chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Burning sensation, Condition aggravated, Dysgeusia, Fibromyalgia
Clinical narrative: I was scared I developed spinal meningitis from the shot; Severe fibromyalgia attack after 2nd dose; I had severe neck and shoulder blade pain; I had severe neck and shoulder blade pain; I couldn't turn my head or raise my arms over my head. My neck hurt so bad; This is a spontaneous report from a contactable consumer (patient herself). A 60-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: ER8730, Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 27Mar2021 10:30 (Age at vaccination 60-years-old) as dose 2, single for covid-19 immunisation (Pharmacy or Drug Store). Medical history included hypertension, fibromyalgia, degenerative cartilage disease, history of retina detachment, prediabetes from an unknown date and unknown if ongoing. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient had not received any other vaccine within 4 weeks prior to the COVID vaccine. The patient was not pregnant at time of vaccination. The patient known allergies included penicillin, ultram, lisinopril, dimethyl fumarate. Concomitant medications included clonidine (CLONIDINE), spironolactone (SPIRONOLACTONE) taken for an unspecified indication, start and stop date were not reported. The patient previously took ultram [paracetamol; tramadol hydrochloride], lisinopril, dimethyl fumarate and experienced drug hypersensitivity on an unspecified date. Historical drug included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: En6202, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 27Feb2021 10:30 as dose 1, single for covid-19 immunisation. On 28Mar2021 05:00, the patient had experienced severe fibromyalgia attack after 2nd dose. The next morning, I had severe neck and shoulder blade pain. I couldn't turn my head or raise my arms over my head. My neck hurt so bad I was scared I developed spinal meningitis from the shot. It took 4 weeks for the pain and stiffness to subside. The patient received acupuncture and daily doses of meloxicam as treatment for the events. Therapeutic measures were taken for the events. The patient received clonidine spironolactone other medications the patient received within 2 weeks of vaccination. Prior to vaccination patient had not been diagnosed with COVID-19. Prior to vaccination and had not been tested since the vaccination. The outcome of events I was scared I developed spinal meningitis from the shot, severe fibromyalgia attack after 2nd dose was unknown and rest of the events was recovered on an unspecified date on 2021.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Immediate post-injection reaction, Musculoskeletal stiffness, Neck pain, Tinnitus
Clinical narrative: I was scared I developed spinal meningitis from the shot; Severe fibromyalgia attack after 2nd dose; I had severe neck and shoulder blade pain; I had severe neck and shoulder blade pain; I couldn't turn my head or raise my arms over my head. My neck hurt so bad; This is a spontaneous report from a contactable consumer (patient herself). A 60-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: ER8730, Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 27Mar2021 10:30 (Age at vaccination 60-years-old) as dose 2, single for covid-19 immunisation (Pharmacy or Drug Store). Medical history included hypertension, fibromyalgia, degenerative cartilage disease, history of retina detachment, prediabetes from an unknown date and unknown if ongoing. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient had not received any other vaccine within 4 weeks prior to the COVID vaccine. The patient was not pregnant at time of vaccination. The patient known allergies included penicillin, ultram, lisinopril, dimethyl fumarate. Concomitant medications included clonidine (CLONIDINE), spironolactone (SPIRONOLACTONE) taken for an unspecified indication, start and stop date were not reported. The patient previously took ultram [paracetamol; tramadol hydrochloride], lisinopril, dimethyl fumarate and experienced drug hypersensitivity on an unspecified date. Historical drug included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: En6202, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 27Feb2021 10:30 as dose 1, single for covid-19 immunisation. On 28Mar2021 05:00, the patient had experienced severe fibromyalgia attack after 2nd dose. The next morning, I had severe neck and shoulder blade pain. I couldn't turn my head or raise my arms over my head. My neck hurt so bad I was scared I developed spinal meningitis from the shot. It took 4 weeks for the pain and stiffness to subside. The patient received acupuncture and daily doses of meloxicam as treatment for the events. Therapeutic measures were taken for the events. The patient received clonidine spironolactone other medications the patient received within 2 weeks of vaccination. Prior to vaccination patient had not been diagnosed with COVID-19. Prior to vaccination and had not been tested since the vaccination. The outcome of events I was scared I developed spinal meningitis from the shot, severe fibromyalgia attack after 2nd dose was unknown and rest of the events was recovered on an unspecified date on 2021.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: I was scared I developed spinal meningitis from the shot; Severe fibromyalgia attack after 2nd dose; I had severe neck and shoulder blade pain; I had severe neck and shoulder blade pain; I couldn't turn my head or raise my arms over my head. My neck hurt so bad; This is a spontaneous report from a contactable consumer (patient herself). A 60-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: ER8730, Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 27Mar2021 10:30 (Age at vaccination 60-years-old) as dose 2, single for covid-19 immunisation (Pharmacy or Drug Store). Medical history included hypertension, fibromyalgia, degenerative cartilage disease, history of retina detachment, prediabetes from an unknown date and unknown if ongoing. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient had not received any other vaccine within 4 weeks prior to the COVID vaccine. The patient was not pregnant at time of vaccination. The patient known allergies included penicillin, ultram, lisinopril, dimethyl fumarate. Concomitant medications included clonidine (CLONIDINE), spironolactone (SPIRONOLACTONE) taken for an unspecified indication, start and stop date were not reported. The patient previously took ultram [paracetamol; tramadol hydrochloride], lisinopril, dimethyl fumarate and experienced drug hypersensitivity on an unspecified date. Historical drug included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: En6202, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 27Feb2021 10:30 as dose 1, single for covid-19 immunisation. On 28Mar2021 05:00, the patient had experienced severe fibromyalgia attack after 2nd dose. The next morning, I had severe neck and shoulder blade pain. I couldn't turn my head or raise my arms over my head. My neck hurt so bad I was scared I developed spinal meningitis from the shot. It took 4 weeks for the pain and stiffness to subside. The patient received acupuncture and daily doses of meloxicam as treatment for the events. Therapeutic measures were taken for the events. The patient received clonidine spironolactone other medications the patient received within 2 weeks of vaccination. Prior to vaccination patient had not been diagnosed with COVID-19. Prior to vaccination and had not been tested since the vaccination. The outcome of events I was scared I developed spinal meningitis from the shot, severe fibromyalgia attack after 2nd dose was unknown and rest of the events was recovered on an unspecified date on 2021.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fibromyalgia, Meningitis, Musculoskeletal pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: I was scared I developed spinal meningitis from the shot; Severe fibromyalgia attack after 2nd dose; I had severe neck and shoulder blade pain; I had severe neck and shoulder blade pain; I couldn't turn my head or raise my arms over my head. My neck hurt so bad; This is a spontaneous report from a contactable consumer (patient herself). A 60-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: ER8730, Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 27Mar2021 10:30 (Age at vaccination 60-years-old) as dose 2, single for covid-19 immunisation (Pharmacy or Drug Store). Medical history included hypertension, fibromyalgia, degenerative cartilage disease, history of retina detachment, prediabetes from an unknown date and unknown if ongoing. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient had not received any other vaccine within 4 weeks prior to the COVID vaccine. The patient was not pregnant at time of vaccination. The patient known allergies included penicillin, ultram, lisinopril, dimethyl fumarate. Concomitant medications included clonidine (CLONIDINE), spironolactone (SPIRONOLACTONE) taken for an unspecified indication, start and stop date were not reported. The patient previously took ultram [paracetamol; tramadol hydrochloride], lisinopril, dimethyl fumarate and experienced drug hypersensitivity on an unspecified date. Historical drug included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: En6202, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 27Feb2021 10:30 as dose 1, single for covid-19 immunisation. On 28Mar2021 05:00, the patient had experienced severe fibromyalgia attack after 2nd dose. The next morning, I had severe neck and shoulder blade pain. I couldn't turn my head or raise my arms over my head. My neck hurt so bad I was scared I developed spinal meningitis from the shot. It took 4 weeks for the pain and stiffness to subside. The patient received acupuncture and daily doses of meloxicam as treatment for the events. Therapeutic measures were taken for the events. The patient received clonidine spironolactone other medications the patient received within 2 weeks of vaccination. Prior to vaccination patient had not been diagnosed with COVID-19. Prior to vaccination and had not been tested since the vaccination. The outcome of events I was scared I developed spinal meningitis from the shot, severe fibromyalgia attack after 2nd dose was unknown and rest of the events was recovered on an unspecified date on 2021.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Rash
Clinical narrative: Glands under jaw swelled; Left side facial numbness; Diarrhea; A (sunburn like) rash on the chest, back, stomach; Nausea; This is a spontaneous report from a contactable healthcare professional, the patient. A 55-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the left arm on 15Aug2021 at 10:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as not applicable (N/A). The patient had no known allergies. 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. The patient did not receive any concomitant medications. On 15Aug2021 at 10:45, within the hour after getting the first COVID-19 shot, the patient experienced left side facial numbness and diarrhea, that lasted approximately 24 plus hours. Then on the same day, the patient developed a (sunburn like) rash on the chest, back and stomach that lasted 48 plus hours. On 18Aug2021, on the third day, the patient's glands under her jaw swelled which lasted for another 24 hours. On an unspecified date in 2021, the patient also had nausea that lasted for approximately 1 week. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. 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 outcome of the events left side facial numbness, diarrhea, a (sunburn like) rash on the chest, back, stomach and glands under jaw swelled was recovered on an unknown date in Aug2021. The clinical outcome of the event nausea was recovered on an unknown date in 2021.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Hypoaesthesia, Lymphadenopathy, Nausea, Rash erythematous
Clinical narrative: Glands under jaw swelled; Left side facial numbness; Diarrhea; A (sunburn like) rash on the chest, back, stomach; Nausea; This is a spontaneous report from a contactable healthcare professional, the patient. A 55-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the left arm on 15Aug2021 at 10:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as not applicable (N/A). The patient had no known allergies. 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. The patient did not receive any concomitant medications. On 15Aug2021 at 10:45, within the hour after getting the first COVID-19 shot, the patient experienced left side facial numbness and diarrhea, that lasted approximately 24 plus hours. Then on the same day, the patient developed a (sunburn like) rash on the chest, back and stomach that lasted 48 plus hours. On 18Aug2021, on the third day, the patient's glands under her jaw swelled which lasted for another 24 hours. On an unspecified date in 2021, the patient also had nausea that lasted for approximately 1 week. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. 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 outcome of the events left side facial numbness, diarrhea, a (sunburn like) rash on the chest, back, stomach and glands under jaw swelled was recovered on an unknown date in Aug2021. The clinical outcome of the event nausea was recovered on an unknown date in 2021.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test abnormal, Chest X-ray normal, Chest discomfort, Chest pain, Chills
Clinical narrative: felt like someone lit her lungs on fire; felt like someone was sitting on her chest; couldnt breathe; she had to prop herself up on pillows just to catch her breath; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received bnt162b2, dose 2 via an unspecified route of administration, administered in left arm on 16Aug2021 (Batch/Lot number was not reported, unable to locate or read the details) as dose 2, single at the age of 27-year-old for COVID-19 immunisation. The patient was not pregnant. No medical history.    No concomitant medications. No other vaccine in four weeks. No other medications in two weeks. No known allergies. No covid prior vaccination. No covid tested post vaccination. Historic vaccine was bnt162b2 received via an unspecified route of administration on an unknown date (Batch/Lot number was not reported, unable to locate or read the details) as dose 1, single for COVID-19 immunisation. The patient woke up in the middle of the night and felt like someone lit her lungs on fire and was sitting on her chest. She couldnt breathe at all, she had to prop herself up on pillows just to catch her breath. No treatment received. The outcome of events was not recovered.  The lot number for bnt162b2, was not provided and will be requested during follow up.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Dyspnoea, Electrocardiogram normal, Fear, Heart rate increased
Clinical narrative: felt like someone lit her lungs on fire; felt like someone was sitting on her chest; couldnt breathe; she had to prop herself up on pillows just to catch her breath; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received bnt162b2, dose 2 via an unspecified route of administration, administered in left arm on 16Aug2021 (Batch/Lot number was not reported, unable to locate or read the details) as dose 2, single at the age of 27-year-old for COVID-19 immunisation. The patient was not pregnant. No medical history.    No concomitant medications. No other vaccine in four weeks. No other medications in two weeks. No known allergies. No covid prior vaccination. No covid tested post vaccination. Historic vaccine was bnt162b2 received via an unspecified route of administration on an unknown date (Batch/Lot number was not reported, unable to locate or read the details) as dose 1, single for COVID-19 immunisation. The patient woke up in the middle of the night and felt like someone lit her lungs on fire and was sitting on her chest. She couldnt breathe at all, she had to prop herself up on pillows just to catch her breath. No treatment received. The outcome of events was not recovered.  The lot number for bnt162b2, was not provided and will be requested during follow up.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Non-cardiac chest pain, Palpitations, Pulmonary pain, Pyrexia
Clinical narrative: felt like someone lit her lungs on fire; felt like someone was sitting on her chest; couldnt breathe; she had to prop herself up on pillows just to catch her breath; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received bnt162b2, dose 2 via an unspecified route of administration, administered in left arm on 16Aug2021 (Batch/Lot number was not reported, unable to locate or read the details) as dose 2, single at the age of 27-year-old for COVID-19 immunisation. The patient was not pregnant. No medical history.    No concomitant medications. No other vaccine in four weeks. No other medications in two weeks. No known allergies. No covid prior vaccination. No covid tested post vaccination. Historic vaccine was bnt162b2 received via an unspecified route of administration on an unknown date (Batch/Lot number was not reported, unable to locate or read the details) as dose 1, single for COVID-19 immunisation. The patient woke up in the middle of the night and felt like someone lit her lungs on fire and was sitting on her chest. She couldnt breathe at all, she had to prop herself up on pillows just to catch her breath. No treatment received. The outcome of events was not recovered.  The lot number for bnt162b2, was not provided and will be requested during follow up.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sleep deficit, Vaccination complication
Clinical narrative: felt like someone lit her lungs on fire; felt like someone was sitting on her chest; couldnt breathe; she had to prop herself up on pillows just to catch her breath; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received bnt162b2, dose 2 via an unspecified route of administration, administered in left arm on 16Aug2021 (Batch/Lot number was not reported, unable to locate or read the details) as dose 2, single at the age of 27-year-old for COVID-19 immunisation. The patient was not pregnant. No medical history.    No concomitant medications. No other vaccine in four weeks. No other medications in two weeks. No known allergies. No covid prior vaccination. No covid tested post vaccination. Historic vaccine was bnt162b2 received via an unspecified route of administration on an unknown date (Batch/Lot number was not reported, unable to locate or read the details) as dose 1, single for COVID-19 immunisation. The patient woke up in the middle of the night and felt like someone lit her lungs on fire and was sitting on her chest. She couldnt breathe at all, she had to prop herself up on pillows just to catch her breath. No treatment received. The outcome of events was not recovered.  The lot number for bnt162b2, was not provided and will be requested during follow up.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Irregular breathing, Lung disorder
Clinical narrative: felt like someone lit her lungs on fire; felt like someone was sitting on her chest; couldnt breathe; she had to prop herself up on pillows just to catch her breath; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received bnt162b2, dose 2 via an unspecified route of administration, administered in left arm on 16Aug2021 (Batch/Lot number was not reported, unable to locate or read the details) as dose 2, single at the age of 27-year-old for COVID-19 immunisation. The patient was not pregnant. No medical history.    No concomitant medications. No other vaccine in four weeks. No other medications in two weeks. No known allergies. No covid prior vaccination. No covid tested post vaccination. Historic vaccine was bnt162b2 received via an unspecified route of administration on an unknown date (Batch/Lot number was not reported, unable to locate or read the details) as dose 1, single for COVID-19 immunisation. The patient woke up in the middle of the night and felt like someone lit her lungs on fire and was sitting on her chest. She couldnt breathe at all, she had to prop herself up on pillows just to catch her breath. No treatment received. The outcome of events was not recovered.  The lot number for bnt162b2, was not provided and will be requested during follow up.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Adverse pain in left arm; swollen glands under both arms; Upper left shoulder has a burning sensation; shortness of breath; anxiety; could not sleep at night because of the pain from the swollen left arm pit gland; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, Lot Number: ew0179), at the age of 62 years old, in left arm on 23Jul2021 at 17:15 at single dose for COVID-19 immunisation. Medical history was none. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks or other medications within 2 weeks prior to the COVID vaccine. On 25Jul2021 at 06:00, the patient experienced adverse pain in left arm, swollen glands under both arms, 3 days later gland under right arm back to normal. Left arm armpit gland was still swollen to the size of a tennis ball 6 days since injection. Upper left shoulder had a burning sensation and he was having a shortness of breath anxiety. He could not sleep at night because of the pain from the swollen left arm pit gland. The events resulted in none of the above. Since the vaccination, the patient had not been tested for COVID-19. No treatment received. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Burning sensation, Dyspnoea, Insomnia, Lymphadenopathy
Clinical narrative: Adverse pain in left arm; swollen glands under both arms; Upper left shoulder has a burning sensation; shortness of breath; anxiety; could not sleep at night because of the pain from the swollen left arm pit gland; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, Lot Number: ew0179), at the age of 62 years old, in left arm on 23Jul2021 at 17:15 at single dose for COVID-19 immunisation. Medical history was none. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks or other medications within 2 weeks prior to the COVID vaccine. On 25Jul2021 at 06:00, the patient experienced adverse pain in left arm, swollen glands under both arms, 3 days later gland under right arm back to normal. Left arm armpit gland was still swollen to the size of a tennis ball 6 days since injection. Upper left shoulder had a burning sensation and he was having a shortness of breath anxiety. He could not sleep at night because of the pain from the swollen left arm pit gland. The events resulted in none of the above. Since the vaccination, the patient had not been tested for COVID-19. No treatment received. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Adverse pain in left arm; swollen glands under both arms; Upper left shoulder has a burning sensation; shortness of breath; anxiety; could not sleep at night because of the pain from the swollen left arm pit gland; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, Lot Number: ew0179), at the age of 62 years old, in left arm on 23Jul2021 at 17:15 at single dose for COVID-19 immunisation. Medical history was none. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks or other medications within 2 weeks prior to the COVID vaccine. On 25Jul2021 at 06:00, the patient experienced adverse pain in left arm, swollen glands under both arms, 3 days later gland under right arm back to normal. Left arm armpit gland was still swollen to the size of a tennis ball 6 days since injection. Upper left shoulder had a burning sensation and he was having a shortness of breath anxiety. He could not sleep at night because of the pain from the swollen left arm pit gland. The events resulted in none of the above. Since the vaccination, the patient had not been tested for COVID-19. No treatment received. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Benign hydatidiform mole, Blood test, Exposure during pregnancy, Human chorionic gonadotropin, Ultrasound scan
Clinical narrative: I conceived 5 days after 1st shot and had a full molar pregnancy.; I conceived 5 days after 1st shot and had a full molar pregnancy.; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (at the age of 33-years-old) via an unspecified route of administration on 04May2021 16:00 (Batch/Lot Number: Ew0179) as dose 1, single for covid-19 immunisation. The patient has no medical history and concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications received within 2 weeks of vaccination. The patient conceived 5 days after 1st shot (09May2021) and had a full molar pregnancy which caused hospitalization. Event resulted in doctor or other healthcare professional office/clinic visit and patient had D and C surgery. Since the vaccination, the patient has been tested for COVID-19 via nasal swab 01Jun2021 which was negative. The outcome of the events was recovering.; Sender's Comments: Based on plausible dose- event relationship post-vaccination the causal role of BNT162B2 vaccine cannot be excluded for the reported events  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Uterine dilation and curettage
Clinical narrative: I conceived 5 days after 1st shot and had a full molar pregnancy.; I conceived 5 days after 1st shot and had a full molar pregnancy.; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (at the age of 33-years-old) via an unspecified route of administration on 04May2021 16:00 (Batch/Lot Number: Ew0179) as dose 1, single for covid-19 immunisation. The patient has no medical history and concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications received within 2 weeks of vaccination. The patient conceived 5 days after 1st shot (09May2021) and had a full molar pregnancy which caused hospitalization. Event resulted in doctor or other healthcare professional office/clinic visit and patient had D and C surgery. Since the vaccination, the patient has been tested for COVID-19 via nasal swab 01Jun2021 which was negative. The outcome of the events was recovering.; Sender's Comments: Based on plausible dose- event relationship post-vaccination the causal role of BNT162B2 vaccine cannot be excluded for the reported events  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Benign hydatidiform mole, Maternal exposure before pregnancy, SARS-CoV-2 antibody test
Clinical narrative: I conceived 5 days after 1st shot and had a full molar pregnancy.; I conceived 5 days after 1st shot and had a full molar pregnancy.; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (at the age of 33-years-old) via an unspecified route of administration on 04May2021 16:00 (Batch/Lot Number: Ew0179) as dose 1, single for covid-19 immunisation. The patient has no medical history and concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications received within 2 weeks of vaccination. The patient conceived 5 days after 1st shot (09May2021) and had a full molar pregnancy which caused hospitalization. Event resulted in doctor or other healthcare professional office/clinic visit and patient had D and C surgery. Since the vaccination, the patient has been tested for COVID-19 via nasal swab 01Jun2021 which was negative. The outcome of the events was recovering.; Sender's Comments: Based on plausible dose- event relationship post-vaccination the causal role of BNT162B2 vaccine cannot be excluded for the reported events  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Differential white blood cell count, Dyspnoea, Electrocardiogram, Feeling abnormal
Clinical narrative: Shortness of breath; abdominal pain; fatigue; slight headache; This is a spontaneous report from a contactable consumer reported for herself. A 54-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: FC3180; Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 18Aug2021 16:00 (at the age of 54-years-old) as DOSE 1, SINGLE for covid-19 immunisation at Pharmacy or Drug Store. Patient was not pregnant at the time of vaccination. Medical history and concomitant medications included none. The patient previously took SULFONAMIDE and experienced known allergies (reported as known allergies: Sulfer). No 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 had not been tested for COVID-19. The patient experienced shortness of breath, abdominal pain, fatigue, slight headache on 19Aug2021 15:00. Therapeutic measures were taken as a result of the reported events. The events were reported as not serious and seriousness criteria included none. AE resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Patient received treatment with IV, oxygen, dicyclomine, ketorolac, ondansetron. Clinical outcome of events was recovering at the time of this report.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count, Lipase, Liver function test, Metabolic function test, Troponin I
Clinical narrative: Shortness of breath; abdominal pain; fatigue; slight headache; This is a spontaneous report from a contactable consumer reported for herself. A 54-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: FC3180; Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 18Aug2021 16:00 (at the age of 54-years-old) as DOSE 1, SINGLE for covid-19 immunisation at Pharmacy or Drug Store. Patient was not pregnant at the time of vaccination. Medical history and concomitant medications included none. The patient previously took SULFONAMIDE and experienced known allergies (reported as known allergies: Sulfer). No 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 had not been tested for COVID-19. The patient experienced shortness of breath, abdominal pain, fatigue, slight headache on 19Aug2021 15:00. Therapeutic measures were taken as a result of the reported events. The events were reported as not serious and seriousness criteria included none. AE resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Patient received treatment with IV, oxygen, dicyclomine, ketorolac, ondansetron. Clinical outcome of events was recovering at the time of this report.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Dyspnoea, Fatigue, Headache
Clinical narrative: Shortness of breath; abdominal pain; fatigue; slight headache; This is a spontaneous report from a contactable consumer reported for herself. A 54-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: FC3180; Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 18Aug2021 16:00 (at the age of 54-years-old) as DOSE 1, SINGLE for covid-19 immunisation at Pharmacy or Drug Store. Patient was not pregnant at the time of vaccination. Medical history and concomitant medications included none. The patient previously took SULFONAMIDE and experienced known allergies (reported as known allergies: Sulfer). No 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 had not been tested for COVID-19. The patient experienced shortness of breath, abdominal pain, fatigue, slight headache on 19Aug2021 15:00. Therapeutic measures were taken as a result of the reported events. The events were reported as not serious and seriousness criteria included none. AE resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Patient received treatment with IV, oxygen, dicyclomine, ketorolac, ondansetron. Clinical outcome of events was recovering at the time of this report.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood urine, Chest discomfort, Chest pain, Dizziness, Dysuria
Clinical narrative: felt like I was going to pass out; chest still hurts and feels tight; chest still hurts and feels tight; pulse and it was 116; couldn't breathe; dizzy; couldn't stand up; had a very worrisome response; This is a spontaneous report from a contactable consumer (patient).   A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported, Expiration date: not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient experienced felt like I was going to pass out, chest still hurts and feels tight, pulse and it was 116, couldn't breathe, dizzy, couldn't stand up, had a very worrisome response. Patient also stated I just had my first vaccine dose and had a very worrisome response. I'm trying to determine what this means going forward with the second dose and whether I should receive the second dose or not. About 15 minutes after receiving my first dose I my chest started hurting and felt as if I couldn't breathe. It got worse to where I couldn't stand up. My husband checked my pulse and it was 116. A few minutes after while still sitting I got very dizzy and felt like I was going to pass out. My husband checked again and it read "low" and continued for a couple of minutes. It then went away and I felt okay. My chest still hurts and feels tight. I have some shortness of breath but not like before. My pulse has stayed between 99-100 for the past hour. Lab test included pulse rate: 116 and 99-100. The outcome of events was unknown.  Follow-up(25Aug2021): No new follow-up information received from a contactable consumer (patient).  Follow-up(25Aug2021): This follow-up processed as non-significant. Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations
Clinical narrative: felt like I was going to pass out; chest still hurts and feels tight; chest still hurts and feels tight; pulse and it was 116; couldn't breathe; dizzy; couldn't stand up; had a very worrisome response; This is a spontaneous report from a contactable consumer (patient).   A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported, Expiration date: not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient experienced felt like I was going to pass out, chest still hurts and feels tight, pulse and it was 116, couldn't breathe, dizzy, couldn't stand up, had a very worrisome response. Patient also stated I just had my first vaccine dose and had a very worrisome response. I'm trying to determine what this means going forward with the second dose and whether I should receive the second dose or not. About 15 minutes after receiving my first dose I my chest started hurting and felt as if I couldn't breathe. It got worse to where I couldn't stand up. My husband checked my pulse and it was 116. A few minutes after while still sitting I got very dizzy and felt like I was going to pass out. My husband checked again and it read "low" and continued for a couple of minutes. It then went away and I felt okay. My chest still hurts and feels tight. I have some shortness of breath but not like before. My pulse has stayed between 99-100 for the past hour. Lab test included pulse rate: 116 and 99-100. The outcome of events was unknown.  Follow-up(25Aug2021): No new follow-up information received from a contactable consumer (patient).  Follow-up(25Aug2021): This follow-up processed as non-significant. Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Chest discomfort, Chest pain, Dizziness, Dyspnoea
Clinical narrative: felt like I was going to pass out; chest still hurts and feels tight; chest still hurts and feels tight; pulse and it was 116; couldn't breathe; dizzy; couldn't stand up; had a very worrisome response; This is a spontaneous report from a contactable consumer (patient).   A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported, Expiration date: not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient experienced felt like I was going to pass out, chest still hurts and feels tight, pulse and it was 116, couldn't breathe, dizzy, couldn't stand up, had a very worrisome response. Patient also stated I just had my first vaccine dose and had a very worrisome response. I'm trying to determine what this means going forward with the second dose and whether I should receive the second dose or not. About 15 minutes after receiving my first dose I my chest started hurting and felt as if I couldn't breathe. It got worse to where I couldn't stand up. My husband checked my pulse and it was 116. A few minutes after while still sitting I got very dizzy and felt like I was going to pass out. My husband checked again and it read "low" and continued for a couple of minutes. It then went away and I felt okay. My chest still hurts and feels tight. I have some shortness of breath but not like before. My pulse has stayed between 99-100 for the past hour. Lab test included pulse rate: 116 and 99-100. The outcome of events was unknown.  Follow-up(25Aug2021): No new follow-up information received from a contactable consumer (patient).  Follow-up(25Aug2021): This follow-up processed as non-significant. Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysstasia, Heart rate, Heart rate increased, Loss of consciousness
Clinical narrative: felt like I was going to pass out; chest still hurts and feels tight; chest still hurts and feels tight; pulse and it was 116; couldn't breathe; dizzy; couldn't stand up; had a very worrisome response; This is a spontaneous report from a contactable consumer (patient).   A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported, Expiration date: not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient experienced felt like I was going to pass out, chest still hurts and feels tight, pulse and it was 116, couldn't breathe, dizzy, couldn't stand up, had a very worrisome response. Patient also stated I just had my first vaccine dose and had a very worrisome response. I'm trying to determine what this means going forward with the second dose and whether I should receive the second dose or not. About 15 minutes after receiving my first dose I my chest started hurting and felt as if I couldn't breathe. It got worse to where I couldn't stand up. My husband checked my pulse and it was 116. A few minutes after while still sitting I got very dizzy and felt like I was going to pass out. My husband checked again and it read "low" and continued for a couple of minutes. It then went away and I felt okay. My chest still hurts and feels tight. I have some shortness of breath but not like before. My pulse has stayed between 99-100 for the past hour. Lab test included pulse rate: 116 and 99-100. The outcome of events was unknown.  Follow-up(25Aug2021): No new follow-up information received from a contactable consumer (patient).  Follow-up(25Aug2021): This follow-up processed as non-significant. Information about lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis
Clinical narrative: Facial paralysis; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient). A 32-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Right on 08Aug2021 13:30 (at the age of 32-yearsold) as dose 1, single for COVID-19 immunization. Medical history included hepatitis c from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Patient had no Known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnose with COVID-19. Since the vaccination, did not patient been tested for COVID-19. In Health Clinic facility patient received vaccine. The patient experienced facial paralysis on 24Aug2021 at 20:00. The events assessed as serious (medically significant). Patient visited Emergency room/department or urgent care. No treatment was received for the event. The outcome of the events was reported as not recovered.  The lot number for the vaccine (BNT162B2) was not provided and will be requested during follow-up.