chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Spinal pain, Vaccination site pain
Clinical narrative: my right arm is starting to hurt; arthritis pain; muscle hurts/muscle pain; injection pain; joint pain; pain is in her shoulder to the hip bone on the left side; pain is in her shoulder to the hip bone on the left side; Chills; three days after not feeling well/ didn't feel well; tired; lousy; last night I didn't sleep; whole left side from her shoulder to bottom of her back bone hurts; she couldn't get her temperature. It was reading like 93.0 when her normal was 97. something; This is a spontaneous report from a contactable consumer reported that. A 87-years-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 17Sep2021 (Batch/Lot Number: FE3592; Expiration Date: 28Feb2022) as DOSE 1, SINGLE for covid-19 immunizations (Age at vaccination 87 years). The patient past Medical history included ongoing arthritis, ongoing atrial fibrillation. Concomitant medication was none.  Caller states "I just feel tired and lousy and like I was telling her, I take my vital signs every morning and everything is usually pretty low, my temperature is normally 97. something and last night I didn't sleep at all because of the pain in my left side and now my right arm is starting to hurt I guess because I'm using it more on an unspecified date in 2021. The patient reported she had chills and didn't feel well on 17Sep2021. She reports she was tired and so she just rested. The next day she didn't have chills but still rested that day. It is explained that the night before, the pain in her left arm, where the shot was given, and that whole left side from her shoulder to bottom of her backbone hurts and this is not going way. She has been using the right arm, and now that muscle hurts too. The caller explains she feels unwell and wants to know how long this and the muscle pain will last. The caller clarified that the pain is in her shoulder to the hip bone on the left side. This started on 18Sep2021 but last night it was the worst. Today it is a little better. Treatment- The caller notes that she checked her vitals, her temperature and blood pressure, like she does every morning. On 20Sep2021, she couldn't get her temperature. It was reading like 93.0 when her normal was 97. Something. She had to use the heating pad and it took a while to get her temperature back up. She doesn't take vaccines because she is so sensitive to things, she doesn't even the flu shot. She might have gotten it 5 years ago. Caller states "they said in 3 or 4 weeks I'm supposed to get my second dose, but that seems awfully close. The event outcome Unknown for fatigue, lousy, Insomnia, Pain in arm, Joint pain, Pain in spine, Muscle pain, Body temperature decrease, Vaccination site pain and Arthritis flare up, Not recovered Feeling unwell, recovered for Chills, recovering for Shoulder pain and Pain bone
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID and they were vaccinated; tested positive for COVID and they were vaccinated; This is a spontaneous report from a Pfizer sponsored Program via a non-contactable consumer reported for a patient. A male patient of an unspecified age received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the reporter's in laws were tested positive for COVID and they were vaccinated (drug ineffective). The patient underwent lab test which included COVID-19 test (SARS-CoV-2 test): Positive on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive for Covid and they were vaccinated; positive for COVID and they were vaccinated; This is a spontaneous report from Pfizer sponsored Program. A non-contactable consumer reported for patient (mother-in-laws).  A female 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 an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical and concomitant medications were not reported. on an unspecified date, the patient was tested positive for covid and she was vaccinated. It was reported that reporter was not sure how to comment on that but as far as know reporter in laws were tested positive for Covid and they were vaccinated. The patient underwent lab tests and procedures which included sars-cov-2 test, which was positive, on an unknown date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Rash papular, Rash pruritic
Clinical narrative: breakout rash again, but more on lower legs and lower arm. This was less of a flat rash but raised and round.; Rashes itched; This is a spontaneous report from contactable consumer (patient). This 82-year-old patient of unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 07Sep2021, as the second single dose, in upper left arm, for COVID-19 immunization. Medical history included ongoing high blood pressure. The patient received the first dose of BNT162B2 vaccine on 28Jul2021 at 08:00 AM, at the age of 82 years, in upper left arm experiencing upper arm, right arm started itching and red rash which continued to spread down that arm and then to other arm and then to lower legs. Prior vaccination (within 4 weeks): none. Concomitant drugs: none. After the 2nd dose, on an unspecified date in Sep2021, the patient had a breakout rash again, but more on lower legs and lower arm. This was less of a flat rash but raised and round. Rashes itched and the patient went to Doctor who gave steroids. The area still itched occasionally and was still healing. The events were resolving.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101064198 Same reporter/patient, different dose/AEs.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Illness, Influenza, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: who had both doses of the Pfizer BioNTech Covid 19 vaccine in March, and has now been diagnosed with Covid.; who had both doses of the Pfizer BioNTech Covid 19 vaccine in March, and has now been diagnosed with Covid.; throwing up; ill; fever; Flu; This is a spontaneous report. A 80-year-old female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as dose 1, single and BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Formulation: solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as dose 2, single both for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller reported on behalf of a female relative in her early 80s who had both doses of the Pfizer BioNTech COVID-19 vaccine in March and had now been diagnosed with COVID. He did not complete a safety report. He was asking how long, with the positive diagnosis, she had to wait to get the booster dose. He reports that she became ill with the flu and mild fever, throwing up and Tested positive for COVID   . They asked another relative, an RN, to check on her, and she talked her into getting COVID test. The relative who was an RN checked on this relative because she had been ill with the fever, and flu. She talked her into getting tested for COVID and found out she was COVID positive. He looked everywhere to see if he could find the answer. On an unspecified date, the patient underwent lab test and procedure which includes SARS-CoV-2 antibody test which was found to be positive. Outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure, Vomiting
Clinical narrative: who had both doses of the Pfizer BioNTech Covid 19 vaccine in March, and has now been diagnosed with Covid.; who had both doses of the Pfizer BioNTech Covid 19 vaccine in March, and has now been diagnosed with Covid.; throwing up; ill; fever; Flu; This is a spontaneous report. A 80-year-old female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as dose 1, single and BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Formulation: solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as dose 2, single both for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller reported on behalf of a female relative in her early 80s who had both doses of the Pfizer BioNTech COVID-19 vaccine in March and had now been diagnosed with COVID. He did not complete a safety report. He was asking how long, with the positive diagnosis, she had to wait to get the booster dose. He reports that she became ill with the flu and mild fever, throwing up and Tested positive for COVID   . They asked another relative, an RN, to check on her, and she talked her into getting COVID test. The relative who was an RN checked on this relative because she had been ill with the fever, and flu. She talked her into getting tested for COVID and found out she was COVID positive. He looked everywhere to see if he could find the answer. On an unspecified date, the patient underwent lab test and procedure which includes SARS-CoV-2 antibody test which was found to be positive. Outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia, Suspected COVID-19
Clinical narrative: fever; achy; extremely tired; I think the person had covid at the time; This is a spontaneous report from a contactable consumer. A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included toxoplasmosis, infectious mononucleosis. The patient's concomitant medications were not reported. On an unknown date, the patient experienced fever, achy, extremely tired, think the person had covid at the time. The patient was going to get open heart surgery. The outcome of the events was unknown. There was no product quality complaint present.  The lot number for the vaccine was not provided and will be requested during follow-up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Limb discomfort, Lymphatic disorder
Clinical narrative: Menstrual bleeding for 19 days; Lymphatic cord in left arm; Unable to lift arm up; This is a spontaneous report from a contactable consumer reported for herself. A 41-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Fc3183, Expiration date: unknown), via an unspecified route of administration, administered in Arm Left on 20Aug2021 15:00 (age at vaccination was 41 years) as dose 1, single for COVID-19 immunization. The patient's medical history included no from an unknown date and unknown if ongoing. The patient have known allergies. The patient's concomitant medications were not reported. The patient did not receive any other medications in two weeks. The facility where the most recent COVID-19 vaccine was administered was the Health Clinic. 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. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took cefaclor and experienced drug hypersensitivity, valium and experienced drug hypersensitivity. On 23Aug2021 the patient experienced menstrual bleeding for 19 days, lymphatic cord in left arm and unable to lift arm up. Patient visits Doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Full blood count, Haematoma, Headache
Clinical narrative: developing vaginal clots/has not stopped bleeding; Body Ache; shortness of breath and breathing; developed TPI in left arm; rash on my toe; blood underneath my nail beds; chest pain; severe headache; Construction in my left arm and bleeding underneath the skin of my left arm/bleeding in my left arm; This is a spontaneous report from a contactable consumer (patient).  A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (at the age of 50 years) via an unspecified route of administration, administered in Arm Right on 09Sep2021 (Batch/Lot Number: FC3184) as dose 1, single for covid-19 immunisation. Medical history included thyroid cancer, pituitary microadenoma and anxiety. Concomitant medications included levothyroxine sodium (SYNTHROID) and clonazepam taken for anxiety. The patient got the Pfizer COVID vaccine on 09Sep2021. The day after she got her shot (10Sep2021), she had severe headache and body ache; she end up with chest pain, "shortness of breath and breathing", she developed "TPI" in her left arm, bleeding in her left arm, had rash on her toes, and blood underneath nail beds. Four days after the vaccine (13Sep2021), she started developing vaginal clots that required her to go the gynecologist because that has not stopped bleeding. She had her lab work done when she went to see her doctor because of the side effects. She went in on 13Sep2021 and listed as CBP, CMP. The result was stable that is all she knows. She has had more lab work yesterday (Sep2021) because she was continually having vaginal clots, she does not know those results yet. On 10Sep2021, she started with a headache and body ache, chest pain shortness of breath, and "construction in my left arm and bleeding underneath the skin of my left arm". As of right now, she was witnessing back to her gynecologist; she had an ultrasound done yesterday (Sep2021) and was waiting for the final result so they know what they have to do. The patient mentioned that the bleeding is persisting. The second dose was scheduled on 30Sep2021, but her doctor has told not to take second dose. The outcome of the events "construction in my left arm and bleeding underneath the skin of my left arm/bleeding in my left arm", and "developing vaginal clots/has not stopped bleeding" was not recovered while the other events were unknown.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Limb discomfort, Metabolic function test, Nail bed bleeding, Pain
Clinical narrative: developing vaginal clots/has not stopped bleeding; Body Ache; shortness of breath and breathing; developed TPI in left arm; rash on my toe; blood underneath my nail beds; chest pain; severe headache; Construction in my left arm and bleeding underneath the skin of my left arm/bleeding in my left arm; This is a spontaneous report from a contactable consumer (patient).  A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (at the age of 50 years) via an unspecified route of administration, administered in Arm Right on 09Sep2021 (Batch/Lot Number: FC3184) as dose 1, single for covid-19 immunisation. Medical history included thyroid cancer, pituitary microadenoma and anxiety. Concomitant medications included levothyroxine sodium (SYNTHROID) and clonazepam taken for anxiety. The patient got the Pfizer COVID vaccine on 09Sep2021. The day after she got her shot (10Sep2021), she had severe headache and body ache; she end up with chest pain, "shortness of breath and breathing", she developed "TPI" in her left arm, bleeding in her left arm, had rash on her toes, and blood underneath nail beds. Four days after the vaccine (13Sep2021), she started developing vaginal clots that required her to go the gynecologist because that has not stopped bleeding. She had her lab work done when she went to see her doctor because of the side effects. She went in on 13Sep2021 and listed as CBP, CMP. The result was stable that is all she knows. She has had more lab work yesterday (Sep2021) because she was continually having vaginal clots, she does not know those results yet. On 10Sep2021, she started with a headache and body ache, chest pain shortness of breath, and "construction in my left arm and bleeding underneath the skin of my left arm". As of right now, she was witnessing back to her gynecologist; she had an ultrasound done yesterday (Sep2021) and was waiting for the final result so they know what they have to do. The patient mentioned that the bleeding is persisting. The second dose was scheduled on 30Sep2021, but her doctor has told not to take second dose. The outcome of the events "construction in my left arm and bleeding underneath the skin of my left arm/bleeding in my left arm", and "developing vaginal clots/has not stopped bleeding" was not recovered while the other events were unknown.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Ultrasound scan, Vaginal haemorrhage
Clinical narrative: developing vaginal clots/has not stopped bleeding; Body Ache; shortness of breath and breathing; developed TPI in left arm; rash on my toe; blood underneath my nail beds; chest pain; severe headache; Construction in my left arm and bleeding underneath the skin of my left arm/bleeding in my left arm; This is a spontaneous report from a contactable consumer (patient).  A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (at the age of 50 years) via an unspecified route of administration, administered in Arm Right on 09Sep2021 (Batch/Lot Number: FC3184) as dose 1, single for covid-19 immunisation. Medical history included thyroid cancer, pituitary microadenoma and anxiety. Concomitant medications included levothyroxine sodium (SYNTHROID) and clonazepam taken for anxiety. The patient got the Pfizer COVID vaccine on 09Sep2021. The day after she got her shot (10Sep2021), she had severe headache and body ache; she end up with chest pain, "shortness of breath and breathing", she developed "TPI" in her left arm, bleeding in her left arm, had rash on her toes, and blood underneath nail beds. Four days after the vaccine (13Sep2021), she started developing vaginal clots that required her to go the gynecologist because that has not stopped bleeding. She had her lab work done when she went to see her doctor because of the side effects. She went in on 13Sep2021 and listed as CBP, CMP. The result was stable that is all she knows. She has had more lab work yesterday (Sep2021) because she was continually having vaginal clots, she does not know those results yet. On 10Sep2021, she started with a headache and body ache, chest pain shortness of breath, and "construction in my left arm and bleeding underneath the skin of my left arm". As of right now, she was witnessing back to her gynecologist; she had an ultrasound done yesterday (Sep2021) and was waiting for the final result so they know what they have to do. The patient mentioned that the bleeding is persisting. The second dose was scheduled on 30Sep2021, but her doctor has told not to take second dose. The outcome of the events "construction in my left arm and bleeding underneath the skin of my left arm/bleeding in my left arm", and "developing vaginal clots/has not stopped bleeding" was not recovered while the other events were unknown.  Follow-up attempts are completed. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Anxiety, Asthenia, Back pain, Chest pain
Clinical narrative: Multiple tender points with constant pain; Multiple tender points with constant pain; Abdomen pain intensity 4-5 constant, increase with movement; Frequent chest and back pain; Frequent chest and back pain; Frequent headaches (becomes migraine as well); Frequent headaches (becomes migraine as well); Unable to deep sleep; Brain fog; Numbness; Weakness; Pain in arm and legs; Fatigue; Anxiety; Unable to focus; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (patient reported for himself). A 16-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EP7534), via an unspecified route of administration, administered in Arm Left on 21Mar2021 (at the age of 16-years-old) as dose 2, single for COVID-19 immunisation. Medical history included none (no). There were no concomitant medications. Patient received the most recent COVID-19 vaccine facility in other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, ws the patient did not diagnosed with COVID-19. Since t he vaccination, patient has been tested for COVID-19. The patient did not received any other medications within 2 weeks of vaccination. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6203 via an unspecified route of administration, administered in Arm Left on 28Feb2021 (at the age of 16-years-old) as dose 1, single for COVID-19 immunisation. The patient experienced multiple tender points with constant pain, abdomen pain intensity 4-5 constant, increase with movement, frequent chest and back pain, frequent headaches (becomes migraine as well), unable to deep sleep, brain fog, numbness, weakness, pain in arm and legs, fatigue, anxiety, unable to focus on 09Apr2021. Treatment was received for the events as complete GI evaluation omneprazole and gabapentin. Patient visited Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test: negative (Nasal Swab) on 10Apr2021, sars-cov-2 test: negative (Nasal Swab) on 03Sep2021. The outcome of the events was reported as not Recovered.  Follow-up attempts are completed. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Fatigue, Feeling abnormal, Headache, Hypoaesthesia
Clinical narrative: Multiple tender points with constant pain; Multiple tender points with constant pain; Abdomen pain intensity 4-5 constant, increase with movement; Frequent chest and back pain; Frequent chest and back pain; Frequent headaches (becomes migraine as well); Frequent headaches (becomes migraine as well); Unable to deep sleep; Brain fog; Numbness; Weakness; Pain in arm and legs; Fatigue; Anxiety; Unable to focus; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (patient reported for himself). A 16-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EP7534), via an unspecified route of administration, administered in Arm Left on 21Mar2021 (at the age of 16-years-old) as dose 2, single for COVID-19 immunisation. Medical history included none (no). There were no concomitant medications. Patient received the most recent COVID-19 vaccine facility in other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, ws the patient did not diagnosed with COVID-19. Since t he vaccination, patient has been tested for COVID-19. The patient did not received any other medications within 2 weeks of vaccination. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6203 via an unspecified route of administration, administered in Arm Left on 28Feb2021 (at the age of 16-years-old) as dose 1, single for COVID-19 immunisation. The patient experienced multiple tender points with constant pain, abdomen pain intensity 4-5 constant, increase with movement, frequent chest and back pain, frequent headaches (becomes migraine as well), unable to deep sleep, brain fog, numbness, weakness, pain in arm and legs, fatigue, anxiety, unable to focus on 09Apr2021. Treatment was received for the events as complete GI evaluation omneprazole and gabapentin. Patient visited Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test: negative (Nasal Swab) on 10Apr2021, sars-cov-2 test: negative (Nasal Swab) on 03Sep2021. The outcome of the events was reported as not Recovered.  Follow-up attempts are completed. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine, Pain, Pain in extremity, Poor quality sleep, SARS-CoV-2 test
Clinical narrative: Multiple tender points with constant pain; Multiple tender points with constant pain; Abdomen pain intensity 4-5 constant, increase with movement; Frequent chest and back pain; Frequent chest and back pain; Frequent headaches (becomes migraine as well); Frequent headaches (becomes migraine as well); Unable to deep sleep; Brain fog; Numbness; Weakness; Pain in arm and legs; Fatigue; Anxiety; Unable to focus; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (patient reported for himself). A 16-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EP7534), via an unspecified route of administration, administered in Arm Left on 21Mar2021 (at the age of 16-years-old) as dose 2, single for COVID-19 immunisation. Medical history included none (no). There were no concomitant medications. Patient received the most recent COVID-19 vaccine facility in other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, ws the patient did not diagnosed with COVID-19. Since t he vaccination, patient has been tested for COVID-19. The patient did not received any other medications within 2 weeks of vaccination. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6203 via an unspecified route of administration, administered in Arm Left on 28Feb2021 (at the age of 16-years-old) as dose 1, single for COVID-19 immunisation. The patient experienced multiple tender points with constant pain, abdomen pain intensity 4-5 constant, increase with movement, frequent chest and back pain, frequent headaches (becomes migraine as well), unable to deep sleep, brain fog, numbness, weakness, pain in arm and legs, fatigue, anxiety, unable to focus on 09Apr2021. Treatment was received for the events as complete GI evaluation omneprazole and gabapentin. Patient visited Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test: negative (Nasal Swab) on 10Apr2021, sars-cov-2 test: negative (Nasal Swab) on 03Sep2021. The outcome of the events was reported as not Recovered.  Follow-up attempts are completed. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Multiple tender points with constant pain; Multiple tender points with constant pain; Abdomen pain intensity 4-5 constant, increase with movement; Frequent chest and back pain; Frequent chest and back pain; Frequent headaches (becomes migraine as well); Frequent headaches (becomes migraine as well); Unable to deep sleep; Brain fog; Numbness; Weakness; Pain in arm and legs; Fatigue; Anxiety; Unable to focus; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (patient reported for himself). A 16-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EP7534), via an unspecified route of administration, administered in Arm Left on 21Mar2021 (at the age of 16-years-old) as dose 2, single for COVID-19 immunisation. Medical history included none (no). There were no concomitant medications. Patient received the most recent COVID-19 vaccine facility in other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, ws the patient did not diagnosed with COVID-19. Since t he vaccination, patient has been tested for COVID-19. The patient did not received any other medications within 2 weeks of vaccination. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6203 via an unspecified route of administration, administered in Arm Left on 28Feb2021 (at the age of 16-years-old) as dose 1, single for COVID-19 immunisation. The patient experienced multiple tender points with constant pain, abdomen pain intensity 4-5 constant, increase with movement, frequent chest and back pain, frequent headaches (becomes migraine as well), unable to deep sleep, brain fog, numbness, weakness, pain in arm and legs, fatigue, anxiety, unable to focus on 09Apr2021. Treatment was received for the events as complete GI evaluation omneprazole and gabapentin. Patient visited Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test: negative (Nasal Swab) on 10Apr2021, sars-cov-2 test: negative (Nasal Swab) on 03Sep2021. The outcome of the events was reported as not Recovered.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report from a contactable consumer reporting same event under the same suspect product for 28 patients. This is one of 28 reports. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced COVID-19 (medically significant) on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on unknown date. The reporter stated that 28 people from a certain University tested positive.  The lot number for bnt162b2 was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101234857 Same reporter/product, different patient/event;US-PFIZER INC-202101258353 Same reporter/product/events, different patient;US-PFIZER INC-202101264507 Same reporter/product/events, different patient;US-PFIZER INC-202101264528 Same reporter/product/events, different patient;US-PFIZER INC-202101264529 Same reporter/product/events, different patient;US-PFIZER INC-202101264530 Same reporter/product/events, different patient;US-PFIZER INC-202101264531 Same reporter/product/events, different patient;US-PFIZER INC-202101264532 Same reporter/product/events, different patient;US-PFIZER INC-202101264508 Same reporter/product/events, different patient;US-PFIZER INC-202101264509 Same reporter/product/events, different patient;US-PFIZER INC-202101264510 Same reporter/product/events, different patient;US-PFIZER INC-202101264511 Same reporter/product/events, different patient;US-PFIZER INC-202101264512 Same reporter/product/events, different patient;US-PFIZER INC-202101264513 Same reporter/product/events, different patient;US-PFIZER INC-202101264514 Same reporter/product/events, different patient;US-PFIZER INC-202101264515 Same reporter/product/events, different patient;US-PFIZER INC-202101264516 Same reporter/product/events, different patient;US-PFIZER INC-202101264517 Same reporter/product/events, different patient;US-PFIZER INC-202101264518 Same reporter/product/events, different patient;US-PFIZER INC-202101264519 Same reporter/product/events, different patient;US-PFIZER INC-202101264520 Same reporter/product/events, different patient;US-PFIZER INC-202101264521 Same reporter/product/events, different patient;US-PFIZER INC-202101264527 Same reporter/product/events, different patient;US-PFIZER INC-202101264526 Same reporter/product/events, different patient;US-PFIZER INC-202101264525 Same reporter/product/events, different patient;US-PFIZER INC-202101264524 Same reporter/product/events, different patient;US-PFIZER INC-202101264522 Same reporter/product/events, different patient;US-PFIZER INC-202101264523 Same reporter/product/events, different patient
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Contacted Covid; Contacted Covid; This is a spontaneous report from support programme Via a contactable consumer (Patient). A 57-year-old female consumer (patient) received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/ Lot number: Not reported) dose 2, Via an unspecified route of administration on Apr2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the Pfizer vaccine in April, both does. The patient now contacted Covid (SARS-CoV-2 test: positive) and vaccination failure occurred in Sep2021. He truly believes with getting vaccine, it kept her out of the hospital and even death. The outcome of the events were unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Drug hypersensitivity, Dyspnoea, Fatigue, Headache
Clinical narrative: Headache; allergic reaction all over my body and my face; A lot of muscle ache and pain; bones hurt a lot; can''t sleep at night; drained like very fatigue; Inflammation; I have some times hard time breathing or wheezing, not wheezing, catching my breath; I have this body itching all over; This is a spontaneous report from a contactable consumer (patient). A 35-years-old female patient received First dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: not reported), via an unspecified route of administration, administered in Arm Right on Aug2021 (at the age of 35-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included I got injury in my arm, covid-19 from Nov2020. The patient's concomitant medications were not reported. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Aug2021 patient experienced headache, allergic reaction all over my body and my face, a lot of muscle ache and pain, bones hurt a lot, can't sleep at night, drained like very fatigue and on an unspecified date in 2021 patient experienced inflammation, i have sometimes hard time breathing or wheezing, not wheezing, catching my breath, i have this body itching all over (pruritus). Patient stated that she to do COVID shot again this month on the 15th but couldn't do it. I am hurting so much, and I am scared. Therapeutic measures were taken as a result of events can''t sleep at night, inflammation, I have some times hard time breathing or wheezing, not wheezing, catching my breath, I have this body itching all over. Patient underwent lab tests and procedures include covid-19 positive in Nov2020 .Treatment taken in response to adverse events was patient have been putting hydrocortisone on face for the inflammation. Recently got prescribed some sleeping pills (Trazodone) but still not sleeping. they gave an inhaler also. Patient stated that she got injury in my arm so sometimes, just for pain she would take Narco but it's when needed but now she have this body itching all over not even Narco takes it away. The outcome of the events Headache, drug hypersensitivity, myalgia, bone pain, insomnia, fatigue, pruritus was not recovered and for all other events unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Insomnia, Myalgia, Pruritus, SARS-CoV-2 test
Clinical narrative: Headache; allergic reaction all over my body and my face; A lot of muscle ache and pain; bones hurt a lot; can''t sleep at night; drained like very fatigue; Inflammation; I have some times hard time breathing or wheezing, not wheezing, catching my breath; I have this body itching all over; This is a spontaneous report from a contactable consumer (patient). A 35-years-old female patient received First dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: not reported), via an unspecified route of administration, administered in Arm Right on Aug2021 (at the age of 35-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included I got injury in my arm, covid-19 from Nov2020. The patient's concomitant medications were not reported. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Aug2021 patient experienced headache, allergic reaction all over my body and my face, a lot of muscle ache and pain, bones hurt a lot, can't sleep at night, drained like very fatigue and on an unspecified date in 2021 patient experienced inflammation, i have sometimes hard time breathing or wheezing, not wheezing, catching my breath, i have this body itching all over (pruritus). Patient stated that she to do COVID shot again this month on the 15th but couldn't do it. I am hurting so much, and I am scared. Therapeutic measures were taken as a result of events can''t sleep at night, inflammation, I have some times hard time breathing or wheezing, not wheezing, catching my breath, I have this body itching all over. Patient underwent lab tests and procedures include covid-19 positive in Nov2020 .Treatment taken in response to adverse events was patient have been putting hydrocortisone on face for the inflammation. Recently got prescribed some sleeping pills (Trazodone) but still not sleeping. they gave an inhaler also. Patient stated that she got injury in my arm so sometimes, just for pain she would take Narco but it's when needed but now she have this body itching all over not even Narco takes it away. The outcome of the events Headache, drug hypersensitivity, myalgia, bone pain, insomnia, fatigue, pruritus was not recovered and for all other events unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Chest pain, Chills, Emotional disorder, Headache
Clinical narrative: Chest pain; Fast heartbeat; I have been experiencing heart palpitations; Chills; Upset; Not really good; unwell; So, it is in my heart/my heart is (distortion)/that it is not really good; very severe headaches; This is a spontaneous report from a contactable consumer. This 27-year-old female consumer (patient) reported that.  A 27-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: FC3183), dose 1 via an unspecified route of administration, administered in Arm Left on 14Sep2021 as (At the age of 27-years) dose 1, single for covid-19 immunisation. Medical history included from an unknown date and unknown if ongoing. There were no concomitant medications. No Other Products, Patient History and No Investigation Assessment. The patient experienced chest pain, fast heartbeat, i have been experiencing heart palpitations, chills, upset, not really good; unwell, so, it is in my heart/my heart is (distortion)/that it is not really good, very severe headaches on 15Sep2021. It was reported that she got the COVID Vaccine, the Pfizer one 14Sep2021 and it was reported that she has fast heartbeat, some chills, she just feeling just generally upset, unwell, some nausea, headaches, very severe headaches and every now and then she gets chest pain as well. Later she started she was experiencing negative effects and symptoms on the 15Sep the next day (2021). It has gotten a little bit better, but it is kind of, his heart is (distortion). So, that it is not really good. It was reported that patient did not take second dose because, she has been experiencing heart palpitations, she does not think it is in his health interest to take it. Patient did not receive any treatment for events, she had gotten this vaccine on the 14Sep, and it is 20Sep. So, it has been only a couple of days. She read that these experiences are normal for one day, two days after but now it is kind of been 5th day now. So, tomorrow she will be going to urgent care to get a doctor opinion. Consumer was informed about the Role of Pfizer Drug Safety. Consumer further stated, "what you would recommend I do. Do you just take the information about the side effects. You tend to take the data." Consumer was requested to contact health care provider for the recommendation. Consumer was provided with the number of Pfizer Medical Information. The outcome of events was recovering at the time of report.  Follow-up attempts are completed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Malaise, Palpitations
Clinical narrative: Chest pain; Fast heartbeat; I have been experiencing heart palpitations; Chills; Upset; Not really good; unwell; So, it is in my heart/my heart is (distortion)/that it is not really good; very severe headaches; This is a spontaneous report from a contactable consumer. This 27-year-old female consumer (patient) reported that.  A 27-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: FC3183), dose 1 via an unspecified route of administration, administered in Arm Left on 14Sep2021 as (At the age of 27-years) dose 1, single for covid-19 immunisation. Medical history included from an unknown date and unknown if ongoing. There were no concomitant medications. No Other Products, Patient History and No Investigation Assessment. The patient experienced chest pain, fast heartbeat, i have been experiencing heart palpitations, chills, upset, not really good; unwell, so, it is in my heart/my heart is (distortion)/that it is not really good, very severe headaches on 15Sep2021. It was reported that she got the COVID Vaccine, the Pfizer one 14Sep2021 and it was reported that she has fast heartbeat, some chills, she just feeling just generally upset, unwell, some nausea, headaches, very severe headaches and every now and then she gets chest pain as well. Later she started she was experiencing negative effects and symptoms on the 15Sep the next day (2021). It has gotten a little bit better, but it is kind of, his heart is (distortion). So, that it is not really good. It was reported that patient did not take second dose because, she has been experiencing heart palpitations, she does not think it is in his health interest to take it. Patient did not receive any treatment for events, she had gotten this vaccine on the 14Sep, and it is 20Sep. So, it has been only a couple of days. She read that these experiences are normal for one day, two days after but now it is kind of been 5th day now. So, tomorrow she will be going to urgent care to get a doctor opinion. Consumer was informed about the Role of Pfizer Drug Safety. Consumer further stated, "what you would recommend I do. Do you just take the information about the side effects. You tend to take the data." Consumer was requested to contact health care provider for the recommendation. Consumer was provided with the number of Pfizer Medical Information. The outcome of events was recovering at the time of report.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I tested positive for COVID-19 on 20Sep21 after being fully vaccinated since April 2021.; I tested positive for COVID-19 on 20Sep21 after being fully vaccinated since April 2021.; This is a spontaneous report from a contactable 50-year-old male consumer (pfizer colleague/patient) reported for himself.   A 50-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection), intramuscularly, administered in arm left on 07Apr2021 (Batch/Lot Number: EW0153) as dose 2, single (at the age of 50-year-old) and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection) intramuscularly, administered in arm left on 15Mar2021 (Batch/Lot Number: EP6955) as dose 1, single for covid-19 immunisation (at the age of 50-year-old). The patient medical history was reported as no. There were no concomitant medications. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug Store. The patient did not receive any other vaccines within 4 weeks prior to the Covid 19 vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient had not been diagnosed with COVID-19 prior to vaccination. The patient has been tested for Covid-19 since the vaccination through nasal swab test on 20Sep2021 and resulted with positive. The patient had no known allergies. On 20Sep2021, the patient reported that he tested positive for COVID-19 on 20Sep21 after being fully vaccinated since April 2021. The patient visited emergency room/department or urgent care. The patient not received treatment. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 20Sep2021. The outcome of the events was recovering.