chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Palpitations, Tinnitus
Clinical narrative: Racing heart; Dizzy; Nausea; Flushed face; Ringing ears; Increase in blood pressure; This is a spontaneous report from a contactable nurse, the patient. A 69-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the right arm on 21Apr2021 at 15:45 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had known allergies to grass, trees, mold, cats, dogs, red food dye and also had multiple drug allergies (unspecified). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included vitamin d nos (MANUFACTURER UNKNOWN), azelastine (MANUFACTURER UNKNOWN) and fluticasone (FLONASE); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the right arm on 22Mar2021 at 13:15 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. On 21Apr2021,at 16:00, the patient experienced racing heart, dizzy, nausea, flushed face, ringing ears and increase in blood pressure. First time within 20 minutes of second dose then again on 3rd day and every day since progressively lasting longer; the most recent episode had lasted 11 hours. The patient was not able to eat much due to nausea. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the racing heart, dizzy, nausea, flushed face, ringing ears, and increase in blood pressure were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# EN6208), at the age of 69, via an unspecified route of administration, in left arm, on Mar 13, 2021, at 12:00, single dose, for COVID-19 immunization. Medical history included bipolar disorder. Concomitant medications included lamotrigine, L-thyroxine (levothyroxine sodium) and Eliquis (apixaban). The patient previously took lactose and she was intolerant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On Mar 14, 2021, at 12:30, patient experienced joint pain. Her wrists, shoulders and hips were affected. She also had intermittent jaw pain, which lasted 3 weeks. On a scale from 1-10, the severity was 7. No treatment received for the events. The adverse event result in doctor or other healthcare professional office/clinic visit. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. On an unspecified date in 2021, the outcome of the events recovered. Follow-up attempts completed. No further information expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Pain, Pain in jaw
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# EN6208), at the age of 69, via an unspecified route of administration, in left arm, on Mar 13, 2021, at 12:00, single dose, for COVID-19 immunization. Medical history included bipolar disorder. Concomitant medications included lamotrigine, L-thyroxine (levothyroxine sodium) and Eliquis (apixaban). The patient previously took lactose and she was intolerant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On Mar 14, 2021, at 12:30, patient experienced joint pain. Her wrists, shoulders and hips were affected. She also had intermittent jaw pain, which lasted 3 weeks. On a scale from 1-10, the severity was 7. No treatment received for the events. The adverse event result in doctor or other healthcare professional office/clinic visit. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. On an unspecified date in 2021, the outcome of the events recovered. Follow-up attempts completed. No further information expected.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Nausea, Throat tightness
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's mother/reported for her daughter). A 16-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot number: not reported, expiry date: unknown), at the vaccination age of 16, via an unspecified route of administration, on May 16, 2021, at 11:00, single for COVID-19 immunization. The patient's medical history and concomitant medications not reported. Reporter stated her daughter, a 16-year-old, had her first COVID-19 vaccine. She had a little bit of trouble breathing; had an itchy throat, itchy ears, headache and nausea. She took her daughter to the emergency room and they said her pulse was a little high. Reporter asked if her daughter should get the second vaccine. She stated her daughter had nausea, stomachache, sore arm/shoulder and a headache on the day of report. Everything else happened evening before the day of report. Trouble breathing, itchy throat and itchy ears ended yesterday on May 16, 2021. Reporter stated her daughter no longer has that now, she just has the headache, stomachache, sore arm and tiredness (began yesterday May 16, 2021) and continues on today. Nausea and stomachache recovered completely on (May 17, 2021). Trouble breathing, itchy throat, itchy ears, headache, increased blood pressure and nausea resulted in emergency room visit. The outcome of arthralgia, increased heart rate and pain in extremity: unknown. The fatigue and headache: not recovered; nausea and stomachache recovered on May 17, 2021 and other events recovered on May 16, 2021. Information on the batch/lot number requested. Follow-up attempts completed. No further information expected.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Arthralgia, Dyspnoea, Ear pruritus, Fatigue
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's mother/reported for her daughter). A 16-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot number: not reported, expiry date: unknown), at the vaccination age of 16, via an unspecified route of administration, on May 16, 2021, at 11:00, single for COVID-19 immunization. The patient's medical history and concomitant medications not reported. Reporter stated her daughter, a 16-year-old, had her first COVID-19 vaccine. She had a little bit of trouble breathing; had an itchy throat, itchy ears, headache and nausea. She took her daughter to the emergency room and they said her pulse was a little high. Reporter asked if her daughter should get the second vaccine. She stated her daughter had nausea, stomachache, sore arm/shoulder and a headache on the day of report. Everything else happened evening before the day of report. Trouble breathing, itchy throat and itchy ears ended yesterday on May 16, 2021. Reporter stated her daughter no longer has that now, she just has the headache, stomachache, sore arm and tiredness (began yesterday May 16, 2021) and continues on today. Nausea and stomachache recovered completely on (May 17, 2021). Trouble breathing, itchy throat, itchy ears, headache, increased blood pressure and nausea resulted in emergency room visit. The outcome of arthralgia, increased heart rate and pain in extremity: unknown. The fatigue and headache: not recovered; nausea and stomachache recovered on May 17, 2021 and other events recovered on May 16, 2021. Information on the batch/lot number requested. Follow-up attempts completed. No further information expected.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Heart rate increased, Nausea, Pain in extremity, Throat irritation
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's mother/reported for her daughter). A 16-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot number: not reported, expiry date: unknown), at the vaccination age of 16, via an unspecified route of administration, on May 16, 2021, at 11:00, single for COVID-19 immunization. The patient's medical history and concomitant medications not reported. Reporter stated her daughter, a 16-year-old, had her first COVID-19 vaccine. She had a little bit of trouble breathing; had an itchy throat, itchy ears, headache and nausea. She took her daughter to the emergency room and they said her pulse was a little high. Reporter asked if her daughter should get the second vaccine. She stated her daughter had nausea, stomachache, sore arm/shoulder and a headache on the day of report. Everything else happened evening before the day of report. Trouble breathing, itchy throat and itchy ears ended yesterday on May 16, 2021. Reporter stated her daughter no longer has that now, she just has the headache, stomachache, sore arm and tiredness (began yesterday May 16, 2021) and continues on today. Nausea and stomachache recovered completely on (May 17, 2021). Trouble breathing, itchy throat, itchy ears, headache, increased blood pressure and nausea resulted in emergency room visit. The outcome of arthralgia, increased heart rate and pain in extremity: unknown. The fatigue and headache: not recovered; nausea and stomachache recovered on May 17, 2021 and other events recovered on May 16, 2021. Information on the batch/lot number requested. Follow-up attempts completed. No further information expected.
Age: 43.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder, Menstruation irregular
Clinical narrative: My period came a week early with cramps; My period came a week early with cramps and arrived earlier than expected.; bleeding like I haven't felt since my 20's. My latest period has a signficantly heavier flow than normal; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EW0164, expiration date was not reported), via an unspecified route of administration, administered in left arm on 18Apr2021 15:30 (at the age of 43-years-old) as dose 2, single for covid-19 immunization at public health clinic/veterans administration facility. The patient medical history was none. The concomitant medication included birth control pills. List of any other medications the patient received within 2 weeks of vaccination included birth control pills. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6208, expiration date was not reported), via an unspecified route of administration, administered in left arm on 20Mar2021 09:00am (at the age of 43-years-old) as dose 1, single for covid-19 immunization. The patient has no known allergies. 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. It was reported that on 26Apr2021 01:00 her period came a week early with cramps and bleeding like she haven't felt since her 20's. Her latest period has a significantly heavier flow than normal and arrived earlier than expected. The patient did not receive any treatment for adverse events. Device Date: 17May2021. The outcome of the events was recovered on an unspecified date of 2021.  Follow-up attempts completed. No further information expected.
Age: 43.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: My period came a week early with cramps; My period came a week early with cramps and arrived earlier than expected.; bleeding like I haven't felt since my 20's. My latest period has a signficantly heavier flow than normal; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EW0164, expiration date was not reported), via an unspecified route of administration, administered in left arm on 18Apr2021 15:30 (at the age of 43-years-old) as dose 2, single for covid-19 immunization at public health clinic/veterans administration facility. The patient medical history was none. The concomitant medication included birth control pills. List of any other medications the patient received within 2 weeks of vaccination included birth control pills. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6208, expiration date was not reported), via an unspecified route of administration, administered in left arm on 20Mar2021 09:00am (at the age of 43-years-old) as dose 1, single for covid-19 immunization. The patient has no known allergies. 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. It was reported that on 26Apr2021 01:00 her period came a week early with cramps and bleeding like she haven't felt since her 20's. Her latest period has a significantly heavier flow than normal and arrived earlier than expected. The patient did not receive any treatment for adverse events. Device Date: 17May2021. The outcome of the events was recovered on an unspecified date of 2021.  Follow-up attempts completed. No further information expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Computerised tomogram normal, Full blood count normal, Lip swelling, Metabolic function test
Clinical narrative: developed a diffuse urticaria rash on my body; lip swelling; This is a spontaneous report from a contactable physician. A 53 year old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 24Apr2021 14:00 (Batch/Lot Number: ER8736) as DOSE 1, SINGLE for covid-19 immunisation.The patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 15May2021 14:00 (Batch/Lot Number: EW0177) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported; amoxicillin trihydrate, clarithromycin, esomeprazole magnesium (NEXIUM 1-2-3) taken for an unspecified indication, start and stop date were not reported; fluticasone propionate (FLONASE ALLERGY RELIEF) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC ALLERGY) taken for an unspecified indication, start and stop date were not reported.  The patient experienced a diffuse urticaria rash on her body on 09May2021 with outcome of recovered and lip swelling on 09May2021 with outcome of recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: negative   on 11May2021  .    Follow-up (07Jul2021): This is a follow-up spontaneous report received from a contactable Physician. This 53-year-old female physician reported for herself that: Additional information about second dose and adverse events were added.   Follow Up(16Jul2021) : No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow-Up (30Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: developed a diffuse urticaria rash on my body; lip swelling; This is a spontaneous report from a contactable physician. A 53 year old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 24Apr2021 14:00 (Batch/Lot Number: ER8736) as DOSE 1, SINGLE for covid-19 immunisation.The patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 15May2021 14:00 (Batch/Lot Number: EW0177) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported; amoxicillin trihydrate, clarithromycin, esomeprazole magnesium (NEXIUM 1-2-3) taken for an unspecified indication, start and stop date were not reported; fluticasone propionate (FLONASE ALLERGY RELIEF) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC ALLERGY) taken for an unspecified indication, start and stop date were not reported.  The patient experienced a diffuse urticaria rash on her body on 09May2021 with outcome of recovered and lip swelling on 09May2021 with outcome of recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: negative   on 11May2021  .    Follow-up (07Jul2021): This is a follow-up spontaneous report received from a contactable Physician. This 53-year-old female physician reported for herself that: Additional information about second dose and adverse events were added.   Follow Up(16Jul2021) : No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow-Up (30Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, SARS-CoV-2 test, Urticaria
Clinical narrative: developed a diffuse urticaria rash on my body; lip swelling; This is a spontaneous report from a contactable physician. A 53 year old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 24Apr2021 14:00 (Batch/Lot Number: ER8736) as DOSE 1, SINGLE for covid-19 immunisation.The patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 15May2021 14:00 (Batch/Lot Number: EW0177) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported; amoxicillin trihydrate, clarithromycin, esomeprazole magnesium (NEXIUM 1-2-3) taken for an unspecified indication, start and stop date were not reported; fluticasone propionate (FLONASE ALLERGY RELIEF) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC ALLERGY) taken for an unspecified indication, start and stop date were not reported.  The patient experienced a diffuse urticaria rash on her body on 09May2021 with outcome of recovered and lip swelling on 09May2021 with outcome of recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: negative   on 11May2021  .    Follow-up (07Jul2021): This is a follow-up spontaneous report received from a contactable Physician. This 53-year-old female physician reported for herself that: Additional information about second dose and adverse events were added.   Follow Up(16Jul2021) : No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow-Up (30Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Injection site pain, Musculoskeletal stiffness, Neck pain, Pain in extremity
Clinical narrative: severe shoulder arm/pain; severe shoulder arm/pain/Arm and head moderate pain; Arm and head moderate pain; Arm and head moderate pain limiting mobility.; Because of the pain, she is not sleeping well; This is a spontaneous report from a contactable consumer (patient). This 42-year-old female consumer reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0176 and expiry date Aug2021) via an unspecified route of administration on 05May2021 between 12:00 and 13:00 (at 42-year-old) on upper right arm as dose 1, single for COVID-19 immunization. The patient's medical history included that she was immunocompromised. Her dad was immunocompromised. The patient's concomitant medications were not reported. No other products were received, and no investigation assessment was done. A few days after receiving the covid vaccine on 11 May2021 she began having severe shoulder and arm pain on the side where she received the injection. It had been going on for about eight days. It had not gotten any better. Her doctor ordered an X-Ray, and the results came back fine. Her doctor ordered an ultrasound, because her doctor thought she might possibly have a blood clot. She had not gotten the ultrasound done yet. Her doctor would not prescribe her any pain medication, because her doctor did not want the pain medication to interfere with the covid vaccine creating antibodies for covid. Because of the pain, she was not sleeping well. She had limited mobility of her arm and head movement on her right side. It was very painful for her to lift her right arm up. She had difficulty washing her hair, and blow drying her hair. The patient did not require visit to emergency room and physician office. The patient wanted to know if she should get the second dose of the covid vaccine. She asked if she could talk to someone who can help her decide if she should get the second dose of the covid vaccine. The patient had not recovered  Communication: Caller notified that Medical Information is unable to provide medical advice but may have resources to help answer questions. Caller verbalized understanding. Caller was offered phone number and declined, prior to warm transfer. Warm transferred caller to Medical Information.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Headache, Insomnia, Mobility decreased, Pain in extremity
Clinical narrative: severe shoulder arm/pain; severe shoulder arm/pain/Arm and head moderate pain; Arm and head moderate pain; Arm and head moderate pain limiting mobility.; Because of the pain, she is not sleeping well; This is a spontaneous report from a contactable consumer (patient). This 42-year-old female consumer reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0176 and expiry date Aug2021) via an unspecified route of administration on 05May2021 between 12:00 and 13:00 (at 42-year-old) on upper right arm as dose 1, single for COVID-19 immunization. The patient's medical history included that she was immunocompromised. Her dad was immunocompromised. The patient's concomitant medications were not reported. No other products were received, and no investigation assessment was done. A few days after receiving the covid vaccine on 11 May2021 she began having severe shoulder and arm pain on the side where she received the injection. It had been going on for about eight days. It had not gotten any better. Her doctor ordered an X-Ray, and the results came back fine. Her doctor ordered an ultrasound, because her doctor thought she might possibly have a blood clot. She had not gotten the ultrasound done yet. Her doctor would not prescribe her any pain medication, because her doctor did not want the pain medication to interfere with the covid vaccine creating antibodies for covid. Because of the pain, she was not sleeping well. She had limited mobility of her arm and head movement on her right side. It was very painful for her to lift her right arm up. She had difficulty washing her hair, and blow drying her hair. The patient did not require visit to emergency room and physician office. The patient wanted to know if she should get the second dose of the covid vaccine. She asked if she could talk to someone who can help her decide if she should get the second dose of the covid vaccine. The patient had not recovered  Communication: Caller notified that Medical Information is unable to provide medical advice but may have resources to help answer questions. Caller verbalized understanding. Caller was offered phone number and declined, prior to warm transfer. Warm transferred caller to Medical Information.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: X-ray
Clinical narrative: severe shoulder arm/pain; severe shoulder arm/pain/Arm and head moderate pain; Arm and head moderate pain; Arm and head moderate pain limiting mobility.; Because of the pain, she is not sleeping well; This is a spontaneous report from a contactable consumer (patient). This 42-year-old female consumer reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0176 and expiry date Aug2021) via an unspecified route of administration on 05May2021 between 12:00 and 13:00 (at 42-year-old) on upper right arm as dose 1, single for COVID-19 immunization. The patient's medical history included that she was immunocompromised. Her dad was immunocompromised. The patient's concomitant medications were not reported. No other products were received, and no investigation assessment was done. A few days after receiving the covid vaccine on 11 May2021 she began having severe shoulder and arm pain on the side where she received the injection. It had been going on for about eight days. It had not gotten any better. Her doctor ordered an X-Ray, and the results came back fine. Her doctor ordered an ultrasound, because her doctor thought she might possibly have a blood clot. She had not gotten the ultrasound done yet. Her doctor would not prescribe her any pain medication, because her doctor did not want the pain medication to interfere with the covid vaccine creating antibodies for covid. Because of the pain, she was not sleeping well. She had limited mobility of her arm and head movement on her right side. It was very painful for her to lift her right arm up. She had difficulty washing her hair, and blow drying her hair. The patient did not require visit to emergency room and physician office. The patient wanted to know if she should get the second dose of the covid vaccine. She asked if she could talk to someone who can help her decide if she should get the second dose of the covid vaccine. The patient had not recovered  Communication: Caller notified that Medical Information is unable to provide medical advice but may have resources to help answer questions. Caller verbalized understanding. Caller was offered phone number and declined, prior to warm transfer. Warm transferred caller to Medical Information.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood ketone body, Chest X-ray, Chest discomfort, Computerised tomogram neck, Culture throat negative
Clinical narrative: Calf tightness; Metallic taste in mouth; Throat swelling; Never lost ability to breath but tightness persisted for a week; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 33-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was reported as EW0182, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 11May2021 11:15 (at the age of 33 years old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history includes C sections from an unknown date and unknown if ongoing. No known allergies were reported. There were no concomitant medications. The patient had not received any other vaccine within 4 weeks. The patient had not received any other medications within 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 11May2021 11:30 the patient experienced Immediate metallic taste in mouth and throat swelling. Never lost ability to breath but tightness persisted for a week and still continuing. At 6 days calf tightness (on 17May2021 11:30). The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. As a treatment patient received, Anti-allergy medicine and steroid and OTC otherwise. The outcome for the events metallic taste in mouth, throat swelling, and calf tightness was recovering, and for the event never lost ability to breath but tightness persisted for a week was not recovered.  Follow-up attempts completed. No further information expected.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Differential white blood cell count normal, Dysgeusia, Electrocardiogram abnormal, Full blood count normal, Metabolic function test
Clinical narrative: Calf tightness; Metallic taste in mouth; Throat swelling; Never lost ability to breath but tightness persisted for a week; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 33-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was reported as EW0182, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 11May2021 11:15 (at the age of 33 years old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history includes C sections from an unknown date and unknown if ongoing. No known allergies were reported. There were no concomitant medications. The patient had not received any other vaccine within 4 weeks. The patient had not received any other medications within 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 11May2021 11:30 the patient experienced Immediate metallic taste in mouth and throat swelling. Never lost ability to breath but tightness persisted for a week and still continuing. At 6 days calf tightness (on 17May2021 11:30). The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. As a treatment patient received, Anti-allergy medicine and steroid and OTC otherwise. The outcome for the events metallic taste in mouth, throat swelling, and calf tightness was recovering, and for the event never lost ability to breath but tightness persisted for a week was not recovered.  Follow-up attempts completed. No further information expected.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle tightness, Streptococcus test negative, Throat tightness, Troponin I, Urine analysis
Clinical narrative: Calf tightness; Metallic taste in mouth; Throat swelling; Never lost ability to breath but tightness persisted for a week; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 33-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was reported as EW0182, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 11May2021 11:15 (at the age of 33 years old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history includes C sections from an unknown date and unknown if ongoing. No known allergies were reported. There were no concomitant medications. The patient had not received any other vaccine within 4 weeks. The patient had not received any other medications within 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 11May2021 11:30 the patient experienced Immediate metallic taste in mouth and throat swelling. Never lost ability to breath but tightness persisted for a week and still continuing. At 6 days calf tightness (on 17May2021 11:30). The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. As a treatment patient received, Anti-allergy medicine and steroid and OTC otherwise. The outcome for the events metallic taste in mouth, throat swelling, and calf tightness was recovering, and for the event never lost ability to breath but tightness persisted for a week was not recovered.  Follow-up attempts completed. No further information expected.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dysgeusia, Limb discomfort, Pharyngeal swelling
Clinical narrative: Calf tightness; Metallic taste in mouth; Throat swelling; Never lost ability to breath but tightness persisted for a week; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 33-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was reported as EW0182, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 11May2021 11:15 (at the age of 33 years old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history includes C sections from an unknown date and unknown if ongoing. No known allergies were reported. There were no concomitant medications. The patient had not received any other vaccine within 4 weeks. The patient had not received any other medications within 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 11May2021 11:30 the patient experienced Immediate metallic taste in mouth and throat swelling. Never lost ability to breath but tightness persisted for a week and still continuing. At 6 days calf tightness (on 17May2021 11:30). The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. As a treatment patient received, Anti-allergy medicine and steroid and OTC otherwise. The outcome for the events metallic taste in mouth, throat swelling, and calf tightness was recovering, and for the event never lost ability to breath but tightness persisted for a week was not recovered.  Follow-up attempts completed. No further information expected.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Pruritus, Rash
Clinical narrative: might be having some allergic reaction or something; a rash underneath my armpit and also underneath my shoulder blade; it is very painful; it is just red and got little mumps on; got little mumps on; seems to get worse, the pain seems to be increasing; I am not moving around, it's gonna bother me too much; This is a spontaneous report from a contactable consumer (patient) reported that:  A 54-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported), via an intramuscular route of administration, administered in Arm Left on 08May2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0161), via an intramuscular route of administration, administered in Arm Left on 17April2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included blood cholesterol, and gastroesophageal reflux disease from an unspecified date and unknown if ongoing. Concomitant medications included omeprazole taken for gastroesophageal reflux disease, start and stop date were not reported. On May2021, patient experienced that he might be having some allergic reaction or something, also had a rash underneath my armpit and also underneath my shoulder blade, it was very painful. Patient was not able to move, and it was bothering too much. As he started to move around, there is a movement in his skin and the rash on the shoulder blade was very painful. The rash was like a high small and on the back of my shoulder there is about an inch and a half diameter circle and it is just red and got little mumps on and his armpit is like a V shape with six markings and it's really painful. The outcome of the events were unknown.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Drug hypersensitivity, Erythema, Mobility decreased, Mumps
Clinical narrative: might be having some allergic reaction or something; a rash underneath my armpit and also underneath my shoulder blade; it is very painful; it is just red and got little mumps on; got little mumps on; seems to get worse, the pain seems to be increasing; I am not moving around, it's gonna bother me too much; This is a spontaneous report from a contactable consumer (patient) reported that:  A 54-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported), via an intramuscular route of administration, administered in Arm Left on 08May2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0161), via an intramuscular route of administration, administered in Arm Left on 17April2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included blood cholesterol, and gastroesophageal reflux disease from an unspecified date and unknown if ongoing. Concomitant medications included omeprazole taken for gastroesophageal reflux disease, start and stop date were not reported. On May2021, patient experienced that he might be having some allergic reaction or something, also had a rash underneath my armpit and also underneath my shoulder blade, it was very painful. Patient was not able to move, and it was bothering too much. As he started to move around, there is a movement in his skin and the rash on the shoulder blade was very painful. The rash was like a high small and on the back of my shoulder there is about an inch and a half diameter circle and it is just red and got little mumps on and his armpit is like a V shape with six markings and it's really painful. The outcome of the events were unknown.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Rash
Clinical narrative: might be having some allergic reaction or something; a rash underneath my armpit and also underneath my shoulder blade; it is very painful; it is just red and got little mumps on; got little mumps on; seems to get worse, the pain seems to be increasing; I am not moving around, it's gonna bother me too much; This is a spontaneous report from a contactable consumer (patient) reported that:  A 54-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported), via an intramuscular route of administration, administered in Arm Left on 08May2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0161), via an intramuscular route of administration, administered in Arm Left on 17April2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included blood cholesterol, and gastroesophageal reflux disease from an unspecified date and unknown if ongoing. Concomitant medications included omeprazole taken for gastroesophageal reflux disease, start and stop date were not reported. On May2021, patient experienced that he might be having some allergic reaction or something, also had a rash underneath my armpit and also underneath my shoulder blade, it was very painful. Patient was not able to move, and it was bothering too much. As he started to move around, there is a movement in his skin and the rash on the shoulder blade was very painful. The rash was like a high small and on the back of my shoulder there is about an inch and a half diameter circle and it is just red and got little mumps on and his armpit is like a V shape with six markings and it's really painful. The outcome of the events were unknown.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysstasia, Erythema, Inflammation, Pain in extremity, Swelling
Clinical narrative: One hour after getting the vaccine, I wasn't able to stand on my right leg. Horrible pain.; It also caused my inflammatory issues to react; I have been red and swelled for 2 weeks; I have been red and swelled for 2 weeks; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 58-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EW0173) via an unspecified route of administration, administered in arm left on 04May2021 08:30 (at the age of 58-year-old) at dose 1, single for covid-19 immunisation. Medical history included Hashimotos, Lupus, Mixed Connective Tissue Disease. Patient has allergies to OXYCODONE, GABAPENTIN, VICODIN, DEXAMETHASON. 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. Concomitant medications included Thyroid medicine, cefixime (FLEXERIL [CEFIXIME]); prednisone (PREDNISONE) patient received these medications within 2 weeks of vaccination all taken for an unspecified indication, start and stop date were not reported. Reported Event: One hour after getting the vaccine, I wasn't able to stand on my right leg. Horrible pain. I couldn't walk. I have mixed connective tissue disease. But it was dormant and I don't hardly have any symptoms. The vaccine brought it to the surface and the pain was awful for 3 days. I could barely move. It also caused my inflammatory issues to react. I have been red and swelled for 2 weeks. I am very scared about having the second vaccine. I wanted to go to urgent care with the first vaccine. If it gets worse from the second, I might have to. Outcome of the events was resolving.  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Inflammation, Pain in extremity, Swelling
Clinical narrative: One hour after getting the vaccine, I wasn't able to stand on my right leg. Horrible pain.; It also caused my inflammatory issues to react; I have been red and swelled for 2 weeks; I have been red and swelled for 2 weeks; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 58-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EW0173) via an unspecified route of administration, administered in arm left on 04May2021 08:30 (at the age of 58-year-old) at dose 1, single for covid-19 immunisation. Medical history included Hashimotos, Lupus, Mixed Connective Tissue Disease. Patient has allergies to OXYCODONE, GABAPENTIN, VICODIN, DEXAMETHASON. 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. Concomitant medications included Thyroid medicine, cefixime (FLEXERIL [CEFIXIME]); prednisone (PREDNISONE) patient received these medications within 2 weeks of vaccination all taken for an unspecified indication, start and stop date were not reported. Reported Event: One hour after getting the vaccine, I wasn't able to stand on my right leg. Horrible pain. I couldn't walk. I have mixed connective tissue disease. But it was dormant and I don't hardly have any symptoms. The vaccine brought it to the surface and the pain was awful for 3 days. I could barely move. It also caused my inflammatory issues to react. I have been red and swelled for 2 weeks. I am very scared about having the second vaccine. I wanted to go to urgent care with the first vaccine. If it gets worse from the second, I might have to. Outcome of the events was resolving.  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Rash pruritic
Clinical narrative: An itchy rash on stomach, back and upper legs; stomach, back and upper legs blistering; This is a spontaneous report from a contactable consumer or other non HCP reporting for herself (patient).   A 69-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6200, expiry date: unknown) via an unspecified route of administration, administered in Arm Left on 02Mar2021 at 12:45 PM (at the age of 69-years-old) as dose 2, single for covid-19 immunization. The patient medical history included penicillin allergy. Concomitant medication(s) included salbutamol (ALBUTEROL HFA), losartan, atorvastatin and latanoprost all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9269, expiry date: unknown) via an unspecified route of administration, administered in Arm Left on 08Feb2021 (at the age of 69-years-old) as dose 1, single for covid-19 immunization. The patient received no other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and patient had not been tested for COVID-19 since the vaccination. On 11Mar2021, the patient experienced an itchy rash on stomach, back and upper legs. sometimes blistering. Patient stated that about a week after got my second covid shot she broke in a rash. She had rash all over her stomach and her back and upper legs. It was very itchy and she went to 5 doctors including a dermatologist and nobody knew about it. Patient stated she had steroid, steroid cream and nothing was helping. Therapeutic measures were taken as a result of event and patient used Prednisone steroid cream. The outcome of event was not recovered.   No follow-up attempts are needed. No further information is expected.