chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Gait disturbance, Impaired work ability, Pain
Clinical narrative: I am actually like in Vertigo phase like somebody in drunk phase; I feel like I am going to vomit while I walk; I am actually like in Vertigo phase like somebody in drunk phase; I feel like I am going to vomit while I walk; I haven't been able to get off from my bed because I am so imbalance; If I walk and I am not holding on to something/ I still like I am going to the right side.; I started to have pain a lot at night couldn't able to work; I started to have pain a lot at night couldn't able to work; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8737), via an unspecified route of administration, administered in Arm Left on 27Apr2021 (at the time of vaccination 39-years-old), as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included vitamins. On 27Apr2021 15:00, the patient experienced she haven't been able to get off from her bed because she so imbalance; she actually like in vertigo phase like somebody in drunk phase; she feel like she going to vomit while she walk; and on an unspecified date Apr2021, she started to have pain a lot at night couldn't be able to work and If she walk and she not holding on to something/ she still like she going to the right side. The reporter stated that reporting adverse effect she not sure this is one of them she put the Covid shot and she haven't been able to get off from my bed because she so imbalance If she walk and she not holding on to something she actually like in Vertigo phase like somebody in drunk phase she feel like she going to vomit while she walk and this is while she having on to walk If she still like she going to the right side. Patient was hospitalized due to events. On 28Apr2021, the patient underwent lab tests and procedures which included blood test: unknown. Second shot scheduled date on 17May2021. The outcome of all the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo, Vomiting
Clinical narrative: I am actually like in Vertigo phase like somebody in drunk phase; I feel like I am going to vomit while I walk; I am actually like in Vertigo phase like somebody in drunk phase; I feel like I am going to vomit while I walk; I haven't been able to get off from my bed because I am so imbalance; If I walk and I am not holding on to something/ I still like I am going to the right side.; I started to have pain a lot at night couldn't able to work; I started to have pain a lot at night couldn't able to work; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8737), via an unspecified route of administration, administered in Arm Left on 27Apr2021 (at the time of vaccination 39-years-old), as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included vitamins. On 27Apr2021 15:00, the patient experienced she haven't been able to get off from her bed because she so imbalance; she actually like in vertigo phase like somebody in drunk phase; she feel like she going to vomit while she walk; and on an unspecified date Apr2021, she started to have pain a lot at night couldn't be able to work and If she walk and she not holding on to something/ she still like she going to the right side. The reporter stated that reporting adverse effect she not sure this is one of them she put the Covid shot and she haven't been able to get off from my bed because she so imbalance If she walk and she not holding on to something she actually like in Vertigo phase like somebody in drunk phase she feel like she going to vomit while she walk and this is while she having on to walk If she still like she going to the right side. Patient was hospitalized due to events. On 28Apr2021, the patient underwent lab tests and procedures which included blood test: unknown. Second shot scheduled date on 17May2021. The outcome of all the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath for about 6 hours on 05/04/2021; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 27Apr2021 13:00 (Batch/Lot number was not reported) (at the age of 23 years old) as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. The facility where the most recent COVID-19 vaccine was administered was in school or student health clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other vaccine in four weeks. Concomitant medication included norethindrone acetate (5mg Tablet) taken for an unspecified indication, start and stop date were not reported. On 04May2021 20:00, the patient experienced shortness of breath for about 6 hours. There was no treatment for the event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event not recovered.  Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Found out last Friday that she is pregnant; This is a spontaneous report from contactable consumer (patient) via Pfizer Sponsored program. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection) via unknown route of administration on 12Apr2021 as dose 1 single for COVID-19 immunization. Medical history and Concomitant medications were not reported. Patient was pregnant at time of vaccination. Patient withheld got the 1st dose of Covid-19 vaccine last 12Apr2021 and her 2nd dose schedule will be tomorrow (03May2021); however, she just recently found out last Friday that she was pregnant in Apr2021, and she wanted to know if she can still continue to take the 2nd dose. The outcome of event was unknown.  Follow up needed, further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Lower limb fracture
Clinical narrative: broke her leg; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer or other non hcp (Patient).  A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 13Apr2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. She was not sure of the date for her second dose appointment (either 03May2021 or 04May2021). On 27Apr2021 or 28Apr2021, she was broke her leg and received 5 mg of Hydrocodone (Vicodin) to relieve pain. Her doctor mentioned she might be needing to undergo surgery. She called to verify the date and time for her second dose appointment. Therapeutic measures were taken as a result of broke her leg. The outcome for the event was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Abdominal pain, Constipation, Diarrhoea, Gastrointestinal fistula, Pain in extremity
Clinical narrative: Gastrointestinal fistula; Constipation; Pain in arm; Diarrhea aggravated; Injection site pain; Injections hurt in the abdomen; This is a solicited report based on information received by Pfizer (Manufacturer Control Number: 21K-163-3872809-00). This is a non-interventional study report from the marketing program facilitated collect received from a contactable consumer or other non hcp. A 57-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported),via intramuscular route of administration on an unspecified date as 1ST DOSE, SINGLE, and BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via intramuscular route of administration on an unspecified date as 2ND DOSE, SINGLE for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen, Batch/Lot number was not reported), subcutaneous from an unspecified date to an unspecified date, at UNK, (Citrate Free) for Crohn's disease. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced gastrointestinal fistula, constipation, injections hurt in the abdomen, pain in arm, injection site pain, diarrhea aggravated. Due to fistula had flare up with diarrhea. The outcome of the events gastrointestinal fistula, constipation, injections hurt in the abdomen was unknown. The outcome of the events pain in arm and injection site pain was not recovered. The outcome of the event diarrhea aggravated was recovered. Causality as per reporter was not reported.  Information about lot/batch number has been requested; Sender's Comments: Based on the limited information in the case and since fistulas usually are formed over time and rapidly, causality of the suspect BNT162B2 for the serious event Gastrointestinal fistula is assessed as Unrelated.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site pain
Clinical narrative: Gastrointestinal fistula; Constipation; Pain in arm; Diarrhea aggravated; Injection site pain; Injections hurt in the abdomen; This is a solicited report based on information received by Pfizer (Manufacturer Control Number: 21K-163-3872809-00). This is a non-interventional study report from the marketing program facilitated collect received from a contactable consumer or other non hcp. A 57-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported),via intramuscular route of administration on an unspecified date as 1ST DOSE, SINGLE, and BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via intramuscular route of administration on an unspecified date as 2ND DOSE, SINGLE for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen, Batch/Lot number was not reported), subcutaneous from an unspecified date to an unspecified date, at UNK, (Citrate Free) for Crohn's disease. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced gastrointestinal fistula, constipation, injections hurt in the abdomen, pain in arm, injection site pain, diarrhea aggravated. Due to fistula had flare up with diarrhea. The outcome of the events gastrointestinal fistula, constipation, injections hurt in the abdomen was unknown. The outcome of the events pain in arm and injection site pain was not recovered. The outcome of the event diarrhea aggravated was recovered. Causality as per reporter was not reported.  Information about lot/batch number has been requested; Sender's Comments: Based on the limited information in the case and since fistulas usually are formed over time and rapidly, causality of the suspect BNT162B2 for the serious event Gastrointestinal fistula is assessed as Unrelated.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Diabetes mellitus, Dizziness, Erythema
Clinical narrative: diabetic; He didn't eat much last night and didn't eat this morning.; temperature was 100.3.; Nausea; feeling dizzy; Rash; face real red; shaky and jittery; shaky and jittery; This is a spontaneous report from a contactable consumer. A 92-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EW0167), via an unspecified route of administration in left arm on 29Apr2021 at 14:30 (at the age of 92-years-old) as unknown, single dose for COVID-19 immunization. Medical history included patient first diagnosed as pneumonia, reporter was unsure pulmonary lung infection and pneumonia are the same and treated 3-4 weeks ago for a pulmonary lung infection and type 2 diabetes mellitus. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer Suspect. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. No adverse event prior vaccinations. Patient did not perform any relevant test. Patient took a lot of medications after being in rehab but concomitant medication was not reported. Vaccine was not administered at (Privacy)Facility. On 30Apr2021, the patient experienced nausea, feeling dizzy, temperature, developed rash, red face and shaky and jittery. Patient had been bringing up stuff from lungs some of the stuff bothers and makes patient nauseated, didn't eat much last night and this morning. Patient was diabetic so she thought it might be related to a sugar thing. Patient won't drink any water and temperature was 100.3. She put a cold towel on face and it came to normal color and face was real red before, on 30Apr2021. Diabetic on an unspecified date. Reporter asks would that condition aggravate the side effects of the vaccine. Patient did not visit to physician office and emergency room. The patient underwent lab tests and procedures which included body temperature: 100.3 on 30Apr2021. The outcome of the event nausea was recovered and rest of the events are unknown.   Follow-up attempts completed. No further information expected.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling jittery, Nausea, Nervousness, Pyrexia, Rash
Clinical narrative: diabetic; He didn't eat much last night and didn't eat this morning.; temperature was 100.3.; Nausea; feeling dizzy; Rash; face real red; shaky and jittery; shaky and jittery; This is a spontaneous report from a contactable consumer. A 92-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EW0167), via an unspecified route of administration in left arm on 29Apr2021 at 14:30 (at the age of 92-years-old) as unknown, single dose for COVID-19 immunization. Medical history included patient first diagnosed as pneumonia, reporter was unsure pulmonary lung infection and pneumonia are the same and treated 3-4 weeks ago for a pulmonary lung infection and type 2 diabetes mellitus. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer Suspect. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. No adverse event prior vaccinations. Patient did not perform any relevant test. Patient took a lot of medications after being in rehab but concomitant medication was not reported. Vaccine was not administered at (Privacy)Facility. On 30Apr2021, the patient experienced nausea, feeling dizzy, temperature, developed rash, red face and shaky and jittery. Patient had been bringing up stuff from lungs some of the stuff bothers and makes patient nauseated, didn't eat much last night and this morning. Patient was diabetic so she thought it might be related to a sugar thing. Patient won't drink any water and temperature was 100.3. She put a cold towel on face and it came to normal color and face was real red before, on 30Apr2021. Diabetic on an unspecified date. Reporter asks would that condition aggravate the side effects of the vaccine. Patient did not visit to physician office and emergency room. The patient underwent lab tests and procedures which included body temperature: 100.3 on 30Apr2021. The outcome of the event nausea was recovered and rest of the events are unknown.   Follow-up attempts completed. No further information expected.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Tested Positive for Covid, after the first vaccine; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient's daughter) reported for a 89-year-old female Patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 27Jan2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing Verbatim: Blood pressure high. The patient experienced tested positive for covid, after the first vaccine on 28Jan2021. Reported as Yes, I have a question concerning my mother. She took the Pfizer vaccine, first shot on 27Jan. She got the Covid, tested positive and got the antibody serum on 09Feb. After she received the serum, they told her that she would have to wait for 9 days in order to start her vaccine program over again. So, she has to take two shots. Is that correct." The patient underwent lab tests and procedures which included covid-19: positive on 28Jan2021. Therapeutic measures were taken as a result of tested positive for covid, after the first vaccine. She took antibodies infusion serum for Covid. The outcome of the event was resolving.  No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.; Sender's Comments: Based on the close temporal relationship, the association between the event COVID-19 positive with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Ascites
Clinical narrative: Ascites/Fluid Buildup Around His Stomach; Stomach ache; This is a spontaneous report from a non-contactable consumer from the Project: COVID-19 Vaccine Social Media Monitoring. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration, on an unspecified date, as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was stated that, after COVID Vaccine, on an unspecified date, the patient experienced ascites, fluid buildup around his stomach and could not fight and also experienced stomach ache. The outcome of the events was unknown.  Follow-up attempts are possible; information about lot/batch number can be obtained.
Age: 75.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Bronchitis, SARS-CoV-2 test
Clinical narrative: Acute bronchitis; This is a spontaneous report from a contactable consumer (patient herself). A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/ Lot number: EL3248), via an unspecified route of administration on 17Jan2021 (at the age of 75-year-old) as dose 1, single for COVID-19 immunization, palbociclib (IBRANCE, Formulation: Film-coated tablet, Strength: 125 mg, lot number and expiration date were unknown), via an unspecified route of administration from 24Jun2020 and ongoing at 125 mg, cyclic (daily for 21 days, and then off of Ibrance for 7 days) for breast cancer. The patient's medical history included breast cancer from an unspecified date in 2006 and ongoing. Reported she was diagnosed with breast cancer back in 2006 and had both of her breasts removed in 2006. She said she was told in May2020 that her breast cancer had came back in the same place. She said she started Ibrance on 24Jun2020. Concomitant medications were not reported. The patient experienced acute bronchitis on an unspecified date in Feb2021. She was told to stop taking her Ibrance prescription from an unspecified date in Feb2021 to 31Mar2021 by PRIVACY (her oncologist) on 04Feb2021 because she had acute bronchitis. Reporter stated she needed to place an order again for Ibrance. Reported the last time she ordered Ibrance was on 28Jan2021. She stated she had been in the hospital on an unspecified date in Feb2021, was off of her Ibrance from an unspecified date in Feb2021 and didn't come out until Mar2021. She said she restarted Ibrance on 01Apr2021 and needed to place her Ibrance order. She said Dr. (withheld) (her oncologist) had sent in her Ibrance prescription. Patient said she was tested 3 times for the COVID-19 virus test on an unspecified date (clarifying she was negative all 3 times). The event was considered as serious (hospitalization) by the consumer. The action taken in response to the event for palbociclib was dose not changed. The outcome of the event was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dry skin, Throat tightness, Urticaria
Clinical narrative: Dry face; chest was hurting; throat became tight; hives 4 days after the vaccine (just face) right side and then "lingered" to the left side of my face"; This is a spontaneous report from a contactable consumer, the patient. A 21-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0169), via an unspecified route of administration, administered in Arm Left on 18Apr2021, as dose 1, single (age at vaccination: 21 years), for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that, on 22Apr2021, 4 days after the vaccine, she started experiencing hives (just face) right side and then "lingered" to the left side of her face, which did not hurt but were just really uncomfortable because of the fact that the hives were all over her face. She stated that she did not notice the hives until she touched her face and she took Benadryl (Strength: 25mg tablet, expiration date is Nov2022, only took 1 tablet) to see if the hives would go away and it did not. She reported that, one day after work on 24Apr2021, one week after she received her vaccination, her chest hurt and then her throat felt tight which scared her and since she was driving she went to urgent care. Reportedly, at urgent care she was given a steroid shot which helped it go away. The symptoms lasted one hour and gradually went away. Reportedly, the hives were also ended around the 25Apr2021 or 26Apr2021 after she received the steroid shot to help with her symptoms. She told that the hives went away and was clearing up and then the dry face started on the 29Apr2021 through until around the 03May2021 or 04May2021. The only after effect was her dry face. Since, her face was dry she used Aquaphor and that helped. Outcome: hives were recovered on an unknown date in Apr2021, chest was hurting and throat became tight were recovered on 24Apr2021 and Dry face was recovered on an unknown date in May2021.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 6 weeks after the doctor's second COVID-19 Vaccine dose, the doctor got the COVID-19 Virus; 6 weeks after the doctor's second COVID-19 Vaccine dose, the doctor got the COVID-19 Virus; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), on unspecified dates, as dose 2, single and dose 1 single, both via an unspecified route of administration, for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was stated that, 6 weeks after the doctor received her second covid-19 vaccine dose, the doctor got the covid-19 virus. The doctor (patient) stated that, she gave the COVID-19 Virus to her family. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Computerised tomogram, Dizziness, Dyspnoea, Feeling abnormal
Clinical narrative: Asthma; breathing issues; blood clot in my lungs; nightmares; I got my period late; pulmonary embolism in my lungs; headaches; sleep apnea; I felt weird; I felt something pop in my throat when i took the vaccine; sore arm; Im experiencing sensitivities.; I also had my period and it only lasted one day.; light-headedness; This is a spontaneous report from a contactable consumer (patient herself). A 32-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection and Lot number ER8731) via an unspecified route of administration in right arm on an unspecified date in 2021 as single dose for COVID-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history included Bipolar, sleep apnea, Charcot Marie Toothed, COVID-19 and smoke cigarettes. The patient's concomitant medications included aripiprazole (ABILIFY), hydroxyzine hydrochloride (HYDROXIZINE), Quinine, fluticasone propionate (FLONASE) and Vitamins. The patient previously took first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via right arm on 18Mar2021 Lot number EP6955) as single dose for COVID-19 immunization and experienced with nightmare, woke up sweating that night and Tinnitus temp disappeared. On 06May2021 12:00 after receiving the second dose felt nothing but sore arm. Now she is experiencing sensitivities. She had her period and it only lasted one day. It always has lasted heavy for four or five days. This time it was light and only lasted one day. She have sleep apnea and she experienced a little light-headedness. Treatment received was reported as no for the events. On 7Jun2021 patient have previously reported missed periods and then she got her period late which lasted about 10 days while in the hospital and they found a pulmonary embolism in her lungs through the x-ray scan or CT scan of my lungs. She had her health slowly decline since she possibly had COVId 19 in the first week of January 2020, but no tests were available then. She is still getting headaches, sleep apnea/asthma and breathing issues. The vaccine seems to excite the issue not help and she may have already been immune. She thought the vaccine may have triggered the excess of white blood cells they found recently and the blood clot in her lungs which are both completely new and frightening. She have to take blood thinners or she could die if it bursts in her lungs. She was scared to take a booster shot because she felt something pop in her throat when she took the vaccine and she felt weird and had nightmares. Events seriousness was reported as Physician office visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness and Disability. The outcome of event (sore arm, Sensitization, Menstruation abnormal, light-headedness) was unknown and event (headaches, sleep apnea, asthma and breathing issues) was not recovered and recovering for all other events.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Menstrual disorder, Menstruation delayed, Nightmare, Oropharyngeal discomfort
Clinical narrative: Asthma; breathing issues; blood clot in my lungs; nightmares; I got my period late; pulmonary embolism in my lungs; headaches; sleep apnea; I felt weird; I felt something pop in my throat when i took the vaccine; sore arm; Im experiencing sensitivities.; I also had my period and it only lasted one day.; light-headedness; This is a spontaneous report from a contactable consumer (patient herself). A 32-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection and Lot number ER8731) via an unspecified route of administration in right arm on an unspecified date in 2021 as single dose for COVID-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history included Bipolar, sleep apnea, Charcot Marie Toothed, COVID-19 and smoke cigarettes. The patient's concomitant medications included aripiprazole (ABILIFY), hydroxyzine hydrochloride (HYDROXIZINE), Quinine, fluticasone propionate (FLONASE) and Vitamins. The patient previously took first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via right arm on 18Mar2021 Lot number EP6955) as single dose for COVID-19 immunization and experienced with nightmare, woke up sweating that night and Tinnitus temp disappeared. On 06May2021 12:00 after receiving the second dose felt nothing but sore arm. Now she is experiencing sensitivities. She had her period and it only lasted one day. It always has lasted heavy for four or five days. This time it was light and only lasted one day. She have sleep apnea and she experienced a little light-headedness. Treatment received was reported as no for the events. On 7Jun2021 patient have previously reported missed periods and then she got her period late which lasted about 10 days while in the hospital and they found a pulmonary embolism in her lungs through the x-ray scan or CT scan of my lungs. She had her health slowly decline since she possibly had COVId 19 in the first week of January 2020, but no tests were available then. She is still getting headaches, sleep apnea/asthma and breathing issues. The vaccine seems to excite the issue not help and she may have already been immune. She thought the vaccine may have triggered the excess of white blood cells they found recently and the blood clot in her lungs which are both completely new and frightening. She have to take blood thinners or she could die if it bursts in her lungs. She was scared to take a booster shot because she felt something pop in her throat when she took the vaccine and she felt weird and had nightmares. Events seriousness was reported as Physician office visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness and Disability. The outcome of event (sore arm, Sensitization, Menstruation abnormal, light-headedness) was unknown and event (headaches, sleep apnea, asthma and breathing issues) was not recovered and recovering for all other events.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pulmonary embolism, SARS-CoV-2 test, Sensitisation, Sleep apnoea syndrome
Clinical narrative: Asthma; breathing issues; blood clot in my lungs; nightmares; I got my period late; pulmonary embolism in my lungs; headaches; sleep apnea; I felt weird; I felt something pop in my throat when i took the vaccine; sore arm; Im experiencing sensitivities.; I also had my period and it only lasted one day.; light-headedness; This is a spontaneous report from a contactable consumer (patient herself). A 32-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection and Lot number ER8731) via an unspecified route of administration in right arm on an unspecified date in 2021 as single dose for COVID-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history included Bipolar, sleep apnea, Charcot Marie Toothed, COVID-19 and smoke cigarettes. The patient's concomitant medications included aripiprazole (ABILIFY), hydroxyzine hydrochloride (HYDROXIZINE), Quinine, fluticasone propionate (FLONASE) and Vitamins. The patient previously took first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via right arm on 18Mar2021 Lot number EP6955) as single dose for COVID-19 immunization and experienced with nightmare, woke up sweating that night and Tinnitus temp disappeared. On 06May2021 12:00 after receiving the second dose felt nothing but sore arm. Now she is experiencing sensitivities. She had her period and it only lasted one day. It always has lasted heavy for four or five days. This time it was light and only lasted one day. She have sleep apnea and she experienced a little light-headedness. Treatment received was reported as no for the events. On 7Jun2021 patient have previously reported missed periods and then she got her period late which lasted about 10 days while in the hospital and they found a pulmonary embolism in her lungs through the x-ray scan or CT scan of my lungs. She had her health slowly decline since she possibly had COVId 19 in the first week of January 2020, but no tests were available then. She is still getting headaches, sleep apnea/asthma and breathing issues. The vaccine seems to excite the issue not help and she may have already been immune. She thought the vaccine may have triggered the excess of white blood cells they found recently and the blood clot in her lungs which are both completely new and frightening. She have to take blood thinners or she could die if it bursts in her lungs. She was scared to take a booster shot because she felt something pop in her throat when she took the vaccine and she felt weird and had nightmares. Events seriousness was reported as Physician office visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness and Disability. The outcome of event (sore arm, Sensitization, Menstruation abnormal, light-headedness) was unknown and event (headaches, sleep apnea, asthma and breathing issues) was not recovered and recovering for all other events.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis, White blood cell count, X-ray
Clinical narrative: Asthma; breathing issues; blood clot in my lungs; nightmares; I got my period late; pulmonary embolism in my lungs; headaches; sleep apnea; I felt weird; I felt something pop in my throat when i took the vaccine; sore arm; Im experiencing sensitivities.; I also had my period and it only lasted one day.; light-headedness; This is a spontaneous report from a contactable consumer (patient herself). A 32-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection and Lot number ER8731) via an unspecified route of administration in right arm on an unspecified date in 2021 as single dose for COVID-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history included Bipolar, sleep apnea, Charcot Marie Toothed, COVID-19 and smoke cigarettes. The patient's concomitant medications included aripiprazole (ABILIFY), hydroxyzine hydrochloride (HYDROXIZINE), Quinine, fluticasone propionate (FLONASE) and Vitamins. The patient previously took first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via right arm on 18Mar2021 Lot number EP6955) as single dose for COVID-19 immunization and experienced with nightmare, woke up sweating that night and Tinnitus temp disappeared. On 06May2021 12:00 after receiving the second dose felt nothing but sore arm. Now she is experiencing sensitivities. She had her period and it only lasted one day. It always has lasted heavy for four or five days. This time it was light and only lasted one day. She have sleep apnea and she experienced a little light-headedness. Treatment received was reported as no for the events. On 7Jun2021 patient have previously reported missed periods and then she got her period late which lasted about 10 days while in the hospital and they found a pulmonary embolism in her lungs through the x-ray scan or CT scan of my lungs. She had her health slowly decline since she possibly had COVId 19 in the first week of January 2020, but no tests were available then. She is still getting headaches, sleep apnea/asthma and breathing issues. The vaccine seems to excite the issue not help and she may have already been immune. She thought the vaccine may have triggered the excess of white blood cells they found recently and the blood clot in her lungs which are both completely new and frightening. She have to take blood thinners or she could die if it bursts in her lungs. She was scared to take a booster shot because she felt something pop in her throat when she took the vaccine and she felt weird and had nightmares. Events seriousness was reported as Physician office visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness and Disability. The outcome of event (sore arm, Sensitization, Menstruation abnormal, light-headedness) was unknown and event (headaches, sleep apnea, asthma and breathing issues) was not recovered and recovering for all other events.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Throat tightness
Clinical narrative: Felt like throat was constricted; Increased heart rate; This is a spontaneous report received from a non-contactable consumer (patient). This 33-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection) via unknown route of administration on unspecified date in 2021 as dose 1 single for COVID-19 immunization. Medical history and Concomitant medications were not reported. It was reported that after the first vaccine he had an increased heart rate that came out of nowhere. He also felt like his throat was constricted both in 2021. He got it three weeks ago and his second dose was coming up. stated that he was trying to figure out if he should get the second shot or not due to the reaction he had after the first one. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: Daughter experienced fever; Daughter experienced fever; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer reported on behalf of her 12-month-old female daughter.  A 12-month-old female patient received first dose of bnt162b2 (BNT162B2, PFZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 07May2021 as single dose for covid-19 immunization. Medical history and concomitant medications were not reported. It was reported that mother received Pfizer Covid-19 vaccine first dose on 07May2021 and experienced sore in the arm. She was a breastfeeding mother with her 12-month-old baby girl (patient). In the middle of the night her baby daughter (patient) experienced fever and Vaccine exposure via breast milk. The outcome for the event was reported as unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Chills, Diarrhoea, Drug ineffective
Clinical narrative: Feels like Covid pneumonia all over again; Feels like Covid pneumonia all over again; Feels like Covid pneumonia all over again; Sore arm; Extreme chills; Body and muscle ache; Body and muscle ache; Diarrhea; This is a spontaneous report from a contactable consumer (patient herself). This 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot number EW0182), via an unspecified route of administration in left arm on 10May2021 10:45 as single dose for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient medical history included COVID-19. Concomitant medication included (paracetamol) TYLENOL. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via unspecified route in left arm on 19Apr2021 24:00 (Batch/Lot number EW0171) as single dose for COVID-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 11May2021 23:00 the patient experienced with felt like COVID pneumonia all over again, sore arm, extreme chills, feels like ice in blood, Body and muscle ache and diarrhea. Treatment received was reported as no. The outcome of events was recovering.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pain in extremity
Clinical narrative: Feels like Covid pneumonia all over again; Feels like Covid pneumonia all over again; Feels like Covid pneumonia all over again; Sore arm; Extreme chills; Body and muscle ache; Body and muscle ache; Diarrhea; This is a spontaneous report from a contactable consumer (patient herself). This 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot number EW0182), via an unspecified route of administration in left arm on 10May2021 10:45 as single dose for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient medical history included COVID-19. Concomitant medication included (paracetamol) TYLENOL. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via unspecified route in left arm on 19Apr2021 24:00 (Batch/Lot number EW0171) as single dose for COVID-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 11May2021 23:00 the patient experienced with felt like COVID pneumonia all over again, sore arm, extreme chills, feels like ice in blood, Body and muscle ache and diarrhea. Treatment received was reported as no. The outcome of events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: Patient held Xeljanz for one week after the vaccine and stated during that period she did feel RA S/S come back; This is a spontaneous report from a contactable other healthcare professional. A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Her past drug included XELJANZ from 07May2020 for rheumatoid arthritis and reported NO SE. On an unknown date in 2021 patient held XELJANZ for one week after the vaccine and stated during that period she did feel rheumatoid arthritis (RA S/S) come back. As corrective treatment she restarted XELJANZ. Patient had been on XELJANZ for about a year and reports NO SE and stated it worked well for her RA. Patient held XELJANZ recently, per DRs instructions, as she had the Covid-19 vaccine. Patient held for one week after the vaccine. Patient stated during that period she did feel RA S/S come back but once restarting XELJANZ, they resolved again. On an unknown date in 2021 the event was resolved.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event, Rheumatoid arthritis aggravated cannot be completely ruled out. The impact of this report on benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethic committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Hospitalisation, Parkinson's disease
Clinical narrative: He has parkins She said it will be a least another 3 weeks before he is out of the hospital; Caller stated that her husband was in the hospital; This is a spontaneous report from a contactable consumer (patient's wife). This is a spontaneous report from a Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 01Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller stated that her husband was in the hospital when it was time for his second dose. He has parkins. She said it would be at least another 3 weeks before he was out of the hospital. She wanted to know if he should start over with the vaccines or just get a second dose even though it was way over the 21 days. The outcome of event was unknown.  Information about the lot/batch number has been requested.  Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clot after taking the first dose; This is a spontaneous report from a Pfizer sponsored program. A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on Feb2021, as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced blood clot after taking the first dose and was just advised to take the second dose by her Doctor. Caller wanted to make an appointment for the patient's second dose. Caller refused to be transferred and will talk to his friend and Doctor first. The outcome of the event was unknown.  Follow up attempts are needed. Information about batch/lot number has been requested.  Follow-up (21Jun2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid one week past her second Pfizer shot; tested positive for covid one week past her second Pfizer shot; This is a spontaneous report from a Non- contactable consumer. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. It was reported that someone in a local group posted that on an unspecified date, the patient (her nanny) has tested positive for COVID one week past her second Pfizer shot. The reporter stated that in the group, the poster mentioned that the patient has been asymptomatic and was tested as part of routing testing in the household and was tested twice and both tests were positive, so the poster did not think it's a false positive. The reporter was reporting this as a potential efficacy issue for the Pfizer Biontech Vaccine. On an unspecified date, the patient underwent lab tests and procedures which included covid-19 test which result showed tested positive for COVID. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.