-19; the patient experienced COVID-19; STUDY NO: FACILITATED COLLECT  This is a non-interventional study received from a non-contactable consumer. A 62-year-old male patient received first dose of bnt162b2 (Batch/Lot number was not reported), intramuscular on an unspecified date as single dose for covid-19 immunization; adalimumab (HUMIRA), subcutaneously, start and stop date, batch/lot number and dose were not reported for psoriatic arthritis. The patient's medical history and concomitant medications were not reported. The patient experienced covid-19 on an unspecified date. Solicited report  by a consumer of an adult male with an event of non-serious COVID-19 with adalimumab. There was no reported medical history. On an unknown date, the patient experienced COVID-19. On an unknown date, COVID-19 resolved. COVID-19 vaccine was also considered suspect. It was unknown if patient was enrolled in a COVID-19 vaccine trial. He received first dose COVID-19 vaccine manufactured by Pfizer. Primary reporter contact for lot number information was unsuccessful. The action taken in response to the events for adalimumab was unknown. The outcome of events was resolved on an unspecified date.   The reporter's causality for the events of COVID-19 with adalimumab and COVID-19 vaccine was no reasonable possibility.   Information on the lot/batch number has been requested.; Sender's Comments: The association between the event lack of effect (COVID-19) with BNT162b2 can not be fully excluded based on the limited information.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Overweight, Pulmonary embolism, Thyroid disorder
Clinical narrative: pulmonary embolism; shortness of breath; she is a little bit overweight her weight is 25 lbs; thyroid problem; an intense shoulder pain just right above the injection site; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Apr2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. Medical history included blood clotting for which was patient was treated. The patient's concomitant medications were not reported. The patient previously took rivaroxaban (XARELTO) from 01Jun2020 to 16Mar2021. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Mar2021 for covid-19 immunisation and experienced sore in the arm and fatigue. The patient got the second dose last 19Apr2021 and after 4 days (23Apr2021) she had an intense shoulder pain just right above the injection site. The patient was treated for blood clotting. After getting the second dose, the patient said that the 2 clots on her knee broke and right now, she has pulmonary embolism. She also had shortness of breath. On the other hand, her doctor told her that there is no new blood clot. The patient added that she is a little bit overweight her weight is "25 lbs" (as reported) and has a thyroid problem. Her hematologist advised her to be placed back on Xarelto and now on bed rest for a few days. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Weight
Clinical narrative: pulmonary embolism; shortness of breath; she is a little bit overweight her weight is 25 lbs; thyroid problem; an intense shoulder pain just right above the injection site; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Apr2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. Medical history included blood clotting for which was patient was treated. The patient's concomitant medications were not reported. The patient previously took rivaroxaban (XARELTO) from 01Jun2020 to 16Mar2021. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Mar2021 for covid-19 immunisation and experienced sore in the arm and fatigue. The patient got the second dose last 19Apr2021 and after 4 days (23Apr2021) she had an intense shoulder pain just right above the injection site. The patient was treated for blood clotting. After getting the second dose, the patient said that the 2 clots on her knee broke and right now, she has pulmonary embolism. She also had shortness of breath. On the other hand, her doctor told her that there is no new blood clot. The patient added that she is a little bit overweight her weight is "25 lbs" (as reported) and has a thyroid problem. Her hematologist advised her to be placed back on Xarelto and now on bed rest for a few days. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Deafness, Ear discomfort, Tinnitus
Clinical narrative: low frequency hearing loss; Right Ear Fullness and Ringing/Tinnitus; Right Ear Fullness and Ringing/Tinnitus; This is a spontaneous report from a contactable consumer (patient).   A 40-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 40-year-old via an unspecified route of administration, administered in Arm Left on 31Mar2021 15:00 (Lot Number: ER8737) as 1st dose, single for covid-19 immunisation.  Medical history was none. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received no other vaccines within 4 weeks prior to the COVID vaccine.  The patient's concomitant medications were not reported.  The patient experienced right ear fullness and ringing/tinnitus. No symptoms before and it had been constant since. Followed up with Hearing test showing low frequency hearing loss on 02Apr2021.  Previous (unrelated) hearing test 3 months earlier shows no hearing loss (normal) in 2021. The events were serious disability. The events start date was on 02Apr2021.  The event resulted in Doctor or other healthcare professional office/clinic visit.  Therapeutic measures were taken including prednisone. The events outcome was not recovered.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness unilateral, Ear discomfort, Sudden hearing loss, Tinnitus
Clinical narrative: low frequency hearing loss; Right Ear Fullness and Ringing/Tinnitus; Right Ear Fullness and Ringing/Tinnitus; This is a spontaneous report from a contactable consumer (patient).   A 40-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 40-year-old via an unspecified route of administration, administered in Arm Left on 31Mar2021 15:00 (Lot Number: ER8737) as 1st dose, single for covid-19 immunisation.  Medical history was none. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received no other vaccines within 4 weeks prior to the COVID vaccine.  The patient's concomitant medications were not reported.  The patient experienced right ear fullness and ringing/tinnitus. No symptoms before and it had been constant since. Followed up with Hearing test showing low frequency hearing loss on 02Apr2021.  Previous (unrelated) hearing test 3 months earlier shows no hearing loss (normal) in 2021. The events were serious disability. The events start date was on 02Apr2021.  The event resulted in Doctor or other healthcare professional office/clinic visit.  Therapeutic measures were taken including prednisone. The events outcome was not recovered.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: tested positive for covid 19 infection recently (after the first shot); tested positive for covid 19 infection recently (after the first shot); This is a spontaneous report from a contactable consumer reporting for himself. A 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 46 years old on 05Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had his first shot of pfizer covid vaccine on april 5th and was due for his 2nd shot this coming Monday. Stated he tested positive for covid 19 infection recently (after the first shot in Apr2021). Asking should he wait to get his second shot? wanting recommendations. The outcome of the event was unknown. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: Sudden pulsatile tinnitus and loss of hearing in left ear within a week or so after 2nd shot.; Sudden pulsatile tinnitus and loss of hearing in left ear within a week or so after 2nd shot.; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number Er8727, on unknown date at single dose in right arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had no known allergies. The patient had no covid prior vaccination. The patient had not tested covid post vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 Lot number En6202, on 28Feb2021 and had a blot clot discovered in lung within 2 weeks of first shot. The patient had sudden pulsatile tinnitus and loss of hearing in left ear within a week or so after 2nd shot. The patient went for ENT Dr for hear. Treatment was received for the events. The outcome of the event was unknown. The event is serious with hospitalization and disability.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Epididymitis, Testicular pain, Ultrasound scan, Urine analysis
Clinical narrative: Epididymitis; Severe testicle pain; This is a spontaneous report from a contactable consumer (patient). A 28-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose, via an unspecified route of administration, in the left arm on 27Mar2021 at 09:30 am (Batch/Lot Number: ER8727) as a single dose for COVID-19 immunization at a clinic. Medical history was reported as none. There were no known allergies. The patient previously received the first dose of the BNT162B2  (Batch/Lot Number: EN6202) on 06Mar2021 at 10:00 am in the left arm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included omeprazole and cetirizine.  On 24Apr2021 at 02:00 am, the patient reported hospitalized in the ER with severe testicle pain. Ultrasound revealed epididymitis which he never had before and his wife and him have only ever been with each other. The result of the urine sample was not reported. The adverse event resulted in emergency room/department or urgent care visit. Treatment was reported as ultrasound and urine sample. The events were reported as nonserious. Since the vaccination, the patient has not been tested for COVID-19. The patient did not test positive for COVID-19 post vaccination. The outcome of events epididymitis and testicle pain was recovering.
Sex: U
Vaccine: COVID19
Symptoms: Confusional state, Senile dementia
Clinical narrative: going senile; mental blank; This is a spontaneous report from a contactable consumer (patient). An 84-year-old patient of unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose single for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease and 'run out of breath'.  The patient's concomitant medications were not reported. The patient got the first dose of COVID-19 vaccine. Patient just pulled a mental blank and reported going senile. Patient called it lack of oxygen to the brain. Outcome of the event was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Erythema, Facial paralysis, Pain in extremity, Pyrexia
Clinical narrative: facial paralysis; Fever; Chills; arm pain; tenderness; redness; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 08Mar2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated, "I called because on 8th March I got vaccination the first shot of Pfizer after 3-4 hours I did have side effects like normal Fever, Chills, arm pain, tenderness and redness but after one day and half to that I ended up facial paralysis half of the face that's why I called you." When paraphrased the concern, consumer stated, "Yes, on 12th March, so I did have the symptoms after the vaccination I had face paralysis and I also have fever chills and everything like the common one and then I did not know what happening, I realized it could be because of the vaccine. It was within 72 hours the doctor put me on the treatment and also I started the physiotherapy because I am had for 6 weeks this condition and condition is improved but still I want to know more information about this side effect and what can be done in this situation, what is the contraindication or if this one like second shot side effects. That moment I did not take the second dose and I was not allowed to take the second dose, so I called your company (Pfizer)." The outcome of events was unknown.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: facial paralysis; Fever; Chills; arm pain; tenderness; redness; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 08Mar2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated, "I called because on 8th March I got vaccination the first shot of Pfizer after 3-4 hours I did have side effects like normal Fever, Chills, arm pain, tenderness and redness but after one day and half to that I ended up facial paralysis half of the face that's why I called you." When paraphrased the concern, consumer stated, "Yes, on 12th March, so I did have the symptoms after the vaccination I had face paralysis and I also have fever chills and everything like the common one and then I did not know what happening, I realized it could be because of the vaccine. It was within 72 hours the doctor put me on the treatment and also I started the physiotherapy because I am had for 6 weeks this condition and condition is improved but still I want to know more information about this side effect and what can be done in this situation, what is the contraindication or if this one like second shot side effects. That moment I did not take the second dose and I was not allowed to take the second dose, so I called your company (Pfizer)." The outcome of events was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: cancer; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient acquired cancer after receiving the vaccine on an unspecified date. The outcome of the event was unknown.  Information on the batch/lot number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Illness, Nausea, Pain, Rash
Clinical narrative: autoimmune disease; body pains; nausea; rash under both of her breast and upper stomach; Sick; This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included psoriatic arthritis. Concomitant medication included guselkumab (TREMFYA) taken for psoriatic arthritis, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date for COVID-19 immunization. With the second shot on Wednesday, she got sick, had body pains, nausea, rash under both of her breast and upper stomach on an unspecified date. She wanted to know if this is from the vaccine or if she should go to the doctor. Stated that she has an autoimmune disease which she does not know if it is the reason why she is having the reaction. She also has psoriatic arthritis and has not taken the injection since 19 Mar - she takes Tremfiya. She wanted to know if others had reported it. The outcome of the events was unknown.  No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Infection, Pulmonary oedema, Pyrexia
Clinical narrative: patient states she had a lot of fluid on her lungs; she stated that she started having a consistent fever for 21 days and trouble breathing in early April after receiving her last dose of the Pfizer covid vaccination; infection; she stated that she started having a consistent fever for 21 days and trouble breathing in early April after receiving her last dose of the Pfizer covid vaccination; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient reports a current hospitalization for what she says are COVID 19 vaccination side effects/issues. She stated that she started having a consistent fever for 21 days and trouble breathing in early April after receiving her last dose of the Pfizer COVID vaccination. Patient was admitted on 12Apr2021 because she could not breath. Patient states she had a lot of fluid on her lungs, and the doctor pulled it off and she is breathing better. Currently in the hospital on antibiotics and pending testing to see where the source of the infection may be. Patient has stopped all medications temporarily in an effort to identify the source of the current issue of fluid buildup on her lungs. The patient was hospitalized for pulmonary oedema and dyspnea from 12Apr2021 to an unknown date. Therapeutic measures were taken as a result of the events. The outcome of the event dyspnea was recovering while for the rest of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Maculopathy
Clinical narrative: Left eye seems like worse as she got more problem with it (macular is worse); Left eye seems like worse as she got more problem with it (macular is worse); This is a spontaneous report from a non-contactable consumer (patient). An 81-year-old female patient received BNT162B2, via an unspecified route of administration on an unspecified date (Lot number was not reported) at unknown dose #, single for COVID-19 immunisation. Medical history included trouble swallowing pills, could not breathe, pain in stomach, nausea, bad sleeper, gas, high blood pressure (BP), irritable bowel syndrome, depression, constipation, sneezing, 2 miscarriages, fibroid tumor, piloidal cyst, and left eye problem (macular); all from an unknown date and unknown if ongoing. Concomitant medication included ranibizumab (LUCENTIS); losartan; amlodipine; citalopram; levothyroxine; dicyclomine; diflunisal (SENTA); ondansetron; trazodone; cyanocobalamin (VITAMIN B 12); ascorbic acid, bioflavonoids nos (VITAMIN C); simeticone (GAS-X); and unspecified vitamins for focus; all taken for an unspecified indication, start and stop date were not reported. The patient reported that left eye seems like worse as she got more problem with it (macular is worse) on an unspecified date with outcome of unknown.  No follow-up attempts are possible; information on the lot number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: allergic reaction/acute allergic reaction; hives on the majority of her body/the hives were gone within an hour; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 13:30 at the age of 23 years old (Lot Number: EP7533) as 1st dose, single for covid-19 immunisation. Medical history included problem with allergies/ hives. There was no concomitant medication. No History of all previous immunization with the Pfizer vaccine considered as suspect. No Additional Administered Vaccines administered on same date with the Pfizer vaccine considered as suspect. No Prior Vaccinations (within 4 weeks). The caller stated she had an allergic reaction to the first dose of the vaccine and in the Emergency Room was given famotidine, epinephrine, and Benadryl. No Investigation Assessment. The patient was calling about the Covid 19 vaccine. She got her first dose a couple weeks ago and she did have an allergic reaction (10Apr2021). The day after she received the Covid 19 vaccine she ended up going to the hospital and she received some other injections. She was asking if she was able to get her second dose today, 30Apr2021. She was given Sodium Chloride, Epinephrine, Famotidine, and Benadryl. She was not admitted to the hospital. She was discharged from the emergency department. The emergency room doctor said she had an acute allergic reaction. She had hives on the majority of her body. The hives started the day after the vaccine on 10Apr2021. She went to the emergency department at around 2:00AM on 11Apr2021. The hives started the night of the 10Apr2021 but in a couple hours the hives got bad quickly and that's when she went to the emergency department. The medicine she was given in the emergency room worked and the hives were gone within an hour. She reported she did have a problem with allergies as she had had the hives before. Her doctor was not positive what causes her hives. She did have to get allergy tested. She had no drug allergies that she knows of. The outcome of the event "hives on the majority of her body/the hives were gone within an hour" was recovered on 11Apr2021, of the other event was was unknown.  No follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Lips started burning, tongue started, lost taste buds, throat drying/Basically an anaphylaxis but my throat did not close up; This is a spontaneous report received from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 01May2021 11:15 (Batch/Lot Number: EW0172) (at the age of 67-year-old) as 2nd dose, single for covid-19 immunisation. Medical history included heart, hashimoto, high cholesterol, fibromyalgia and allergies. Concomitant medication(s) included levothyroxine sodium (SYNTHROID); amitriptyline (MANUFACTURER UNKNOWN); carvedilol (MANUFACTURER UNKNOWN); clopidogrel (MANUFACTURER UNKNOWN); all taken (received within 2 weeks of vaccination) for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 administered in Arm Left on 10Apr2021 11:15 (Batch/Lot Number: EW0162) for covid-19 immunisation and had no adverse event. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01May2021 20:00, the patient lips started burning, tongue started, lost taste buds, throat drying. Basically, an anaphylaxis but my throat did not close up. The seriousness criteria were considered as non-serious. No treatment was given for the events. The outcome of the event was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: Paralysis; This is a spontaneous report from a non-contactable consumer. A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient suffered from paralysis after he was vaccinated. He has been having issues with the left side of his body from head to toe since receiving the first shot of the Pfizer vaccine. He went to local hospitals where doctors ran every test and can't find anything wrong. He went to a local chiropractor who said he's seen similar issues from the vaccine in about 12-20 patients. The outcome of the event was unknown. The event was assessed as serious-medically significant.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Pruritus, Throat tightness, Tongue disorder, Vaccination site pruritus
Clinical narrative: throat closed up and my tongue feels thick; throat closed up and my tongue feels thick; I couldn't  swallow; severe itching in the shot area; severe itching in chest area; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0170) via unspecified route on right shoulder (right arm) unknown single for COVID-19 immunization on 23Apr2021 at 60-year-old. Medical history and concomitant medication were not reported. 15 minutes after the patient took the shot (23Apr2021), patient throat closed up and tongue felt thick, the patient couldn't swallow but the patient was medical services at the bin where the patient had the shot. After about 30 or 40 after minutes (23Apr2021), maybe 30 minutes after the shot, the patient started doing lot of itching, severe itching in the shot area in the shoulder in chest area, severe itching was given some diphenhydramine hydrochloride (BENADRYL) and it did a help so but still had itching in chest area. Outcome of the event severe itching in chest area was not resolved, outcome of the other events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Periorbital swelling, Swelling face
Clinical narrative: Both of her eyes were swollen/ could not really see from it/ her eyes were closed shut; Whole face was swollen/ cheeks were swollen; eyes started getting puffy; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Apr2021 (Batch/Lot Number: EW0150; Expiration Date: Jul2021) (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was none. The patient's concomitant medications were not reported. The patient had side effects which was described as whole face was swollen and both of her eyes and cheeks were swollen in Apr2021. The right side was worse than the left. The patient stated that three days ago, it swelled up a little bit so she put some ice on it, but she woke up this morning and her face was literally swollen. Even yesterday it was swollen but it was not this bad. This morning like it's really really big and it's huge. Right now, her eyes were swollen. She could not really see from it. Few days ago in Apr2021, her eyes started getting puffy. She was kind of ignored it because she put ice on it. But each day it got worse and now this morning, her eyes were closed shut, both of her eyes were swollen. Right eye was more big than the left and her face, her cheeks were swollen. The outcome of events, both of her eyes were swollen/ could not really see from it/ her eyes were closed shut, whole face was swollen/ cheeks were swollen and eyes started getting puffy was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: First dose: Pain on arm at injection site; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 06Apr2021 15:00 (Lot Number: EW0150; Expiration Date: Jul2021) as SINGLE DOSE for covid-19 immunisation. Medical history included colitis, high blood pressure. Concomitant medications included hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ) taken for high blood pressure at 10/12.5mg, one tablet every morning, orally, start and stop date were not reported and she had been taking for about three years; delapril taken for high blood pressure at 240mg, one capsule every night, orally and she had been taking for about 20-25 years. The patient experienced pain on arm at injection site which began about one hour after receiving the covid vaccine around 06Apr2021 16:00. It hurt all that night and was gone by the next day. The outcome of the event was recovered on 07Apr2021.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: her leg is swelling; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (Patient) reported that a female patient of an unspecified age received bnt162b2 (reported as COVID 19 Vaccine), dose 1 via an unspecified route of administration on 07Apr2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient was supposed to get her second dose on today (28Apr2021) but would like to reschedule it tomorrow (29Apr2021). The patient had her first dose on 07Apr2021. The patient was unable to make it today (28Apr2021) because she had surgery and her leg was swelling. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: chest pain; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 15Apr2021 at first dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient expressed her concerns about getting the second dose of vaccine on 06May02021 because she experienced chest pain on an unspecified date in 2021. The outcome of this event was unknown at the reporting time.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Hypoaesthesia
Clinical narrative: This is a spontaneous report from a contactable nurse (other health care professional (HCP)) via medical information team. A 41-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced some numbness/burning sensation in his right foot on the same side where he got the vaccine on an unspecified date. It happened dozens of time and lasts for 10-15 seconds. It's a warm burning sensation and occurred 10 days of post vaccination. It was reported to the nurse that the patient should not get the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) if he had a severe allergic reaction after a previous dose of the vaccine or to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by the company. It was advised to use the clinical judgement as the company cannot provide individual recommendation. The outcome of these events was unknown at the reporting time.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (batch/lot number and expiration date were not reported) as an unknown dose number, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced heavy menstrual cycle bleeding after receiving the COVID-19 vaccine on an unspecified date. The outcome of the event was unknown.  Information on the batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dizziness, Hypoacusis, Pain, Tremor
Clinical narrative: not hearing very well; Shaking; Chills; Pain; I am not already feeling very well, I feel dizzy.; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as unknown, single for covid-19 immunization. Medical history included being diabetic, asthma, high blood pressure and arthritis. Concomitant medication included insulin for diabetes. The patient stated, "I am sorry but I am being kind of brushing because I am not hearing very well". The patient was not feeling really well. She was shaking pretty bad; the patient took the injection yesterday. She took something for the pain and it went away. This morning when she got up, everything shake, she was already not feeling very well, she feel dizzy. The patient wanted to know what she can and cannot take. She took her insulin yesterday and took her medicines in the morning and now, she was not feeling well like she said feeling shaky, dizzy. The patient stated that it does not say there is the side effects that you feel shaky, chills, and pain and headache. The patient has not had the headache. The patient got the pain the first day and now she was shaking pretty hard. The outcome of the event pain was recovered on an unspecified date while the other events was unknown.  Information about Lot/Batch number is requested.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall, Thirst
Clinical narrative: Fell Down; Dizzy; Unusually Thirsty; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Apr2021 17:00 at single dose for COVID-19 immunization. Medical history and concomitant medications none. The patient had no Prior Vaccinations within 4 weeks. The patient previously received first dose of BNT162B2, Lot Number: ER8734 on 07Apr2021. The patient got his second dose of the Covid injection yesterday 27Apr2021 at 1700. Today 28Apr2021 at noon he got out of his car, got very dizzy, and then fell down. The patient stated he felt he was about 90 percent recovered from being dizzy. Later in call mentions that he had been unusually thirsty all day today. The outcome of Dizzy was resolving. The outcome of other events was unknown.  information about lot/batch number requested.